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Key Interventions and Patient Perspectives From #ASCOQLTY21
23:01Dr. Gabrielle Rocque, chair of the 2021 ASCO Quality Care Symposium, breast oncologist and health services researcher at the University of Alabama at Birmingham, and symposium chair-elect, Dr. Stephanie Wheeler, professor in the Department of Health Policy and Management at the University of North Carolina at Chapel Hill, discuss key interventions in quality care and compelling patient perspectives presented at #ASCOQLTY21. Transcript ASCO Daily News: Welcome to the ASCO Daily News podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. On today's episode, we'll discuss promising interventions to improve the quality of care for patients and survivors and other key takeaways from the 2021 ASCO Quality Care Symposium. I'm delighted to welcome the chair and chair-elect of the [ASCO Quality Care] Symposium, Dr. Gabrielle Rocque and Dr. Stephanie Wheeler, for this discussion. Dr. Rocque is a breast oncologist and health services researcher. She is also associate professor of medicine in the Division of Hematology and Oncology and Gerontology, Geriatrics, and Palliative Care at the University of Alabama at Birmingham. Dr. Wheeler is a professor in the Department of Health Policy and Management at the University of North Carolina at Chapel Hill. She also serves as associate director of community outreach and engagement at the UNC Lineberger Comprehensive Cancer Center. My guests' full disclosures are available in our show notes, and disclosures relating to all episodes of the podcast are available on our transcripts at asco.org/podcasts. Dr. Rocque and Dr. Wheeler, thanks for being on the podcast today. Dr. Gabrielle Rocque: Thank you for having us. ASCO Daily News: Dr. Wheeler, it was wonderful to have a hybrid event this year, with people participating in person in Boston and virtually. This is surely a sign of things to come. Can you tell us about some of the most important interventions in quality improvement that were presented at the [ASCO Quality Care] Symposium? Dr. Stephanie Wheeler: Absolutely, and thank you so much for hosting us. It was a really terrific [ASCO Quality Care] Symposium. And the fact that we had hybrid engagement from investigators all over the country and internationally was really exciting. There's a couple of intervention classes, if you want to call it that, that I think were particularly inspiring and interesting to me. The first were sets of interventions that focused on strategies to improve goals of care conversations and advanced care planning directives for patients with cancer or people with terminal illness in particular. And I just wanted to highlight a couple of those that I thought were particularly innovative. One was Abstract 8, which focused on using computer modeling and care coaches to increase advanced care planning conversations for people with advanced cancer. And this was presented by Dr. Divya Gupta. And it was just a wonderful example of how we can utilize technology and also care coaches. And in many cases, these don't necessarily have to be clinicians. They sometimes can be community health workers and others who can help direct those conversations and make it more comfortable for people living with advanced disease, and also their families, to consider next steps. In a similar vein, there were two other presentations--Abstract 1 delivered by Dr. Manali Patel and Abstract 2 delivered by Dr. Divya Parikh--that also utilized a similar model in a different care setting. And in those cases, the care settings ranged from VA to integrated health care settings. And we even had a conversation about how to do this work in community rural oncology practices. And I think that this kind of intervention has the potential for translation across a variety of settings. And the next steps are going to be figuring out exactly how to implement it in these settings. So, that's one class that I thought was particularly interesting. And I just want to highlight another group of interventions and studies that I found really innovative. And those were the presentations about hospital at-home models and how we can better deliver oncology care in the comfort of individuals' homes. And I thought Dr. Cardinale Smith did a great job from Mount Sinai describing the landscape of those interventions and the future for this kind of care delivery (“Overview of Programs and Ethics”). ASCO Daily News: Excellent. Great to hear about those promising new approaches. Dr. Rocque, the [ASCO Quality Care] Symposium captured many trends in quality care, including patient-reported outcomes measurement as an important way to monitor quality of care and patients' experiences. Can you highlight the studies that will help inform our listeners about how to integrate patient-reported outcomes into real-world settings? Dr. Gabrielle Rocque: Yeah. This was a major topic of the conference this year to think about how patient-reported outcomes are informative both in traditional research settings and in real-world settings. So, I was really intrigued by the Abstract 154 by Joy Jarnagin. And that abstract talked about how the changes in patient-reported outcomes actually had a very strong association with patients' treatment response, and in fact, was even more informative than those patients' tumor markers and I think show a novel way that patient-reported outcomes can be used. We also saw some more traditional abstracts on patient-reported outcomes. I'd like to highlight Abstract 152 by Valerie Lawhon, which really used patient-reported outcomes to identify patients' experience and their mental health outcomes during the COVID-19 pandemic, and I think provided us some really important insight into the experiences of our patients. And then as you mentioned, there is a lot of focus on real-world settings and how to transition from typical research patient-reported outcomes to a more broad scale implementation. And the session implementing PROs in oncology practice was really outstanding in terms of considering how this can be done. So, Dr. Terry Mulvey from Massachusetts General Hospital presented their experience on how to get these patient-reported outcomes into routine care, and what are some of the challenges associated with that, and how did they have to adapt to make sure that this was doable in real-world settings (“Challenges to Getting Started in a Practice Setting”). I was also impressed with the study by Dr. Raymond Osarogiagbon on the potential populations where there can be barriers of care and their study looking at an intervention in which they're implementing patient-reported outcomes over a wide variety of different practice types across the country (“Potential Populations Where This Can Be a Barrier to Care”). And I think these early insights also pointed us to future questions. Dr. Wynne Norton did a wonderful job of outlining some of the future questions that are likely to come up as we move into an era where patient-reported outcomes are a part of standard of care, and really think about how do we refine these for maximal benefit (“Overview of Current Strategies”). So, I think all of these sessions were highlighting the promise of patient-reported outcomes, as well as the future questions in this space. ASCO Daily News: Excellent. As a specialist in gerontology, geriatrics, and palliative care, please tell us about new approaches that oncologists should be aware of as they strive to provide high quality care for older patients and those receiving palliative care. Dr. Gabrielle Rocque: Absolutely. So, we've talked a bit about the patient-reported outcomes. And I think we'd be remiss in not highlighting the presentation on geriatric assessment--the presentations on the geriatric assessments into clinical practice by Dr. [Rawad] Elias (“Incorporating Geriatric Assessments Into Practice”). And I think this highlights another opportunity for us to move the field forward and take better care of our older adults. In terms of palliative care, there were multiple very informative abstracts. Dr. Wheeler has highlighted a few in the space of care guides or lay health coaches providing support in advanced care planning. In addition, we saw an interesting discussion of caregiver interventions for patients that are receiving--with cancer treatment by Dr. Nick Dionne-Odom (“Caregiver Interventions”). And I think it's important that we remember both the patients and the caregivers who are affected by cancer and by the amount of work that has to be done to support a patient with cancer going through their journey. ASCO Daily News: Absolutely, so important to remember caregivers and their needs and resources that could be available to them as well. Dr. Wheeler, financial toxicity is an enormous concern for many patients and their families, and the oncology care community has been trying for some time to figure out how best to address the concerns of patients and the health care system. Are there any new interventions that we should be aware of? Dr. Stephanie Wheeler: Yes, and I think that the [ASCO Quality Care] Symposium was an opportunity to hear about several of those. And some of them didn't make it onto the main stage but were featured in abstract sessions and poster sessions. So, as we're all well aware, financial toxicity is a multidimensional set of constructs that includes patients and their family’s material out-of-pocket burden, as well as the psychological distress and potentially harmful care altering behaviors that financial hardship induces. And so, we continue to hear at the [ASCO Quality Care] Symposium multiple talks about the strain that patients are undergoing, including the non-medical hardship that's introduced by a cancer diagnosis. And that was really interesting, and I think important to document. But I think that where the field is moving is more towards interventions, both behavioral interventions and systems interventions, multilevel approaches to dealing with the hardship itself as well as the importance of policy. So, there were several abstracts that talked about the introduction of biosimilars and generics and how that affected price of many of the oncologic drugs available on the market. And frankly, the message is a bit discouraging. Prices continue to rise. And in some cases, the price increases are not limited to pharmacologic products. In some cases, we saw abstracts presenting the increased cost of surgery, of outpatient care appointments, and things like that as well. So, we're not going to fix the problem by managing drug pricing alone. In terms of patient and family-directed interventions, I thought that there were some interesting abstracts. I want to highlight a number 53--or excuse me, Abstract 43 by Melissa Beauchemin that focused on the existence of hospital specialty pharmacies and partnering with freestanding care coordination organizations to improve access to oncology medications, as well as Abstract 96 presented by Ms. Rachel Marquez which was focused on resolving transportation disparities and access to cancer treatments. These kinds of interventions are obviously patient directed but have tremendous potential. And then I also want to just note a couple of additional studies that are ongoing that are important to recognize in this field. There are at least five National Cancer Institute (NCI)-funded R01 trials underway right now investigating the role of financial navigation and various iterations of it in different care settings. So, I think we will want to look to this meeting as an opportunity to hear about that work as it moves forward. And how that work is implemented is going to be vital, because the types of care settings where it's being done--ranging from AYA populations in Utah, to urban populations in Washington state, to integrated care organizations in Northern California, all the way to parts of rural North Carolina--we're going to see a diversity of outcomes and different ways in which those types of interventions can manifest in those different studies. I also want to note that the NCI has funded a series of supplements through its Cancer Center Core Grant Initiative that are all focused on identification, timely identification of financial toxicity in practice. And many of the investigators leading that work were attending the [ASCO Quality Care] Symposium, and so that will be important to keep an eye on as we move forward as well. ASCO Daily News: Excellent. Dr. Rocque, let's focus on health equity and access. I'd like to ask you about the session on eliminating barriers to clinical trial access. The presenters of this session shared strategies to directly address inclusion and diversity in cancer care. Can you tell us about approaches that caught your attention? Dr. Gabrielle Rocque: Absolutely. So, this was a really great session talking about clinical trial access and barriers, and particularly as it relates to health equity. And so, in Abstract 74, Dr. Joe Unger presented a really interesting conceptual model that highlighted that the barriers to clinical trial access are not necessarily always at the patient level, but they are at the system level, the provider level. And this framework for considering how do we target in the future our ability to engage patients in clinical trials was really important, and I think was complemented well by the patient perspective from Rick Bangs, who's worked closely with SWOG, in thinking about how do patients view clinical trials and how can we better engage them. And I think folding together these different experiences and models to develop future interventions. I also thought the Abstract 75 looking at survival in the real-world analysis was noteworthy. And in particular, the ability to consider patients who are typically excluded from clinical trials based on their laboratory criteria and potentially having something like chronic kidney disease, and how little data there is on those patients who actually, in this study, had different outcomes after chemotherapy for breast cancer. I think when you think about clinical trial access and inclusion, I also think you need to think about how we collect our data and how we consider race and other social determinants of health. So, there were a few other abstracts that, although not in this session, I think were incredibly important for us to consider. The first is Abstract 78 by Ms. Niveditta Ramkumar that talked about the association between rurality and race and surgical treatment and outcomes for non-metastatic colon cancer. And so, she talked a bit about the intersectionality between race and rurality, and I think brings up an important topic that we need to think about these constructs, not only as individual constructs but how they impact each other as we consider analysis in the future. And also Abstract 80 by Dr. Kekoa Taparra, which was a really interesting abstract that talked about the disaggregation of Pacific Islanders in major Asian subpopulations to reveal hidden cancer disparities. So, in this abstract, he discussed how we often lump together different populations, potentially because of small numbers, who really may have very different experiences and characteristics. And I think challenges us to move the field forward by identifying populations in groups that are, in fact, very similar to each other and not just pulling this together. And I think that will have an impact on how we view engaging patients in clinical trials, as well as reporting those clinical trial results that allows our providers to understand how the trial results fit for the patient that is sitting in their clinic for whom they're making their decisions. ASCO Daily News: Indeed. Dr. Wheeler, is there anything that you'd like to add on the issue of access to clinical trials? Dr. Stephanie Wheeler: So, there was an abstract that particularly sparked my attention, [Abstract] 79 presented by Dr. Jenny Xiang about the VA Connecticut Cancer Experience, where universal pre-screening and using computer algorithms to identify patients who might be eligible for clinical trials was used. And I think that this is an important approach that can help us rely less on the assumptions and the biases that exist in clinical care practice about whether a patient may or may not participate in a clinical trial, and instead use the vast amounts of information that we know about them in their electronic health record to try to preemptively identify them and approach them. We know that when patients are asked and invited to be part of trials, they are much more likely to say yes than people assume. And this could be a more unbiased way of assessing that eligibility, and then proactively identifying people, ideally, with a trial navigator. I think that would enable us to potentially overcome some of the barriers that exist and that are, frankly, institutionally biased in many cases. ASCO Daily News: Thank you, Dr. Wheeler. Dr. Rocque, the [ASCO Quality Care] Symposium featured an excellent keynote address by Dr. Ben Corn of Hebrew University of Jerusalem (“Integrating Hope – Real Hope! – Into Clinical Oncology”) and a wonderful lecture by Dr. John Cox, who was honored with the Joseph V. Simone award for advancing quality cancer care (“Reshaping Practice: Necessary Trouble”). Can you share some highlights from their talks? Dr. Gabrielle Rocque: Definitely. So, the keynote address by Dr. Ben Corn was perfectly timed for this meeting. I think everyone has had a difficult past 2 years with the pandemic. And his message of the importance of hope really struck a chord with me and many of the attendees, and how this is something that we can strategically work to improve, and that hope is something we can modify and train for. And so, I'm really excited to both hear this lecture and then also see what's to come in the future in this domain of hope-related research. Another session that I would like to highlight as well is Dr. Cox's talk after receiving the Joe Simone Achievement Award. And his lecture highlighted that change is coming. And he emphasized the importance of changing payment structures to be able to improve the quality of care that patients receive and to be able to leverage those changes for infrastructure that allows us to enable our health system to have a more patient-centered approach with many of the types of interventions that we've been talking about here today. So, I think both of those sessions are really must-watch sessions that I would like to highlight today. ASCO Daily News: Excellent. Well, the [ASCO Quality Care] Symposium also heard some compelling patient perspectives. Dr. Wheeler, can you share some of these messages with us? Dr. Stephanie Wheeler: One of the most powerful sessions in the entire meeting was the very first one, which was focused on the metavivor experience (“The Patient Voice: “Metavivors” and Long-Term Survivorship Care”). And I think because part of the intention of the planning committee was to proactively feature patients' voices at this meeting, this particular session was almost entirely comprised of patients and survivors. And living with advanced disease, as we know now, is very different than it was in the past. And we know that patients living with incurable disease may sometimes go on to live 15, 20, 25 years. And their needs are quite different than patients who have early-stage cancer. And so, this session was impactful because it represented a range of experiences. We heard from a caregiver. We heard from a young woman who's living with stage four melanoma, Dr. Tarlise Townsend (“An AYA Perspective”). And one of the things that I took away from this session in particular was that our approaches in the way that we talk to metavivors has to be fundamentally different, that they want providers to be truthful, they want providers to acknowledge the uncertainty and prognosis and the sometimes complex and rapidly changing regimens that may be available for them in terms of dealing with their disease. But they don't want to be condescended to, they don't want to feel like there's information that is being withheld. One of the things that Dr. Townsend shared that was very powerful was that she talked about how her providers, in many cases, outlined an optimistic future for her and would give her maybe unfair expectations about what the future might hold and think about it in terms of the outlier effect. But that's not the case for many people with her condition. And so, she talked about having to do her own death work--and that's her term--and how much time she spent really trying to understand for herself what the future looked like. And it just resonated so much with me. And everybody on this panel had similar stories to share about their experiences. And it reminded me that at the end of the day, we're all human. None of us deal with uncertainty well. None of us deal with death well, or the prospect of death. But the best that we can do in these situations is to be open and honest and straightforward and recognize the fear and the hope and all of that being intermingled, and really respect the person's autonomy and the person's experience and their ability to make plans for themselves going forward. ASCO Daily News: Thank you, Dr. Wheeler. We will have links to these important patient perspectives in the transcript of this episode, as well as the other abstracts discussed today. Dr. Rocque and Dr. Wheeler, thank you very much for sharing these important highlights from the 2021 ASCO Quality Care Symposium. Dr. Stephanie Wheeler: Thank you for having us. Dr. Gabrielle Rocque: Thank you so much. ASCO Daily News: And thank you to our listeners for your time today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclosures: Dr. Gabrielle Rocque: Consulting or Advisory Role: Pfizer, Flatiron Research Funding: Carevive Systems, Genentech, Pfizer Travel, Accommodations, Expenses: Carevive (an immediate family member) Dr. Stephanie Wheeler: Research Funding (institution): Pfizer Foundation Travel, Accommodations, Expenses: Pfizer Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Strategies to Improve Cancer Care for LGBTQI Patients and Survivors
33:26Dr. Scout and Dr. Charles Kamen discuss the findings of a key survey by the National LGBT Cancer Network of LGBTQI cancer survivors and strategies to improve cancer care for sexual and gender minority patients and survivors. Dr. Scout is the executive director of the National LGBT Cancer Network. Dr. Kamen is a clinical psychologist, assistant professor in the Department of Surgery at the University of Rochester Medical Center, and assistant director for community outreach and engagement at the Wilmot Cancer Institute. Transcript ASCO Daily News: Welcome to the ASCO Daily News podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. The National LGBT Cancer Network has released the findings of a key survey of LGBTQI cancer survivors about their cancer treatment experience. To discuss the survey's findings and strategies to improve care for sexual and gender minority patients, I'm joined by Dr. Scout, executive director of the National LGBT Cancer Network, and Dr. Charles Kamen, a clinical psychologist and assistant professor in the Department of Surgery at the University of Rochester Medical Center and assistant director for Community Outreach and Engagement at the Wilmot Cancer Institute. Dr. Kamen also leads the University of Rochester's health equity research for the NCI Community Oncology Research Program. My guests report no conflicts of interest relating to our discussion today. Their full disclosures and those relating to all episodes of the podcast are available on our transcripts at asco.org/podcasts. Dr. Scout and Dr. Kamen, welcome to the ASCO Daily News podcast. Dr. Scout: Thanks. We're really happy to be here. Dr. Charles Kamen: Thanks so much for having us. ASCO Daily News: Dr. Scout, the survey captured the experience of over 2,700 individuals. And I think it's important to let our listeners know that approximately 100,000 LGBTQI people are diagnosed with cancer in the United States every year. So although the survey represents just a fraction of this total patient population, these data are important and shed light on the many challenges facing these patients and survivors from diverse communities across the country. What are the major themes that emerged from these data? And can you give us some specific examples from the survey. Dr. Scout: Yeah, absolutely. And first of all, I just want to say I'm happy that ASCO is paying attention to this. It's something that we're really proud of having done with the help of about 150 community partners. So, it was really kind of a community-wide effort. And we're really delighted to have this much information about a topic that is so important. The main takeaway is--we have really kind of four overarching themes we really think about a lot related to the survey. One of them--and this is nice, because we did a survey about 11 years ago, and this is actually pretty different--and that's that many people were able to report that they were able to get welcoming care. So, that we can't directly compare. But we do think that that is kind of a sign of changing times, a sign of the fact that a lot of providers really are trying to do a better job in this arena. But, unfortunately, there's a few big caveats to that. One is that people often had to go through a much longer journey to get to welcoming care, whether that be physical distance or trying several doctors, different things like that. No one needs that when they're under the duress of a cancer diagnosis. Second of all, if you were any underserved or underrepresented population within the queer communities, like trans or a person of color, your chance of getting that welcome care, of course, dropped. And then the second big theme is that our families, our chosen families, not only are they a real source of resilience for us, but our support teams are different, usually, than general population support teams. It might be an ex, a best friend, and one cousin kind of thing. But if they're really our chosen family, we need to do a better job of having hospitals acknowledge and recognize and treat them as the people who are our key support teams. Not as much work is being done on that as we'd really like to think is the case. The third big theme is that a lot of us, we're really looking for tailored resources about all sorts of things, including cancer prevention strategies, even right down to we wanted LGBTQ-tailored resources for physical-activity strategies. And we were almost uniformly unable to get those resources. So there is, especially these days, in a time when you can tailor things down to lots of different subpopulations, we still have a pretty big miss related to what's happening with the queer population on that. And then the fourth thing--and this we can only really kind of hypothesize--but people were talking about some kind of brutal statements that their doctors were making to them, people who were being told they have cancer in a very rough way, things like that. And we don't wonder if this could be the phenomena of the microaggressions emerging through standard care. And that's something that concerns us and, I think, something to watch. Dr. Charles Kamen: It's amazing to me, Scout, that the themes from this survey are so similar to the previous survey that you conducted back in, what was that, 2011? Dr. Scout: Yeah. Dr. Charles Kamen: So it's been 10 years, and still the same themes are coming up for this population. Dr. Scout: It is the case. Geraldine, you may not even know this, but Charlie is the other human who is the best expert in the world on what our last survey was, because he worked with us to do a bunch of publications off of it. And yeah, I would say it's distressing. We might have had, potentially, a reduction in some of the phenomena. But we had action steps, coming out of the last survey, that we've been training and we've been going around talking to everybody about for obviously over a decade now. And unfortunately the news is still the same. ASCO Daily News: Well, Dr. Scout, I'd like to follow up on a point you made about the importance of welcoming care. Certainly the environment in which people receive care can have a significant impact on their experience. Only 12% of respondents in the survey felt that they had received care in a welcoming environment where they saw, for example, a rainbow flag, they saw affirmative messages, and so forth. This is a very significant takeaway for oncologists in community practice and elsewhere. So, Dr. Scout, do you have any tips for providers about how to make LGBTQI individuals feel welcome, in a safe space, whether they are face to face with their oncologist, or getting blood work done, or even a biopsy? Dr. Scout: Yeah, we absolutely do. If you think about it, there is a history of bias and discrimination against this set of communities. And unfortunately, right now, if you're not doing something to distinguish yourself from that history, we can't tell. You know, we can't tell that you're not part of the problem. So, what we say and all the cultural competency trainers say to providers would be, show us. Do something. Don't just think to yourself, well, I support Pride or something like that. But, do something so we can tell as the patients. So, there's a whole bunch of strategies that are very simple. Put the Rainbow Pride flag up in your office. Partner with a local queer organization to do some outreach. Make sure that you have tailored materials on your website. If I go on your website and search the word, bisexual, and find nothing, not even a non-discrimination statement, then how in the world am I supposed to understand that I might potentially be welcomed there? And in addition, one of the ways you can do it in a regular, routine, everyday interaction, people often ask, well, what about if I'm [doing this]--work on the systems at your organization, work on the media, work on what's in your waiting room, but then what do you do in that face-to-face interaction? Simplest thing is--it's a beautiful new thing--introduce yourself with your pronouns. So just say, hi, my name is Scout. My pronouns are he/him. So, I'd like to get to know you. If you can tell me your name and your pronouns. And go from there. It doesn't say that you're queer, it simply says that you acknowledge one aspect of the difficulties experienced by the queer communities and that you're open and trying to be welcoming so that people, if they have unexpected pronouns or even if they have expected pronouns, they still get that little bit of a message that you're welcoming. ASCO Daily News: Dr. Kamen, do you have any thoughts on approaches that oncologists should be taking? And do you have a sense that these tips are being heard? Dr. Charles Kamen: I think that extra level to everything that Scout said, which I 100% agree with, is don't put the rainbow sticker on the door unless your staff are competent to treat LGBTQ patients. So, before you have the visible sign of being affirming and welcoming, make sure that you're doing some training of the staff. Make it mandatory if you can. And think about how you are identifying and reaching out to your LGBTQI patients in your practice so that their identities are acknowledged and that they're referred to appropriate services after their cancer care ends or even during their cancer care. Dr. Scout: You know, I will also just say, related to that--and I completely agree--lots of providers, when you refer anybody out to another provider, if you're welcoming, you want to refer them to a welcoming provider. And unfortunately the strategy for figuring that out right now is still usually a provider calling another provider and figuring out how welcoming they are, and then doing follow-up with the patient. So, kind of even above and beyond that, remember, especially as an oncologist, your patient is going to now have to experience a bunch of other people. What have you done to make sure that you're able to refer them to welcoming providers instead of just having your own office be welcoming? Dr. Charles Kamen: And how are you working within the community to be sure that about resources that are outside the walls of your institution, but that may be very LGBTQ-affirming? You may not have an LGBTQI support group in your cancer center, but there may be a great one in town that you could refer patients to. So, I think it is both acknowledging visibly that you are an ally, but putting action to that by looking around for resources to send people to. Dr. Scout: And if not, we have new national ones you can refer people. Dr. Charles Kamen: Yes. ASCO Daily News: Thank you both for making those great points. Dr. Kamen, you've done [so] much research on the experience of LGBTQI individuals in cancer care and have stressed the need for research that is specific to the needs of this population. Can you tell us about the role that identity plays among LGBTQI individuals in determining levels of distress? Dr. Charles Kamen: If I can dip back into history for just one second, people probably know that, up until 1973, homosexuality was listed by the American Psychiatric Association as a mental illness. And there's still, to this day, discussion around diagnoses like, quote unquote, "transsexualism," or gender identity disorder, or gender dysphoria as sources of psychological distress. So, there's been a longstanding recognition that LGBTQI identities carry with them a burden of distress. But it wasn't really until the early 2000s that researchers like Vickie Mays or Susan Cochran and Ilan Meyer started to recognize that issue wasn't the LGBTQI identities themselves, the issue was living in a society where LGBTQI individuals were exposed to constant stigma and discrimination. And this led to the development of the Minority Stress Model which many researchers still use today as a way to understand why LGBTQI people experience higher levels of distress and have higher rates of diagnoses like anxiety and depression than heterosexual and cisgender people. I won't go into an incredible description of Minority Stress, but just the basic premise of it is that LGBTQI individuals walk around the world every day with a stigmatized identity. They could be directly exposed to discrimination as a result of this identity, or they could see people in their community being discriminated against, or anticipate discrimination going into a new environment or situation. So, all of this can cause chronic underlying stress. There was some very cool pioneering work by Mark Hatzenbuehler and his team that showed that really it's the process of ruminating about these experiences that causes physiologic changes like inflammation. And that has a cascade effect, downstream, on having high rates of distress among LGBTQI people. And I think, in cancer, we can see this whole process playing out very clearly. We were talking before about the survey that was done in 2011 that I worked on with Scout. And I always talk about this one participant in that study who said, "My oncologist knew about me."--she was a lesbian patient--"My oncologist knew I was a lesbian." But every time I had to encounter a new person, whether for an X-ray or a blood draw, I had all the anxiety of that cancer procedure plus the possibility of homophobia and having to watch out for myself. Cancer is stressful for everybody. But then, if you have to constantly negotiate whether and how to come out to your providers, you have to brace yourself for discrimination if you do come out. And then, if you don't come out, you have to worry, well, does my provider really know me as a human being if they don't know this important part of myself? All of that can exponentially magnify the stress that LGBTQ people with cancer experience. And so that's really, I think, at least the theoretical framework for understanding these rates of distress. Dr. Scout: Hey, Charlie, you may not know this, but did I ever tell you that I was diagnosed as a homosexual in 1984? Dr. Charles Kamen: I wasn't sure how much to go into it. Yeah, I mean, it was still floating around in the Diagnostic and Statistical Manual until 1987, I believe, you could be diagnosed. Dr. Scout: Also, just really bring home what Charlie is talking about on the other end of it, you know, here I am, the executive director of the National LGBT Cancer Network. And trust me, my partner had to push me to go to the dermatologist to get something checked out, which ultimately was cancer. You know, it's fully treatable. But there's this real difference between those of us who are kind of like, stiffly this is what we should do, you know? And then when you face the fact of standing naked in front of a provider who you think could be cruel to you, it's a very daunting possibility. So, there's a million ways you can find something else that's going to be your priority that day other than take care of your health needs. Dr. Charles Kamen: Absolutely. And it also causes people to not want to disclose. But then we had another person from the survey who said there's a part of the cancer experience that never gets shared with providers if they don't know who you really are as an LGBTQI person. So, it's really a catch-22. ASCO Daily News: So, what is the absolute best practice, in your opinion, to get an assessment of sexual orientation or gender identity that doesn't rely on the patient's disclosure? How should this ideally be done? You've discussed it before, earlier, in our conversation. But is there a best practice that our listeners can take away with them today? Dr. Charles Kamen: I mean, just based on the minority stress model, it's definitely incumbent on the practices to assess Sexual Orientation and Gender Identity, or SOGI, in a way that's comfortable and affirming for patients. And most of the time, as we're saying, right now, the onus is on the patient to disclose, which is super unfair. Usually it happens organically. A patient will come in, an LGBT patient will come up with the same-sex partner, and introduce their partner to the provider. And then it is just kind of known that they are a sexual minority person, or based on a med list, or pronouns, or name on an insurance card, a transgender status is known. But sometimes it doesn't happen that way. It doesn't happen organically. And there's a real breakdown in communication then. And beyond that, a patient's dealing with a million things at the beginning of a cancer journey anyway. So, having them be the ones to figure out how to talk about this is very unfair. I think the best research we have on this topic is from the EQUALITY study which was done a couple of years ago now by researchers from Harvard and Johns Hopkins. And it focused specifically on the emergency medicine context. But they surveyed a ton of people and providers and found that the overwhelming majority of patients were willing to disclose SOGI, but that they preferred to do it non-verbally, so through a form or a survey or a patient portal, and not verbally, face to face with a provider. That felt less stigmatizing and intense to the respondents in this survey. Dr. Scout: The other key piece about that is that an overwhelming number of providers thought that they shouldn't know that information because it was too invasive. So, we really need to close that gap. Dr. Charles Kamen: I forget the exact percentages, but it was something like-- Dr. Scout: It was 90% were willing to disclose, but 80% of providers thought that they shouldn't know. Dr. Charles Kamen: Yes, yes, thought that patients would not disclose. And there was some variation by the LGBTQI identity, with heterosexual patients being a little lower, like 84%, and lesbian respondents, like 98% of them were like, yes, ask us, we want to tell you. So, there is that mismatch. And I think the takeaway message, though, is patients are comfortable providing this data if it's asked of them in a respectful and affirming way. Dr. Scout: And I was going to say, just kind of bringing this down to just real-life experience, I had an experience at a health center recently that I think really is--it was certainly the best practice I'd ever had. And that's that I walked into a waiting room. And in the waiting room, I could see three different cues that they were LGBTQ welcoming. There was a big banner sign saying, "We welcome everybody." There was some stuff up about their Pride activities even though it wasn't Pride Month. And then there was a rainbow sticker on the window or something like that. By the time I saw those three signs, the fourth thing was they asked me my sexual orientation and gender identity on my intake form. And by then I was like, absolutely, no question, I'm absolutely going to give it. And I will say they even had a fifth thing. I then went through the patient--and it was like a dental procedure--I went through the procedure, and afterwards something happened that literally made my hair stand up on my neck because I realized how far away we are from this. Someone called me and said, "I'm from the health center. This is Thundermist"--our local federally-qualified health center. "I saw that you marked down that you were trans. I just wanted to welcome you. I'm the trans outreach coordinator. And I wanted to talk to you about some different trans support activities that we have going on across the health center, like swim night, game night, yoga night, things like that." So, I mean, really it made the hair stand up on my head. I'm like, wow, I'm not just tolerated here, I'm valued. And it was the first time I think that I had ever considered or thought that in a health interaction in my life. Dr. Charles Kamen: That's incredible. And I think that's the real next step we have to take as organizations, health care organizations, and as a society. If we're going to collect these data, why? What is it being used for? Dr. Scout: What are we giving back? Yeah. Dr. Charles Kamen: Yeah. How are we referring people to things like a trans yoga night? Make sure there's action behind collecting the data. Dr. Scout: But even before that, before we collect, are we showing them it's safe before we ask them to disclose? So, basically are we going out on a little bit of--not even a limb, first, but are we putting our cards on the table before we ask them to put their cards on the table? Dr. Charles Kamen: Yeah, don't go in cold. Let them know it's a safe place to have this disclosure. Dr. Scout: Yes. Dr. Charles Kamen: I will add in, too, we in the ASCO Sexual and Gender Minority Task Force recently conducted a survey with the support of ASCO's Center for Research and Assessment. And we found, by polling over 200 ASCO members, that the two main factors that predicted whether a practice would collect SOGI data was leadership support, which makes sense--if the top is saying, this is important to do, we need to collect SOGI data, it's going to happen across multiple levels of the institution--but also having resources. And I think that's resources both for collecting the data itself, like IT resources or even knowing what questions to ask, but also resources like Scout's saying, to have banners and stickers and training and activities and support. All of that together makes the practice able to do this in a holistic and affirming way. Dr. Scout: You know, I will say, with the IT support, though, everybody has it in their software package these days. It's just a question of flipping the switch. There's built-in, pre-baked questions. They're not the best in the universe, but they're perfectly functional. So, I hope people realize that that's already there. Dr. Charles Kamen: Yeah. As of 2018, every electronic medical record has to, by federal law, have a SOGI data collection element within it. And then I think the resource may as much be knowing how to do it as the time and effort to turn those modules on. ASCO Daily News: Absolutely. So, here's a scenario. We have an LGBTQI individual who is receiving cancer care. And that person comes to the appointment with their caregiver. How should the clinician acknowledge the relationship of a patient or survivor and their partner? This is a very important aspect of care. Dr. Scout, what are your thoughts on this? Dr. Scout: Well, I presume this isn't the only set of people you're going to see where it may not be husband or wife. The concept of husband and wife have been expanding these days. So, I hope that the oncologist is asking who the person is who's with them. Is this your primary support person? Is this your partner? I just want to make sure, because, of course, having the right support and the best support is going to be important to you doing the best job getting through this whole health event. So, I would hope that the oncologist is introducing themself with their own pronouns, again, and then asking who all the people at the table are and how they relate to the patient. Because I think we know by now that all those other people are really going to be providing them with a lot of health care support in all those hours when the oncologist is not in front of that patient. Dr. Charles Kamen: I agree with that. And I think there are lots of examples of this process not going well, the question not being asked, and then the caregiver not being acknowledged for the relationship they have to the patient. And the real problem there is you don't get to offer the caregiver resources then. And a lot of LGBTQ patients and their caregivers report that the caregivers experience as much stress or more stress than the patient does. So, by getting at this relationship, by asking a simple question like, "Who do we have with us today?" you can then refer that caregiver to a support group or resources as needed. ASCO Daily News: Of course. I'd like to focus on mental health for a moment. Mental health is a huge concern. And 70% of respondents of the National LGBT Cancer Network survey reported that they never received resources related to mental health developed for LGBTQI individuals. I'd like to read a quote from one respondent, who wrote, "With respect to mental health in particular, it seems that, locally, there are no criteria for what constitutes LGBTQI care. Mental health providers state that they are, quote unquote, 'friendly,' and have no means of describing what that means. Some are not at all aware of their own biases and subtle homophobia." Dr. Scout, what is your reaction to this statement? Dr. Scout: I think it's all too true. I've had a lot of challenges with the mental health system myself, as has probably most of the people that I know. So, it's yet again an area where I think the fix is not that complicated. I hope, by now, mental health providers understand [that] they do not see a homogeneous group of people. And I think, especially these days, since most people are going to the internet for their resources, this really begs the question of, you know, we don't have to wait for the National LGBT Cancer Network to create a bunch of resources. Because trust me, we're not that well funded. But if anybody makes a resource, send it to us. We'll put it on our resource library. And it can be available for anybody around the country. So, this really is going to take a village of providers to fix some of these issues. I'm not going to ask any one provider or provider group to fix all of them. But if everybody can do a little something, we'll pull all those together and make it available to everybody else. And that will really help build a basis of information. Also, just FYI, in cultural competency, there's a bunch of standards about to be released related to cultural competency. And we do provide trainings, as do other organizations. So, as with all of these things, take some steps. Inaction is hurting us. ASCO Daily News: Dr. Kamen, do you have any thoughts on this? Dr. Charles Kamen: Definitely. I agree with everything that Scout just said. And I think the one maybe silver lining to living through the COVID-19 pandemic has been that we are way more facile now at navigating telehealth services than we were pre-pandemic. I know, in our cancer center, our psycho-oncology service has had more business during the pandemic than before because they're offering virtual visits to patients. Even if an LGBTQI patient doesn't find a provider within their health care facility that they feel is competent or welcoming, you can go on the internet, as Scout is saying, and you can find really excellent queer-focused and affirming therapists that you can see virtually. So, that's, I guess, one benefit and one thing I hope that we continue to innovate on as we move through 2021. Dr. Scout: The one thing I would say about that is a lot of that's being threatened by these licensing issues. Because a lot of that is only being provided under licensing exceptions for COVID-19. Likewise our support groups are living under a licensing exception for COVID-19. So, there has been increasing pressure at a lot of places. I was literally just talking to the White House about it 2 days ago--no, that would be over the weekend--right before the weekend, about how telehealth really is a huge concern for our communities. And continuing these exemptions for all rare and underserved and discriminated-against populations and rural populations that just don't have a big provider base around them, is going to be really, really critical. So, I hope that there's going to be action on this telehealth front to make these licensing exceptions stick and not just be a little bright light that goes away once we've decided COVID-19's done. Dr. Charles Kamen: Absolutely agree. And I think that's at the federal level and the state level too. We need advocacy to make sure that these telehealth expansions remain in practice long term. ASCO Daily News: Dr. Kamen, you cited some interesting research earlier in the conversation. Is there any other research that is specific to the needs of the LGBTQI population that you'd like the oncology community to be aware of? Dr. Charles Kamen: Oh my gosh, I feel like there's so much good stuff going on now. And it's an amazing change from 2011, when I first started working with Scout on that survey, which was really the only survey of its type anywhere. Now there is more of a groundswell of interest and effort around LGBTQI cancer care. I'll just highlight three of the projects that are happening with members of the ASCO SGM Task Force. So, I've been working with the Fenway Institute in Boston, which has pioneered a lot of LGBTQI cultural competency training. And we're trying to bring that training and SOGI data collection elements to community oncology. And that's part of the NCI Community Oncology Research Program research base that I work with. So, that's one thing. Mandi Chapman, another member of the ASCO SGM Task Force, has a beautiful, very comprehensive training that's called the Together Equitable Accessible Meaningful, or TEAM, training. And she's tailored this to SGM-specific care and is testing it with multiple cohorts of health care providers. I think there'll be a publication coming out about that sooner rather than later so keep an eye out for that. And also I believe she is recruiting additional cohorts. So, keep an eye out for that as well. And then Ash Alpert, another member of the ASCO SGM Task Force, got a Young investigator Award from the Conquer Cancer, [the ASCO Foundation]. And they are developing patient-centered, non-stigmatizing gender identity data collection methods that can be implemented across oncology settings. And they're also looking at connections between violence and cancer risk for the transgender population. Really, I think this work is incredibly timely. Because people may know or may not know that right now the National Academies of Sciences, Engineering, and Medicine, they're working on a consensus document that's really trying to summarize how best to collect SOGI data across settings. So, Dr. Alpert's work to get a trans-community perspective on this topic is super critical. Of course, I would be remiss if I didn't mention the National LGBT Cancer Network and their training that they're doing as well, which I believe is still in existence and can be accessed, though Scout, you can correct me if I'm wrong on that. Dr. Scout: We're actually also doing a partnership right now, with Society for Gynecologic Oncology, to convert it to an online enduring training so it can scale wider. And we actually expect that to be debuting at the beginning of next year. Dr. Charles Kamen: Yeah, it's so great that there are so many of these efforts happening, because it means that multiple groups can access the training through different channels. And we can end up, hopefully, with a much better pipeline of LGBTQI-competent and trained providers. The last thing I'll mention is that the ASCO SGM Task Force had done that survey to look at the factors that predict SOGI data collection. And we're now doing a phase II follow-up where we're going to be doing qualitative, in-depth interviews and focus groups with member organizations to try to understand what the factors are on the ground that predict people collecting SOGI or not. So, we'll definitely be looking for organizations to participate in that study, probably in the next couple of months. Dr. Scout: And I would say you're hearing us talk a lot about data collection because that really is the biggest next horizon related to advancements in SOGI care. Because just to be clear, we can't tell you what our cancer rates are because we don't have any data in any of the registries because that's all abstracted from health records. So, until we get these questions asked as you go into a health care environment, we won't be able to tell you what our disproportionate COVID-19 impact is, we won't be able to tell you our cancer rates. And of course, without a lot of that hard data, we also can't even apply for more research or do interventions to try and fix it. So, that's why one of the things we really try and encourage providers to look at is when are you going be able to flip that switch and actually do that data collection. If you're really committed to being inclusive for our population, that's a key step. ASCO Daily News: Absolutely. Well, we will share a link to the National LGBT Cancer Network survey in the transcript of this episode, along with all of the other research and resources that you discussed today. Thank you so much, Dr. Kamen and Dr. Scout, for being on the podcast today and shining a spotlight on a very important topic in cancer care. Thanks so much. Dr. Scout: Absolutely. Thank you. ASCO Daily News: And thank you to our listeners for your time today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclosures: Dr. Charles Kamen: None disclosed Dr. Scout Research Funding (institution): Bristol Myers Squibb Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Dr. Steve Pergam on COVID-19 Vaccine Booster Shots
26:24Dr. Steve Pergam, associate professor of the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center and the Infection Prevention Director at Seattle Cancer Care Alliance, discusses new guidance from the National Comprehensive Cancer Network’s COVID-19 Vaccination Advisory Committee, regarding a third dose of the Pfizer-BioNTech or the Moderna COVID-19 vaccines for patients with cancer. Transcript Dr. John Sweetenham: Hello, I'm John Sweetenham, associate director of clinical affairs at the UT Southwestern Harold C. Simmons Comprehensive Cancer Center and guest host of the ASCO Daily News Podcast today. The U.S. Food and Drug Administration (FDA) has authorized an additional COVID-19 vaccine dose for people with certain medical conditions who received the Pfizer-BioNTech, or the Moderna COVID-19 vaccines. Following the FDA'S announcement, the National Comprehensive Cancer Network's COVID-19 Vaccine Advisory Committee released new guidelines regarding the third COVID-19 vaccine doses for people with cancer. Joining me to discuss the booster shots is the committee's co-leader, Dr. Steve Pergam. He is associate professor of the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center and the Infection Prevention Director at Seattle Cancer Care Alliance. Steve, thanks for coming on the podcast today. Dr. Steve Pergam: Well, thank you so much Dr. Sweetenham. It's an honor to talk to my colleagues from oncology who I work with every day and to speak to patients and others who might be listening, so thanks for having me on. Dr. John Sweetenham: Great, thank you. Before we start, I should mention that my guest and I have no conflicts of interest relating to the topic today, and full disclosures for all guests on the ASCO Daily News Podcast are available on our transcripts at ASCO.org/podcasts. Steve, can you tell us a little about the groups that should be considered eligible for a third dose of the mRNA COVID-19 vaccines right away based on the latest FDA decision? Dr. Steve Pergam: Sure, the guidelines from the Centers for Disease Control and Prevention (CDC) and from the ACIP after the approval by the FDA are quite broad, and they include patients who are immunosuppressed by medications, such as steroids, drugs like tacrolimus, and then patients with cancer as well, many of whom are often considered immune-suppressed. It gets into patients with immunodeficiencies, and it really addresses a large group of people who are considered immunosuppressed. And I think part of the reason the guidance was written that way is defining what is immunocompromised to a level where you're not going to respond well to the vaccine is a little bit complex because immunosuppression is such a broad term. So they've left the guidance pretty broadly worded, and so I think it's important that when we think about what this guidance looks like, it's really about trying to be inclusive and trying to be somewhat specific at the same time, which is a really, really hard balance to go across, if that makes sense. Dr. John Sweetenham: Sure. For those patients who are immunosuppressed in some way, can you say a little about what the data shows regarding the level of protection that these patients may get from a third dose? Dr. Steve Pergam: Sure, so first, it's actually a little bit difficult to speak to patients with cancer directly. There's not very much data if at all regarding third doses for patients with cancer. So much of the data that supports these recommendations is focused on data that we understand that second dose, receiving that first primary dose, followed by a booster, which is what is common and what's recommended for mRNA vaccines, suggests that patients who have cancer may not respond well to that two-dose regimen. And it's varied between different groups. Some groups have much less response. So, a patient receiving rituxan (rituximab), which is the anti-CD20 antibody, clearly do not have adequate responses. As an example, patients who are receiving anti-CD20 antibodies like rituxan (rituximab) clearly do not have good responses versus solid tumor patients, which may have a better response to these vaccines. But regardless, those with immune suppression appear to have decreased responses overall, and the antibody levels that they receive, that they can maximize too are less than the general public. And so there was data looking at different groups who were immune-suppressed and demonstrating some benefit to boosting. And primarily the data is in and amongst solid organ transplants. There's actually two papers. There is a paper dealing with solid organ transplant recipients, one from France and another from the University of Toronto. And both of these have shown that despite poor responses after the second dose that additional doses amongst those who have solid organ transplants were improved with a third dose approximately at least 28 days post that second booster. So, that third dose did provide improvements. And in some of that data, up to 60% of those individuals responded to the third dose, where the first dose was only about 4%, and the second dose only about 40%. So you get about, I would say, somewhere around half of the people that had no response in the solid organ transplant population had a defined response with that extra dose. So, looking at data from other populations of immune-suppressed individuals who have in trials been given these third doses does suggest that there's improved responses. In addition, in some data they have been able to look at T cell immunity and although T cell immunity can be documented in some that received second doses, there are some suggestions that potentially third doses may also potentially improve that. So I think the immune response appears to be better after a third dose, but there are caveats to that. Dr. John Sweetenham: That's really interesting, and it provokes me to ask a question, which I guess in some ways is a little off the wall, but it's certainly something that I've already heard from a number of patients with cancer. And that is, if as it appears to be the case that a third dose in these patients can get them somewhere closer to the kind of response you might anticipate in the normal population, do you see any role for a fourth dose looking forward? Appreciating that there are no data, but do you think there might be a role for a fourth dose in some of these patients? Dr. Steve Pergam: Yeah, well, first, I think it's important to understand that a third dose, it's not a panacea. It is not suggesting a third dose is going to protect all patients with cancer. In fact, many of our patients with cancer are highly immunosuppressed, and a third dose, while it may improve the responses in some, it won't completely improve responses. And of those who do respond, they may have a detectable antibody, but the level of protection that they receive with that extra dose may not be a level that is fully protective against infection. What's hard is the data that's available right now is we don't know whether that third dose is effective or protective against things like hospitalization and death, which are the outcomes that are the most important. So, I think there's still some gaps in our knowledge. But what we do know is that you need a significant amount of antibody to be protected, and some of the data from the Moderna trial has suggested that you need an antibody level of over 1,000 to really be fully protected. That's what they've determined as a correlate of protection. And I think most of the patients that we're talking about, while some can get over that level, others may have a harder time reaching that level of protection. So, it's important when you're thinking about antibodies and detecting antibodies that it's important to remind your patients that just because they have any antibody doesn't mean it's necessarily fully protective. Now I think the question of fourth dose is hard because we don't have any data in this space. And more is better is often a mantra in medicine that sometimes is discussed, but I really encourage before we go down that pathway to just giving a fourth dose because we can. And because now Pfizer is an FDA-approved medication that we have a little more flexibility that I think we really should be doing trials to better understand what that extra dose might do, and are we providing more benefit? I mean, we've seen this with some drugs is that there is a limit to how much cancer response there is with certain agents before we get into issues like toxicity. While I'm not concerned so much about toxicity with mRNA vaccines, what we don't know is what these multiple doses might do. And there's theoretical concerns where if there's been myocarditis seen in younger adults, someone who's receiving multiple doses of one of these agents who's also received cardiotoxic chemotherapy as an example, there might be a change in risk with additional doses. So, that's all theoretical. I'm not suggesting that's true. But I think what's really important is if we're going to be going down pathways where we're doing additional doses beyond what is FDA recommended, then I would not recommend that at this point that studies need to be done. We need really robust studies in our patients with cancer to really determine whether additional doses are beneficial. Dr. John Sweetenham: OK, that's really helpful. Thank you. Just switching gears a little bit, could you say a little bit about the timing recommendations for the third shot in immunocompromised patients? And I wonder whether, particularly based on some of the discussions that were held in the National Comprehensive Cancer Network (NCCN) panel, whether you could comment on the timing for those undergoing stem cell transplantation or CAR T-cell therapy. And perhaps say a little bit about those patients who may be undergoing surgery and the appropriate timing for them. Dr. Steve Pergam: Yeah, so we hope that most of the patients that we're discussing have already received their two doses of one of the mRNA vaccines. And that for those patients who would be potentially eligible to get a booster, we would encourage getting it as soon as possible. The caveats to that, of course, are the bone marrow transplant recipients and those who are CAR T-cell recipients. Where we really encourage people to delay any doses of the vaccine to a point where the immune response is more likely, and that tends to be around--from data from other vaccines--tends to be around 3 months post-stem cell transplant or 3 months post-cellular immunotherapy. So that's the time frame, and we definitely recommend that. And then for patients who are undergoing really aggressive chemotherapy, for those that are patients with acute myeloid leukemia (AML) who are getting myelo-specific treatments, maybe they like to organize for them to have their count recovery before they're given their doses. So, patients who were inpatient actively receiving leukemia therapy as an example, as their counts recover, starting their doses after they've completed their therapy, and their counts have recovered, maybe at the time of discharge would be great to give that booster. And then with those who are getting surgery, what we don't want to do is give somebody a booster the day before surgery, where they might develop some of the symptoms that can occur with people that got these vaccines, which can be general fatigue, but additionally things like fever, which can occasionally happen in patients who have a really robust immune response. And if you have a fever, it can delay your cancer surgery. So, to think about the idea of planning to get your doses after you've had your surgery and had a bit of time to recover might be best. Planning your vaccine, at least a week before your surgery would be ideal before getting it immediately prior to a surgical procedure would probably be the best. Dr. John Sweetenham: Right, and I'm assuming that we'll maintain the same guidance for those patients if they're undergoing some kind of radiological procedure that they should avoid undergoing that imaging. Dr. Steve Pergam: Correct. Yeah, it's a really important comment that's discussed in the guidance is, if you know you're going to be getting something like a PET scan that will be looking for lymphadenopathy or evidence that you might have tumor in other locations for rescreening or restaging, have a discussion with your team about when it would be appropriate because we have seen with these vaccines, they can lead to enlargement of some lymph nodes on the side where your vaccine has been given. And there have been some images that many of us have seen where your lymph nodes can light up slightly because of an immune response. And what we don't want people to be worried that they have changes in their cancer treatment. I think what's important is having that discussion prior to a screening that you're going to have with your team to determine the best time to get that extra dose. Dr. John Sweetenham: Great, thanks. Another question that we've heard in our own practices quite a lot, and it goes back to the beginning of the pandemic really, when the government was recommending that patients at that time got whatever vaccine they could get. So, for our patients with cancer who may have had the Johnson & Johnson (J&J) vaccine as their initial vaccine, what would be your advice now regarding how we should manage those patients as they look for what, for them, would be a second shot. Should they get an mRNA vaccine at this point or should they wait? Dr. Steve Pergam: Currently according to FDA approval documents, there is not really a pathway to get an extra dose for patients to receive the Johnson & Johnson. You can, of course, have patients get this through--because the Pfizer vaccine is fully approved, it's possible to offer it through that mechanism. But, generally that the FDA approval components at this point don't suggest doing that. And I think part of the reason is Johnson & Johnson was a later vaccine, so it was rolled out at a later time frame. So, the timing between when Johnson & Johnson was available to now is less time. And so the thought is that potentially waiting for a additional dose may be important. And I think what's critical about this is that there is data, there is a study that the Johnson & Johnson trial was approved through a trial called the ENSEMBLE trial. And ENSEMBLE 2, which is a trial, which looks at additional doses of Johnson & Johnson--it's a mechanism similar to how mRNA vaccines are given, where there is a prime boost strategy, is actually nearly finalized. And early reports in the news media--I haven't seen any of the actual data--does suggest that the second dose is quite effective and may improve responses. So my inclination is that Johnson & Johnson patients may eventually have the option of getting either another Johnson & Johnson preferably, but if not available, could receive an mRNA vaccine. I just don't know the timing of that. So at the moment, what I've been telling patients is to hold tight. And then as soon as we know more and what's available and whether they can get a second Johnson & Johnson dose or if there's further recommendations for additional dosing to just hang tight at the moment. Dr. John Sweetenham: OK, thanks. Again, just switching gears just a little bit here, one of the other discussions that was held in the NCCN Advisory Committee was around people living in the same house as the immunocompromised. I wanted to just take a moment just to say as a member of that panel how much the group appreciated your leadership and how much I personally learned from listening to you and the other leaders of that group. I think it's been a very engaging conversation. And the group acted, I think, with your leadership, very quickly to get these recommendations out. And I have to tell you that from our own cancer community and cancer center down in Texas, we were very grateful for the guidance we got from the Committee as a whole and from the leadership in particular. But just a question about those who are living in the same home as the immunocompromised. Could you say a little bit more about the advice the Advisory Committee had for those folks who are living with patients who are immunocompromised? Dr. Steve Pergam: Sure. So, first, thank you for that comment. I would just say at first that this committee is a committee that makes decisions together. And it's been a wonderful group who has gotten together and been able to develop guidelines quickly as a group. As much as you've learned from those who lead the group, I would say we've all learned from the members of the committee. It's been really wonderful to see the cancer community come together to make guidance that can really, I think, help providers and patients. So it's important. I think, in terms of household members and close contacts and family of patients cancer, this fits into what some would call a cocoon strategy, some would call a ring strategy. Where really what you want to do is you want to protect the people around that patient with cancer. Because with patients with cancer, the biggest risk they have for transmission is from a household member. You're often not masked at home. You are in much more prolonged contact. You're in a household where you can't necessarily socially distance. You're sharing the same air space. Ventilation in homes is also not the level as it is in clinics and such. The levels of protection that you get at home are significantly less. And so having someone who is a close contact who's positive is quite risky for our patients. And so what we really recommend is for those who are and live in households of patients with cancer that they get vaccinated because even decreasing a small amount of the potential that they get infected doesn't really protect those around them. I think it's really important that the efforts that are made shouldn't just focus on patients with cancer themselves. And so when our cancer centers are meeting with patients and they're interacting with caregivers and family members that come with them, those conversations should include efforts to ensure that those around them are vaccinated, because that is likely the most clear pathway for infection of an individual. And that really it really crosses a lot of issues, right? So, a caregiver of a patient with cancer is the person who's most likely to go out to the pharmacy or out to get groceries or do activities where a patient with cancer who is getting therapy may not feel up to that. The patient with cancer themselves is likely to wear personal protective equipment like masks and to socially distance and be staying home and really go to clinic and other things, but to try to avoid social exposure. So, if we can do everything we can to protect that individual, one of the most important things is to get those vaccinated around them. And I think it's a really important conversation for patients to have with their loved ones and to include the providers in those conversations to help change their opinions about this. And also, I think it's really important for those who live and work in our communities [and] that it needs to be something that businesses understand and that our friends and families understand beyond the even household itself that all of the people a patient with cancer comes into contact with ideally are vaccinated. And the way we do that is by vaccinating our community. By vaccinating people in our community, we protect the most vulnerable. And we've seen that with vaccines for things like measles, where it takes 95% of the community to be vaccinated to really protect the most vulnerable, where it's important. So, the more we can get out there and talk about the importance of [the] vaccine in our communities and why it's important for vulnerable patients and to really convince those in close households to get vaccinated, I think we're doing our patients a major service and really can help protect them from developing COVID. Dr. John Sweetenham: Yeah, thanks for those comments. And you did raise the issue of wearing masks. And do you have any comments to make on some of those other measures which we are still working very hard with our patients and our communities over, such as mask wearing and so on? Could you comment a little on that? Dr. Steve Pergam: Yeah, so what I tell patients is even if they've received both doses of the primary series of mRNA vaccines or a Johnson & Johnson vaccine, and even if they've received a booster that they should still assume that they're not fully protected. Now, it may be that if they are potentially exposed, their chances of developing COVID-19, and for needing hospitalization and for going on to need ICU admission, et cetera are substantially reduced with [the] vaccine. But since we don't understand for an individual what an individual's protection is going to be, because of the wide variety of cancer therapies that patients receive, what my general approach is to say, even if you've been vaccinated, to continue to be cautious. And I think that's particularly important with the Delta strain, which is much more infectious and much more able to spread amongst individuals that our patients with cancer, despite receiving full doses of vaccine, should continue to mask up in public, should try to avoid close contacts with large groups, to socially distance when possible, and to have discussions with everyone in their household to get vaccinated. I even recommend to try to avoid interacting with other households where there are others that are not vaccinated because of the advantages that you get from having those around you vaccinated. This is really challenging, as you can imagine, within the patients who live in households with young children who are going back to school. And so in those situations, having a discussion with the school if possible and having your children wear masks when they go to school can be helpful. We don't know the total benefit in terms of protecting an individual at home, but any way that you can protect yourself from getting COVID-19 is really critical. So what I suggest is [to] get everyone who can be vaccinated vaccinated, wear masks in public, socially distance, wash your hands really well, and avoid crowds as much as possible. And if it means doing a few more Zoom calls with your family that have unvaccinated individuals, then that's something that may need to be something you do. And let's say you're an older patient who's a patient with cancer who's received your third dose of the vaccine, and you want to go visit your grandchildren who are unvaccinated. Well, have a conversation with family about that. First, is it necessary to do in-person? If you can do it by virtual methods, you can. But if you do need to go see them, plan to do those interactions outside and consider wearing a more protective mask, something like a KN95 or a surgical mask with potentially even a cloth mask on top--so a double mask. But I think a can KN95 mask would be my best recommendation. And then you can interact with them outside and not indoors where the potential risk of transmission may be higher. And that may not be what everyone wants to do, but it's all about being there for your grandchildren and your family for the long term, and that's the goal in all of this is to protect our patients as long as we can. Dr. John Sweetenham: Great, thanks, Steve. That's great common sense advice, and I think a great way to round out our conversation today. I want to thank you very much for sharing the update on COVID-19 third shots today for our patients with cancer. And also once again, just to say thanks for the work that you've been doing with the NCCN and beyond in helping the oncology community navigate the pandemic. So, [I] really appreciate your time today. Dr. Steve Pergam: Well, thanks for having me, and best of luck to all my colleagues out there and to all of the patients who are listening in. Know that all of us are working really hard to do what we can to protect you. Dr. John Sweetenham: Thanks, Steve. And thanks to our listeners for joining us today. If you enjoyed this episode, please take a moment to rate and review us wherever you get your podcasts. Thanks and goodbye. Disclosures: Dr. John Sweetenham: None disclosed Dr. Steve Pergam: Research Funding: Global Life Technologies, Chimerix, Merck & Co., Sanofi Pasteur Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Dr. Derek Raghavan Has a Remedy to Mitigate Financial Toxicity in Cancer Treatment
24:53Transcript: Dr. John Sweetenham: Hello, I'm John Sweetenham, Associate Director of Clinical Affairs at UT Southwestern's Harold C. Simmons Comprehensive Cancer Center, and the guest host of ASCO Daily News Podcast today. I'm joined by my friend and colleague, Dr. Derek Raghavan, President of the Levine Cancer Institute to discuss a new study that he and his group published in JCO Oncology Practice outlining a novel approach adopted by his institution to address financial toxicity caused by the rising costs of cancer care. Dr. Raghavan is going to tell us about the creation of a Financial Toxicity Tumor Board, which shows promise as a potential solution to significantly ease the financial burden of cancer treatment on patients and their families (DOI: 10.1200/OP.21.00124). Dr. Raghavan's full disclosures are available on our show notes, and disclosures relating to all episodes of the podcast can be found in our transcripts at asco.org/podcasts. Derek, it's always a pleasure to be speaking with you again on the podcast. Dr. Derek Raghavan: Hi, John. It's a pleasure to have time with you again. Dr. John Sweetenham: You know, I've had an opportunity to read the publication in JCO Oncology Practice, and it really is fascinating and a very interesting new approach. We know from many studies that financial toxicity is among the most rapidly growing adverse effects of cancer treatments. And patients report financial distress is a major hurdle to the quality of life. And its association with worse outcomes is now very well documented. At the Levine Cancer Institute, as your paper describes, you created a Financial Toxicity Tumor Board, which you abbreviate to FTTB, to address this problem. And I wonder if you'd be able to describe a little bit about this tumor board, and perhaps in particular which components of this you feel are really a new approach to addressing the issue of financial toxicity. Dr. Derek Raghavan: Thanks, John. Yeah. I mean, I guess it's important just to define what we're talking about because there are still people, particularly clinicians, who don't really understand the concept. So, I think it was probably Jonas de Souza, among others, from Mark Ratain's group, who were early in both identifying this as an issue and studying it. And so, the concept of financial toxicity is really pretty simple. And that is that people are struggling to pay their bills and the bills are going up. With the way the pharmaceutical industry is able to set prices ad libitum, the fact that there's a lot of lobbying that goes on in Washington, and elsewhere, the prices that people have to pay can be really quite extreme. People that are insured are, perhaps in this domain, particularly at risk because if you have, for instance, a good insurance policy with a 10% copay, and think about the cost of maybe half a million or a million dollars a course of targeted therapies or for CAR T treatment, or whatever, 10% of $500,000 is an awful lot of money for someone to come up with unexpectedly. So, the whole idea of financial toxicity is something that has emerged with the rising costs, and more particularly, the rising prices of health care. I think the other thing that that's important is while we are seeing this reported more, and you know this from your experience, as to why, patients really protect their financial status almost more than anything else. They don't like to admit that they're struggling financially. And there will be people who are mortgaging the house, but who don't share with the medical team that they've run out of money, that the health insurance plan isn't working. And so, they're really making choices that are very tough. If you have no income and no insurance, I'm not implying that it isn't a problem. There are people who will still have bills to pay and have to make choices between buying food and buying their drugs. And in your practice and in mine, we both know that sometimes patients select in favor of food, which makes perfect sense, because they can't afford food and drugs. So, the whole concept of the Financial Toxicity Tumor Board came from understanding that. At the Levine Cancer Institute, we have a big commitment to outreach and underserved populations that the team that's led by my colleague, Melissa Wheeler, last year had 68,000 people that they saw at outreach. And that included a lot of uninsured or underinsured people. And they were bringing back to me stories of the difficulties these folks were having in terms of why they weren't seeking medical care. Given that we are the safety net in this part of North Carolina, that's particularly troubling. And then the final thing that I'd say is with respect to underreporting, we here use a system called Tridiuum, which is an electronic system that asks patients about their quality of life. And one of the cases--one of the questions that is asked is, are you having difficulty paying your bills? And when we compare what we've learned at the FTTB, the Financial Toxicity Tumor Board, with the answers on Tridiuum, it's quite clear that patients, while they'll talk about nausea, and vomiting, and pain, and things like that--depression--they will often say, no, I'm not having trouble financially. They'll answer to the question, no, I'm not having trouble. But we actually find out they are. And the final point I'd make--and I suspect that because you and I went through medical school a couple of decades ago, we were both taught that it's rather inappropriate to discuss something as unpleasant as money with patients because it will make them feel that we're judging them or that we're withholding treatment. As a consequence of that, physicians have been trained really not to discuss the costs of care. And that becomes a pretty big deal when you're actually going to have a patient that might give up little Johnny's college education for a new treatment. I mean, it might be worth it if it's going to cure them. It might be worth it if it's going to give them a 10-year survival. But if you're talking phase I study, or a drug in the third or fourth line, which might give 2 or 3 months of extra survival, giving up little Johnny's education might be a bad trade-off. And so, the whole concept of the FTTB was to get us to do things to help patients, but also to get a physicians and the advanced practice nurses and the whole team to be focusing a little more carefully on the whole issue of this problem for patients. So, coming back to your core question, we developed a tumor board, much like breast cancer tumor board, or GI, or whatever, that is multidisciplinary. It has all the service chiefs at our institute, several of the physicians from different domains, the nurse navigators--we have about 40, 45--our financial counselors, the people in the billing office--so administrators. I'm at present, at these finance people. We get together and identify the worst of the problems. We have a couple of our finance people and a couple of our financial counselors who triaged the cases. If it's something simple--so Mr. Smith is age 70 and hasn't managed to get Medicare for some reason. That's not an FTTB problem. That just gets handled by the financial counselor or the navigator. But if it's one of the big problems that we found, like people who don't have insurance, people who are getting impediments from the payers, issues that relate to coding and billing, problems of precertification, that's the time when the FTTB becomes involved. Dr. John Sweetenham: That's great. Thanks. And I think that the point you make about these are issues which affect the insured as well as the uninsured are really important. And interesting that you have--it sounds like you have a pretty systematic way in which you can identify and engage those patients who might be embarrassed or reluctant to disclose that they have some level of financial distress. Dr. Derek Raghavan: Yes. That's correct, John. We have some signs posted. All of our staff are trained to raise the issue in as nonjudgmental and as engaging and passionate as they can. Interestingly, it's often the front-line staff at the front desk or the nurse navigators that get the information. A proportion of our patients will actually just ask for help and see a financial counselor. But the whole group has been trained to be as empathetic as possible and to create a scenario where it's kind of put to the patient that we understand this is not on you. This is the way health care is today. There are gaps that relate to how we pay for it. So, let us try to help you. And I think for that reason, patients are much more comfortable to address the issues once they understand how this works. Dr. John Sweetenham: Right. Could you say just a little bit more and expand on how the patient assistance program kind of fits into this model? And then as a follow-on question to that, could you tell us a little bit about what the cost savings for your patients have been and how many patients have been impacted by the tumor board so far? Dr. Derek Raghavan: Sure. Well, the process, as I explained, is multidisciplinary with a whole bunch of different people. We've folded all the bits together. So, we have social workers and financial counselors who can access philanthropic support for the people where we simply can't figure out an answer. And so, in that context, that'll be copay assistance or other philanthropic things. We actually measured this in 2020 and 2019. And so, in 2019, we gave out about $1.4--a little bit more--million to about a little over 1,200 patients. In 2020, it was about $1.39 million, and it was about 1,000 patients we helped. In terms of saving out-of-pocket expenses, I was surprised when we actually measured it and looked at it. So, in 2019, we helped nearly 600 patients. And we saved them out of pocket expenses of $55 million. Dr. John Sweetenham: Wow. Dr. Derek Raghavan: In 2020, it was 749 patients. And there, to my surprise, it was $60.7 million. So, this is not chump change. This is really big sums of money. We did an analysis and we reported this in JCO OP and found that 29% of the patients just were dealing with lack of insurance or under insurance. Oftentimes, a policy that had fine print that said, while you're well, we'll cover you. And when you're sick, we won't. So, we had to deal with that. There were payer impediments. And you and I both--I know we've chatted about this over the years. There are wonderful payers and health insurance companies and there are some that are pretty tough. They all pay their insurance executives seven or eight-figure sums--and claim to be struggling. But the payer impediments will relate to changing their rules, having fine print that doesn't cover the rules. One month, you'll have to get--so for example, at one point, we discovered that they were turning down rituxan for diffuse large cell lymphomas. And there was one word in the diffuse large cell that was missing from what the doctors might have been writing. And so, they were denying payment for that and sending bills to patients. There will be coding or billing complexities. That's, again, at about 20% of the cases we've seen. The toughest one is only a small proportion at the moment because we've worked on it, but it's variable--and that's precertification. And the problem there is the companies change their rules for who needs it and who doesn't. For example, in North Carolina, Medicare recently required precertification for chemotherapy that didn't require it previously. And they set a start date and suddenly we had to cancel a bunch of patients for that date because the website to allow precertification didn't open until the day began. And so, we had to just defer by 24 hours chemotherapy so that we could get the patients precertified to avoid them getting bills. And then I have to say--I mean, 20% of our problems have been inadequate internal processes. And that means if we'd done things better internally, we could have avoided problems. And so that brings in the way we approach management of denials. We've become very proactive. So, I now have a team of pharmacy techs who, for example, chemotherapy will go through the rules for each health plan for the individual patient to make sure that we're actually doing the precertification correctly as of the day of treatment because the rules may have changed. So that's pretty much how it works. We've got pharm techs who work the cases in advance. We often spend an awful lot of time talking to insurance companies. As you know, they can make it very difficult to get to the right point with the recent changes with white bagging and brown bagging where they're deflecting and deferring referrals of treatment to their own pharmacy companies, that will often not be patently obvious till we have a patient here ready to go, and we suddenly discover that they want us to get the drug from a specialty pharmacy that's their special one. So, all of this requires an awful lot of advanced planning. Now I think if government took a little more interest in the way the insurance companies work, it would make life easier--but they don't. And so, we have used this strategy of Financial Toxicity Tumor Boards to move this forward. And I will say that one of the very useful things it's done, it's sort of like ripping a Band-Aid off. It's created a scenario where we are now able to educate our physicians about things that they simply didn't know existed in terms of problems of reimbursement insurance and so on. Dr. John Sweetenham: Right. And so, the process and the success that you've described with this tumor board is really pretty remarkable. I'm quite struck by the fact that this requires a lot of resource-- particularly, human resource--and a lot of organization to make it work. So, we often talk about whether a new initiative is something that's scalable. Do you think that this FTTB model is something that's scalable down, if you see what I mean, so that it could be successful in relatively small practices as it has been in a large system such as the one that you operate? Dr. Derek Raghavan: Yeah, John, I think that's a really good question. So, if you're thinking about scalability, if you're thinking about a place like the Simmons Cancer Center at UT Southwestern led by Carlos Arteaga and yourself, I'm sure that you could do something similar. It's a big center, it's a national referral center, it's NCI designated, and you've got reasonable support and philanthropy. So, you could do this, if you wanted to, easily. If you then scale it down to a private practice or an office oncology practice, I think the answer is, you can do much of it. You might not be able to do everything that we do. But it's certainly reasonable that if you have, say, 30 patients coming up over 5 days for chemotherapy, your chemotherapy nurses can be rostered to actually do some of the work that we do in terms of checking insurance situations and so on. Many of the smaller practices worked predominantly with two or three health insurance companies, so therefore there are less sets of rules. I think the other thing is a lot of the stuff is repetitive. So, I gave you an example of rituxan and lymphoma. So, if you've got people focusing on those who can send a note around the practice to say, moving forward, if you want to prescribe rituxan, is the phrase that needs to be there to describe the type of diffuse large cell lymphoma you're addressing. So, I think it is scalable. It's more a question of changing attitudes and accepting that medicine has changed, people are struggling to pay their bills. And physicians--particularly in an oncology space--can actually spend a little time going through the cost of care with patients, thinking about the alternatives. We use biosimilars a lot. We're very careful to use biosimilars where the evidence really supports the fact that they are an equivalent product. Occasionally, we struggle with that because the insurance companies obviously are doing deals with some of the biosimilar companies, and we may be at short notice discovering that we need to prescribe biosimilar number two rather than number three when we thought number three was the best drug. That becomes an ethical issue. And then I think you just have to look at the quality of the data and decide whether it's reasonable or not. Some of the biosimilars, I think, are ones where we're not sure that they're equivalent and then we do not use them. Dr. John Sweetenham: So, we've talked a lot at a system level and the kind of global problem that we all face now with the financial toxicities. But ultimately, this is an issue for individual patients. And with the system that you've put in place, the ultimate beneficiary of this, of course, is the patient. And I just wondered if you may be able to share perhaps one example or a couple of examples of patients whose stories kind of exemplify how helpful this can be. Dr. Derek Raghavan: Yeah. Yeah. I think in the story that we told; we described a patient where there was confusion on the explanation of benefits that was provided to the patient. This was a person with--who'd had adjuvant chemotherapy following surgical treatment of pancreatic cancer and then suddenly got a whole bunch of bills because it was noted that one of the drugs--just one of the drugs in the chemotherapy regimen--required specific precertification, which actually was not clearly seen in most of the documentation that was available. So, in that situation, our financial counselor actually talked to the company and was able to make things better. In the situation of patients with malignant lymphoma heading to bone marrow transplantation, that's been one where various companies have used denials as a mechanism of creating leverage for contracting. There, what we've done is generally approach doctor-to-doctor to the physicians who work for the companies. As a general rule--and I don't think this is an overstatement--I think it's easier if you talk doctor-to-doctor to a company that will employ an oncologist or a retired oncologist. Unfortunately, sometimes it'll be a retired surgeon or an internist who's punching well above his or her weight. And that's a little bit more tricky. Frankly, I in my own practice in the past have used politicians. When we get finally to a dead end, I will provide a letter that describes what we've done, give it to the patient, and say I suggest you go and see your local congressman or senator. It's amazing how quickly payers respond to a phone call from a politician. And that's because there's an awful lot of lobbying that goes on in Washington. The companies certainly don't want to bring attention on themselves. But I think, generally, it can be quite a good partnership if the physicians are doing their part and thinking about the bang for their buck. In other words, are they providing treatment that's going to make a difference? They make sure they're following the rules, and that requires proactive management. Develop a good relationship--the companies certainly respond to a group that are trying to provide cost-effective care. Dr. John Sweetenham: Thanks. And just one last question before we wind up. And that is, I think this wasn't the primary motivator for setting up your tumor board, but what do you think the impact of this kind of approach--if we were all to adopt this more formalized approach, what do you think might be the impact that it would have on cancer care disparities? Dr. Derek Raghavan: I think it can help. I think the biggest problem--and John, you'll roll your eyes because you've heard me say it before--I have a problem with analysis paralysis. So many people working in the NCI-designated network and beyond it love to do studies of underserved populations. And my thought is, why don't you start trying to problem solve and tweak it as you go along? And so, I think what this sort of approach does is it makes physicians and advanced practice nurses, and oncology pharmacists think more about the issue of the cost versus outcome. It allows us to help patients to deal with the problem. And because we're trying to bring all the costs down, it really goes to the value proposition. As I think you know, we have electronically accessible pathways that are evidence-based, but certainly looking at the costs of care for equi-active and equitoxic drugs is a big piece of that. That's why we sometimes use biosimilars. So, it will generally bring the costs and prices down while also trying to help reduce the out-of-pocket costs for our patients and make us more value-orientated in terms of the whole product. And the other thing I think is really important is if we can do it in oncology, then the cardiovascular people, and the neuroscience people, and so on can equally be thinking along these lines. Dr. John Sweetenham: Yeah, absolutely. I agree with you. And I'd have to say, I really appreciate having an opportunity to talk with you about this. When I read the article, I immediately fired it off to our leadership team here to take a look at because I think there is much to learn and commend this particular article and the application of this type of tumor board to everyone who's listening. It's a really very, very interesting and novel approach to what is clearly going to become an increasing problem for our patients with cancer. So, in conclusion, I would just like to say, thanks again, Derek, for sharing some time with us and sharing your insights into the tumor board. Dr. Derek Raghavan: John, it's always a pleasure to chat with you, and especially to be interviewed by, and I've enjoyed this discussion. I hope it's been helpful to your audience. Dr. John Sweetenham: I'd also like to thank our listeners for joining us today. You'll find a link to Dr. Raghavan's study in the transcript of this episode. And finally, if you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Thanks, and goodbye. Disclosures: Dr. John Sweetenham: None disclosed. Dr. Derek Raghavan: Consulting or Advisory Role: Gerson Lehrman Group, Caris Life Sciences Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Building a Sustainable Approach for Telemedicine in Cancer Care
24:30Dr. Ana Maria Lopez, professor and vice chair Medical Oncology at the New Jersey division of the Sidney Kimmel Cancer Center – Jefferson Health, discusses the future of telemedicine in cancer care and how to make it sustainable and accessible to all patients and survivors. Transcript: ASCO Daily News: Welcome to the ASCO Daily News Podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. My guest today is Dr. Ana Maria Lopez, a medical oncologist, professor, and Vice Chair of Medical Oncology of the New Jersey division of the Sidney Kimmel Cancer Center, at Jefferson Health. Dr. Lopez is a member of ASCO's Telemedicine Working Group, and joins me to discuss the future of telemedicine in cancer care and how to make it sustainable in the years to come while striving for quality care for all patients and survivors. Dr. Lopez's full disclosures are available on the transcript of this episode, and disclosures relating to all episodes of the podcast can be found on our transcripts at ASCO.org/podcasts. Dr. Lopez, it's great to have you on the podcast today. Dr. Ana Maria Lopez: Thank you so much. Happy to be here. ASCO Daily News: Dr. Lopez, do you think that the COVID-19 pandemic and the increased use of telemedicine will permanently change the way patients with cancer are cared for? Dr. Ana Maria Lopez: You know, I hope so. And the reason I say that is because we've learned a lot. And we've learned that there are ways that we can care for people better at a distance. And so, what we've learned and what we can take forward, I do hope that we'll be able to do. So, for example, we know that a lot of the screening for a cancer clinical trial may be able to be done at a distance. And that way, when the patient actually comes for the appointment, there can be a more rapid entry into the trial. We know that patients may be able to stay at home safely at certain time points--perhaps at time points during survivorship, perhaps if they're doing very well with their treatment. Or if they need an acute assessment, something that needs to be done right away, the camera could be opened, and the conversation can be had. We also have some recent data that being able to care for patients at home may be able to pre-empt some hospitalizations. And to be able to do this with the benefit of telemonitoring, of visual monitoring--that all of these may be very helpful for patients, and may be able to improve their quality of life as well as let us help them with whatever the acute problem is at the time. ASCO Daily News: Absolutely. Those are very positive developments. I know you do have some concerns about disparities in care that emerged during the pandemic. You know, the COVID-19 pandemic exposed a host of disparities in cancer care, including access to telemedicine. During the 2021 ASCO Annual Meeting, you chaired an education session that assessed disparities in digital access and implications for telemedicine. Our listeners will find a link to the session in the transcript of this episode. So, Dr. Lopez, can you tell us about the major barriers to telemedicine that are of concern to you today? Dr. Ana Maria Lopez: Yes. It's really been such a learning experience. You know, telemedicine was really developed to increase access to care. And then to realize during the pandemic that in some situations, telemedicine, telehealth was really a barrier to care. And the reason for that is we used to do telemedicine--for example, a rural patient. The rural patient would go to the local clinic, the local clinic would have this incredible telemedicine setup that maybe included a tele-stethoscope, a tele-otoscope, so that you were really able to do the full exam virtually, with the exception of palpation. And everything was very well set up. But when telemedicine, during the pandemic, really translated--and this began before the pandemic as well, but not to the massive scale. But telemedicine really went to the patient's device. So, the patient needed to have some sort of a smartphone or a tablet, or some device that was connected, preferably, to broadband internet. And not everyone has that. And even if they're in an area where they might have access, it might be spotty in a certain part of the house. Or everybody is trying to get on the network for home schooling, for work. They may not have enough access, enough bandwidth, for the telemedicine appointment. So, access to broadband internet is critical. And then if people had access, their device might not have the right access, or they may not know quite how to get onto their device to get to the telemedicine visit. So digital literacy really came up. You know, we've always talked about literacy. We've talked about numeracy. But now, digital literacy. And we, as clinicians, really needed to advocate for our patients so that they would have the digital literacy to do the telemedicine visit. And I think, actually, also for us, as clinicians, and for the health care team, did education training on the technology, but also on how to engage. You know, there's so many questions that people will have. Well, can I really engage the patient well enough? Can I really make that connection with the patient, which is really what we treasure in the patient/physician relationship? Will I really be able to make that through this machine? And so how can we help people so that they can engage? And again, it may not be the same. But can it provide the care that both parties can really feel, yes, that meets the need at the time? So, I think all of those factors can be important. And they are all, I think, areas that can be overcome. ASCO Daily News: Absolutely. You spoke about access to broadband; you spoke about digital literacy. These things, of course, impact patients in rural settings, [and] older patients. So, it is very important for oncology practices and advocates to be thoroughly aware of best practices, and be knowledgeable about telemedicine tools moving forward to increase access for patients and to help stakeholders learn how to use the tools more effectively. Can you highlight best practices and ways to ensure that clinicians are using telemedicine to best serve the needs of patients and survivors? Dr. Ana Maria Lopez: There's so much in that question. So best practices, I think, we're still learning, which is one of the, I think, great things. I often think of telemedicine as a translational science because we go to the engineers, you know, I've got this problem, and they work it out. And then we can take it back to the bedside, or as some people say, the website, and try it out, really develop these approaches so that they can really help our patients best. But I think what you're pointing to is the real importance of education and training for the clinical teams. Something as simple as, you know, when a patient comes in normally to an appointment, there are vital signs. And again, in the pandemic, in many settings, we didn't have a way to collect those vital signs. So how can we, now that we have our lessons learned, work together to develop processes so patients can do their vital signs at home? Do we send a blood pressure cuff? A pulse-ox often has the heart rate on it. So, do we send these as a little kit? Or do we give these test kits to patients, and educate them on how to take their vital signs at home, so that those data are not missing when we see our patients through telemedicine? I also think when we were talking about engaging earlier, we're taught, in medical school, how to engage with the patient who's sitting next to us. But how do we engage with the patient when our connection is the camera? How do I look at the camera so that the patient--it appears that I'm looking at them, as opposed to looking at their eyes on the screen? So that that's engaging of the patient? I may find myself speaking a little more slowly or pausing more often in order to facilitate that engagement through the telecommunications technology. So, I think there are best practices just from the how to use the technology piece that we need to think about. But also, we need to better understand. What are the areas where telemedicine is most apt? Where do I really feel confident that this is the application to use, and in what situations do I say, you know what? I really need a hands-on approach. And how do I educate so that--let's say I'm following a patient who has a skin lesion. How do I educate the patient to be able to transmit those images faithfully to me, so I can really get a good-quality image, so that my interpretation is clinically appropriate? I think the most important best practice is that we shouldn't think that we're settling. Telemedicine, the technology, has incredible capacity. And if we are ever in doubt as a clinician that, you know, I wish I could do x, or if I had such and such, I would be better able to make this interpretation, if that crosses my mind, then I should see the patient in person. The assessment that I am giving the patient at the time, as a clinician, I should be really comfortable in, whether it's telemedicine, in-person, medicine, telephone, it should really be--I should feel confident. And if I'm not confident, then I should do what I need to do to care for the patient. ASCO Daily News: Absolutely. Is it your sense that oncology practices, [and] smaller community practices, are hearing your call, so to speak, and putting proper trainings in place and follow-up, et cetera? Oncology practices are very busy places. What are your thoughts on this? Dr. Ana Maria Lopez: So, in the same way that--what I said to the med students, you know, is you'll always do the right thing if you put the patient first. Always. Because you'll read, if you're not sure. You'll go talk to a colleague. You'll do what you need to do if you keep your goal the best care of the patient. And similarly, here, if we are going to use telemedicine, then as a clinician, I want to be proficient. I want to do the best job that I can. And so, then I want to get the training that I need in order to get that done. One of the things that we're instituting is, really, new doctors come in. Whenever anybody comes in, you're accustomed to, there is a whole set of learnings that have to happen, right? Because every institution is a little different. And we have our telemedicine trainings that are a part of that. And I think that's really important, because that shows that the health system, that the University system, that the Cancer Center has, as its core, that we understand you may not be 100% proficient at all of this. We don't expect you to. But we expect you to take these learnings and boost your knowledge in this area. ASCO Daily News: Right. In that context, then, of quality care, putting the patient first, how do you think telemedicine will serve patients and survivors in the future? Do you see great improvements in technology? Building better platforms for patients? Do you see these technologies on the horizon? Dr. Ana Maria Lopez: Absolutely. I think we sometimes think, for example--so cancer care. Cancer is a disease, predominantly, of elders, in the sense that as we get older, we're at higher risk for the disease. And as we get older, for example, our eyes age, our hands may become arthritic. Any of these issues could happen to any one of us. And technologies are being developed so that these are easier--so it's easier to maneuver the keypad, so that the lighting is more appropriate. And I think that all patients have a keen interest--and certainly patients that have been diagnosed with cancer--have a keen interest in their health care, and have a keen interest in maximizing their health care. So, bringing to them, you know, here are ways where you can maximize your telemedicine visit is generally very welcome. That sort of education is generally very welcomed by patients. ASCO Daily News: Right. What do you see as the biggest challenges for telemedicine in oncology in the future? There's been the promise of federal funding for these things. What are your thoughts? What what's your checklist for the future? Dr. Ana Maria Lopez: So, one of the things that really helped telemedicine expand as widely as it did during the pandemic and currently is that telemedicine is reimbursed. Very simple. But it's something that we've been working towards for a long time. So, telemedicine reimbursement really needs to continue if telemedicine is to continue. So, advocacy. And ASCO, other professional associations, are certainly at the forefront in advocacy. Reimbursement, tele-education for patients, for clinicians. Broadband, we've talked about. But something that we need to do as a profession is really be able to say, in what way do we want telemedicine to be sustainable in the future? And what will that require? So, for example, things like when patients, let's say, join a practice. Do they receive a telemedicine kit for vital signs? We know, for example, some practices in pediatrics--otitis media are a very common pediatric problem. Parents receive a little otoscope that they can be taught to use, and can have available should they need it. So, for us to really think, what do we need for sustainability? The camera on the phone is now, generally, a pretty high-quality camera. So, in what way can those tools be leveraged to be able to transmit more diagnostic-type images? That's probably not the right term, but images that are of higher quality that one can really make a better interpretation if that is something that's being looked at during a clinical exam. So, we really need to think of sustainability. As you may know, the numbers shot up during the COVID epidemic, the peak of it. We're not past the epidemic. And they have now--telemedicine has not decreased in use in many, many places. So, the easiest thing for us to do as clinical people, as patients, is to just go back to what we're used to. And then we would really lose all the lessons learned. So, I think it's really important to think proactively. Where are the benefits? How can we maximize them? How can we sustain them? ASCO Daily News: You mentioned sustainability. With sustainability in mind, would you agree that further research is necessary to leverage the best of telemedicine in oncology while making changes to improve the patient experience in a sustainable way? And are there any studies, any research, that you're keeping an eye on at the moment? Dr. Ana Maria Lopez: Yes. I think research is critically important to inform telemedicine sustainability, and to think about, really, what are the right applications for future care? And that these are ways, again, to increase access. Fundamentally, this will increase access. So, I think there are many studies to even think of what are the right metrics? What is it that we really are looking at, and what is it that we need to measure? There are things, for example, in cancer care. Cancer care is multidisciplinary by nature. So, there's teleradiology. There's telepathology. In what ways can those services be helpful to the patient, whether the patient is seen in person or at a distance? We've talked a little bit about the access to clinical trials. And again, in what ways can "tele" be integrated in order to increase access to clinical trials? And I think that area, will really blossom. That's an area, again, where hopefully, our lessons learned will not just retreat as something of historical interest. And then is there a right interval, for example, for seeing patients, whether in survivorship, or even during treatment, where you can do an assessment and feel comfortable that if you're doing a visual assessment or if you're doing an assessment that is at a distance with different tools that can do more of the traditional type of physical exam, that we can feel comfortable that that was the right exam? So, these are things that are very concrete, and are very studiable. And I'll give you an example. So, we could have a patient who is being treated for a malignancy. They could have an in-person exam, an in-person assessment, and then they could go into another room and receive a tele-exam, tele-visit, with another clinician. And then the assessments could be compared. Did we get to the same outcome? And is it maybe every other visit that would be comfortable to do at a distance? So, I just think these are really important questions to think about sustainability. And although they may seem very concrete, they're very important to think about how we will carry telemedicine into the future, as well as some of the aspects that we talked about--helping the telemedicine tools be more useful, be more, really, user-friendly for the patient population. And also, to take into consideration that there may be times where the patient, where the clinician, may say, you know, yes, we could do it through telemedicine, but I think it's time for us to see each other face-to-face. And so, too, there's the flexibility to honor the patient's preferences as well. ASCO Daily News: Absolutely. You've raised so many very important [and] interesting points today. Are there any other thoughts you'd like to share before we wrap up the podcast today, Dr. Lopez? Dr. Ana Maria Lopez: One of my favorite images--and I know it's a podcast, so you can't show the image--but there was a cartoon in the front of a magazine that was called “The Radio Doctor.” And I think it was from the 1920s. And I was always so impressed by this because it basically showed a telemedicine setup. And of course, telemedicine didn't happen until much later. And here we are, probably close to 100 years from that image in the front of that magazine, and we're tackling what was visualized, what was envisioned then. So, change, growth, takes time. So, I think that that's really important to remember, that things take time. So sometimes, we may get impatient. At the same time, we want to do it right. And we want to do it with the patient, really, at the center of all of this. So, I very much feel that we've learned a lot of lessons. I look forward to thinking about telemedicine sustainability in cancer care and in clinical care overall. And a part of that work really needs to be working with patients and hearing their voice, and hearing how we can work together so that the clinical experience is as good as [it can be], and there are some data that in certain settings, patients prefer the experience. So, to help us understand what feels better to them, then, and how we can improve the experience overall. So, it's an exciting time. And I look forward to what the future will bring. ASCO Daily News: Indeed. Well, thank you very much, Dr. Lopez, for shining a spotlight on the role of telemedicine in cancer care. Some interesting times ahead. Thank you, Dr. Lopez. Dr. Ana Maria Lopez: Thank you very much. Thank you. ASCO Daily News: And thank you to our listeners for your time today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclosure: Dr. Ana Maria Lopez: None disclosed. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
How Oncologists Can Address Lifestyle Factors in Cancer Care
21:23Transcript: ASCO Daily News: Welcome to the ASCO Daily News podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. The American Cancer Society reports that at least 42% of newly diagnosed cancers in the United States, excluding non-melanoma skin cancer, are potentially avoidable because they are attributable to lifestyle factors. Today we will discuss strategies and resources to help the oncology community focus on health promotion as a key component of cancer risk reduction as well as in survivorship care. Joining me for this discussion are Dr. Amy Comander, the director of breast oncology and cancer survivorship at the MGH Cancer Center in Waltham and at Newton-Wellesley Hospital, and Dr. Poorvi Desai, a hematologist-oncologist at Comprehensive Hematology Oncology in Tampa Bay, Florida. Both Dr. Comander and Dr. Desai are board certified in lifestyle medicine. My guests report no conflicts of interest relating to our topic today. And their full disclosures and those relating to all episodes of the podcast are available on our transcripts at asco.org/podcasts. Dr. Comander and Dr. Desai, it's great to have you on the podcast today. Dr. Amy Comander: Thank you so much for the invitation. Dr. Poorvi Desai: Thank you, it's really great to be here. ASCO Daily News: Dr. Comander and Dr. Desai, you recently co-wrote an interesting editorial featured in the ASCO Daily News that raises concerns about newly diagnosed cancers in the United States that are potentially avoidable because they are attributable to lifestyle factors. You also note that as the population of cancer survivors in the U.S. continues to grow, risk factors for cancer development are becoming more prevalent. So the obesity epidemic in the United States is a huge concern. This is just one risk factor for cancer. Dr. Comander, can you tell us about this and other risk factors and why oncologists should be addressing these risk factors sooner rather than later? Dr. Amy Comander: As you clearly stated, there's increasing prevalence of obesity in this country. And this has troubling consequences in terms of cancer risk and outcomes for specific types of cancer. Interestingly, just this week, we learned data from the annual report to the nation on the status of cancer that, overall, cancer death rates in the United States are declining, especially for lung cancer and melanoma. And this is amazing. And that is due to the incredible advances in treatments that we've witnessed over these past few years. But interestingly, for prostate cancer, colorectal cancer, and female breast cancers, death rates continue to increase or these declines have slowed or even leveled off. And in terms of understanding why that may be the case, it seems that lifestyle factors, such as obesity, lack of physical activity, [and] increased alcohol use, may be risk factors for why we are seeing these results. And therefore, further research will certainly need to be done in this area, but attention to these factors is very important. ASCO Daily News: Well, Dr. Desai, I'd like to ask you about your interest in lifestyle medicine. I understand you became interested in lifestyle medicine during your fellowship training. Can you tell us about this? Dr. Poorvi Desai: Yes, I recently just graduated from my hem-onc fellowship at USF and Moffitt Cancer Center. And I was really impressed during my fellowship looking into all of the data very particularly when it comes to every single different type of cancer. But one thing I thought was lacking was just the overall picture of lifestyle factors, and especially modifiable risk factors, when it comes to pre-survivorship along with things that patients can do during active treatment and in the survivorship phase. And I think that there are structures that are starting to appear to help guide us with more evidence-based data. And so I became very interested, as I had an attending in my internal medicine residency who was a part of lifestyle medicine. And through the American College of Lifestyle Medicine, I met several people around the country who had been working with organizations such as AICR, as well as the World Health Organization, [and] American Cancer Society. And there was a very big push on these lifestyle factors to look at them in a way that is actually studied through evidence and actual guidelines that I was never really taught about throughout my fellowship. So I made it a point to kind of self-teach a lot of this. But I definitely think that there's a role moving forward in bringing this to not just fellowship education but just all of oncology care, whether it's medical oncology, surgical, radiation, but just any oncology care team. ASCO Daily News: Well, you make a really great point. Evidence-based guidelines do exist to help facilitate lifestyle modification in cancer care, but there are barriers to health promotion in cancer care. Dr. Comander, what are the major barriers? Dr. Amy Comander: That's an excellent question because we know this is an important issue. And actually, it was an issue studied recently by ASCO. Dr. Ligibel and colleagues published a paper in 2013 that was a survey of oncologists and their understanding of obesity and other lifestyle factors and how they address these issues in clinic (DOI: 10.14694/EdBook_AM.2013.33.52). And I think we can all say that our colleagues are well aware that obesity and lifestyle factors play an important role in cancer outcome. But in terms of the practical steps of how to address these issues with our patients, how to get our patients to lose weight, how to get our patient to exercise, how to help our patient cut back on alcohol use--those are just some examples--there really are limitations. And in that paper, they really outlined some of the reasons for that. Some of it is lack of education, as Dr. Desai just noted. She sought out teachings and lifestyle medicine as part of her fellowship training. She had to go elsewhere to look for that because it really wasn't part of the standard curriculum. So a lack of education, lack of resources. I'm fortunate to work in a cancer center with excellent oncology colleagues with expertise in nutrition, exercise, et cetera. But we know, in the rest of the country, not every doctor has access to these resources. And the third reason is really lack of clinician time. Our visits are very focused. And often the priority, of course, is discussing the patient's treatment, how is--I'm a breast cancer doctor. How is my patient doing on her endocrine therapy? What kind of side effects is she experiencing? How can I ensure she's complying with her medication? So there really isn't a lot of time to address these issues in a visit. So these are all factors we need to work on. ASCO Daily News: Well, how about solutions? How tough is it to convince patients who are grappling with the physical and emotional toll of cancer treatment to prioritize their nutrition and exercise? Dr. Desai, what do you think are the next steps? What would you say to oncologists who really do need to pay more attention to this? Dr. Poorvi Desai: So I think that one of the biggest things to take out of our article is that oncologists don't need to carry the burden of doing this by themselves. I think that while it does take a lot of resources, which is a big constraint, especially financially, I do think that there is a lot of worth in building a care team that's dedicated towards this. Or if that's not possible, then seeking out community, local, or national resources and kind of bringing together any other structure that's already in place and having a good referral to those areas, so that patients do understand that it is important to continue physical activity and working on nutrition. And I definitely think that it's something that patients feel they can have some control over. I think a lot of oncologists don't feel qualified to talk about these things because they are not very well taught in our education. And so I think then a lot of patients in this realm of lifestyle feel on their own in trying to figure out what's good for them, what's not good for them. There's a lot of misinformation online and unsolicited advice that can be given to our patients. There's a lot of fear around foods and what the right type of activity is. And I think that the more evidence-based information that we have to provide to our patients, we can be more confident in making these suggestions. And again, we don't--as oncologists, we don't need to be the ones who are actually doing all the counseling, doing all of this, making sure that they have their exercise prescriptions or whatever it may be, but at least acknowledging that this should be a part of the care team and seeking out resources that the care team can then take over. So that in conjunction with active treatment or in conjunction with survivorship care, this then becomes something that patients feel they have some kind of control over. And I also think that it's important that we don't over-promise and under-deliver as well. I think that it's important to show patients that these are things that are as important as their active treatment to pay attention to, but also as oncologists start becoming more comfortable with the idea of risk reduction and having the information to back up our claims that lifestyle is of the utmost important in cancer. ASCO Daily News: Absolutely. Dr. Comander, do you have any thoughts on this? Is it more difficult to do what Dr. Desai has described in a community practice than where you are in a larger institution? Dr. Amy Comander: I think Dr. Desai answered that question beautifully. I will add that, as an oncologist, what we say makes such an impression on our patients. Often our patients are recording what we say, or they have a family member with them writing down everything we say. So if we just tell our patient, it's really important for you to exercise--and that might just mean a 10 minute walk each day or walking to the mailbox to get the mail, starting with something very basic in terms of exercise counseling--can make a big difference. And so I think just the fact that, as Dr. Desai just stated, a doctor acknowledging that exercise has a role, nutrition has a role, stress management has a role, I think just that simple act has a big impact on our patients. And it's very important. ASCO Daily News: Indeed. Well, patients and survivors often grapple with depression, anxiety, fear of recurrence, financial issues, and more. Sleep disorders and insomnia can interfere with adherence to a nutrition plan or an exercise regime. Are there helpful tools available, or what are the helpful tools available to oncology practices to help them address these issues with their patients? Dr. Amy Comander: I think that's a really important question. We know that distress screening is actually incorporated into each visit. And that's recommended through the NCCN guidelines really to assess these issues you just inquired about--coping skills, anxiety, depression, financial issues, et cetera. So certainly, it's very important to ask our patients about these issues and refer them to appropriate colleagues, whether that's a mental health provider or social worker, to help address these concerns. I will also acknowledge ASCO has a number of great resources to help guide patients to. The website Cancer.Net has many resources that help patients find perhaps something in the community that could help them address these specific concerns. Dr. Desai, I'm interested in your comments as well. Dr. Poorvi Desai: I absolutely agree with you. I think that the NCCN is doing a really great job in compiling a comprehensive set of resources in their survivorship guidelines. There is that distress assessment thermometer that we had addressed in our article. We definitely understand that these psychosocial evaluations are pretty much of utmost importance. There's a lot of anxiety and distress that comes with a cancer diagnosis. And we know that it lasts. It has an impact that's lifelong. And so definitely one of the big pillars of lifestyle medicine is stress and social connectivity. And so we definitely are an advocate for having mental health professionals as a part of the care team and looking at mental and physical well-being going hand-in-hand. And I think one of the biggest things to understand is that we have to meet our patients where they are. And so we don't want to advocate for anybody saying, OK, now you have to exercise five times a day strenuously, and you have to eat perfectly, and all of these things that can be extremely overwhelming. And so I think that there are great guidelines. And I think the NCCN Survivorship Panel has put together a good amount of resources for us to show patients how to work on mindfulness strategies and sort of systematically work them through a very difficult diagnosis in order to slowly, but surely, result in those healthy lifestyle changes. I like to tell my patients that it's a marathon, not a sprint. Any progress is good progress. You don't have to be perfect. And I think that's definitely something that we should be mindful of when we talk about changing lifestyle behaviors. ASCO Daily News: Right. Dr. Comander, do you think there is a role for increased collaboration between oncology providers and primary care providers in the context of cancer survivorship, for example? Survivors might see their oncologists every few months, every 6 months, every year, but who is monitoring the hypertension, the weight gain? Who should own that responsibility, or is it a collaboration? Dr. Amy Comander: That's a great question. And as you stated at the beginning, thankfully due to advances in treatment and screening, the number of cancer survivors in this country is increasing greatly each year. And therefore, it is very important that we have a strong collaboration with our primary care colleagues in terms of providing excellent care for our patients following completion of primary treatment. So in my practice, it definitely is a collaboration. I'm fortunate to work with so many wonderful primary care physicians [and] we work together in terms of monitoring our patients' blood pressure, risk for cardiovascular disease, risk for diabetes and other chronic diseases, and certainly when it comes to other lifestyle interventions, such as weight management, management of substance abuse, et cetera. So that collaboration is really key. And I see primary care providers already playing a huge role in survivorship care. And I think that will continue to grow in time to come. ASCO Daily News: Well, as you said, the number of cancer survivors continues to grow. It's projected to increase to 22 million in the United States by 2030. So do you think the focus on lifestyle medicine will increase in the future? Let's start with Dr. Desai. Dr. Poorvi Desai: Yeah, I think that this has to become one of the major things that we regard. I think that most oncologists are very aware that our treatments are--they have long term consequences. We had mentioned in our article that there are two major themes to look at when it comes to survivorship care. One is infection-related mortality. But the other big one, which is what we focused on, was lifestyle--cardiovascular disease, cerebrovascular disease, accelerated aging with telomere shortening and metabolic changes that happen after cancer diagnosis and the treatments that patients receive. So a lot of what we are subjecting our patients to is truly aging in nature. And we have evidence to suggest that we can work on these lifestyle modifications as the forefront way to really help them overcome the fact that we have given them radiation to their chest or cardiotoxic medications, or whatever it may be. And that when they are overweight or obese, this can then further accelerate that process of metabolic aging. I think one of the things that's really important to talk about is assessing metabolic health. And so not just looking at their BMI, but how does their BMI actually break down into metabolic patterns? How much of this is bone density or muscle weight? We put patients a lot on hormonal treatments, which can then affect their fracture risk moving forward. And I think that we are very well aware of that. And so these are the things that should really be assessed because, like we've mentioned, one of the biggest reasons for, I guess, moving forward with the number of cancer survivors that we're going to have, a lot of it--the focus needs to shift, basically, to long term chronic disease management, in which lifestyle really does play a huge role. ASCO Daily News: Absolutely. Dr. Comander, is there anything else that you'd like to share before we wrap up the podcast today? I certainly do think your article pointed out the importance of using evidence-based guidelines to strive for the best possible outcomes for survivors and patients to prevent newly diagnosed cancers. Dr. Amy Comander: Yes, I think, as summarized in our article, we did provide resources that can help our colleagues address these concerns with our patients, since, again, some of us have not been educated about these topics during our medical training. So in addition to the excellent resources provided by ASCO, I would really refer our listeners to the AICR website, American Institute for Cancer Research. In addition, the American Cancer Society is playing a role in helping provide further education about the role of nutrition and physical activity in cancer survivorship. So the American Cancer Society is a great resource, as is the American College of Sports Medicine when it comes to exercise recommendations. And on their website, they have some great graphics that really illustrate what the recommendations are for exercise and what the benefits are for cancer survivors as well. And finally, we referred to the NCCN during this podcast. And of course, their guidelines are excellent and address these lifestyle behaviors as well. So I would just highlight those resources for our listeners in case they want to get more information. ASCO Daily News: Absolutely, some great resources there. Well, thank you, Dr. Comander and Dr. Desai, very much for sharing your valuable insight with us today on the ASCO Daily News podcast. Our listeners will find a link to your article in our show notes. Thank you very much. Dr. Amy Comander: Thank you so much for the invitation. Dr. Poorvi Desai: Thank you so much. ASCO Daily News: And thank you to our listeners for your time today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclosures: Dr. Amy Comander: Consulting or Advisory Role: Advance Medical, CRICO Harvard Risk Management Foundation, Harvard University Consulting or Advisory Role (immediate family member): Applied Genetic Technologies Corporation, Beam Therapeutics, Biogen, Inc., Blue Cross Blue Shield Association, Editas Medicine, GenSight Biologics, infiniteMD, RBC Investments, Sanofi SA, Vedere 1, WAVE Life Sciences Dr. Poorvi Desai: None disclosed. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Integrating Hopefulness Into Cancer Care With Dr. Ben Corn
28:31Transcript: Dr. Ben Corn, professor of Oncology at Hebrew University of Jerusalem Medical School, and deputy director of the Shaare Zedek Medical Center, discusses his current research with NRG Oncology and SWOG on the study of the science of hope, and it's role as a mediator in well-being and health care improvement. Dr. Corn is co-founder and CEO of the NGO, Life's Door, which teaches health professionals, patients and others strategies for hope, meaning and well-being throughout illness and at the end-of-life. Transcript ASCO Daily News: Welcome to the ASCO Daily News Podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. Our guest today is Dr. Benjamin Corn, a professor of oncology at the Hebrew University of Jerusalem Medical School and deputy director of the Shaare Zedek Medical Center. Dr. Corn is the co-founder and chairman of the nonprofit organization Life's Door, which teaches health professionals, patients, and caregivers strategies for hope, meaning, and well-being throughout illness and at the end of life. Dr. Corn was honored with the 2021 ASCO Humanitarian Award and joins me to discuss his work, including his current research on the study of the science of hope and its role as a mediator in well-being and health care improvement. Dr. Corn's full disclosures are available in our show notes, and transcripts for all episodes are available at asco.org/podcasts. Dr. Corn, it's great to have you on the podcast. Dr. Benjamin Corn: It's a pleasure to be here, and thank you very much, Geraldine. ASCO Daily News: Dr. Corn, can you tell us about the experiences early on in your personal life and then your medical training that prompted your interest in helping patients find hope and meaning while navigating cancer treatment? Dr. Benjamin Corn: Sure. I think everyone has a story that sent them on their way for a career in medicine, which for many of us is not a job. It's not a career. It's a mission. My personal story had to do with losing a parent, my dad, at a very young age. He died of prostate cancer, left behind three young children and a lovely widow, who was my mom. And I was quite disappointed with the way the system tried to cope with the reality that was now forced upon us. There were no viable options for somebody with metastatic prostate cancer then. But yet, there was not a cognizance of some of the psychological trauma that we would all have in trying to navigate our daily lives. And I was very surprised also the way my dad's death was communicated to the family. And I've spoken about this in a variety of podcast settings and written a piece for the JCO narrative section about 10 years ago on that, some of what I found to be harshness, coldness of telling us that our dad was not going to make it and how the bad news was conveyed (PMID: 24733795). And so, with that, I was an 11-year-old child, and I very much was intent on curing this thing called prostate cancer to make sure other middle-aged men wouldn't suffer from it, and their families wouldn't have to pick up the pieces. And I went to medical school. I entered my residency in oncology at University of Pennsylvania, thinking that that was my destiny. And when I got to the wards, I was quite disillusioned because I saw a variety of scenarios that told me things hadn't changed drastically in 7 or 8 years since losing my dad and initiating my medical studies. I saw many cases of senior attending physicians, who were fantastic scientists, brilliant researchers, and yet didn't seem to pay enough attention to the subtleties of making sure that a family was whole, bringing in other resources. This was right before what I would call a palliative care revolution. We didn't have the Tamil paper, the Zimmermann paper, the Bakitas paper. And we didn't really know the value of early interventions with teams that included not only oncologists but also nurses and psychologists, chaplains, who could help navigate such a difficult period for patients and for the people in the concentric circles around those patients. So it was very important for me to begin to explore those issues. I never found it to be a conflict for pursuing an academic career that asks bread-and-butter questions about disease, areas of interest. I published a lot in gynecologic malignancy, in prostate cancer itself, and in central nervous system tumors. But by the same token, I thought it was very important to be looking at the psychosocial dynamics that are involved. And that's pretty much the genesis of how I got interested in this area. ASCO Daily News: Well, your work integrating hopefulness into cancer care has had an important impact even on communities beyond the medical setting. Can you tell us about this work, about the hope enhancement model, and how you've used this approach to train medical professionals, patients, and caregivers? Dr. Benjamin Corn: Well, first of all, I want to say that, in many ways, even though I've been blessed with having terrific education at outstanding institutions of higher learning, my greatest teachers have really been the patients, and I'll bet you most colleagues would say the same thing. And I noticed there was a subset of patients who were very intuitively aware of what was important to them, patients for whom the prognosis was very bleak and yet managed to maintain hopefulness. And I saw that the common thread for these patients was that, even though they couldn't be hopeful for cure, they could still find other goals, other objectives that they could pursue. And that sent me on a quest of sorts to see if anybody had formally tried teaching people how to become more hopeful. And with not too much effort, I found literature of Professor Rick Snyder from University of Kansas. It basically modeled this notion of hope theory. And without turning this into a lecture, very briefly, Snyder said that there are three conditions that will allow hopefulness to thrive. The first is defining a goal. And by that, he meant some kind of an objective that was not only plausible but also that could provide meaning in one's life. So it would be a good goal in hope theory if I said my goal is to win the lottery tomorrow because that's really not anything I can have an impact on, so it's not really statistically plausible. But likewise, if I took a goal that was just very mundane and didn't add that much purpose to my life, it would be out there, and I'd be interested in pursuing it. But I probably wouldn't have the same degree of motivation if I thought about something that, without too much effort, could really make my day or make the day of the people around me. So, the first thing was the goals that have these two criteria--plausibility and meaning. The second is a pathway to get to the goal. And when Snyder discusses pathways of thinking, he's supposedly speaking to a mature audience and saying none of us were born yesterday. We all realize that on almost every path that we travel on during our lifetimes, we see that there are obstacles. The question is, how do we manage and circumvent those obstacles, or how do we dance with those obstacles if, in fact, it's something very much within me, an obstacle such as anger, an obstacle such as jealousy? How do I deal with those particular factors? A hopeful person is a creative person, is a resourceful person, who finds a way to sally forth even when these obstacles are out there. So we have goals. We have pathways. And finally, the other secret sauce that I mentioned before is motivation. The word that Snyder used for motivation is called "agency." Agentic thinking, like almost an agent that might represent an NBA basketball player or a Hollywood movie star. That agent will do everything on behalf of his or her colleague so that they'll succeed. And so to the person who has an agentic way of seeing the world is going to be an activist, is going to want to set out on those trails, those pathways, to reach those goals. So those are the three components. And what we found is that--and this is based on some work that was done by one of Snyder's proteges, Dr. David Feldman, who's at Santa Clara University--one could actually construct workshops that are very palatable, that take less than 2 hours to conduct, in which a tool called hope mapping is used. Hope maps are basically dependent on those three components. So you can actually sit there in dyads, buddying up with people in this workshop, people who you know before the workshop, or people who you meet in the workshop, because there's a similarity, a selection for those who attend such workshops. People want to work together. And it's a wonderful energy, because let's say, as I said before, I have a goal, and I have a pathway. But there's a big, bad obstacle there, and I don't know how to get around it. What could be that my buddy in the workshop is going to say, "You know what, Ben? Here's a great way. You might not have thought about this. Why don't we contemplate creating a workaround?" And they're very, very instructive. And we've done some of these workshops now, both in Israel, where I practice, as you mentioned at the opening, and with colleagues at Johns Hopkins in Baltimore with really thought leaders in hopefulness--Tom Smith, who has for many years written the ASCO guidelines on palliative care, and Anna Ferguson, who is the coordinator of the hope enhancement program at Hopkins. And together, we've proven, especially in a population of women suffering from stage IV breast cancer, that we really can invest 2 hours or less and make them much more hopeful. Now, you mentioned in your question that some of this has an impact on communities beyond the medical setting, and that's exactly what's been happening. As the word has trickled out, especially during the COVID pandemic, we've been approached by a variety of communities on the international level--communities in London, communities in Athens, communities in South Africa, communities in the Pacific Rim--who are very interested in bringing together different strata within those communities, perhaps people who have recently become married or people who have recently become parents, who have a similar set of struggles, and to help us help them become more hopeful, especially when you add on to that a little something called COVID-19. So I'm an oncologist. I think there's tremendous upside for this in the setting of cancer care for patients and for the health care professionals who have the privilege of treating these patients. But the spillover phenomenon has really been marvelous to behold, especially during 2020. ASCO Daily News: Well, you're also collaborating with the National Cancer Institute groups of NRG Oncology and the Southwest Oncology Group to study the science of hope and its role as a mediator in well-being and health care improvement. Can you tell us about this research? Dr. Benjamin Corn: Sure. So in the context of NRG Oncology, there are two protocols. One is called CC003 (NCT02635009). That's a protocol for patients with small cell lung cancer. And another one is a protocol called BN005, which is a protocol for individuals with, I guess, what we want to call low-grade gliomas, to look at neuroanatomic loci that could constitute a source for hopefulness (NCT03180502). I'll just give you one example, which is from the small cell lung cancer study I mentioned before. So in years past, at least, it's been a standard of care to provide prophylactic cranial irradiation--that is, prevention with radiation--where there's a tumor, small cell lung cancer, that has a proclivity to spread to the brain. And so one of the hot areas that has emerged in radiation research over the last decade is hippocampal avoidance. It seems trivial, but it took us a while to understand how to protect concentric circles, such as, let's say, the spinal cord when treating the vertebral body or to protect the hippocampus when treating the whole brain. So in prophylactic cranial irradiation, we typically treat the whole brain. And a randomized trial was developed by NRG investigators, where the randomization was between prophylactic cranial irradiation itself to 25 Gray in 10 fractions versus that same regimen with hippocampal avoidance. Now, when I saw that study design, I actually put forward the idea that this could be a wonderful model to study the neuroanatomic correlative hopefulness because there are several candidate anatomic structures in the brain, which are thought to be associated with hopefulness. No one, by the way, is saying that the circuitry is so primitive that all of hopefulness resides in one structure. But if I had to say that there's a lead candidate that's been identified in the literature, it's exactly the hippocampus. So the proposal to the NRG committee and to the PI of the protocol, Dr. Vinai Gondi, and the head of the brain tumor committee, Dr. Minesh Mehta, was, could we very simply administer one of the validated scales for hopefulness that was built by Snyder. It has all of 12 questions. It takes about 5 minutes to complete. Give that to a patient at baseline, then have them randomly assigned to either prophylactic cranial irradiation of the whole brain or the same treatment wherein the hippocampus is protected. Re-challenge the patients 6 months after the irradiation is completed, and see if there is less of a decrement in hopefulness on these validated scales among the group that had the hippocampus protected. When you compare the hopefulness among the groups that didn't have the hippocampus protected, that would offer some interesting, at least circumstantial, evidence that the hippocampus is implicated in the hope pathways. And so this has been very interesting to NRG Oncology. We've enrolled now over 250 patients en route to 300 patients. We have very meticulous quality assurance, where the co-investigators sit down once a month and make sure that the hippocampus was properly contoured and protected. And in the other study, we're looking at particular dosimetric analyses in case someone thinks that 25 Gray might be, for instance, below the threshold of hippocampal tolerance. There, we'll look at a variety of doses to see where we might see the correlation with hippocampal toxicity and decrements in hopefulness. So those are two variations of ideas that are on burners in NRG Oncology. SWOG has taken a different tack. And here, I want to truly applaud SWOG leadership, the group chair of SWOG, Dr. Charles Blanke, as well as the leaders in the palliative care movement at SWOG, including Mark O'Rourke, Marie Bakitas, and Ishwaria Subbiah, who have said, "Look, we know that you've got some preliminary pilot data on the impact of a hope workshop for patients with cancer. Can we, first of all, look at this now among the SWOG investigators?" That had never been done before. In other words, we talk all the time about levels of burnout among health care providers who are treating a patient with cancer. It's very gratifying on the one hand, but it's very challenging on the other hand. It can even be demoralizing for some, and as you know, there are very high rates of burnout. So they've been very interested, first of all, in meticulously establishing levels of hopefulness at baseline and correlating that with levels of burnout among SWOG investigators. So by "investigators," I'm talking about physicians, nursing professionals, even patient advocates. And we have some data that were just recently published in JCO Oncology Practice (DOI: 10.1200/OP.20.00990). In addition, we've been very interested in offering now these hope enhancement workshops that I told you about before to the SWOG investigators. So in the month of May, we got together every Monday night--at least for me, it was Monday night at midnight, I have to say, which was about 5:00 PM Eastern time. And we did these 2-hour workshops every week for about a dozen SWOG investigators. And we actually have some data right now that we just submitted to the ASCO Quality Conference, showing the feedback we got from the SWOG investigators. And to me, the most encouraging part was that these investigators were so enamored of these techniques and found them to be so useful that they--almost all wanted to find ways to bring them into their own clinical environment to share them with their patients, wanted to learn how to become facilitators of such workshops to also help prophylax burnout and increase hopefulness among their colleagues. So SWOG has taken the tack of using this intervention to help providers. We're soon going to be trying to do it among the patients and roll it on to our protocols. And there, what we want to do is take meaty, challenging questions. Let's say the question of adherence, a situation where perhaps women who need endocrine therapy are somewhat--want to take the endocrine therapy but are somewhat reluctant to be adherent to the regimen because of all the hormonal side effects. So we want to see if we can use our workshop to align this value of a patient and this motivation with the patient to help them, in fact, become very adherent, because as I'm sure you know, upwards of 40% of these patients just don't want to take these therapies. So we're interested in using this for adherence. And we're also interested in using it as a tool for medical decision making. We give a lot of lip service to the idea of shared decision making between provider and patient, but most of us haven't really been trained in how to have a robust experience that helps me as a provider understanding what my patient wants. When I counsel patients with prostate cancer, it's almost impossible for me to do such a consultation in less than 90 minutes because there's such a range of options. And before I can really get to understanding which of those options might be most appropriate for a patient, I have to really know the patient. I have to know, in the case of prostate cancer, what makes him tick. And so I think there's going to be tremendous upside for these hope enhancement techniques, not just using it for hope's sake but also for these other epiphenomenon in medicine, like adherence and like decision making, that we speak about all the time, but I wonder to what extent we're really committed to doing a better job on those parameters. ASCO Daily News: Right. Do you see a role for technology to grow hope enhancement workshops, to make them accessible to more people in other parts of the world, in other medical settings? How do you think technology has changed the way people confront the experience of illness? And what role do you think you can play in this? Dr. Benjamin Corn: Yeah. Well, I guess all of us were brought in very rapidly, sometimes kicking and screaming, into this new era. And health care providers are smart, and they're resourceful, and they've figured out a way to ride this challenging wave that COVID has brought into our lives, this tsunami, if you will. So COVID has pushed us all into digital health. My organization, Life's Door, which developed an application, a smartphone app, called Hopetimize--kind of a play on the words "hope" and "optimize"--in other words, the idea is to optimize your life with using these hope techniques I described before. So we had a game plan to get to digital work in the year 2022. That was a strategy that we basically developed about 5 years ago. When COVID came along, we realized that we had this wonderful product called hope enhancement workshops that we thought could really help oncologists who we thought could help their patients. But we couldn't get people together because of the new criteria for social distancing. So what was once a tailor-made concept for intimate settings with 15 people, I can tell you that even in our IRB-approved protocol--and people can see this on nih.gov, clinicaltrials.gov--our protocol specifies the kind of environment one has to have to conduct these workshops when you're doing it face to face. But that just couldn't happen for a full year, maybe a little bit more than that. So we very quickly developed the smartphone app, and we found a way to move our entire workshop to a Zoom platform. And we'll have some data that we'll be sharing that basically says that we can do it just as well with the Zoom platform as doing it face to face. And what's more, it gives more people access to the technology. It allows for more sustainability because we're not only using Zoom, we're using different social media outlets. Most of the literature on hope enhancement--it's sometimes called hope augmentation--can demonstrate a spike in hopefulness after such an intervention. But the challenge then becomes how to sustain that hopefulness, and that's not easy. Well, by creating these digital communities of hopefulness, with the aid of different social media, we think that maybe this is exactly how we can deal with the sustainability question. And finally, this kind of technology gives us scalability. I mentioned before that we've been approached by groups around the world, throughout Europe, now throughout Asia, parts of Africa, not to mention North America. Haven't heard much from South America and Antarctica now that I'm thinking about it, so we're waiting for you guys. But we could never--all of us--I'm a busy physician as well. So there's a limit to how many times my colleagues would have to cover me when I say, "Oh, I'm off on another trip, teaching these hope techniques to people." But once we have it on Zoom platform, and we can bring, let's say, 15 to 20 people into the experience by bringing them into a Zoom room, I don't have to go anywhere. I can do it right from my living room, just like they're in their living room. And it sounds very simple, but I don't think anybody would have really imagined that we could be on our way like this if you sat down to contemplate this upside of 2019. ASCO Daily News: Right. And do you feel the response from the oncology community, from your peers across the world, has been quite positive? Scientists are sometimes skeptical about things such as hope enhancement techniques. Or have you found that not to be the case? Dr. Benjamin Corn: Yeah. That--so there's another example. I think that a barrier is the working assumptions of, let's say, my colleagues--let's say, me myself before I got into it. I mean, we're trained in a truly biological, scientific model. We talk about a biopsychosocial model, sometimes a biopsychosocial narrative model, but at its core, we pride ourselves as being scientists, and this kind of an idea was very off-putting to a lot of people. When we started publishing on this and the word got out that there were actually reproducible results showing that we can enhance hopefulness, people said, "Wait a second. I'm having a problem myself with patients who are just not hopeful." "Wait a second. I'm having a problem myself with my own burnout and my own compassion fatigue." And these colleagues have been seeking this out now in droves. And what our challenge has been right now is to be training facilitators so that we can really fan out and make sure that we answer this need of people saying, "I want to learn these techniques." Again, not just hope for hope's sake--I mean, I'm for hope. But for all the other upsides that we mentioned before--anti-burnout, increased adherence, probably bettered medical decision making--I think these are the motivators for people as opposed to just saying, "Make me more hopeful." So whatever gets you to the workshop, I couldn't care less. Everybody comes with their own reasons. That's always quite fascinating to hear why somebody decided to enroll in one of our workshops. But once people are there, most of them find that they really benefited from it. Typically, if we do a workshop with 20 people, the next day, we'll get a third to 40% of the participants saying, "You know what? I love this so much. I took these techniques, and I called in my children after dinner, and we talked about their goals and what struggles they're having in trying to reach the goals." So to me, that's very touching. And to get through your earlier question about the impact of this thing in communities outside of medicine, I think we're really on the cusp of forming what I like to describe as communities of hopefulness. And I think, again, we saw that in the COVID era. There was, in particular, a community in London that was very interested and brought us in also for a series of four workshops. And one of the things that we're working on right now in a hospital setting is what we call the seal of hopefulness. And that's based on, when I was growing up, this notion of the Good Housekeeping Seal of Approval. Well, we want to be able to approach hospitals and to say, "Just like you like to go through the accreditation process, perhaps you want to go through this process of making your staff more hopeful." Patients pick up on these things. So imagine, Geraldine, a world in which the physicians were taking care of you and the people you love, the nurses, the orderlies who bring them down to CT scans and the MRI. There's a lot of time that a patient in a hospital spends outside his or her bed. Imagine if en route to having a study, which you're very anxious about, you have somebody who's been trained and knows how to speak to you about your goals and your value. I think that would be the kind of environment I'd want to be taken care of in. I mean, of course I want to know that the knowledge base is top shelf. But could you imagine if there was this hope seal on the door that said, "People here really give a damn. They care about you, not just your tumor, and that is their commitment." I think that can be very reassuring. And we've begun to pitch that idea to hospital administrators, both in Israel, where I'm based, and in large-scale hospitals both on the community level and the academic level in the U.S. and Canada. ASCO Daily News: Excellent. Thank you so much, Dr. Corn, for telling us about your innovative work today. You really seem to be having a great impact. And I thank you very much for taking the time today. Dr. Benjamin Corn: Thank you. It was a pleasure. ASCO Daily News: And thank you to our listeners for your time today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclosures: Dr. Ben Corn: None disclosed. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Tailoring Care to the Unique Needs of AYA Patients and Survivors
37:06Dr. David Freyer, professor of clinical pediatrics at the University of Southern California; Dr. Michael Roth, director of the AYA Program and Childhood Cancer Survivorship Program at The University of Texas MD Anderson Cancer Center; and onco-fertility expert Dr. Leslie Appiah, associate professor of Obstetrics and Gynaecology at the University of Colorado Anschutz, weigh in on the challenges and advances in care for adolescents and young adults with cancer and survivors. Transcript ASCO Daily News: Welcome to the ASCO Daily News Podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. On today's episode, we'll discuss the unique challenges facing adolescents and young adults with cancer. I'm delighted to welcome three experts for this discussion. Dr. David Freyer is a professor of clinical pediatrics, medicine, and preventive medicine at the University of Southern California's Keck School of Medicine. Dr. Michael Roth is director of the AYA Program and Childhood Cancer Survivorship Program at The MD Anderson Cancer Center. And Dr. Leslie Appiah is associate professor of obstetrics and gynecology and director of the Fertility Preservation and Reproductive Late Effects Program at the University of Colorado and Children's Hospital Colorado. My guests report no conflicts of interest relating to our discussion today, and full disclosures relating to all episodes of the podcast are available on our transcripts at ASCO.org/podcasts. Dr. Freyer, Dr. Appiah, and Dr. Roth, it's great to have you on the podcast today. Dr. David Freyer: Thanks, Geraldine. It's really great to be here. Dr. Leslie Appiah: Thank you for having us. It's our pleasure. Dr. Michael Roth: Yeah, really great to be here. ASCO Daily News: So today we're highlighting some of the issues and strategies you all presented during the ASCO Annual Meeting that addressed equity issues and strategies to improve outcomes for AYAs. Our listeners will find a link to the presentation in the transcript of this episode. Dr. Freyer, there are approximately 89,000 AYA patients diagnosed with cancer in this country each year. Tell us about the challenges they confront and why they're so vulnerable to health care disparities. Dr. David Freyer: Absolutely. I'd like to say, first of all, thanks, Geraldine, for the opportunity for us to participate in this podcast. I think, as your question points out, AYAs who developed cancer are in a sort of double jeopardy, because not only of the challenges of cancer, but also their life stage where there's so much change and vulnerability. Normal changes for AYA life stage differ across the spectrum. 15 to 39 years is a very broad range. And at the younger age, I would say in the 15 to 21-year-old group, these challenges commonly involve education. It's finishing high school, possibly education or trade school, pursuing a career or vocation, expanding and reorienting their social network from their nuclear family, experiencing serious relationships for the first time, and then starting to explore intimacy and sexuality. For that younger group, self-image and physical appearance is very, very important. And there's overall a move toward greater personal autonomy and independence. When you get into the middle years, roughly [ages] 22 to 29, I would say that the issues begin to take on a financial character. It's becoming financially independent, paying for housing, starting or maintaining their own health insurance, maybe having their first meaningful employment. And a great many in this group are saddled with substantial debt from previous education. And then in this age group, they're starting to identify significant partners for the first time. And then finally, in the later years, roughly [ages] 30 to 39, the concerns really begin to focus on career advancement, maintaining a home life, starting or building families, raising children, taking on new financial obligations of adulthood like owning a home. And interestingly and importantly, some in that latter phase, we're seeing more and more, are beginning to feel the pinch from above as they're beginning to take care of unwell or older dependent parents who also need the financial support of this normally productive age group. So there's this developmental continuum. And to add cancer on top of all of that is, to say the least, highly disruptive. So even the experience of being treated for AYA cancers that have a good prognosis, and many do nowadays, it still interrupts education, delays career starts and return to work, upends their social networks, [and] undercuts their independence. They revert to being dependent on their nuclear family, and they have enormous financial burden. And then on top of all of that, of course, many of these patients are dealing with long-term health problems, because they have late effects from their treatment. And so to get your point about why this is an equity issue, I think that this session is perfect for this 2021 ASCO meeting actually, because AYAs, it's a cancer population that's defined by age. It's characterized by life stage dependent challenges. And so for that reason, they're systematically disadvantaged in ways that other cancer populations are not. And that's the definition of health care disparity. So they need special support in all these areas. And as a final note, I would say that AYAs who represent other disadvantaged cancer populations, such as low income or racial and ethnic minorities, I mean, they're actually in triple jeopardy, because they're at the intersection of their age, cancer, and also their background social status. ASCO Daily News: Absolutely. AYAs confront a host of disparities. AYAs frequently identify fertility threat as a major concern, and many patients have suffered fertility loss due to the effects of treatment. Thankfully, there continues to be much progress in fertility preservation, but not everyone has access to this care. Dr. Appiah, you've done a lot of work in onco-fertility and have even engaged with legislators to help pass bills mandating insurance coverage of fertility preservation for patients with cancer. Can you tell us about best practices in fertility preservation and your concerns that not all patients and survivors have access to available technologies? Dr. Leslie Appiah: Thank you, Geraldine, for that question. As you stated, with 80,000 plus AYA patients being diagnosed a year, we know that there are approximately 100,000 survivors. And so survivors are living longer. Up to 75% of them will experience at least one adverse event or late effect of their cancer therapy. Infertility, as you stated, is the most prevalent, one of the most discussed reproductive late effects in the literature, affecting up to 12% and 66% of female and childhood cancer survivors respectively. And then in addition to the infertility or fertility-related effects, there are other reproductive late effects that cancer survivors experience. And so as in many aspects of adolescence and young adult care, disparities also exist in onco-fertility or fertility preservation. The governing bodies of our societies--so the American Society for Reproductive Medicine, the American Society of Clinical Oncology--have all put out consensus statements describing how we should be caring for this population and how we should be providing equal care to these patients (DOI: 10.1200/JCO.2018.78.1914). And all of the societies or the guidelines recommend that physicians inform every patient of reproductive age about the risk of therapies to fertility and the options for fertility preservation. And by reproductive age, we mean from birth through, typically, for women age 42 and our male counterparts can be fertile much later into 50s and 60s. And so all of these patients should be counseled about the risks and then referred or offered the opportunity to see a reproductive specialist for further counseling, and that this really should occur before any treatment is provided. We know that once patients receive any cancer therapies that our options are limited in terms of what we can provide them for fertility preservation. So this conversation should occur regardless of the patient's age, gender, culture, socioeconomic status, or health care team bias. And these discussions should continue into survivorship, because even at the end of therapy, there may be some options for these patients. Despite recommendations, however, less than 50% of patients ever recall having these discussions with their providers, and then less than 30% of patients go on to use fertility preservation therapies. This disparity is sometimes due to information overload. Many times the patients don't recall the discussion, even though the discussion was had. But really when we look at the data, many times they are not being offered this information. We know that in terms of disparities, men are more often referred for counseling and referred for fertility preservation therapies because of the idea that it's easier to bank. And for those men who are feeling well and are of age, sperm banking can be a simple process. But many of these patients are very ill, and so extracting sperm becomes an issue for them and it becomes very challenging. We know that patients with fewer financial resources are less likely to be offered fertility preservation counseling. So our patients in the lower socioeconomic statuses, these patients are less likely to be referred. And again, that's not providing equitable care. There are many resources available for patients that can provide some financial resources. And so these patients really should be given the opportunity to have a discussion and seek resources, or we can provide options for them. And then lastly, I'll say that in terms of disparities, cultural biases play a huge part in this. Our providers come with their own biases as to how many children they feel that a family should have, and that can be a bias. Sometimes prognosis can be a form of bias. If the patients have a poor prognosis, then perhaps the provider is uncomfortable referring them for fertility preservation therapy. But there are some options for patients if they should succumb to their cancer diagnosis, there are some posthumous reproductive options that our young adults can participate in or agree to. And it requires a lot of legal discussion and documentation and contracts, but there are options. And we really should be providing our patients the opportunity to decline these options. And in that way, we can really address the disparities in fertility preservation for our patients. And then lastly, I will say cost is a factor, but there are I think now 13 states with insurance mandates for fertility preservation. And these mandates are starting to occur more and more often. And so we need to continue to push our legislatures to move the needle forward in this way. ASCO Daily News: Can you highlight some of the new technologies in fertility preservation that oncologists should be aware of? Dr. Leslie Appiah: Absolutely. I think two of the very important aspects of this is that we are able to provide fertility preservation for adolescents in terms of egg freezing. So until recently, we limited this option for girls who were 18 and older or late adolescents, but we now can provide egg freezing for girls once they reach puberty, and especially once they are monarchal or have achieved menses. And so that is something that we really want our oncology colleagues to know. It's also important for our colleagues to understand that we can start for egg freezing at any point in the patient's menstrual cycle. Historically, the patient needed to be on their cycle in order to stimulate, but now we have random start protocols. So if we see a patient today, we can start stimulating tomorrow or the next day. And the average number of days to stimulate the ovaries to be able to grow eggs to freeze is about 10 to 12 days. And so we really can intervene for these patients if we are informed of their diagnosis very early. And in that way, there will be no delay in their cancer therapies. And then lastly, we are very excited to share that ovarian tissue freezing is no longer experimental. As of December 2019, the experimental ban was lifted by the American Society for Reproductive Medicine and ASCO. And so patients from birth through age 40 can have an ovary removed, or part of an over removed, and frozen for their future fertility. And this is considered clinical care. We're able to put this through the insurance, and therefore alleviate the financial burden on many of our families. ASCO Daily News: That's great, Dr. Appiah. Thanks for highlighting these positive developments in fertility preservation. Managing the care of AYA patients and survivors as they age and deal with toxicities from treatment and other physical and mental health issues requires collaboration between providers. Dr. Roth, can you share some strategies to address the unique challenges of AYAs and the providers who care for them through various phases of their lives? Dr. Michael Roth: Thank you, Geraldine, for that important question. As Dr. Appiah and Dr. Freyer clearly noted, AYAs face many unique challenges both during and after cancer treatment. And it really is essential that, as medical providers, we seek to meet and treat these challenges. Unfortunately, the system as it's currently set up is really not well suited to care for some of these unique needs. Specifically, many of our younger AYAs who deal with cancer such as leukemias and lymphomas, they're treated within the pediatric oncology department. And often, the approach to their care is focused on the care of younger children. On the flip side, many patients in their 30s with breast cancer, colorectal cancer, these AYAs are treated within the medical oncology community and are often seen in clinics with many older adults. So most of the care across the country is not specifically tailored to the unique needs of AYAs, and that's really where collaboration comes specifically into play. We know that there are many opportunities to address these psychosocial needs, the education and work needs, the onco-fertility needs, the genetic counseling needs of our AYAs, but it really takes a champion, or a number of champions, at each site to ensure that AYAs needs are prioritized. Recently, there has been a large growth in the number of AYA programs. And what a number of institutions have done is they've brought medical oncology together with pediatric oncology to centralize these specific AYA resources under one house. Some of these AYA programs are treatment-based programs. For example, some sites have an AYA heme-malignancy program, where they will provide both the cancer care, as well as the supportive care required for their AYA patients with leukemias and lymphomas. Other AYA programs are purely supportive care-based programs, where patients will be referred to them for their onco-fertility needs, for their psychosocial health needs, for their education and work needs as well. At the end of the day, we really just need to do what's right for our patients. And we've learned over many, many years that just treating our AYAs the same as we treat our younger children, or just treating our AYAs the same as we treat our older adults, doesn't cut it. And we really need tailored, focused approaches to make sure that we both optimize cure rates, as well as to optimize health-related quality of life for these patients both during and long after treatment. ASCO Daily News: Right. So Dr. Roth, what will it take to improve collaboration between providers? Dr. Michael Roth: Cancer care is traditionally very siloed. And these silos do decrease the rate of progress in which we can make within cancer care. But specifically within AYA oncology, historically, pediatric oncologists did not interact much with medical oncologist. By having AYA tumor boards, by having more multidisciplinary clinics, essentially you're taking down those barriers. You're breaking down those walls. And being face to face, or now in the virtual world, being able to connect and to collaborate, it really allows the optimization of care for our AYAs. It's not possible to know everything about every AYA oncology diagnosis. And when you're in a large academic center, you often have many subspecialists within each of the different cancer types. When you're in a smaller community setting, oftentimes you have more generalists who take care of all patients with a large number of diagnoses. And often in the community settings, there aren't many specialists who focus on AYAs with breast cancer or young adults with colorectal cancer. And oftentimes, it really takes teamwork and a real consensus and an approach within a team setting to make sure that both the cancer-directed care is appropriate and is the most appropriate treatment approach, but also there's a need to focus on that health-related quality of life, and specifically that often gets lost for many of our patients during their treatment. Dr. Leslie Appiah: We are also finding that when we incorporate our fertility preservation colleagues, our experts, into the multidisciplinary oncology meetings that were also able to break down those silos and help educate our colleagues about fertility options for patients as they are diagnosed. And that really does expedite the care that we provide to these patients. We also want to look at leveraging technology to improve how we incorporate fertility preservation into oncology care and using our best practice advisories within our Epic systems, as well as using the Epic referral process to really expedite the referrals of patients. And by that I mean, there are ways to do an opt-out referral system where the referral is automatic, unless the oncologist opts out of that referral. And in order to opt-out, the oncologists will have the discussion with the patient about their fertility risk and then recommend consultation. And the patient can then decline, and that's when the provider would opt-out of that consult. So utilizing technology that we have already can really expedite the care for these patients and break down some of those barriers. ASCO Daily News: Absolutely. Well, there's a huge need for more research on AYAs. Dr. Freyer, how does clinical trial accrual among AYAs compare to older patients? Are there any innovative strategies that could improve trial accrual among this patient population? Dr. David Freyer: This is a really important issue, and I'm glad you raised it, Geraldine. So clearly, to continue advancement of AYA oncology and really every realm, whether it's survival or supportive care, more epidemiology studies, studies on basic biology questions about cancer types in this age group, long-term outcomes, and so forth, we can't make any advancements in AYA or any other age without conducting the research. Clinical trials for many years have been sort of the heart and soul of clinical oncology science, because it's actually testing new questions, new therapies, and following in an organized way the outcomes of the patients who are enrolled in clinical trials. The problem is that the proportion of AYA patients who are enrolled in clinical trials is exceedingly low. The gold standard, I think, or benchmark for clinical trial enrollment actually tends to be children, pediatric oncology, which for decades has been very, very successful at enrolling patients on clinical trials. And they have improved survival and improved knowledge around cancer to show for that effort. So most studies--there's a little bit of variation--but most studies indicate that about 20% to 40%, at any given time, of children enroll on a clinical trial if they're newly diagnosed with cancer. For AYAs, that number is less than 10%, usually more around 5%. And that's actually similar to older adults. The drop off occurs sometime between 15 and 20 years of age in terms of enrollment on clinical trials. So the question is, how can AYA patients--how can the picture be shifted to look more like that of younger children? And it turns out, I think it's really a complicated scenario. There's multiple levels to this problem. Part of the challenge is having the right kinds of trials available for the diseases that occur in adolescents and young adults. And then another layer is getting those trials that are developed by the, say, the National--the NCTN Oncology groups getting those opened up at the sites where the AYA patients are being treated. There are a lot of barriers that institutions need to overcome in order to get those trials opened up. And if they can be opened up, then they're available to the AYA patients. But it doesn't stop there. Then the next step is that you've got to get those trials presented to the AYA patients. So the pediatric or medical oncologist that's taking care of the children--or excuse me, the AYA patients--need to be aware of these trials. They need to have access to research infrastructure that can make it feasible to offer these and enroll the patients. And then finally, of course, the AYA patient himself or herself needs to be convinced that this is the right thing for them to do and to go ahead an enroll on the clinical trial. So there's multiple steps to this. And clearly, addressing any single step won't ensure that more AYAs are being enrolled into clinical trials. So it requires a multi-level, multipronged approach. I think, in terms of innovative strategies, again, it's all of these things at one time. So on the national level, there's a good deal of work being done to try to increase the collaboration across the different NCTN groups--the National Cancer Institute (NCI) National Clinical Trials Network groups, the adult groups, and children's oncology group--to increase collaboration across those groups. So that there are more trials being opened that are appropriate for that entire spectrum of 15 to 39 years of age, which, as Dr. Roth pointed out earlier, cannot be addressed without collaboration between the pediatric and the medical oncology groups. So trying to pull those together. And then on the delivery end to the patient, trying to find better ways to support our oncologists and to make the information about clinical trials more digestible, more maybe less threatening, more understandable to AYA patients, so that they can make a good, well-informed decision for themselves. Perhaps the least exciting for most of us, but in some ways maybe the most crucial and the most overlooked, is that middle stage of getting these trials opened at the sites. That requires resources to get these passed through the IRBs at the institutions. It takes resources to have clinical research coordinators there to shepherd them through the regulatory processes and then to make those readily available to the practicing oncologists. I think at the local level, that's where some of the greatest challenges are. And I think one of the factors that sort of feeds and aggravates or exacerbates the health disparities issue for AYA patients is where these patients are being treated. There are a number of studies that show that AYAs tend to be treated at community sites rather than traditional academic centers. And that's wonderful in terms of making health care accessible to these patients in their home communities. There's a lot to be said for that actually. But one of the features of that treatment setting that may undercut the clinical trial question at least is that some sites, many of them, don't necessarily participate in a regular way or have fewer resources to participate in the clinical trial enterprise. So those patients, if they're treated in the convenience of their home community, they may not have access to the same sorts of clinical trials of those who are treated in academic centers. We need to figure out a way to overcome those kinds of challenges. It's not easy. ASCO Daily News: Right. Dr. Roth, what are your thoughts on clinical trials for AYAs? Dr. Michael Roth: So a couple of the layers that Dr. Freyer addressed in terms of barriers to enrolling more AYAs in clinical trials, I do think at the national level, we've made a lot of progress over the past decade with these collaborations within the NCTN network groups. Currently, we have a record number of truly AYA collaborative trials open and available for our sites to be able to have available for their local patient population. And like Dr. Freyer said, a lot of these trials, they're really getting stuck at the local level because, in many ways, there's not an incentive to open the AYA trials when you have limited resources, because it's easier to enroll many more patients on the prostate cancer trial or the older adult breast cancer trial just due to patient numbers. So we really do need to overcome that large barrier of when we have trials available at the national level, they need to be opened up at all sites really across the board to make sure that our AYAs have access. The other point on the local level is to address the challenges we have in lack of knowledge on disparities in AYA enrollment and care. And we've tried to overcome that by having local AYA site champions, having folks on the ground really spreading knowledge. These folks typically are investigators, sometimes they work in the research office. And their goal is to help prioritize the opening, activation, and enrollment on AYA specific trials. There's still a lot of work to be done. It's a complex situation, but I do believe we are chipping away at many of these issues. ASCO Daily News: Great. I'd just like to wrap up with a final question about models of survivorship care delivery. So AYA patients who complete treatment need to be supported. They need appropriate follow up to monitor treatment-related health problems and psychosocial support. Dr. Freyer, what are the models of survivorship care delivery that can successfully address these needs? Dr. David Freyer: I think, again, similar to the clinical trial situation that we just discussed, I think that survivorship care for this population--in other words, patients treated during the 15 to 39-year-old age group--is in a process of emerging and growing and taking many of its leads from the pediatric oncology experience. Survivorship care in pediatric oncology is well established. It's been now decades in the development. And there's been a huge amount of research, really high quality research, done to map out the spectrum of late effects of cancer treatment, both medical and psychosocial, for patients who are treated. Those children then grow up into adulthood and they become AYA patients, but they were treated as younger children. So that landscape is pretty well mapped out, and there are excellent models of care in place around the country. That has now become the standard of care in pediatric oncology for comprehensive holistic care of these patients long term. That situation is emerging in AYA oncology--in other words, for patients treated in the 15 to 39-year-old age group. Of course, part of what drove that in pediatrics is that survival rates improved so dramatically that these issues were staring oncologists in the face. And it was absolutely necessary to deal with it. It's taken a little bit longer for survival to come up to those levels in AYA and older adults, but we're there in many cases. And with the high survival now that we're seeing in the AYA age group, the same question is begging itself as was in pediatric oncology, which is now we've got these patients who have completed treatment with all of the problems that you just mentioned. I mean, many do very, very well. And it's important not to paint a more negative picture than is warranted, but I think the data are beginning to show that many long-term survivors of AYA cancer also deal with health problems that are getting superimposed on the normal problems of aging that all human beings develop over time. Now how to deliver that, again, the experience is just emerging. I think that different centers have developed programs that sort of play to their own strengths and overcome their own challenges, just like Dr. Roth said with AYA programs and I'm sure Dr. Appiah could say about fertility preservation programs. Every place has its own experience of one. And while there are some common themes, there are some things that need to be addressed that are individual. I think probably the basic requirements for a survivorship care model for AYA patients is having somebody, a champion, who has some expertise in this area, commitment on the part of the facility to put together at least the basic resources to begin to bring these patients together. There are different kinds of models. The models can be doing survivorship care in the context of each disease team. Breast cancer may have their own survivorship focus, colorectal cancer, leukemias and lymphoma, and so forth. And they may be delivered within the context of the diseases or another model is, I would say, more the classic pediatric model, which is to have a survivorship clinic that can meet the needs across these different diagnoses. And it's important for each program to determine these for themselves. I'll put one final closing pitch in for the clinical research, which is needed in this area as well. Just as clinical trials are needed to improve survival with treatment and also our understanding of these diseases and the cancer hosts that the AYA [patients] represents, there's also a need for research in the long-term as well. And the best way to do that is in the context of survivorship efforts that are organized and have resources like databases and participation in larger cohort studies, so that we can begin to amass the data in the same way that we've done for children. Dr. Michael Roth: So, I completely agree with Dr. Freyer. I think AYA survivorship is still in its infancy. And we're really only learning now about what happens to our patients diagnosed as AYAs with cancer in 15 years, 20 years. What are some of the cardiovascular events that are happening in these patients as they age into their 50s, early 60s? I think there's a real need for standardization of how we care for our AYAs post-treatment based on exposures, based on cancer diagnoses. And currently, with the models in place for survivorship within some of the large institutions, there's a lack of standardization across departments, and then across institutions as well. There really are no set guidelines as to how do we monitor for cardiotoxicity. What should we be doing in terms of monitoring for psychosocial health concerns? And I worry even more, as you go into the community setting, that many of these sites don't have the resources to offer expert survivorship care. As Dr. Freyer mentioned, this is really a plug, a call to action, to focus more attention on our patients' lives, not just during treatment but well beyond treatment. We know that 5-year overall survival for AYAs is approximately 85%. So the majority of our AYAs diagnosed with cancer will live long and well past beyond their cancer diagnosis. And it really is essential that we help them live long, healthy, and happy and productive lives. Dr. Leslie Appiah: And I will add one final word to that. So the U.S. news and World Report reporting system has now started to include fertility preservation as a marker of providing excellent care in the children's hospitals. And of course, that's going to go into the adolescent population as well. So I think that's one impetus for our colleagues and our institutions to really make this a priority. Additionally, as Dr. Roth stated, using national databases, where we can really bring together all of the information so that we can standardize how we care for this population, is really important. And the University of Colorado is developing a national database in fertility preservation as a data coordinating center for the Oncofertility Consortium and will be including various sites across the country, so that we can start to look at this data longitudinally. And then lastly, I would say, again, leveraging technology. I don't think that, in medicine, we utilize technology the way that we should. And I think using our electronic medical record to signal to us, as fertility specialists, when a patient has completed their treatment and they are in survivorship, this is a time for us to intervene again into this patient's care and to make sure we've really addressed all of their fertility and reproductive and gynecologic/urologic needs that they are going to experience. So those are the ways that I think we can incorporate better fertility preservation care into the survivorship care model. ASCO Daily News: Excellent. Thank you, Dr. Appiah. And thank you, Dr. Roth and Dr. Freyer as well, for highlighting the challenges facing AYAs and approaches in care for this patient population. Dr. David Freyer: Thank you, Geraldine. Dr. Leslie Appiah: Thank you for having us. It's been a pleasure. Dr. Michael Roth: Thank you so much. ASCO Daily News: And thank you to our listeners for joining us today. If you've enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclosures: Dr. Michael Roth Research Funding: Eisai, Pfizer Dr. David Freyer: None disclosed. Dr. Leslie Appiah: None disclosed. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Addressing Gender Disparities In The Global Oncology Workforce and Sexual Harassment
13:48On today’s episode, Dr. Pamela Kunz, director of the Center for Gastrointestinal Cancers at the Yale School of Medicine, and vice chief of Diversity, Equity and Inclusion for Medical Oncology at Yale, discusses compelling sessions from the 2021 ASCO Annual Meeting that addressed gender disparities in the global oncology workforce and sexual harassment experienced by oncologists. Transcript: ASCO Daily News: Welcome to the ASCO Daily News Podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. My guest today is Dr. Pamela Kunz, an associate professor of medicine in the division of oncology at the Yale School of Medicine where she also serves as the director of the Center for Gastrointestinal Cancers. Dr. Kunz also serves as the vice chief of Diversity, Equity, and Inclusion for medical oncology at Yale. Today, Dr. Kunz will highlight strategies to dismantle gender disparities in the global oncology workforce featured at the 2021 ASCO Annual Meeting. She will also tell us about the first study in oncology to systemically characterize the incidence of sexual harassment experienced by oncologists. Dr. Kunz reports no conflicts of interest relating to our discussion today and her full disclosures are available on the transcript of this episode. Dr. Kunz, welcome back; it's great to have you on the podcast again. Dr. Pamela Kunz: Thank you so much. My pleasure to be here. ASCO Daily News: The theme of the 2021 ASCO Annual Meeting was Equity. Every Patient. Everyday. Everywhere. Equity issues also apply to the oncology workforce and there were some very interesting discussions at the meeting on workplace disparities and harassment. You chaired an education session on dismantling gender disparities in the global oncology workforce. This session brought together a really interesting and diverse panel of experts in medicine. They discussed compelling data around gender disparities and steps to diversify leadership in medicine. They also looked at the role of male allies and how allies and advocates can support all women, and shared strategies on how to activate and empower female leaders. Can you tell us more about this session? ("Dismantling Gender Disparities in the Global Oncology Workforce Together"). Dr. Pamela Kunz: Sure. This was--thank you for asking about that session. I think that really the theme of equity permeated so many different aspects of this Annual Meeting. And I think it was really inspiring and I think incredibly helpful to think about really reimagining how we provide cancer care. And I think I really like to think of workforce disparities as the other side of the same coin of patient disparities or inequities in patient care. I think that in order for us to provide equitable patient care, we really have to provide and create a diverse, inclusive, and equitable workforce. And so this is really one aspect of that is around gender disparities or, of course, other disparities in the workforce. And we actually do touch on that in one of the talks. So we put together a diverse panel that represents a number of different viewpoints. They were not all oncologists. In fact, I was the only medical oncologist on. Dr. Reshma Jagsi is a radiation oncologist. And Dr. Hannah Valentine is a cardiologist who was previously at the National Institutes of Health (NIH) and the inaugural director of their diversity program. Dr. Leon McDougle also spoke. He's a family medicine physician, the current president of the National Medical Association. And Mrs. Dee Anna Smith is the CEO of Sarah Cannon Research Institute. So we had this really incredibly diverse group of perspectives. And as you mentioned, we really touched on a whole variety of topics. I think it's also worth just mentioning kind of the scenes for this. This session originated well over 2 years ago. And I think that the timing of this now happening in 2021 following the pandemic I think was really incredibly important. I think we didn't really recognize it at the time. We were supposed to do this session last year in 2020. And it was really the 2020 planning committee that approved the session with Dr. Howard Skip Burris and Dr. Tatiana Prowell and Dr. Melissa Johnson. We had all these conversations of how do we get men in the room to talk about gender disparities? And we really crafted this panel to try to address a diverse audience and get everyone in the room. And then it was really so well timed with Dr. Pierce's ASCO theme of equity for every patient, every day, everywhere. It really just tied in nicely. ASCO Daily News: Excellent. What are the key takeaways here for oncologists? Dr. Pamela Kunz: Sure. I can add some of that. I think that the first--and this was really addressed by Dr. Reshma Jagsi--is that we need to collect the data. We need to measure evidence of disparities at our institutions, in our organizations in order to really know where we're starting and in order to know how we're getting better. We have a lot of objective data already. But I think that I want to challenge all of our listeners to think about how can we be better about collecting that data in our own institutions. I think that the takeaways from Dr. Valentine's talk were some really wonderful concrete solutions to diversify the workforce. She took some lessons learned from programs she initiated at the NIH. And I'd like to specifically highlight a program at the NIH called the Scientific Workforce Diversity Toolkit. And in that, they instituted a program for cohort hiring in the Distinguished Scholars program. And this was bringing together a diverse group of underrepresented minorities and women into this scholars program. And they demonstrated really increased rates of female tenure track investigators. And I think that we can all do that in our institutions and organizations by instituting cohort hiring. From Dr. Leon McDougle's talk, he really highlighted this concept of intersectional feminism. And this term was coined by Kimberle Crenshaw. She's a professor of law at Columbia University. And it speaks to the fact that many marginalized characteristics or people who are in underrepresented groups may have characteristics that intersect. So that includes gender, age, sexuality, education, race, culture, ethnicity. And if any one person has a number of these characteristics, they may, in fact, increase the burden on that individual and may increase their risk for discrimination and for disparities. And I think it's recognizing the intersection. Intersectionality happens. And our women of color and our women who may have these other marginalized characteristics may be especially at risk. He also talked about a program at the Ohio State where he is on faculty entitled Advocates and Allies. And it's a National Science Foundation-funded program that trains men how to be advocates and allies. And then lastly, Miss. Dee Anna Smith spoke about creating a tapestry of allyship. She had this beautiful visual metaphor of really bringing together not just mentors. It's sort of modernizing the idea of mentorship and to really thinking more about allyship and how our trainees need to bring together, yes, perhaps mentors, but that allies really can represent an alternative to mentorship and a tapestry meaning that you need more than one person to serve as an ally for you. So I think those were--it it truly was--I moderated. I think these folks did all of the work in presenting. But it was really inspiring and I think very solution focused. ASCO Daily News: Well, you were also the discussant of session that addressed a new study, Abstract 11001 on sexual harassment of oncologists. Now, few studies have used comprehensive validated measures to investigate the incidence and impact of workplace sexual harassment experienced by physicians and none, according to the authors of this study, by oncologists. So this is really important. What can you tell us about it? Dr. Pamela Kunz: Yes, absolutely. And I think the points that you made already really make this important and validate it. And I think the findings then in and of themselves are quite striking. So this group of authors led by Dr. Ishwaria Subbiah conducted a study. It was a cross-sectional survey of ASCO's research survey pool. And they then used the sexual experiences questionnaire, which is a validated questionnaire, as you mentioned. And this is really I think a real strength of the study. And they examined various aspects of sexual harassment. I think it's important for our listeners to understand the definition of sexual harassment. So this includes gender harassment, unwanted sexual attention, and sexual coercion. And gender harassment includes things that if we use the iceberg analogy, which they included in their presentation and was so nicely described in the NASEM, the National Academies of Science Engineering and Medicine report from 2018, the iceberg really underneath the surface contains many of these aspects of gender harassment that go unnoticed and unrecognized and include things like microaggressions. And in this study, they evaluated four downstream domains impacted by workplace sexual harassment including mental health, job satisfaction, sense of safety at work, and turnover intentions, meaning if an individual planned on leaving that specific job. And they looked at incidents of sexual harassment both by perpetrator, so institutional insiders or patients and families, and then by type of sexual harassment. So they received about a 30% response rate. They had 304 practicing oncologists access the survey link. And 273 provided responses. And I'll just hit some of the take-homes. So I think what I was struck by is the high rate of sexual harassment when the perpetrator is an institutional insider. So those are peers or supervisors. 70% of physicians reported one or more incidences of sexual harassment. This was higher in women. So, 80% of women reported sexual harassment compared to 56% of men. So, that was statistically different. But I was really struck by the fact that men were experiencing this as well. And then in terms of sexual harassment incidents when the perpetrator was a family or patient, 53% of physicians reported one or more incidences of sexual harassment. And this was 67% for women and 35% for men, also statistically significant. In terms of that difference. And then really a significant downstream impact from these experiences both for physicians who experienced this harassment from institutional insiders or from patients and families. And I think that we saw that really across the board for mental health, workplace safety, job satisfaction, and turnover intentions. And I think the take home for our listeners is that this can really lead to a significant loss of talent. And I think that if we are really hoping to--see, this is me editorializing. We are hoping to improve the diversity of our workforce because we know that that leads to better patient care and better patient outcomes. This is really important for our workforce to try to tackle and solve this problem of sexual harassment. ASCO Daily News: Absolutely. Well, thank you, Dr. Kunz, for highlighting some really important issues in oncology today. Dr. Pamela Kunz: Thank you so much. ASCO Daily News: Our listeners will find links to the two sessions discussed today on the transcript of this episode. And thank you to our listeners for joining us today. If you enjoyed this episode, please take a moment to rate and review us wherever you get your podcasts. Disclosures: Dr. Pamela Kunz Stock and Other Ownership Interests: Guardant Health Consulting or Advisory Role: Ipsen, Lexicon, SunPharma, Acrotech Biopharma, Novartis (Advanced Accelerator Applications) Research Funding (institution): Lexicon, Ipsen, Xencor, Brahms (Thermo Fisher Scientific), Novartis (Advanced Accelerator Applications) Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Therapeutic Advances in Multiple Myeloma Featured at #ASCO21
27:32Dr. Mitul Gandhi, medical oncologist-hematologist at Virginia Cancer Specialists of the US Oncology Network, highlights therapeutic advances in multiple myeloma featured at the 2021 ASCO Annual Meeting. Transcript: ASCO Daily News: Welcome to the ASCO Daily News Podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. My guest today is Dr. Mitul Gandhi, a medical oncologist specializing in hematologic malignancies at Virginia Cancer Specialists, which is part of the US Oncology Network. Dr. Gandhi will discuss therapeutic advances in multiple myeloma featured at the 2021 ASCO Annual Meeting. He reports no conflicts of interest relating to our discussion today, and full disclosures relating to all episodes of the podcast are available on our transcripts at asco.org/podcasts. Dr. Gandhi, welcome to the ASCO Daily News podcast. Dr. Mitul Gandhi: Thank you for having me. ASCO Daily News: Let's first look at the OPTIMUM MUKnine trial. It's Abstract 8001. And it reported high overall response rates in patients with ultra high-risk multiple myeloma with Dara-CVRd induction therapy. What are your takeaways from this study, Dr. Gandhi? Dr. Mitul Gandhi: Sure. So, the OPTIMUM study was conducted by the UK group, and it's noteworthy for several reasons. The way they had constructed the trial, they designed and developed a platform primarily to enrich for a predefined subset of very high-risk individuals, whether it was through a set of genetic assessment or with central gene expression profiling. And the way the trial was conducted, while patients were waiting to ascertain the results of the gene expression profiling (GEP) they could receive two cycles of bridging therapy. Once those results were furnished or they met the cytogenetic risk criteria, patients who subsequently consented to the intervention protocol which was a dose intensified regimen, five drug regimen, incorporating daratumumab, cyclophosphamide, bortezomib, lenalidomide, and dexamethasone. So, patients would receive induction for up to six cycles, and that would include the two cycles of potential bridging therapy as GEP was being evaluated on an every 21 day basis. And then this was followed by a modified conditioning regimen consisting of high-dose melphalan at 200 milligrams per meter squared along with weekly bortezomib which was continued even following autologous stem cell rescue, really until count recovery. Subsequently, patients received an additional six cycles of daratumumab, bortezomib, revlimid, or lenalidomide followed by 12 cycles of daratumumab and rituximab until progression. This was a complex study design with an intensified induction consolidation and maintenance phase, but it did yield a impressively high OR rate, or overall response rate, at 94% with very good partial response or greater seen in 77% after assessment following autologous transplantation, including 46% complete response (CR). And of those with CR, they had identified 63% achieving MRD negativity as well. And I think the authors should be commended for one, enriching a high-risk subset of patients both on conventional cytogenetics and/or GDP, and then two, utilizing the most active agents that we currently have to elicit high responses and then to consolidate on those following transplant. I think some of the take homes from the study are the ability to demonstrate feasibility of central genomic risk stratification related to more precisely identify and select high-risk patients as this is kind of an area of unmet need of where to augment therapy appropriately. I think it's still a question whether or not this is the exact dose intensified regimen that's going to elicit the best long-term outcomes in these highest risk patients and whether or not the conventional surrogates for a long-term progression-free survival (PFS) benefits such as MRD really apply to this as there is some controversy regarding that. Nonetheless, I think this offers a kind of a reproducible platform that can be emulated to identify the highest risk patients. You can do that prospectively, and then to selectively incorporate the most active agents and potentially the next generation of novel agents, including immunomodulators, cellular therapy, bi-specific antibodies earlier in the treatment course, and really try to elicit the deepest initial response and hopefully see that translate into longer term durable control. So, this was a complex study design that was impressively executed, and again with an ability to enrich for the highest risk subsets. ASCO Daily News: Excellent. Thanks for sharing your takeaways from the OPTIMUM trial. Well let's focus on the phase II CARTITUDE-2 study. That's Abstract 8013. This study reported that deep and early responses were yielded with a single infusion of cilta-cel in patients who had received one to three prior lines of therapy for multiple myeloma. What are your thoughts on this trial? Dr. Mitul Gandhi: So, Dr. Usmani presented the CARTITUDE-2 update on behalf of his co-collaborators. And the listeners probably are aware of some of the preliminary data that was presented at ASH as well in 2020, but this is a phase I/II protocol. Currently the phase II data are being presented with a proprietary CAR T platform which has two BCMA single domain antibodies on the CAR T construct along with a co-stimulator domain. And as kind of summarized in the title, the single dose was infused. So, amongst 113 patients who were initially recruited, 97 ultimately were treated with some fallout attributed to progressive disease. Like many of the other CAR T studies, this was a uniformly high-risk and heavily pretreated population. Median age was 61. High-risk cytogenetics were in 23% of patients. And there was about 20% of patients who had harbored plasma cytomas as well. Response rates were impressively high at almost 98%, and 67% obtaining a stringent complete response (CR). Much like the other CAR T experience, response continued to deepen over time. And encouragingly, duration of response was actually not reached time of presentation. Kind of amplifying the depth of response, of the patients assessable for MRD, 93% had achieved an MRD negative state at a sensitivity of 10 to the minus fifth cells, leading to a 12-month PFS of 77% and an OS of 89%. So, these are all welcome numbers and response data, again, in a heavily pretreated population who have been exposed to what we believe all the more active agents in the disease. In parallel with kind of response, with particularly with CAR T is the toxicity data. And encouragingly, while CRS, or cytokine release syndrome, which is typified in CAR T therapy was seen in about 95% of patients, only 4% had grade 3 to 4 CRS. So, on the whole, quite manageable. Median time to onset was 7 days with duration of 4 days and resolved with appropriate medical therapy, including tocilizumab. They did report one patient who had grade 5 CRS with hemophagocytic lymphohistiocytosis (HLH) with the remainder, I was summarizing kind of the low level of grade 3, 4 experience. There was additionally neurotoxicity and 21%, with 10% having grade 3 or higher. Again, resolved with supportive care measures. So, in totality this builds on the CAR T experience with high response rates, deep response, rates including achievement of stringent CR and high rates of MRD negativity with only a single dose of CAR T cells infused, again amplifying the efficacy of this platform on a heavily pretreated population and potentially allowing for extended treatment-free intervals as well or options for retreating in people who don't achieve MRD with a manageable toxicity profile at experienced centers. Certainly there's still work that's going to be done to better delineate the extent of CRS and how to appropriately treat that along with the neurotoxicity, but along with several other abstracts presented at this meeting and meetings prior, builds on the CAR T experience, knowledge rapidly coming to the forefront in myeloma therapy. ASCO Daily News: Great. So, some good developments for previously treated patients. Well, now I'd like to focus on newly diagnosed multiple myeloma. Let's look at the CARDAMON trial, Abstract 8000, and the FORTE trial, Abstract 8002. These studies explored novel therapies that are emerging for newly diagnosed multiple myeloma. So in their presentations, these trial investigators seem to question the value of standard of care autologous stem cell transplant (ASCT). So do you think these new data call into question the advantages of the up front ASCT approach in newly diagnosed multiple myeloma? Dr. Mitul Gandhi: That's a great question. And as providers in the myeloma community know, there's still an ongoing debate whether or not to ubiquitously apply a high dose melphalan conditioning and stem cell rescue across the spectrum of all patients with myeloma who are transplant eligible or reserving it for certain patients or not. Some of this is borne out of saving unnecessarily aggressive therapy, who would otherwise achieve an excellent response of induction. Along with some concern for secondary genotoxic effects imparted by the melphalan itself and perhaps propagating more biologically aggressive subclones. And to that end, these two abstracts explored whether or not transplant-free approaches would be feasible. So, the CARDAMON study enrolled 281 patients where all patients received kyprolis, cyclophosphamide, and dexamethasone for four cycles, and of those patients achieving at least a partial response (PR), they were subsequently randomly assigned to continuous KCd or autologous stem cell transplant. And what the authors concluded, KCd induction followed by KCd maintenance was not inferior to autologous stem cell transplant with PFS at 2 years measured at 70% versus 76%, and that difference meeting the criteria that was prespecified in terms of their confidence interval for noninferiority. So, on the surface you could argue based on the results that were presented that there was equivalence. But a few caveats that are important to bring up, the first was that follow-up was short. It was only two years, and so it's very plausible that with longer follow up, the noninferiority that was seen may not be borne out with extended follow up. The other point the author's note was that MRD negativity was higher in the autologous stem cell group at 53% compared to 35.8% of the non-transplant group. And various studies have reported this to be a reasonable surrogate for long-term PFS, not always. And so again highlights the fact that with longer follow up, we may see a separation of the curves. Their subset analyses did not demonstrate any obvious areas, rather a subset of patients that would have derived preferential benefit, although the numbers were quite small. So, while an initial conclusion may be that there was a relative equivalence for a transplant-free approach, I'd argue that it's probably still a bit premature to make that conclusion and noninferiority may not be identical with longer follow up. And additionally, this probably is an induction regimen that is not as commonly employed in the U.S. But it does again help to the body of literature regarding this question of transplant for all versus not, although there may be hopefully more discriminatory power to see where it would be beneficial. The FORTE study presented by Dr. Gay and her colleagues was a bit larger at 464 patients and slightly different. Patients were randomly assigned to one of three arms, carfilzomib plus cyclophosphamide plus dexamethasone for four cycles induction followed by autologous stem cell rescue, carfilzomib, lenalidomide, dexamethasone induction for four cell cycles followed by autologous stem cell rescue, or carfilzomib, lenalidomide, dexamethasone without autologous stem cell for 12 cycles. So, those were the three arms, and then there was a second randomization to lenalidomide versus lenalidomide plus carfilzomib maintenance. Patients were prespecified in terms of their cohorts of high-risk, standard risk, or the so-called double hit which was people, patients rather, harboring two high-risk cytogenetic features. And so what the authors concluded that across the board, the arm containing carfilzomib, lenalidomide, dexamethasone with autologous stem cell rescue demonstrated superior PFS compared to all of the other, rather, the other two arms. And similarly intensification of maintenance incorporating kyprolis plus revlimid resulted in superior 3 year PFS compared to revlimid alone in 90% versus 73%. So what do we take away from this? Well, it's not a conventional induction approach in the U.S., with RVd still predominantly being used, particularly after the endurance data was presented at last year's ASCO showing equivalence of a bortezomib induction strategy versus carfilzomib strategy. It does support and lend credence to the use of high dose melphalan autologous stem cell rescue as patients who are in this arm seem to enjoy a more longer and durable progression-free survival across all subsets, including standard risk, high-risk, and the double hit strategy. So there wasn't any particular subset that could be identified that would have performed equally well with KRd alone without autologous stem cell rescue. Putting these two abstracts together, I would still argue that there remains a very important role for our high dose melphalan and autologous stem cell rescue currently an induction, rather following induction, in appropriately selected patients. And while we may not have identified patients on preselected criteria based on their cytogenetic risk, it's conceivable that we might identify response based criteria, whether it's MRD or otherwise, to perhaps see who may be able to abstain from transplantation. And there are several protocols that are actively accruing, some that have been preliminarily presented, and some that will be presented in subsequent meetings that might lend evidence to this. But for now based on the data sets that were presented at this year's meeting at ASCO, there still seems to be support for use of high dose melphalan and autologous stem cell rescue. ASCO Daily News: Right. Well staying with the issue of transplantation, for over a decade investigators have been exploring the curative ability of alloHCT in select patients with high-risk multiple myeloma. Fast forward to 2021 and the phase II double blind, placebo controlled, blood and marrow transplant clinical trials network 1302 trial. That's Abstract 7003. This study found that when performed with a reduced intensity conditioning regimen of bortezomib, fludarabine, and melphalan, alloHCT was safe in patients with high-risk multiple myeloma. What are your thoughts on this, and do you anticipate further research on the role of alloHCT in patients with multiple myeloma and high-risk features? Dr. Mitul Gandhi: So, this is an interesting abstract presented by Dr. Nishihori and her colleagues specifically looking at the role of ixazomib maintenance following a reduced intensity conditioning regimen of fludarabine, melphalan, and bortezomib in patients with high-risk myeloma. So this study was a phase II study enrolling patients under the age of 70 with high-risk myeloma defined by cytogenetics, or presence of plasma cell leukemia, or relapse within 24 months of an autologous stem cell transplant, which has been identified as a prognostic factor independent of baseline risk of poor outcomes, with the goal of administering the reduced intensity conditioning followed by HLA matched donor unmanipulated graft with methotrexate and tacrolimus GVHD prophylaxis, and starting at day 60, randomization ixazomib versus placebo maintenance. It should be noted that the goal initially was to enroll 110 patients, but ultimately only 57 patients were accrued over the course of 4 years from 2015 to 2018, 52 ultimately receiving an allogeneic HCT and 43 proceeding to maintenance. And so this in and of itself highlights the challenges of running an alginate transplant trial in myeloma mainly because sick patients may be by the point where allogeneic transplant is being entertained or inability to achieve sufficient disease control in order to pursue the transplant. But with respect to the study itself, they reported a PFS and overall survival (OS) outcome at 24 months, of 52% and 85% respectively, with transplant-related mortality at a respectable 11%. So in context of the small studies that had previously been reported in this space of allo SCT and myeloma, this was improved treatment-related mortality related to the procedure itself. With respect to the question at hand regarding the role of ixazomib maintenance, interestingly they showed no difference in PFS, with ixazomib versus placebo at 55% and 59% and OS at 95% and 87%. In terms of the toxicity, it was not trivial. Grade 3 to 4 acute GVHD at day 100 was 9.5% in the ixazomib arm, 0% in the placebo arm. And chronic GVHD was 69% versus 64%. So, where do we take all of this data in context? I think there is a signal of lower transplant-related mortality compared to historical controls, and so it probably speaks to the improved ability to identify patients and also get them through transplant with this modified conditioning. The follow up, however, was abbreviated, and so there may be increased relapse over time as well. In terms of where does this fit in the armamentarium of therapy with refractory myeloma, I think that's still to be determined. And perhaps it's going to be occupying more of a niche role given the blossoming repertoire of highly efficacious immune-based agents, whether it's modified cellular therapy with CAR T a upcoming NK cell products that are being explored, and of course by specifically antibodies that have been robustly presented at this meeting demonstrating impressive responses. So, it's very conceivable that patients who were previously would be entertained for allogeneic SCT will now be in are treated with this kind of repertoire of novel immune agents. And so it may become a more of a niche role in patients who have exhausted all conventional or investigational approaches, but it does suggest that with this modified reduced intensity conditioning, treatment-related mortality can be lowered. With respect to the question at hand, it does not appear as though maintenance ixazomib helps these patients. And so observation alone following transplant versus an alternative maintenance strategy would be indicated. ASCO Daily News: OK. Well I'd like to ask you about the Apollo trial. That's Abstract 8046. This study looked at health-related quality of life of previously treated patients with multiple myeloma on a regimen of pomalidomide and dexamethasone plus subcutaneous daratumumab. Any surprises here, Dr. Gandhi? Dr. Mitul Gandhi: So, the Apollo study is a phase III trial primarily evaluating the efficacy of pomalidomide plus dexamethasone versus pomalidomide dexamethasone plus the incorporation of subcutaneous daratumumab in patients with myeloma who had received one prior line of therapy. And primary outcomes data had already been presented with improved rates of disease control with incorporation of daratumumab. With respect to this abstract, Dr. Terpos presented quality of life and patient-reported outcomes that was collected in parallel with the intervention arm of this study, and so they utilized the EORTC 30 item questionnaire to assess quality of life and subjective data from patients. And what they found was in the patients who had been on the DPD arm, or the daratumumab arm, there was a greater reduction in pain and no real augmentation or introduction of increased adverse events related to the additional agent. Moreover, there was no decline in physical or emotional functioning with DPD, but there was worsening decline in those elements compared to baseline for patients receiving pomalidomide and dexamethasone alone. There were higher rates of improvement with respect to control of disease symptoms, physical functioning, emotional functioning on the DPD arm. So, what does this tell us? Well in general, I think we've seen a plethora of agents that have improved outcomes with our patients with myeloma who are now living for years on therapy, increasingly and often even into a second decade. And so gaging the impact of therapy on quality of life, subjective sense of well-being is critical as these patients are going to be on therapy for quite a while. And so independent of serologic and laboratory response, we certainly want the interventions to improve functional capacity. And this data would suggest that you can achieve that in parallel with achieving better and deeper responses, which intuitively makes some sense, and they are often congruous. Involving the incorporation of an additional agent didn't worsen the sense of adverse events, but in fact improved the general sense of well-being. So this adds to the body of work of daratumumab on a MM dexamethasone backbone parting benefit without toxicity and also lending credence to the notion that by improving myeloma parameters, we're going to be in parallel improving quality of life. And so with the advent of all the other agents and novel compounds that are being developed after the acute toxicity period, we'd also expect to see improvement in quality of life as well. And so I think this was an important contributor to telling us this. ASCO Daily News: Excellent. Well thank you so much, Dr. Gandhi. I really appreciate your time today. Before we wrap up, any final thoughts from you on advances in multiple myeloma? There's certainly some really impactful work being done in the field. Dr. Mitul Gandhi: Yeah. I think I would encourage all the listeners to review the abstracts presented, particularly the oral abstracts as they get into some of the granularity on detail regarding the individual CAR T and bispecific antibody products, and very nicely demonstrate the durable responses that are being achieved in heavily pre-treated patients. Obviously kind of the next sort of hurdle in the field is to democratize these agents and make sure they're readily available for all patients. And there's a lot of work being done to ensure that management of the acute toxicity can be managed more broadly. So I think I'd pay particular attention to the oral abstract sessions which really demonstrate the novel agents that are being investigated. ASCO Daily News: Dr. Gandhi, thanks again for being on the podcast today to highlight some great new therapies in multiple myeloma. Dr. Mitul Gandhi: Thank you for having me. ASCO Daily News: And thank you to our listeners for your time today. If you enjoyed this episode, please take a moment to rate and review us wherever you get your podcasts. Disclosures: Dr. Mitul Gandhi: None disclosed. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.