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JCO Oncology Practice Podcast

American Society of Clinical Oncology (ASCO)
JCO Oncology Practice Podcast
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  • Promoting Resilience in Adolescents and Young Adults (AYAs) with Cancer via Developmentally Targeted, Evidence-Based Interventions
    An estimated 85k adolescents and young adults (AYAs) between the ages of 15 to 39 will be diagnosed with cancer in the United States this year. AYAs with advanced cancer face care gaps for psychosocial support and communication. A recent paper published in JCO OP titled “Promoting Resilience in Stress Management: A Randomized Controlled Trial of a Novel Psychosocial Intervention for Adolescents and Young Adults With Advanced Cancer” detailed the findings of a clinical trial testing a skills-based coaching program with the goal of decreasing psychological distress and improving quality of life. TRANSCRIPT Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast from the JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center, with a research focus on access, affordability, and equity. An estimated 85,000 adolescents and young adults (AYAs) between the age of 15 and 39 will be diagnosed with cancer in the United States this year. Although this accounts for less than 5% of all cancers, AYA cancers have been rising over the past decade, and AYA survivors have unique survivorship needs, including physical, emotional, social, and spiritual communication. A recent paper published in JCO OP titled "Promoting Resilience and Stress Management: A Randomized Control Trial of a Novel Psychosocial Intervention for Adolescents and Young Adults With Advanced Cancer" detailed the findings of a clinical trial testing a skills-based coaching program with the goal of decreasing psychological distress and improving quality of life. I'm excited to welcome two guests to the podcast today to discuss optimal care for the AYA population. Dr. Abby Rosenberg, MD, MS, MA, is the Chief of Pediatric Palliative Care at the Dana-Farber Cancer Institute, Director of Pediatric Palliative Care, Boston Children's Hospital, and an Associate Professor of Pediatrics, Harvard Medical School. She is also the current designated pediatric oncologist at the ASCO Board of Directors. Both Dr. Rosenberg's clinical approach and her research focus on helping patients facing critical illness live their best lives and for as long as possible. Specifically, she and her team develop programs that help patients and families build resilience and optimize quality of life. She is the first author of the published trial we will be discussing today. Dr. Lauren Ghazal, PhD, FNP-BC, is an Assistant Professor and researcher at the University of Rochester School of Nursing. As an AYA cancer survivor herself and a family nurse practitioner with a background in economics, she brings a unique perspective to cancer care delivery research. Dr. Ghazal completed a postdoctoral research fellowship at the University of Michigan on an NCI T32 in cancer care delivery after earning her PhD at NYU, where her dissertation focused on work-related challenges and financial toxicity in AYAs. Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today. Abby and Lauren, it's wonderful to speak to you. Dr. Abby Rosenberg: Thanks for having us. We're so happy to be here. Dr. Lauren Ghazal: Yes, thank you for having us. Dr. Fumiko Chino: Our specific topic today is: improving outcomes for the AYA population. Abby, do you mind starting us off by sharing some background on this trial and giving us a brief overview of the study and your findings? Dr. Abby Rosenberg: Yeah, I'm happy to. And thanks again for having us. You mentioned, Fumiko, the prevalence and problems that adolescents and young adults with cancer often have. One of the things that I like to point out is we know that if you're diagnosed with cancer as an adolescent or a young adult, you have higher risks of poor psychosocial outcomes forevermore compared to younger pediatric or older adult counterparts. With that in mind, we have been thinking for a long time about: how do you promote well-being and resilience in this particular population? One of the things that we also know is that adolescents and young adults with advanced cancers, those that have recurred or progressed through initial treatment, not only tend to be less engaged with a lot of the really important conversations that we have in healthcare, but later on, especially if their time becomes short, they tend to regret that disengagement. And so what we had done in our previous research is we had created this program called PRISM, and that stands for Promoting Resilience in Stress Management. And PRISM was a peer-to-peer–based coaching program designed by our team in partnership with AYAs for AYAs, specifically to help them navigate these stressors. And what it does is it leverages simple, reproducible, evidence-based what we call ‘resilience skills’. And these are things like skills in stress management, setting goals, cognitive reframing - that's how you appraise a situation - and then benefit-finding or meaning-making. And our prior randomized trial suggested that PRISM compared to usual care amongst adolescents and young adults with early-diagnosed cancers improved their resilience and their hope and their quality of life, and it reduced their psychological distress. In those studies, teens and young adults who had advanced cancers said, "Hey, you know what? These skills really helped me navigate this first experience, and now that my cancer has come back, what I really need help with is applying these skills to these really hard conversations I'm having with my medical team and with my family." So the current study that you are talking about today really tried to ask the question of: could we combine our previous PRISM projects with some integrated advanced care planning communication skills for AYAs with advanced cancer? And if we did that, could we improve some of these important outcomes? And so what we did was we randomly assigned 144 adolescents and young adults with advanced cancer to either PRISM or usual care. In this study, PRISM included those same four skills - stress management, goal setting, cognitive reframing, and benefit-finding - plus an optional component where they could engage in formal advanced care planning skills. And then we saw what we got at 3, 6, 9, and 12 months. Amongst the 144 people who enrolled, their average age was about 16 and a half years, and they were half-half male and female. Within the first 3 months, the people who got usual care, not PRISM, did better with their quality of life. It's not what you want to see as an investigator. But the people who got PRISM did better with their hope and their resilience skills. And then I think what was more important is over time, the improvements in the usual care arm, they weren't sustained. And in fact, the people who got usual care instead of PRISM tended to kind of bounce all over the place with their psychosocial well-being. There was really no predictability, and on average, they did worse over time. But on the other hand, people who got PRISM not only immediately improved that resilience and hope at 3 months, but then they had sustained and continuous improvements in quality of life and distress. They were more engaged in things like advanced care planning and conversations with their doctors and nurses over time. And the overall suggestion of those data is that building skills and resilience and hope early on can lead to lasting improvements in overall well-being. Dr. Fumiko Chino: That is a fantastic overview of the trial, and again, I love this concept of building from within, you know, what started with a peer-to-peer type program and realizing that these skills are so helpful to people going through any kind of critical illness. Now, Lauren, I'd love your take on why this type of study is important, why interventions in the AYA space can be so challenging to develop and test. So, for example, in this trial, one-third of the intervention group discontinued sessions because they were either too busy or too sick. Dr. Lauren Ghazal: Yes. And thanks again, Fumiko, for the introduction and for having me here. As you mentioned in my introduction, I'm an AYA. I was diagnosed at 26 with stage 2 Hodgkin lymphoma. And as many of us AYAs in the advocacy space, as you know, at the time of diagnosis, I was doing far more important things in my life than wanting to worry about and deal with cancer. And so when cancer came very dramatically into my life, I had to tackle it with whatever, as Abby said, resiliency skills and resilient skills that I had built up to that point. I was 26, so 10 years over the median age of Abby's study, but that's what I was left with at the time to deal with my diagnosis and my survivorship. So I was also working as a family nurse practitioner in primary care, and I was also in my first year of a PhD program in nursing research. So I had caught that nursing bug to be a researcher really early on in my clinical training. And I remember seeing this paper come across my inbox a few months back, and I was so excited to read this publication. As an AYA, I'm always like selfishly so grateful to see work being done in studying resiliency and stress management and overall quality of life because I feel like I'm constantly kind of suffering with that and really trying to understand kind of how do I separate my AYA advocacy role and my personal experience in this work, and then also as a researcher in the AYA world. And so, yes, very excited to see this study. And we all know AYAs face these unique challenges, challenges that include high symptom burden, developmental transitions, these competing life demands that can make participation in research particularly complex. I know firsthand how overwhelming having a cancer diagnosis can be during this life stage that's already filled with so much uncertainty. And so when you're straddling again this independence-dependence as an AYA, for me again, just beginning graduate training and trying to make sense of who I was, who I was becoming, all of these competing demands that can complicate not only how we experience care, but how we also engage with research. So I think when I think about Abby's study too and something that you had mentioned in the overview is really like the time investment of putting up this hard work up front of building the resilient skills that maybe you didn't see it within the first 3 months compared to usual care, but later on in the 6- and 12-month time point, that's so critical to promoting resilience and sustaining that resilience not only throughout the rest of your survivorship and navigating, you know, your healthcare engagement, but also your overall life skills too. And so I don't think you even know this, Fumiko, for as well as you know me, that I actually participated in another clinical trial on resilience and stress management. And this was 5 years ago now. And I actually pulled out the toolkit that we were given really early on this year when there was a lot of other stressor trigger points in my life, and I did one of the activities, and it was really just on targeting the trigger points, the stress points, and then trying to kind of address what I had control over in that moment, right, what was out of my control. And so that's 5 years. We know that we have not a lot of funding available that we can study AYAs for 5 years in these clinical trials, but they’re skills that are really that you're using for the rest of your life. And so being able to capture that, I think is just so important. That was one thing I wanted to take home here was that I used those skills that I learned 6, 7 years out from that trial. Dr. Fumiko Chino: I was going to ask you a follow-up question to see if anyone had ever actually tried to develop coping skills for you as part of your standard of care, and it sounds like as part of a clinical trial, actually, you did get some of those, that development of those skills, and they're still paying off for you 5 years later, which is phenomenal. And I think we'll see potentially people on Abby's trial still benefiting in survivorship, be that as it may, in years if they get to that point, which is, you know, again, the whole goal of trying to think about resilience and building hope and sustainable interventions. Now, this study was really focused on patients in the early adolescent and young adult ages 12 to 24 on the trial and was recruited from the children's hospital pediatric cancer departments. Abby, as part of your clinical experience as a pediatrician, what are the potential differences in the cares and needs of the younger versus the older AYA population? From my own experience, I can give you an example. I remember when my husband was diagnosed with cancer in his 20s, one of his team members referred to him as, quote unquote, "basically a pediatric case." It kind of hit me sideways at the time, but in hindsight, I can actually understand how being treated in the pediatrics department could have had some unique advantages, especially with wrap-around services at the end of life. Dr. Abby Rosenberg: I so appreciate that question, Fumiko, and I feel like I first want to apologize on behalf of all oncologists for the way that your husband received or heard those words because I think the beauty of AYA oncology is that we really want to find the right place for people. And the way we balance it, before I answer your question, is I think there's two domains that people think about. One is what kind of cancer does this person have? Because there are a lot of, quote, “pediatric” types of tumors, and those types of biologies, those types of cancers are things that adult medical oncologists just may be less familiar with and we pediatric oncologists know how to treat really well and vice versa. So like if a young woman came into my clinic with breast cancer, I would be like, “Yeah, we don't do that in peds, you need to go across the street to the medical oncologists.” If the goal is, we need the best oncologist to treat and hopefully cure you of your disease, then that's decision point number one. Decision point two is: what is the developmental and psychosocial place that you are in in your life? And so similarly, you know, AYAs are defined by the National Cancer Institute from people between the ages of 15 and 39, and that is an enormous developmental age spectrum. And my 15-year-old patients are really different than the 35-year-olds across the street. And so what we think about in this sort of triaging of where people should go is are you still living with your parents? Who are your decision-makers? In pediatrics, we are inherently family-centered. Like, we do not ever make decisions in isolation with patients, at least I should say very rarely. It's always understanding that they are in a dynamic of relationships and other caregivers and loved ones. And that's somewhat different in adult cancer centers where the patient can have a lot of private conversations with or without their caregivers. The other thing we think about a lot in pediatrics is people are still developing in their autonomy, their identity, many people are still on their parents' insurance, many people need caregiving support full-time, and it's different from if you're an independent young adult. And so we sort of think about how do we provide all of the services that you need. You mentioned wrap-around services. So now I get to stand on my ‘pediatrics is better’ soapbox. We in pediatrics practice these holistic ways of approaching healthcare in general. So in most pediatric places, every person with cancer has an assigned social worker. They often have access to things like psychology and child life and music therapy and art therapy and school rehab, and there's schools embedded within the children's hospitals and all the things that you can think of to try to maintain your life track as best we can while you're going through all the stressors of cancer. As you said, I'm a pediatrician, I'm a pediatric oncologist. My focus has been in AYA oncology, but in the pediatric space, and we thought about, should we also enroll people who are in the adult medical oncology centers, and we realized that that quote “usual care” would be so different between groups depending on where people were receiving their oncology care that we just decided for the rigor of the science to focus on pediatric centers. And I think what's kind of cool about that is if you imagine usual care in pediatrics is pretty high bar, like you get a lot. If PRISM is still better, that says something about what we are missing even in pediatric oncology care, let alone what the rest of the oncology treatment centers might be missing too. Dr. Fumiko Chino: Absolutely, absolutely. And again, not to dog on adult cancer services or to speak the benefits of pediatrics, but I definitely see that gap certainly in my own clinic and from my own lived experience. Now, Lauren, I have certainly heard from other AYA survivors in their 20s and 30s that they felt that sort of they were between worlds during their cancer treatment and just survivorship. Many have to maybe even move back home or they might need family caregivers during their treatment, and this can cause really a disconnect in identity that can also add to stress and anxiety. In your opinion, how can we be supporting AYA survivors' psychosocial needs better? Dr. Lauren Ghazal: Yeah, that's the million-dollar question. And I want to preface this by saying that it's so difficult to speak on behalf of all AYAs, and I can never do that. And I say this a lot, but we know this, the NCI, ACS knows, the one-size-fits-all for survivorship model does not work, especially for AYAs, and Abby alluded to this very wide age range that we see in AYA cancer survivorship. I think that there are really great programs across the nation that standardize AYA formal programs that are being designed, that are being implemented across the many different areas of AYA survivorship that Abby had mentioned including financial navigation, getting financial services, psychosocial support, embedding psych and mental health therapy into those survivorship programs as well because those are the biggest barriers for AYAs is being able to access mental health providers that are trained in seeing AYA patients. And for many AYAs, I've been hearing more and more from friends of mine that they had to transition to a new mental health provider, which we know is so difficult during that period of diagnosis. I would also say too that there's a lot of research being done at UNC in their, the University of North Carolina Chapel Hill, in their AYA program in implementing their AYA Needs Assessment or their Bridge that Dr. Emily Haines has developed, and I know they're undergoing a bit more testing too in shortening that. But when I look at that too and I see all of the different areas that AYAs endorse as these top unmet needs and then really being able to screen and identify in one place that, "Okay, there's more support needed here." That's when then there can be tailoring done. But to actually centrally funnel in through a standardized assessment that can be implemented, and then also recognizing that not every cancer program and AYA program across the nation has every answer and every resource available. And so being able to say, "Okay, we have these formal connections not only with a local AYA organization but also nationally through incredible organizations like Triage Cancer and Cancer and Careers or through the Cancer Support Network." Those have been areas that I've, you know, have really tried to push for is really strengthening referrals to address the health-related social needs of AYAs more formally through community-based organizations and then also streamlining a needs assessment for AYAs. Dr. Fumiko Chino: I often think about the challenge for someone who potentially could travel or maybe should travel to receive specialty care at these large centers that have so many resources versus staying closer to home where they have more support, where it is a lower cost, right? And trying to figure out what's really worth it. And I think you brought up a really good point, which is that there are national community-based services that are available to everyone. You don't have to go to an MD Anderson or a Dana-Farber to receive them necessarily as long as people are properly plugged into those services. Now, this trial enrolled AYA patients with advanced cancer. I know Abby, you already spoke to this a little bit, but one of the goals was to increase AYA engagement in goals of care and formal advanced care planning. And I was saddened but not shocked to see that less than 10% of patients in either arm had formal documentation of advance directives in their chart. This certainly aligns with my own experience, not to make this all about me, but, you know, I had a very traumatic conversation in a hallway outside of an ICU about intubation for my husband. And this paper really puts it quite eloquently, stating that even though the intervention may have, quote unquote, “enabled AYAs to engage”, it did not help oncologists do the same necessarily. Abby, I would appreciate your insight into the barriers that oncologists may have about starting some of these hard conversations, particularly with younger patients. Dr. Abby Rosenberg: First of all, again, I'm going to apologize on behalf of all healthcare providers for the non-ideal ways that you guys were hearing serious news. Now I'm going to put on my oncologist hat and say, there's a couple things that I think explain these data. The first is, we oncologists love our patients. We want to fix this problem. We want to cure the cancer. We have the same hopes and prayers that so many of our patients and families do, and so I think there is this real sense of failure when we see the beginnings of treatment not working, and I think oncologists and patients will align together to keep fighting as long as they can. What we found in this study, we measured engagement in a lot of different ways and we saw that AYAs who received the PRISM program were more likely to directly engage in conversations that we would extract from like medical records, like sort of text notes about what conversations were happening in the room. They were more likely to ask direct questions and respond directly to palliative care consultation when palliative care teams were having sort of really hard conversations about prognosis and goals of care and what matters to you given what is happening. But the next step, as you're describing, is the formal documentation of something like an advance directive and the formal documentation of, “What would I want if I can't speak for myself?” So there's a couple sort of last things that I'll say that I think explain why we didn't see any difference in uptake of those advance directives in our study. One is, we had younger people. So 16 and a half, those young folks don't complete their own advance directives. They can complete a document called “Voicing My CHOiCES” which talks about what they would hypothetically want, but that is another sort of formal documentation that I think a lot of people might have felt like, "I'm not going to engage in that," or the oncologist wouldn't have offered it because they were talking to the parents or it was too scary or too hard for these young people who were still not of the age of majority making their own decisions, number one. And number two is, I think we really try to avoid, not for the right reasons, but I think oncologists in general with well intentions try to avoid those hard conversations because they worry that we will cause harm, we will cause pain, we will, quote, “take away hope”. And this is where I and probably many other folks in palliative and supportive oncology struggle because we know that patients and families have those things on their minds. We know that inviting the conversation doesn't in fact take away their hope, it helps them really make more precise the things that they are hoping for and enable them to achieve the goals that they can realistically achieve, especially if time is short. And I think in this study, maybe the first obstacle was: will AYAs engage? We found the answer is ‘yes’. And so now the second obstacle is, how do we enable the oncologists to reciprocate and to ask the hard questions? And maybe it's partnering with psychosocial clinicians and palliative care. Maybe it's just a little bit of risk-taking on the part of the oncologists to be curious and say, "Hey, what's on your mind? Many people like you think about these things. I'm happy to talk about them with you too. What do you think?" And then if an AYA says, "Hell no, I don't want to talk about that," fine, we can be like, “Great.” But at least we're providing a doorway for them to walk through if they want. Dr. Fumiko Chino: It reminds me of what Dr. Tarlise Townsend- she gave this profound speech at ASCO Quality from a couple of years ago, and she said she had to kind of do her own death work to kind of come to terms with these issues and really think for herself what she was kind of willing to put up with and for what kind of end point. Lauren, do you have anything to add? Dr. Lauren Ghazal: Oh yeah, I just had a follow-up question for Abby too in that you mentioned, you know, you were able to answer, "Will they, will AYAs engage?" and ‘yes’. Were you able to kind of decipher if they can engage with other healthcare professionals or other healthcare team members? Is there more of that engagement happening, let's say, with the infusion nurse or with the nurse practitioner? Dr. Abby Rosenberg: Great question. Just based on the way we measured this, we did not pick that up, and that's one of the limitations of the project is that we didn't expressly ask people, “Who is your person, who are you talking to about this?” Because what we were trying to do is sort of see organically if it came up without prompting. But I think you're right, Lauren, what we know about the experiences of folks with advanced cancers, and this is true certainly in pediatric and AYA oncology, is that it's not necessarily the oncologist who is the trusted person. It could be the infusion nurse. Often, it's the bedside nurse when folks are in the hospital for long periods of time. It could be the chaplain. It could be a whole host of people, the social workers. And I think what is really important is recognizing two things. One is, we need to honor the interprofessional team and recognize who needs to be in the room for this young person to engage in these really hard conversations And then secondly: how do we still empower the oncologists? And I say that not because I'm elevating the oncologist's role as much as I'm saying the oncologists are the ones who are offering treatment choices and guiding the care plan, and if they aren't part of the conversation, if they aren't hearing an AYA say, "You know what, actually what's most important to me is to be home," then we oncologists are potentially misguiding people. And so how we find that balance, we have to figure out how to integrate all of the players and important people into the room. Dr. Fumiko Chino: That dovetails so nicely to my next question for Lauren because I know that you had written in The Cancer Letter a couple of years ago that - and this is a direct quote - "Our current status quo is not working. It leaves patients without the resources or the knowledge to be fully engaged. We need more research directed at effective provider-patient communication and tailored interventions that engage the full care team to address each patient's unique needs and experiences." Now, having said that, what would you like to see next in the context of either research or practice to advance this very necessary communication and patient-centered care? Dr. Lauren Ghazal: Yes, and I had an incredible co-author for that piece as well. It was Fumiko, Abby. Dr. Fumiko Chino: That's awesome. Dr. Lauren Ghazal: So she's set me up very well for this. Thank you for referencing that piece again, Fumiko. You know, it's really great that Abby had touched on and everything that she's said so far is kind of what I had jotted down and brainstormed in preparation for this and what I'd like to see next, I think coming from an AYA in really this shift from like just simply documenting communication or communication breakdowns to actively building, testing, implementing solutions and that we know that will center AYAs and their care partners, whomever it is, throughout their experience with cancer. And really taking the time too to note that it's especially important for marginalized and underrepresented groups like queer and LGBTQ AYAs with cancer who we know face additional challenges throughout cancer survivorship. And so, I'm speaking to the choir here, but we trained as a nurse and as a nurse practitioner, communication in our training, you know, is treated as a soft skill rather than like a clinical competency that really we know has direct implications for outcomes for AYAs that include adherence, that include quality of life, include trust with our healthcare providers and in our healthcare system. And so I always advocate for more interventions that are co-designed with AYAs and their care partners and their communities that really account for structural barriers, identity-based barriers to communication, and that can extend beyond this dyad of just provider and patient but to include our broader healthcare team that include navigators, social workers, nurses, child life specialists even. And I had another piece that I had written around trauma-informed care for LGBTQ cancer survivors, but we know that embedding even tailored communication strategies into routine care improves care and care delivery, like trauma-informed care practices. And so I also always advocate for proactive conversations around the taboo topics of AYA care that we know things like fertility and family-building, finances, and employment, as you know so well, Fumiko, things about cost-of-care conversations, but all areas where AYAs can see, can often feel unseen or silenced or that it's not important right now because their goal is just to survive throughout this. Yeah, so that's a little bit about kind of my take on communication. Dr. Abby Rosenberg: Can I just jump in and say, I mean, I think, Lauren, the other thing to amplify from what you just said is if we don't model that it's okay to talk about these subjects, most patients in particular follow the lead of the clinical team. And so if it's not brought up, then the patient will appropriately assume that's not what I'm supposed to talk to my healthcare team about. But if we introduce all these topics and normalize them as part of a holistic care approach, then we're more likely to have these full, rich conversations that need to happen. Dr. Fumiko Chino: Absolutely, communication is not a soft skill. It is an essential skill for patient care. And again, this idea that the oncologist is the end-all be-all for communication is also, I think, deeply flawed, and thinking about the full team as being a team that actually envelops the patient in care is also essential. All right. Well, wrapping up, do you have any last thoughts today, anything that we missed, anything that you want to highlight again in terms of opportunities to reinforce for our listeners from Lauren or Abby? Dr. Abby Rosenberg: When I think about this whole horizon of research and clinical care, to me, I guess I'm taking away two things. One is to really be unafraid, those of us who are at the bedside, in whatever role, to open the door to these pathways of communication about all sorts of scary topics because then we can provide better care. And then the second, I think now, as a resilience researcher, is we can expect and normalize that some of these coping skills can be learned, and the investing in them in an evidence-based way can have these durable impacts in overall patient and family well-being, and so it's worth the investment. Dr. Fumiko Chino: We're worth it. Our patients are worth it. I was just thinking about as a caregiver, how much I wish resilience training and coping skills had been directed at me, selfishly again, I'm sorry, I'm again, this is all about me, apparently. But I do think that that might be one of the next frontiers as well because the caregivers really are part of that team unit that helps envelop the patient in love and care and support. Dr. Abby Rosenberg: Well said. Dr. Lauren Ghazal: I'm snapping for you, Fumiko. Dr. Fumiko Chino: Well, on the exit of the snaps, then, I want to thank you both so much for this wonderful conversation. Many thanks to both Dr. Rosenberg and Dr. Ghazal as well as our listeners for your time. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear from the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope that you will join us next month for another Put into Practice episode, and until then, I hope you are staying safe. Dr. Abby Rosenberg: Thanks, everybody. Dr. Lauren Ghazal: Thank you. 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. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Fumiko Chino Employment Company: MD Anderson Cancer Center Consulting or Advisory Role Company: Institute for Value Based Medicine Research Funding Company: Merck   Abby R. Rosenberg No Relationships to Disclose Lauren Victoria Ghazal No Relationships to Disclose
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  • Incomplete Reporting and Toxicity-Minimizing Language in Oncology
    There is often a disconnect in toxicity assessment between what is reported on clinical trials as being “well tolerated” and the lived experience of taking a treatment for patients. Toxicity minimizing language including “safe” and “tolerable” are subjective and can downplay quality of life limiting side effects from treatment. A recent paper published in JCO OP reported that less than half of phase 3 clinical trials had “complete” toxicity reporting including total adverse events, deaths, and discontinuation due of toxicity. Dr. Chino welcomes two guests to discuss patient-centered clinical trial design with a focus on side effect profiles of treatment. TRANSCRIPT Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity. There is often a disconnect in toxicity assessment between what is reported on clinical trials as being, quote-unquote, "well tolerated" and the lived experience of taking a treatment for patients. Toxicity-minimizing language includes words like "safe" and "tolerable." They are subjective and can downplay quality of life–limiting side effects from treatment. A recent paper published in JCO OP reported that less than half of phase 3 clinical trials had complete toxicity reporting, including total adverse events, deaths, and discontinuations due to side effects. I'm overjoyed to welcome two guests to the podcast today to discuss patient-centered clinical trial design with a focus on side effects from treatment. Dr. Ethan Ludmir is an Assistant Professor at MD Anderson Cancer Center with a primary appointment in GI radiation oncology. He is a prolific researcher on topics encompassing clinical trials, cancer outcomes, and the integration of biostatistics in oncology. He has a specific interest in improving clinical trial design, including designing patient-centered endpoints and complete reporting. He led collaborators in the manuscript that will frame our discussion today called, "Incomplete Toxicity Reporting and the Use of Toxicity-Minimizing Language in Phase III Oncology Trials," which was published earlier this year in JCO OP. Stacey Tinianov is the executive director and co-founder of Advocates for Collaborative Education, a global advocacy organization uniting patient, research, and policy advocates through pan-cancer collaborations, basic and advanced advocacy education, and the sharing of leading practices to change the narrative in cancer outcomes. Following her diagnosis and treatment for early-stage breast cancer 12 years ago, Stacey  has become a leading national voice for patient advocacy and empowerment via collaborative education, community building, shared decision-making, health data access, and person-centered design. Our full disclosures are available in the transcript of this episode, and we've already all agreed to go by our first names for the episode today. Ethan and Stacey , it's wonderful to speak to you. Dr. Ethan Ludmir: Terrific. Thank you so much for having us, Fumiko. It's a pleasure to be here with friends and colleagues of many years to be able to talk about this important topic. Stacey Tinianov: Yes, thank you. Delighted to be invited, delighted to be part of the conversation. Dr. Fumiko Chino: Our specific topic today is toxicity minimization, either by underreporting or by language and framing that downplays the lived experience of treatment. Ethan, do you mind starting us off by telling us how you got interested in toxicity reporting and then briefly discussing what your study team did and the findings? Dr. Ethan Ludmir: Absolutely. Thank you, Fumiko. I have the privilege and luxury of being able to present research that is 100% the brainchild and terrific work of colleagues and friends, including the first author, a terrific graduate student named Avi Miller; colleagues like Alex Sherry. So I think it's always important to acknowledge I'm here mostly for window dressing. They really did the lion's share of the work and really have reported this fascinating story. Our lab works primarily on issues related to the optimization of clinical trial design and reporting. One of these key topics that has come up more and more over the course of time is how are we presenting toxicities? And so we gave this project the sort of cute name of "The Table 3 Fallacy." Right? When you present a clinical trial report, usually Table 3, just by the way things end up getting numbered, is generally where you find these toxicities. You see a massive Excel sheet of reported toxicities, and invariably it ends up kind of culminating in a sort of pithy couple of sentences saying, "Toxicity was manageable." So we wanted to really drill down on this with sort of two features in mind. One of them was, how well are we doing at objectively reporting physician-assessed toxicity? And of course, that comes with the itinerant kind of limitation that all three of us have both written about and talked about, that is physician-assessed toxicities are very different than patient-experienced toxicities - and maybe we'll put that to a side for one second - but objective toxicities on one hand and then subjective characterization of those toxicities on the other. So for this project, we looked at, we've sort of cultivated over the years an actively updated database of every phase 3 trial that's been completed in clinicaltrials.gov since the website's inception. And so in this report, we looked at over 400 trials representing over 300,000 patients enrolled. And we wanted to assess objectively how many trials reported in their manuscripts serious adverse events, treatment-related deaths, study therapy discontinuation, and an emerging area that really bears some emphasis, which is reporting of lower-grade toxicities. And I know we're going to discuss this as this moves forward, but especially in the last few years, this has entered visibility as an area that we really ought to be emphasizing more. As a sort of anecdotal point, it's very easy to characterize a single grade 3 episode of toxicity that potentially is self-limited. But on the other hand, if you've got a patient who has the misfortune of having grade 2 nausea day in and day out - sure, that's grade 2, but that can be much more impactful on somebody's quality of life. So being cognizant of these kinds of differences is important. So we went through these 400 trials and objectively categorized using pre-established guidelines how many reported serious adverse events, treatment-related deaths, study therapy discontinuation. And the answer is only 44% of trials consistently do this. We added and created sort of our own guideline - everyone comes up with guidelines these days, so we said we're going to do our own guideline - and add into the mix reporting of lower-grade toxicities. And if you call "complete toxicity reporting" doing what's been done before and reporting lower-grade toxicities, then only 32% of trials report out these complete toxicities. And perhaps the most interesting covariate there is that our industry-supported trials, which increasingly dominate the scene, those tend to do a better job at reporting toxicity profiles than cooperative group–sponsored studies. And we can kind of dissect that, perhaps, on the back end. And the final point is we looked at how often investigators are using language like, "Study therapy had toxicity that was acceptable or tolerable." These subjective languages that fundamentally minimize the experienced toxicities. And the answer is nearly half of trials report- have that language in the study text itself, often in the discussion section or the abstract. And this is what's picked up, right? This is what our patients read. This is what news outlets read. And I think this really fundamentally undermines a lot of the nuances here. But if you let me keep talking, I'll just keep talking forever, so I'll stop talking. Dr. Fumiko Chino: That was a really excellent summary of what your team did, and I agree 100%. Give credit where credit is due. It is a whole team that brings research like this to publication, and so I really always respected the fact that you have worked in very large teams and have given due credit to people like trainees along the way that are doing some really elegant work under the auspices of the- I'll just call it ‘The Ludmir Lab’. Now, as you mentioned, patients may really consider side effect profiles very differently than what investigators determine could be, quote-unquote, "clinically relevant." Stacey, I'd really love your take on the toxicity topic and how you've seen this play out in both the advocacy space and in your role as a scientific advisor. Stacey Tinianov: First of all, I am truly thrilled that all of this is being examined. We know that words matter. We know that we've managed to change our collective language in the oncology space and our understanding significantly of that impact in the last 10 years. We've modified phrases like, you know, "patients failing treatment" and we've moved to what is kind of more “what actually failed patients”. So, you know, I think the key piece there is when we describe things like "manageable" and "tolerable" in scientific publications or in that Table 3, we are looking at “clinically relevant". And so I want to acknowledge that when you talk to people in clinic, you know, "manageable" means that there's a way to clinically manage a side effect. "Tolerable" means that treatment can continue. So we understand where these phrases originated from. However, as Ethan mentioned, these terms have very different meanings in day-to-day living. I spent some time actually quite recently at the FDA talking about the gratitude I have that, you know, safety and efficacy is a primary concern for the FDA because as advocates and certainly as patients, we care about safety and efficacy. But we also are incredibly concerned with quality of life, and it's particularly important to say because all of these great therapies are only great therapies if individuals can stay on them. And if these so-called "manageable" and "tolerable" side effects, as they start to accumulate, people have to come off treatments, well then all of that incredibly hard work and all of those resources to bring something to market are for naught. The other thing I think it's highly dependent on individuals, and I think that, again, when we quantify and when we, you know, qualify something, we have to do it kind of in a population setting. And yet I think we need to acknowledge that all individuals are different, and something that may truly be "manageable" and/or "tolerable" in one individual might not be in another. And so I think we need to make room for that. And the reason the language is so important is so we can make those choices. We can weigh the benefits to the risks, not just on a cellular level, but on an impact level. So again, so excited to have this conversation. Dr. Fumiko Chino: I love that personal take on it, which is that it is personal. You have your own experiences, obviously, with toxicities, but that individuals may not be comparable across each other and aggregate number on a spreadsheet is very different than lived experience. Stacey Tinianov: When you look at those hundreds of thousands of individuals, those were the cancer Olympians. Those were the individuals that qualified for a clinical trial because even though they were sick and in some cases very, very, very sick, they were the best of the best. And so that toxicity profile is on a population that has actually made it into a clinical trial. But once a drug is approved and once it's put into market, it's potentially available to anybody, and so we see those side effects, you know, sometimes in a much more complicated situation. But too, you know, again based on the individual, even if this drug gets out and it's the same diarrheagenic profile for one individual as another, the impact of that on a quality of life is very, very different. Somebody who really enjoys sitting outside and birdwatching and hanging out with friends and reading books, as long as they’re within ten feet of a bathroom, the diarrheagenic effects of a drug are going to impact that person probably far less than somebody who rates their quality of life on how many summits they can peak. Dr. Fumiko Chino: 100%. I can even say for my own lived experience, when my father-in-law received cancer treatment, they actually chose one of his treatments based on the fact that he is a guitar player, and so they really wanted to minimize his risk of peripheral neuropathy. And so, you know, instead of cisplatin, they chose cetuximab for his treatment, even though it is maybe suboptimal in a straight numbers comparison, but the toxicity was very meaningful. Now, there was another recent JCO OP study published this year focusing on patients with melanoma on immunotherapy. It found that of the 70% of patients with any toxicities, about half of them were, quote-unquote, "only" grade 1 or 2. But in this so-called "low-grade toxicity," 15% were hospitalized, 31% had treatment stopped because of toxicity, 33% needed to go on an immunosuppressive medication. Now, Ethan, do you mind putting this into perspective from the kind of clinician and clinical trialist standpoint? Dr. Ethan Ludmir: With pleasure. And this is a terrific piece and really highlights and informs a lot of the reasons that complete toxicity reporting is crucial. Right? We need to know about the grade 1-2 side effects because invariably, as much as we like to relegate those to second-class status in how we've to date been characterizing physician-reported toxicities, clearly, there's a dramatic impact in many of those toxicities on people's ability to tolerate therapy, their ability to require additional intervention like immunosuppressives, and it's really quite central in the way we think about things. The other facet, I think, that's increasingly relevant here is the treatment discontinuation aspect of things is one that increasingly from a statistical perspective comes to the fore. We've written about this before in a couple of different pieces, but it's something that I'm not always sure gets enough billing, which is that study therapy discontinuation is often not considered an event. And so when you design Kaplan-Meier curves and you report these out, those patients are censored rather than marked as having an event. And so you get weird statistical effects of how those curves are perceived because you're almost ignoring the folks who had the toughest time with the therapy when those are among the most informative patients when you're thinking about things from both a large-scale regulatory perspective to Stacey 's point, and again to Stacey's point, the individual in front of you. So I mean, it's a terrific piece of work and also speaks to, as we think about the era of PROs really getting more and more mature in how we analyze them and integrate them into our trials, it also speaks to the challenges of just objectively quantifying toxicity from a physician perspective as tick mark “That is one grade 3 toxicity.” Can we make this multidimensional? Are we thinking more about the time perspective? How long is the grade 2 toxicity going for? Are you having a day of nausea or continuous nausea for a month? These are the things that I think are relevant as we think about optimization of our endpoints going forward. Dr. Fumiko Chino: Patient-reported outcomes has entered the chat. I love it. Now, Stacey, do you have anything to add from a patient perspective? Stacey Tinianov: I absolutely do, and I think the discontinuation piece is critical. But again, I also want to add that once things get approved and are in market, it's not a digital discontinuation or continuation. We have, obviously, dose reductions that tend to be led by clinical expertise. But what we're seeing in the community, especially with some of these newer targeted therapies, is individuals medicate themselves. For instance, diarrhea, you know, fatigue, there's a lot of very, very clinical side effects, but I think diarrhea is the one I like to focus on because I don't think I've ever talked to anybody who has not experienced diarrhea. So I think there's a level of understanding and empathy there. But when we look at some of these diarrheagenic, especially in the CDK4/6 space, we have individuals who, one, because it's manageable and tolerable, are given an over-the-counter prescription for an antimotility drug, and that drug then causes another side effect, and this side effect isn't measured. This is not in the toxicity profile of a therapeutic. It's in the toxicity profile of the supportive care medication. And so what we're seeing is this incredible cascading effect of diarrhea, constipation, diarrhea, constipation, diarrhea. And so patients say, "You know what, enough is enough. I'm about to go on a vacation. I'm going to take two weeks, and I'm not going to take my meds." And whether they communicate to their doctor or not probably depends a lot on their relationship. But from a drug standpoint, with these drugs, we don't know what that does, right? And so we know that we have people not taking the therapy as it was intended and approved, and this is directly a result of the side effects. The other piece is, I think it's important to note that when we think about side effects, I think oftentimes we think about a finite period of time, but some individuals are on drugs forever. They're on it forever until it stops working. And so, if you say that, okay, fatigue is really, really a challenge, but if it's your new regular, you're never going to feel better than this, that's a really hard decision to make. The other piece is, again, I think that when we think about these grade 1 and these grade 2 side effects, we don't necessarily visualize what that actually means. And so going back to poop, because we all like talking about poop, you know, a grade 2 side effect - and one of the things you already know - is defined as four to six loose, watery stools as baseline. So one of my favorite conversations or favorite phrases or questions, I guess, is to say, “You know, just take a second. Where in your busy day would you put four to six extra loose, watery stools?” And then, you know, you're like, "Oh my gosh, that's not tolerable." So it really is just this like huge, huge, huge consideration for people, and I'm not saying that these drugs shouldn't be on the market, but what I am saying is when you publish the results of how these drugs affect individuals, that needs to be part of the conversation so it can be part of the shared decision-making. Dr. Fumiko Chino: 100%, 100%. Now, Stacey  and I both just returned from ASCO 2025, where the so-called "latest and greatest" new treatments were showcased. There were at least a handful of times where I heard that X new treatment was both efficacious and tolerable without any patient perspective presented. And it's been over four years since I heard the incredible Jill Feldman speak about the importance of patient-reported outcomes, including her famous slide highlighting the difference between how you look and how you feel. Stacey, you've been in the advocacy space for over a decade. Do you think we're making any progress over time on this issue? Stacey Tinianov: I should probably lead with the fact that I am an optimist. So my answer, my answer is ‘yes’. And I mentioned earlier that I've watched the focus on words and and our language is starting to change based on the recognition that words matter. I think for the most part we don't call individuals who decide to join clinical trials, we don't call them ‘subjects’ anymore. We're recognizing them as humans. We're also incredibly excited about what is starting to be presented on the main stage. I know that, you know, at this past ASCO, we had, you know, many individuals who were on stage as advocates in conjunction with the luminaries in the clinical and the research space. And so I think that's progress because I don't think there's one advocate who wasn’t on stage to kind of share, you know, some of these similar concerns. But we're also seeing it in the research space itself. So Advocates for Collaborative Education decided that quality of life was something that was not being well studied and not being well represented. So a couple of years ago, we actually did an advocacy-led study, "More Than a Diagnosis: A Quality of Life Survey for Individuals with a History or Diagnosis of Cancer.” We did it because we knew it needed to exist. We also created our own survey because the current validated measurement tools that look at quality of life, one, they're administered by a clinician, right, so you're not necessarily getting that- they're not necessarily looking at the things that we as patients care about. So we created this survey with patients and with advocates. And the most exciting thing is once we accrued - we had 516 responses across a variety of cancers, and we did this in a matter of five weeks - and we submitted abstracts to SABCS, to ASCO, to ASCO Quality, and we've had posters or presentations at every one. We are talking about these words "manageable" and "tolerable," but more importantly, I think we're talking about being able to integrate quality of life into the decision-making process in clinic and also integrate quality of life into how we evaluate from a patient-reported outcomes standpoint in the clinical trials. And so it's a process. I recognize it's a process, and I also recognize for those who are struggling now, it is moving too slowly. But ultimately, and I know the three of us can agree, when choosing cancer therapies, people should not have to choose between being alive and living. So living, really, really living is what we're focused on. Dr. Fumiko Chino: Absolutely. I would say quality of life and quantity of life are both equally important. Ethan, do you have anything to add to what Stacey  just eloquently said? Dr. Ethan Ludmir: Candidly, she framed it exactly the way I would want to if I were more eloquent myself. So no, I think that's exactly where we're at. I live in my own little pond of statistics, so a lot of things that I'm worried about deal with how we're measuring quality of life, how we're analyzing it. The devil is usually in the details there, but on one hand, like, that's something I feel is a direction that, kind of behind the curtain, the statistic- statisticians really have to do a lot of work and education to get there. But in a certain way, that's a much easier challenge than what both of you are describing now as we see sea change at the level of who's talking at ASCO, who's being brought into the conversation and trial design, whose voices are being heard and propagated. So I think the math is much easier to work out than the vision. And so kudos to both of you for spearheading that vision and seeing it realized, I think, in real time, which must be very, very rewarding. Dr. Fumiko Chino: I've been so enthused about how many patient advocates I've seen on both big ASCO and then, of course, ASCO Quality, the health services meeting. I know that at least the session that I had at ASCO had a patient advocate as a speaker. So I think, again, our sort of ideal world is that every single session has a patient advocate to help frame the research and the data from the perspective of the lived experience of someone on cancer treatment or a survivor of cancer. Stacey Tinianov: It's so important for me to acknowledge that none of that would have happened without people like you that are embracing it. We recognize, advocacy recognizes that we needed champions on the inside to be able to come in and share those perspectives. We so, so recognize that. So, thank you for that. Dr. Fumiko Chino: We have a mole in ASCO, and it's a patient-centered mole. Thank you for that. All right, switching tack just a little bit for our last little bit of the podcast. Ethan, I know you've been on really a mission to improve clinical trial design and really have a growing body of meta-research or, you know, "research about research." Why is meta-research important, and how do we learn from it to refresh and reinvigorate clinical trials so that they provide better information to providers but also more meaningful outcomes to patients? Dr. Ethan Ludmir: That's a terrific question. A little bit loaded in the life and times in which we live right now, but a terrific question. So I think clinical trials are fascinating. I think there's tremendous avenues of opportunity in how we design them, how we execute them, how we interpret them, how we analyze them. So that gets me up in the morning. That really puts a skip in my step. I love JCO OP. I will put in the very smallest of plugs for a different journal in which we just published a report two days ago that was presented concurrent at ASCO on how many clinical trials in the last 25 years have actually moved the needle in quantity of life or quality of life. And I know all three of us can share this perspective, you know, each with different words, but at the end of the day, that's what matters. We need to know that whatever we're doing, we're improving somebody's quality of life, their quantity of life, or ideally both. And so my trainees kind of hear me say this repeated often and often and often. And I think it's very important because in many ways, for a little while now, we've lost the thread at the regulatory level, at the sponsor level, and that's nothing new. There's a lot of ink that has been spilled about this. But the beauty of meta-research in a certain way, and to be clear, I'm a clinical trialist in my day job too, and I think there's a key role of not just being there and being an armchair quarterback, but then living it yourself and running your own trials and having to work with sponsors and partners, ensuring that you involve patient advocates and hearing their voices, not just ticking a box off on a checklist. Meta-research gives us this separate avenue to really sort of think about things, trying to see the forest through the trees. What really does evidence-based medicine show us? Where are we doing well? Where are we not doing well? There's a tremendous body of literature that, in our small way, we've contributed to some of those conversations, and we're incredibly proud as a group about that. But especially in an era and a time when the structure of evidence-based medicine is being called into question, the validity of evidence is being called into question, I think in many ways, it is easy to be on an extreme. It is easy to take a flag and plant it on a hill and say, "I believe X or I believe Y," and the other side, another view, is completely wrong. And as I tell my trainees, many of these people are also in that meta-research space, and I try to spend a lot of effort to say, we might not get the flashiest headlines, and a lot of journals, and I'm very grateful that JCO OP is not among this number, will specifically want papers that are almost trying to be inflammatory. And we very much want to paint an even-handed picture. Here's what we're doing well, here's what we suck at, here's how we can move forward. Do you make changes through editorial policies or regulatory policies? Do you make changes just by, as both of you have done, keeping that conversation alive, using the media and the forums you have at your disposal to just say, "This is something we need to be talking about more and focusing on"? And I think the the important thing that I carry forward, especially as we see changes at the regulatory and the administrative levels, are that use the data in front of you, analyze them with integrity, present them with integrity, and say, "Here's what we're doing well, here's what we're not doing well, here's the believability of our data, here's where we think we're weak." And invariably, the truth is somewhere in the middle. President Eisenhower said, "The middle is a very lonely place to be," but invariably, it's right. And I'm definitely butchering that quote, so you'll forgive me, but that's very much kind of how I think we should be approaching things, is that even-handed, "What are we doing well? What do we need to work on? And how do we find the right partners to get us there?" Dr. Fumiko Chino: Absolutely. I know that Dr. Sherry, who presented that research you mentioned that was simultaneously published in JAMA Oncology, relayed the research showing that very few trials are powered to an overall survival benefit and so they're not showing that. Very few trials are showing a quality of life benefit, and even fewer than few trials are showing both an overall survival and a quality of life endpoint. What was striking to me is that one of the people who came up to the microphone said something along the lines of, "Well, if you have this, you don't need to measure quality of life," and I was like, "Hold me back," because quality of life no matter what is one of the most important endpoints. If you live two months longer but it's in pain, I'm not sure what the living is. I say this as a cancer widow. Now, Stacey , anything to add given your role as a patient advisory for new treatment testing, for development, for patient education? Anything to add? I know you have an opinion about this. Stacey Tinianov: Well, I have opinions about a lot of things. But I want to, you know, thank you for bringing up the divisiveness that exists, and I think that the divisiveness that exists in society is obviously impeding our work. But in advocacy, we're there for every individual, and we're there to advocate for the best possible outcomes and the best possible experience for every individual. And cancer's incredibly nondiscriminatory. It really doesn't matter if you're a, "I did my own research," or if you're kind of leaning into evidence-based medicine. And so I don't know that I live in the middle, but I definitely think that there's a lot of value in being the bridge. Just sitting in the middle and observing, I think, maybe it's just not enough action for me, but really trying to figure out what are the things that we can agree on. I think we can agree on quality of life. I think we can agree on ‘we need to do better.’ I will say I'm excited because I do feel like things are changing. And again, change is hard and sometimes change is slow. But we do have groups, you know, the Patient-Centered Dosing Initiative, a group that was started by a few metastatic breast cancer patients that said, "You know what? We are overdosing people," and we kind of know that because the way we approve drugs is to get to the maximum tolerated dose, a little over, and then pull back. That's where we then go through the rest of everything else. So of course these toxicities are high. I, and I can’t quote the source, but this week, I learned that approximately 1% of payload in some of these large ADCs actually gets through. And a lot of that depends on, you know, how much is going to be able to filter through, but what that means is we are giving such a high load that of course these toxicities are high. And so I think the more we know, the more we can address. There will be situations where it is what it is and people will just need to decide what's right for them. But I think from a clinical trial standpoint, I think, you know, again I'm preaching to the proverbial choir here, advocacy and helping making trial designs, trial protocols much more friendly to the individual who's going to sign up, it's a win-win for everybody because we're going to be able to accrue. We're going to actually be able to do the research and we're going to be able to get people who understand why they're participating, what the potential benefits and risks are, and that's going to really help with reducing the attrition rate. It's really going to help with people who are committed to making sure that we can see this through. So I love this. I think, you know, a goal for me is to see more lay summaries on our research. I think let's communicate what we're doing and the impact of what we're doing so that the rest of - on both sides of this bridge - so that the rest of society has a better understanding. Dr. Fumiko Chino: One thing that you said really stuck at me as a treating physician is that I've had patients on, let's just say a CDK4/6 inhibitor, who really were underplaying their toxicity to their medical oncologist because they did not want to get a dose reduction. And I have to be, "You know what, on that clinical trial," I have it here, "70% of the people on the clinical trial, the Olympians of clinical trial participation, they needed a dose reduction, and we still get this benefit from 70% of those people had a dose reduction." So it is okay for you to have a dose reduction as well. And I, you know, I have to emphasize that to patients fairly frequently how important it is to balance the what you're getting out of it and what it's putting you through. Stacey Tinianov: With regard to that, and I think that's a fantastic topic, the way that dose reduction is often communicated and especially communicated in meetings like ASCO and all the other meetings, is it's de-escalation. And de-escalation, it's a technical term, and it also, especially to individuals who are new to the oncology space and new to treatment, it feels like they're getting less than. You're de-escalating, you're getting less than. And so I think when it's framed as "right-sizing," "Yes, this drug was approved in a population, and right now what we're doing is we're right-sizing it for you as an individual," I think the comfort level in individuals is much, much higher for that. So, and I know you do because I know you. Dr. Fumiko Chino: That's funny. As a radiation oncologist, we're constantly de-escalating. I put that in quotes, but I have shifted it to “right-sizing” more recently because I think I might have heard you say that, and I thought, "Well, that is actually great language, and it's very patient-centered language." As we wrap up our time on this podcast, I want to just give a little bit of space at the end. Is there anything that we missed, any large topic that is uncovered, or any last thoughts before we close out? Ethan, anything from you? Dr. Ethan Ludmir: I echo Stacey entirely. I think there's a tremendous opportunity space, even in today's slightly politically charged environment, to be robust and earnest in our research, to maintain continuously the focus on patients, right-sizing rather than de-escalating, talking about toxicities in a meaningful and appropriate way, understanding the validity of not only the results for the individual but now taking again a big step back, the results at the population level, the results for clinical trial populations, and the general population. As much as we live through chaotic times and and these are tough times, I think this is in certain ways an important opportunity for us to continue focusing on what matters. And I remain just as Stacey, ever the optimist, that we're going to maintain the positive direction, address the things that we need to address. And sometimes I always feel a little guilty writing papers like this because the purpose is not to say that we're doing something wrong or bad, but rather, here are areas of easy, layup opportunities for improvement. And I think those remain sort of the important things to keep in mind, even in a divisive environment. There are easy ways to bring everyone again back together and improve where we're at. Stacey Tinianov: So well said, Ethan, and I just want to acknowledge that everything that happens in this conversation and kind of the larger academic medical world, we need to be having these conversations in community because we were just with 44,000 of our closest friends in Chicago, but how many other thousands and thousands of oncology professionals, advocates, and patients were not in the room and actually won't actually receive any of this information for potentially years. So as we start to think about how we can right-size and reorient in the clinical trials space and in the reporting space, we also need to be thinking how we can start to right-size and reorient in clinical care, not only in these large academic medical centers that are so plugged in, but in these smaller rural community settings where, I promise you, they're having the same adverse event experiences, just maybe not as wonderfully supported. Dr. Fumiko Chino: It's a great way of ending the podcast. Thank you so much for this wonderful conversation today. Many thanks to both Dr. Ethan Ludmir and Dr. Tinianow, as well as our listeners for your time today. You will find the links to the papers that we have discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope that you will join us next month for Put into Practice's next episode. Until then, I encourage you to think deeply before saying that a treatment was "well tolerated." 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. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Conflicts of Interest Fumiko Chino Employment Company: MD Anderson Cancer Center   Consulting or Advisory Role Company: Institute for Value Based Medicine   Research Funding Company: Merck     Stacey Tinianov   Consulting or Advisory Role Company: Blue Note Therapeutics Company: ARTIDIS Company: Napo Pharmaceuticals Travel, Accommodations, Expenses Company: ARTIDIS Company: Napo     Ethan Ludmir   Employment Company: Alaunos Therapeutics Recipient: An Immediate Family Member   Honoraria Company: Nanobiotix   Consulting or Advisory Role Company: Xerient    
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  • Park the Parking: Patient and Caregiver Perspectives on Transportation Barriers in Cancer
    Frustrations regarding the costs and difficulties with parking at hospitals is a common concern voiced by patients, families, and healthcare providers. Transportation barriers to receiving cancer care are incredibly common despite what appears to be relatively straightforward solutions. Dr. Chino welcomes two patient-centered health policy experts to discuss this: Dr. Arjun Gupta, MBBS, an Assistant Professor at the University of Minnesota; and Dr. Shakira Grant, MBBS, MSCR, the Founder & CEO of CROSS Global Research & Strategy. Transcript Dr. Fumiko Chino: Hello, and welcome to Put Into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an assistant professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity. Frustrations regarding the costs and difficulties with parking at hospitals are some of the most common concerns voiced by patients, families, and healthcare providers online. There is nary a topic where you'll find a more unified level of outrage. Transportation barriers to receiving cancer care are incredibly common, despite what appears to be a relatively straightforward solution—to parking costs, at least. To discuss this, I'm excited to welcome two patient-centered health policy experts as guests today. Both have published work in JCO OP about transportation barriers. Dr. Arjun Gupta, MBBS, is an assistant professor at the University of Minnesota. He is a gastrointestinal oncologist, a symptom management enthusiast, and a health services researcher. His research examines cancer care access and delivery, the cost of cancer care, and the hidden burdens imposed on and faced by people with cancer and their caregivers while receiving this care. His 2020 editorial, "Park the Parking," documented parking costs at the top US hospitals as a source of financial toxicity. Dr. Shakira Grant, MBBS, MSCR, is the founder and CEO of CROSS Global Research and Strategy, a boutique consultancy focused on advancing equity-centered strategic solutions to complex healthcare challenges at the local, national, and global levels. She is the former health policy advisor to the US House of Representatives Ways and Means Health Subcommittee. Prior to that, she was an assistant professor at the University of North Carolina. Her qualitative analysis was published earlier this year and is called "Paying to Be a Patient in the Hospital and the Parking Lot: Patient-Caregiver Dyad Perspectives on Health-Related Transportation Access in Multiple Myeloma." Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today. Arjun and Shakira, it's exciting to speak with you today. Dr. Arjun Gupta: Thank you. It's a joy to be here, Fumiko. Dr. Shakira Grant: Thank you so much for having me also. Dr. Fumiko Chino: Our specific topic today is transportation barriers to receiving optimal cancer care. This concern fits within the larger focus of addressing the social determinants of health, with the goal of improving access to high-quality cancer care for all. Research on health-related social risks and needs has proliferated in the last decade, and recent evaluations of food, housing, and transportation insecurity have expanded our knowledge on the barriers that some people face to receive care. Arjun, do you mind starting us off with just a bit of background about why these issues matter for patients? Dr. Arjun Gupta: Sure. So, just some background on social determinants of health. These are non-medical factors that are often at the community level that can have direct impacts on both health and health outcomes. So, these are all the issues that are associated with living and our daily lives: where we live, where we work, do we play, and what we play. All of these issues can, of course, impact what sort of medical conditions one might develop, but also the medical care that one might be able to receive. And we think about someone who does have access to public transportation or does have access to a private vehicle, for example, or someone who is a daily wage earner or an hourly wage earner, or someone who lives next to a toxic wasteland and is exposed to chemicals. So, all of these factors can, of course, influence our health risks. And as one can imagine, all of these social determinants of health can lead to health risks or social risks. And so, my real interest in this topic came about when I was a first-year oncology fellow. So much of our training in residency is on the inpatient side. But when we had our own continuity clinic in oncology during my first year of fellowship is when I realized the importance of parking and transportation for the first time. When a patient who was receiving FOLFOX chemotherapy for colon cancer, I asked them if they wanted to get blood work a couple of days before chemotherapy so that they wouldn't have to wait for the blood work to result on the day of chemotherapy, and they very passionately said, "Oh, of course not. I only want to come in one day because the parking costs $12, and Christmas is coming up, and I need to buy presents for my grandkids." And that really, really struck me. I remember reaching out to you, Fumiko, at that time. We were junior investigators and launching our careers in oncology on what is going on and why is this real. And I think we'd done some work parallelly to highlight how these major cancer centers were charging obscene amounts for parking, which for an individual visit may seem very small, but of course, cumulatively can be large amounts. And also the fact of the nickel-and-diming that comes in for these very, very vulnerable patients and care partners. And my interests in these transportation and parking costs and barriers have evolved since our research group has been working on time toxicity. So, over the last couple of years, this concept of the time burdens of cancer care has evolved. And initially, we were largely focusing on the amount of time spent in medical appointments. So, you go up, and it takes so long. And in qualitative interviews, patients brought up that even for simple blood draws, "I'm actually spending three, four hours out of the home." So, we actually looked at this formally because our oncology discipline didn't believe this data. They kept thinking a blood draw is 10 minutes tops; you just ask a patient to come in. At our cancer center, patients get a radio frequency ID badge when they enter the clinic. This is to track them within the cancer center. So, using that radio frequency ID badge data and the average driving time through their home zip code, we found that actually, even a simple blood draw was taking people more than 3 hours, home to home. And I actually made a couple of residents walk from the parking garage to the entrance of the cancer center and found that it was a median of 7 minutes one way. Now, remember, these are mostly young adults in their 20s, not walking in the Minnesota snow. So, you can imagine someone who's an older adult, at risk of slipping, walking much slower. So, all of this to say, these are major, major issues that patients and care partners face, and I was very excited to read Shakira's work on this topic. Dr. Fumiko Chino: I love how you walked us through the granular of the patient interaction that then drove you to research this type of study because, initially, you were trying to be very patient-centered in your approach, which is, "Let me separate the lab from the visit so we can save you some time." But what they told you was that, "Hey, it actually costs me more money, and it may not actually save me any time." And I think that dovetails really nicely into thinking about the study at hand, the most recent study. And Shakira, your study on transportation barriers really just came out, and it highlights the voice of the patients and the caregivers on the lived experience of cancer treatment. And one patient from your study specifically said that their travel to receive cancer care was not only wear and tear on the cars but wear and tear on the body as well. So that echoes what Arjun just said. And I think that quote really nicely highlights that it's the costs, it's the time, it's the stamina required to navigate the hospital. These all contribute to the burdens that our patients and their families carry. Do you mind, Shakira, giving me a brief overview about why you did this work and what you found? Dr. Shakira Grant: Sure. So, I would say to dovetail on a lot of what Arjun said, this came also what I was seeing firsthand in the clinical practice. And at the time when I was directly involved in patient care, my population was caring for older adults, primarily with multiple myeloma. My background is as a geriatric oncologist, and so by and large, that meant that most of my patients are over the age of 65. But apart from age, they're also battling other things such as disability and other chronic conditions that impact their functional ability. And so, I kept hearing stories over and over, not only from patients, but I recognized there was an integral part that is often overlooked in clinical care, and that is the voice and the role that caregivers play, especially when we're dealing with older adults who may not have the independence to drive a car themselves to get to the cancer center because it might be disability, it might be other chronic conditions that impair their ability to operate a vehicle. And they kept talking about the same issues around accessibility of the parking structures, the time it takes for them to drive from their homes, especially when they're having their chemotherapies or other cancer therapies, and that may impact them by not feeling physically well and then needing to still get to the cancer center to see a physician or to receive additional treatment. And then on top of that, similarly, I heard the concerns about parking because parking was not free at the cancer center for patients. And so, this is an hourly rate, and the longer you're there, you pay more money. And for many of these older adults, they're already on a fixed income, and so it becomes very difficult for them. Even though for someone who's working and has a nice buffer of income, they may be able to readily afford $12 or $15 to pay to park every time you come to the cancer center. But if you're on a fixed income, that becomes more difficult. And so that was one of the real driving reasons behind why I wanted to do this type of research in this particular area. Dr. Fumiko Chino: This work from your team is really an excellent example of patient-centered research and explicitly examining and prioritizing the voice of the patient and the caregiver, their experiences as an avenue to help clinicians and researchers and policymakers understand where care gaps exist and how we can be doing better. And I'd love to hear from each of you why you specifically feel like this type of research is important - I know you've already mentioned some of it - and the range of patient-centered research that you have done in the past or you hope to do in the future. What is the unique knowledge that this research allows us to gain beyond some of the standard research paradigms? Dr. Shakira Grant: I think patient-centered research is really critical, not just in helping us to set the stage as clinicians, as researchers, but it becomes important for policymakers because oftentimes, we hear the stories, and the stories are the things that are most powerful. They speak to the emotional need of people, and that in itself can be very powerful, especially when you're trying to interact with policymakers about why this particular issue is important. It is easier to do that when you have a story, when you can put a face to what is actually happening. So, it doesn't seem as abstract if we're just talking about quantitative data where we're analyzing and putting out a lot of statistics. We're talking about this patient, their caregiver, their lived experience. These are the real barriers. So, I really appreciate doing patient-centered research because it centers the voices, the lived experiences, and that just enriches the experience, and it also gives that emotional and psychological appeal that is sometimes necessary to get the attention of policymakers and other legislators. Dr. Arjun Gupta: Absolutely. And to follow up on that, I think Shakira's point about telling stories is very important, especially these days. We've seen so much misinformation. And I think for me personally, as a researcher, learning how to do mixed-methods work, especially qualitative work, to be able to integrate stories into all of these quantitative data elements that we have is extremely important. To that point, I will say that when starting to research parking costs, the most impactful blog that I read on this topic was about parents whose newborns were in the neonatal ICU or the NICU. And it was such a beautifully written blog, asking someone to imagine their biological child in the neonatal ICU. And if the child had two parents, then each of the parents trying to balance work and coming to the NICU and having to pay parking fees twice a day. And to have to do that day after day and week after week and month after month, I think it's very important to share that part of the story and the horror along with that element of, "Okay, it cost $10 each time." And so, when I think about patient-centered research and how I best integrate my skills and interest, I think about symptom intervention trials. So, how do we make people feel physically better through things like medical cannabis and access through that? And the other big thing is exploring and intervening on the financial toxicity of care, the time toxicity of care, and the logistic toxicity of care. So, Fumiko, you've been such a champion for financial toxicity over the years. And just to go back in history a little bit, before Dr. Zafar coined the term "financial toxicity" 10-15 years ago, being bankrupt from cancer care was just something that happened. It sucks, it happens. But since then, it's been named, it's been shamed, and it's been intervened upon. And that's my hope with the time toxicity field now over the last two, three years. And the latest thing that our group has sort of worked on while studying time toxicity is that it's not just the time outside the home, but it's also all the paperwork and administrative burden that goes along with it. And so, our team is currently trying to provide patients with proactive legal support to actually help with medical debt, insurance denials, things like that. Dr. Fumiko Chino: I like that full scope of the patient experience when thinking about cancer care. And one thing that struck me when I thought about these studies about parking costs is that when we see someone in our clinic, you know, when we open the door and we say, "Hello," they've already had to deal with all of these transportation barriers. They've had to navigate the parking deck and walk over. And so, when we're seeing them, they've already had some amount of small trauma, sometimes large trauma, related to just trying to get in the door. And I think that really nicely encapsulates the fact that there is a larger picture that our patients are experiencing that is not just me talking to my patient and outlining a treatment plan. And one thing I think I heard kind of from both of you is that with these patient stories, you actually get ideas for research that you may not have actually thought of on your own. Again, your patient saying that they couldn't afford Christmas presents is such a compelling anchor for why what we do matters. And when we think about trying to explore things like quality of life or frailty, or the fact that, for example, the cost of a walker may actually be outside of someone's ability to pay, and they can't even afford their durable medical equipment. These are all part of the larger care experience for a lot of our patients. Now, one aspect about this most recent JCO OP study that I particularly loved was the inclusion of the caregiver as an essential member of the healthcare team. Selfishly, perhaps, as a prior cancer caregiver myself, now a cancer widow, I find the caregiver voice to be really underappreciated and understudied. Shakira, do you mind sharing why you felt like this was really important to include caregivers on this study? Dr. Shakira Grant: Sure. So, it came exactly out of the reason that you mentioned. Oftentimes when we think about research, especially within the cancer space, a lot of it is centered on the patient experience. And what I've learned through clinical practice and even working in the health policy space is that cancer is a disease that not only impacts the patient but it impacts the family around them, and that bleeds into financial issues and whether or not someone experiences financial toxicity. Now, especially in the health policy world, we hear a lot about medical debt and thinking about how that then gets passed on to other family members. So, it was critical for me and our team to really think about the caregiver because we saw them as being a central part of the cancer journey or experience. We wanted to capture their voices because so often their voices, their experiences are not taken into consideration. And I think when it's coming to think about something like transportation in particular, it's key to remember that transportation is a core determinant of whether or not people are going to be able to access healthcare. And when you are older and you have disability and you're not able to operate a vehicle, that's one aspect of it. But then there's the financial piece of the transportation, which is paying for costs to uptake your vehicle, insurance costs, parking costs, and then the other costs that happen once you actually reach the cancer center. So, it was important for us to not only understand this from the patient perspective, but we do recognize, especially with older adult caregivers, they too are taking time off from work. That means lost wages potentially for them in order to drive their caregiver to the care recipient to the cancer center. And that can have a downstream impact on them. So, it's important to amplify their voices whenever we are talking about this type of patient-centered, or should I say, patient and caregiver or patient-care partner focused research. Dr. Fumiko Chino: Now, Arjun, I saw that you recently published a piece in JAMA Network Open on time toxicity that similarly had qualitative interviews of patients, caregivers, and actually also clinicians. Can you also speak to the importance of including caregivers in research? Dr. Arjun Gupta: Absolutely. Before that, just I want to acknowledge that my own clinical care has evolved over time. I think I was much more immature earlier. But in my earlier years of clinical practice, it was largely patient-focused. And over time, I saw firsthand the importance of having an engaged care partner if I wanted the patient to do well. So, if our primary allegiance is to the patient, I initially used to look at it as, "I need the care partner to be on my side so that if we say the neutrophil count is 0.1 and we need to come to the emergency department, we need the care partner to be able to drive the patient." But over time, as I matured, the care partner became a distinct human being for me. And someone put it very beautifully that the care partner's suffering, unfortunately, often lives on even after the patient's death. And in my clinical space, which is often advanced GI cancers, that's not uncommon when the median survival for the patient may be one year or so on average. And so that's where this was motivated from. And when looking at time burdens faced by patients and their loved ones, a couple of themes came up prominently. Patients often brought up themselves that, "You know, my time is precious and so much of it is used up, but it's really my loved one who's suffering." They referred to their loved one's time loss as collateral damage. They often described it as, "I am the ball that's not allowed to drop." So, my care partner is juggling four different balls, and I'm the only one that's not allowed to drop. So, all of my care partner's balls are dropping. And one more point I'd like to raise is we often think about a care partner in the singular. So, there's an index or a main care partner. But one of the other interesting things was how often the entire network of friends and family around that patient and the index care partner were affected, which was likened to this domino effect or a rippling effect. And so, for all of our work, I think if we're talking about the patient, I think it's absolutely unfair and not applicable if we don't consider the care partner alongside patients. Dr. Fumiko Chino: I love what each of you have highlighted: that this is an evolving paradigm of broadening the scope of what we need to focus on. And it kind of shocks me that this is a new concept, that suddenly, "Oh my gosh, the caregiver and the caregiver team actually matter." It's sort of like how we thought of quality of life as, "Oh my gosh, suddenly quality of life matters." It used to be just, "Oh, well, you're alive, so good luck with that," or "Survivorship matters." And so again, part of evolving research to be better is to really think about the full picture for our patients, and that includes quality of life and care teams and survivorship and end-of-life care. Now, switching gears a little bit, Shakira, I know you're coming directly off of time within the federal government, working on health policy in the House Ways and Means Committee. Can you briefly speak to your experiences in DC and your work trying to bring some of these issues to the eyes and ears of legislators and how to prioritize national solutions to the affordability healthcare crisis? Dr. Shakira Grant: Sure. So, in DC, my work on Ways and Means under our jurisdiction largely focused on Medicare. And with Medicare being one of the largest federal insurers, with just over 66 million, I believe, as of 2024, enrolled in Medicare plans, it really brought to light a lot of the complexities at play when it comes to thinking about the issues that the older adult population and those who qualify for Medicare based on disability status could face. And so that ran the range from thinking about health equity in everything that we did, which broadly encompasses thinking about social determinants of health such as transportation, as we're discussing, to making drugs more affordable for our older adults, as well as thinking about how do we safely bring innovative technologies and new therapies to the older adult population or Medicare beneficiary space, while ensuring that we are able to be focused on containing costs as much as possible - so, thinking about financial payment models and reimbursement. When it comes to raising these issues, I would say from my experience in DC, I believe that regardless of which side of the aisle you sit, the health of the American people is always at the forefront of everyone, of every legislator. There's always ways to think about how do we improve the health of our communities, of the people that they are elected to serve. The way to do that, however, may look different depending on which side of the aisle you sit on. But I would say efforts that could be done that will help in this space are through the advocacy, especially through the work that ASCO continues to do, especially as it relates to drug pricing and addressing the drug shortages, raising issues such as affordability, healthcare access. Those voices together are really powerful and appeal to the broader legislative landscape to understand why this is so important, especially for your patient populations. The other aspect of this is also related to just thinking about future changes as it relates to the current political climate and a lot of the federal actions that have been taken. I think overall, there still needs to be a push to make healthcare a lot more affordable. In addition to addressing the affordability issues of healthcare, there's also the access issues and ensuring that the 21 million people who have sought health insurance through the marketplace, that they continue to be protected and that they can still continue to have access to health insurance. And then more recently, we've seen a lot of discussion around what is happening with Medicaid, and it would be remiss of me not to mention this because of the proposed $880 billion (with a B) in cuts that is proposed to this program. And so Medicaid is a key pillar. It provides insurance for those who are oftentimes the most vulnerable. It is one of the federal programs that actually addresses social determinants of health such as transportation by actually providing and covering transportation for its beneficiaries, as well as addressing other things such as food insecurity, housing insecurity. And so it's really critical when you think about framing social determinants of health, framing access to care, to think about Medicaid especially and proposed cuts and what that would mean for the most vulnerable among us in terms of being able to access the care that they need, in addition to the other programs that I mentioned. Dr. Fumiko Chino: Now, Arjun, I know with some concerns about federal cuts to Medicare, Medicaid, there's been some idea that maybe there's a shift of focus towards state, institutional, other organizational commitments to try to fill the gap that maybe federal dollars are departing from. Do you have any thoughts about what we should be doing within our clinics, within our institutions, within our societies? Dr. Arjun Gupta: Yes, I think just speaking at an individual clinician or health system level, especially as it pertains to transportation and parking specifically. So, what can I or we do in clinic tomorrow? We've actually been doing some qualitative interviews on this, on how to make people's life easier. And some of the things that patients and care partners have said are actually very, very simple. One of the first things is, "I wish my oncology care team was honest with me. We know you're well-intentioned. I know you're working in a broken system. But I was told, 'Oh, it's a quick infusion,' and then I was set up for a three-hour infusion, and then it ended up taking five hours. And I understand that you're all working hard, but just tell us if it's going to be five hours. And I can then plan my day and arrange childcare and things like that." And so, I just think being honest and vulnerable with our patients is super duper important. The other thing is things like, "Do we really need to make the patient, plus minus their care partner, come in on a given day?" So, trying to coordinate care better. And one of the more specific solutions for that is people have suggested having a designated care coordinator or scheduler with them, a one-stop shop for scheduling, which cuts down so much of this time that's spent scheduling but also avoiding extra visits. So, while these longer-term policy issues are implemented and leveraged, I think there's things we can do every day. Is that CT scan, does it need to be done, or can it be on the same day? These can make massive, massive differences for our patients. Dr. Fumiko Chino: Shakira, any last thoughts as we wrap up this podcast? Dr. Shakira Grant: I just wanted to add to that because one of the key things I would sum up our study in showing is that, again, transportation is a core determinant of whether people are able to access healthcare. And we found, especially that older patients, those with disabilities, low income, and living in remote areas, these are the people who are facing the most significant challenges when it comes to accessing care because of transportation. And so, when you think about interventions, an approach could be, rather than thinking about population-level approaches that incorporate everyone, rather, it may be thinking about who are the high-risk groups amongst the people that are seen within your respective healthcare system, and then targeting interventions at the individual level as well as the healthcare system level, and then building up to thinking about community-level interventions such as rideshares, investing and appealing to policymakers. But I would say we often think about policy changes as needed to really make a difference, but it really starts at the individual level, and you can then use that to build up to the policy because in order to develop a really great policy, it takes several years, sometimes up to a decade or more. And in the meantime, what we can be doing as clinicians, researchers, consultants, are focusing on the people within our immediate ecosystem and seeing how we can build strategic partnerships to address the issues that they're facing at those individual, interpersonal, healthcare system levels, and then leveraging that to build up robust policies. Dr. Fumiko Chino: I love it. It's this idea of not losing the forest for the trees, but also taking the time and care for each individual patient in front of us. And it's a dual goal. Arjun, any last thoughts from you? Dr. Arjun Gupta: Just, I read a very interesting quote which I love. Someone said - I haven't found who said this, but they're clearly very smart - they said that, “With all of this AI and stuff, the biggest technological advance will still be more time with the patient.” And I think in some of our work on time toxicity, clinicians, which is all sorts of people in healthcare, have persistently said, "I just wish I had more time." And so, I think as we think of frontline solutions, I think we need to respect our own time to be able to respect patients' and care partners' time. Dr. Fumiko Chino: Well, thank you both for this wonderful conversation today. Many thanks to Dr. Arjun Gupta and Dr. Shakira Grant, as well as our listeners for your time today. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put Into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put Into Practice's next episode, and until then, I encourage you to continue advocating for your patients, from parking vouchers to health policy solutions. 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. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.     Conflicts of Interest   Fumiko Chino Consulting or Advisory Role Company: Institute for Value Based Medicine   Research Funding Company: Merck   Shakira Grant No relationships to disclose    Arjun Gupta Employment Company: Genentech/Roche Recipient: An Immediate Family Member
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  • Pregnancy and Breast Cancer
    Dr. Chino talks with Dr. Erin Roesch and patient advocate Julia Maues about pregnancy associated cancer with a focus on breast cancer, the most common cancer diagnosed during pregnancy. This discussion is based off an JCO OP review article published in late 2024 called “Multidisciplinary Management of Pregnancy-Associated Breast Cancer.” Transcript Dr. Fumiko Chino:Hello and welcome to Put Into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an assistant professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity. The incidence of early-onset cancer—new cancers in adults under the age of 50—is rising by 1% to 2% annually. Young women appear to be at particular risk, with cancer incident rates over 80% higher than similarly aged male counterparts. Collectively, that means that more patients are being diagnosed with cancer during their childbearing years. Pregnancy-associated cancer occurs in 1 in every 1,000 to 3,000 pregnancies and refers to cancer that is diagnosed either during pregnancy or within 1 year of delivery. On today's episode, we'll be talking about pregnancy-associated cancer, with a focus on breast cancer, as it is the most common cancer diagnosed during pregnancy. This discussion will be based off of a JCO OP article published in late 2024 called “Multidisciplinary Management of Pregnancy-Associated Breast Cancer.” I'm excited to welcome both the first author of this review article and a patient advocate to the podcast today. They are both passionate about improving outcomes for people with breast cancer. Dr. Erin Roesch is an assistant professor of medicine at Cleveland Clinic Lerner College of Medicine and a medical oncologist at the Cleveland Clinic Taussig Cancer Institute specializing in the treatment of breast cancer. She is involved in clinical trials research, and some of her specific interests include the care of young women diagnosed with breast cancer, fertility in oncology patients, and women's health and survivorship. Julia Maues is a patient advocate working with researchers, clinicians, and other stakeholders to ensure research is patient-centered, innovative, accessible, and inclusive. She was working as an economist when she was diagnosed with breast cancer while pregnant in 2013. After delivering her son, she found out that cancer had already spread to her bones, liver, and brain. Julia co-founded GRASP (Guiding Researchers and Advocates to Scientific Partnerships), an organization that connects and fosters collaborations between researchers and patient advocates. She is also active within the Metastatic Breast Cancer Alliance and helped write the ASCO guideline for brain metastasis. Our full disclosures are available in the transcript of this episode, and we've already all agreed to go by our first names for the podcast today. Erin and Julia, it's really wonderful to speak to you today. Dr. Erin Roesch:Thank you. I appreciate the opportunity to be here and discuss this really important topic. Julia Maues:Thank you for having me. It's very important to include the patient voice on this topic, and unfortunately, I have a personal experience with this. Dr. Fumiko Chino:Our topic today is pregnancy-associated cancer. Erin, can you give us a quick overview of the background for pregnancy and breast cancer? I know in the recent era, breast cancer rates for those under the age of 50 have been rising faster than for other cancers, up to 1.4% per year since the mid-2000s. I'd always thought that pregnancy-associated cancer was pretty rare, and so I was really shocked to read in your paper that for women younger than 35, 1 in 6 with breast cancer are diagnosed around pregnancy. Dr. Erin Roesch:Yes. So, a cancer diagnosis during pregnancy is rare, with the incidence, as mentioned, of about 1 in 3,000 pregnancies, with pregnancy-associated breast cancer, or PABC, representing about 7% of all breast cancers diagnosed per year. Among women under the age of 45, PABC accounts for roughly about 2.5% to just over 6% of breast cancer cases. And for women less than 35 years, this rises to about 15.5%. Studies have shown a rise in PABC in recent years, and this is anticipated to continue with the trend of delayed age at childbearing. In regards to the pathophysiology of pregnancy-associated breast cancer, various hypotheses have been proposed to kind of try and shed more light on how this occurs and the driving factors for PABC. So these include hormonal changes that occur during pregnancy and lactation, immunologic changes that can lead to the immune tolerance of tumor cells, and also breast tissue involution that occurs after delivery and breastfeeding, which can lead to a proinflammatory state. In regards to risk factors, these include a positive family history, which is one of the strongest risk factors for breast cancer development, this includes pregnancy-associated breast cancer, pathogenic germline mutations—specifically BRCA1 or 2—and older maternal age at time of birth. We also know that breastfeeding has been shown to have a protective effect against breast cancer development. Dr. Fumiko Chino:So what I'm hearing from you is that just given the incidence rising in younger people and also delayed pregnancy, that this is really something that we're unfortunately going to be facing more and more frequently in our clinics and something that patients unfortunately will find that they have to face as well. Dr. Erin Roesch:Yes, yes, I think that's accurate. And just again, I think points to the importance of awareness of this particular topic. Dr. Fumiko Chino:Now, Julia, your lived experience in this space is really invaluable. Do you mind sharing it with us? Julia Maues:Yeah, of course. I was pregnant at 29, and I found a lump in my breast. I had an excellent OB-GYN and team, and they took it seriously. I think she wanted to watch it for a few weeks, but as soon as it didn't go away, she ordered an ultrasound, and that turned into a biopsy, and that turned into a cancer diagnosis. I lived near a comprehensive cancer center. I had multidisciplinary care, really excellent team, and was treated with chemotherapy during the pregnancy, which was very surprising to me and hard to accept. But they did provide me with a lot of evidence that that is the best treatment for both my baby and me. And so I did four cycles of Adriamycin-Cytoxan during the pregnancy and delivered my son at 37 weeks. He was healthy and full of hair, even though I was bald. That was very important, I think, for many reasons, but it showed visually that the placenta did its job and he was protected. After he was born, I could do scans that I couldn't do while pregnant. I had a lot of back pain and things that were thought to be pregnancy-related, or maybe they knew, and they just didn't go there because it really wouldn't have made a difference at that point, like, the treatment couldn't be any different. But I did that scan and found out that it was metastatic, and that changed the treatment that I did after the pregnancy, and instead of eventually surgery, I just stayed on systemic therapy for that long. And spoiler alert, this is 12 years later. That baby is in sixth grade and thriving. And I am very grateful for the privilege that I have to have received such excellent care and have access to the treatments that I have had, and also the luck to have had good response to treatments. Dr. Fumiko Chino:I love how you've taken your story and the successes, but also the horror and the terror, and really used it to galvanize your life in a mission to try to improve patient care for others. So I've always really thought that was phenomenal in terms of your mission and your drive. Julia Maues:Thank you. I'm very, very happy that it helps other people, but selfishly, it helps me to deal with my own difficult experience, and it's been a way to make something good out of this. Dr. Fumiko Chino:I feel very aligned with you on that in terms of my own personal story as a caregiver. It's one of the reasons why I became a physician. So I feel like you and I have a common touchstone there. And I think so many people in medicine and so many patient advocates are really trying to give back into a system to try to improve it for all because of either the ways that it helped them or the ways that they thought that it could be doing better. So thank you for sharing that with us. Now, Julia had mentioned that the staging scans were delayed until after delivery due to some appropriate safety concerns. And I certainly know that those diagnosed during pregnancy often have diagnostic delays. Erin, do you mind discussing what delays may occur in pregnancy-associated breast cancer and if there are any solutions to improve those delays? Dr. Erin Roesch:Sure. And I'd like to echo and certainly, you know, thank Julia for sharing her story. And I think as an oncologist, we learn so much from our patients, and so it's really, really important for us to understand, to be able to appreciate everything you've gone through. So I just, I really thank you for that. So in terms of, you know, the delays that we see—and I think, Julia, your story through this really kind of outlines much of what we see in terms of some of these delays and challenges related to the diagnosis and the workup of pregnant women with suspicion of breast cancer. So although the majority, about 80%, of breast cancers or breast masses, rather, detected during pregnancy will be benign, any palpable mass present for a couple of weeks or more in the breast or axillary region should really be clinically investigated, you know, as your doctor did. Additionally, any other breast changes—less common things such as an asymmetry, thickening of the skin, redness of the skin, nipple changes—those things should also be investigated, you know, as they raise clinical suspicion. Pregnancy-associated breast cancer often remains undetected in pregnant women until later stages due to potentially symptoms being masked by the physiologic breast changes during pregnancy. Studies have shown that a relatively high proportion, you know, over 80%, of pregnancy-associated breast cancers are self-palpated. We know that later stage at presentation and a delay in care can lead to an inferior prognosis or affect someone's prognosis. So I think in terms of the challenges, in terms from a diagnostic evaluation standpoint, typical imaging modalities that we use for breast cancer, we know some can have harmful effects on a growing fetus. So the evaluation should begin, as Julia mentioned, with an ultrasound. That would be the initial gold-standard diagnostic test. And then subsequently, a mammogram with abdominal shielding can and should be used to provide additional details regarding the breast mass. In terms of systemic staging, so I think again, as Julia pointed out, the traditional evaluation for metastatic breast cancer typically includes CT scans with IV contrast of the chest, abdomen, pelvis, and a bone scan or a PET scan. However, these imaging tests should be avoided during pregnancy, particularly during the first trimester, due to the harmful exposure of radiation and IV contrast to the fetus. In regards to some of the solutions, I think from a systemic staging standpoint, alternative imaging can be used. So when indicated or appropriate, things such as a chest x-ray with shielding, an ultrasound of the liver, an MRI of the spine without contrast could also be considered, again, in the appropriate setting. But I think, you know, Julia certainly highlights the challenges that we face from a diagnostic standpoint. Dr. Fumiko Chino:Julia, you had said something probably that was the most important, which is that you felt the mass and that your physician actually took it seriously. And I certainly have heard from other patients that when they were pregnant and they felt something, it was sort of just ‘pooh-poohed’, for lack of a better term, as, you know, normal changes in the breast, and it wasn't followed up to the extent that it should have. Do you have anything to add in terms of delays? I know you are certainly very active in the advocacy community, so I feel like you've probably heard every good and negative story about delays to diagnosis or care. Julia Maues:Yeah, unfortunately, we hear these stories all the time. The clogged milk duct, which may be very plausible, but needs to be investigated, right, is not always the case. And unfortunately, anecdotally, and I know you all have been part of evidence on this, women that are Black experience this at a much higher rate. And then we see younger women with doctors that just tell them that, “Women your age don't get breast cancer.” Dr. Fumiko Chino:Which is patently false, as we know, because the rates of breast cancer in younger women are rising. So I feel like we need to be standing on top of rooftops trying to make sure we're advocating for our patients and educating our colleagues about the early-onset cancer risk. Julia Maues:And I'll say one more thing that I think patients also have a wrong understanding of this statistic about pregnancy protecting from breast cancer after menopause. The only thing that translates is ‘pregnancy equals lower rate of breast cancer’, right? So that is not necessarily the case while you're pregnant or in the short years after the pregnancy. It is a statistic about postmenopausal breast cancer, which won't affect the pregnant person for many years. Dr. Fumiko Chino:Julia, this review highlights the role of the multidisciplinary team for optimal management of pregnancy-associated breast cancer. And from the article, it says, "At the time of diagnosis, multidisciplinary teams should be consulted, including breast surgery, plastic reconstructive surgery, medical oncology, radiation oncology, maternal-fetal medicine, genetics, and psychosocial services." Can you speak to who was involved with your care, including what really worked well in this incredibly stressful situation or lessons learned for what could be improved? I know you said you did have the benefit of a comprehensive cancer center and a multidisciplinary team. Julia Maues:Yes, absolutely. A team that came from many angles at this problem was very important. I did see a surgical oncologist, a radiation oncologist, a plastic surgeon, the medical oncologist, of course. And then I had two OB-GYNs, my first OB-GYN and a high-risk OB-GYN, and I did see genetic counseling. And I think after those first appointments, the surgeon and the radiation oncologist and the plastic surgeon didn't play a role. They were going to come back into my care after the pregnancy; that was the plan. But the OB-GYN, and especially the high-risk OB-GYN, was very important. And the fact that they were in touch with my medical oncology team and they were complementing each other in terms of medications and what treatment I needed, that was very important. Dr. Fumiko Chino:Erin, do you have anything to add in terms of coordinating these large teams? I know that the medical oncologist often works as sort of the quarterback in this scenario for these teams. Dr. Erin Roesch:Yes, and that's exactly how I typically describe myself to patients, is kind of as that quarterback. I think that Julia's description certainly highlights the importance of multidisciplinary care, and it's really crucial for pregnancy-associated breast cancer. And it's important to recognize that it's not a one-size-fits-all approach either, and that not all patients' needs might be the exact same. But that being said, it's helpful to have, you know, an algorithm that outlines the general steps, diagnosis, and management of our patients with pregnancy-associated breast cancer. And it's really important—it's an overwhelming time for patients and their families. So it's really, you know, essential to make sure that our patients have knowledge of and access to all of the resources that are available, you know, during their diagnosis, treatment, and in survivorship. I think that again, just stressing that multidisciplinary care from the beginning is really key. Dr. Fumiko Chino:That segues nicely into the next topic, which is: I really found the figure in your article to be particularly helpful as a flowchart for decision-making in pregnancy-associated breast cancer. How do you approach shared decision-making, patient autonomy, and informed consent with your patients when faced with some of these really heartbreaking decisions? Dr. Erin Roesch:So, you know, just as I said, it's certainly, you know, it's very individualized, but it is very helpful to have a guide that we can follow and that we can also use for educating other providers on what are modalities that are safe during pregnancy, what we have data on, where we're lacking, et cetera. So I think that when I talk with my patients in this type of situation, you know, I think open lines of communication, transparency, super important. And I think recognizing that breast cancer diagnosed during pregnancy often occurs during a time when a woman is figuring out their life plan. They could be finishing school, family planning, you know, career goals, establishing relationships, just to name a few things. So it's helpful to be aware of these things when we're counseling our patients so that we can better really appreciate, understand their goals and, as much as possible, help them achieve their goals while also effectively treating their breast cancer. So I always really, really strive to involve my patients in the decision-making regarding their care, but also advise them that I'm there to provide full support and whatever information that I can to be helpful. Dr. Fumiko Chino:I love that thing to highlight—that cancer doesn't define someone's existence, and they were a whole human being before their cancer diagnosis, and they should be a whole human being after their cancer diagnosis. And so making sure that we are talking to a person, not to a cancer diagnosis and a treatment plan. It's an individual on the other side. Now, Julia, I know that you said that your stage IV diagnosis came after you delivered. I'm sure that there was a shock and horror related to that. Do you have anything to add in terms of the multidisciplinary team or how it pivoted once you got that diagnosis? Julia Maues:I completely agree with the ‘quarterback’ name to the medical oncologist. They definitely have, even today, this role in my life, and I definitely benefited from really wonderful quarterbacks in my years. But I think another very important connection there is being able to connect to other patients with a similar experience. I did - at different times, I was able to connect to people who had just had a baby after treatment during pregnancy, or who had a child that was maybe a little bit older and they were thriving, and just knowing that that was a possibility or a likely possibility for my child, even though I was making him go through these treatments while inside me. Dr. Fumiko Chino:Now, pregnant women, human fetuses, and neonates have additional protected status under the federal government that mandates special IRB review. This means that pregnant women are often excluded from research, often without actually clear justification, even when the research really poses minimal risk. Erin, how do we improve the body of evidence to support best care for patients with pregnancy-associated breast cancer, understanding some of these concerns? Dr. Erin Roesch:Yes, so I think it is really important to utilize the research means that we do have. So an example of this could include retrospective analyses, you know, looking at registry data. We can really gain important, valuable information this way. Additionally, learning from thought leaders in this space and experts in this field can help providers and patients better understand the data that we do have and where our gaps may exist. I think, furthermore, various institutions have niche programs that are dedicated to education and research for young women with breast cancer and, within that umbrella, pregnancy-associated breast cancer. So it's really important, I think, to be aware of those resources as well that do exist. Dr. Fumiko Chino:You really highlighted something important, which is that in this situation of pregnancy-associated breast cancer, it likely is best to go to a specialty center, you know, a comprehensive cancer center of some variety, or a center of excellence so that you can really rely on both the expertise of the team but also their capacity for building that multidisciplinary team that is, I think, really required to treat a patient with cancer and pregnancy well. Now, Julia, I personally see some parallels here with exclusions for people during pregnancy and also the exclusions for metastatic breast cancer from research studies. Do you mind speaking about that? I know you've been a strong advocate about inclusion. Julia Maues:Yes, absolutely. We see a lot of clinical trials that include metastatic breast cancer patients when it comes to the actual treatment and the new drugs. But when it comes to survivorship trials, and let's say, what is the effect of exercise on your outcome? Patients with metastatic breast cancer are often excluded. And we are surviving too, right? We need to be studied in that scenario as well. And I think we're fortunately seeing some change in that. And there are a few trials, for example, open right now looking at diet and exercise for specifically metastatic breast cancer. Dr. Fumiko Chino:It's amazing to think about how you've really straddled both high-risk groups, you know, the pregnancy-associated breast cancer, metastatic breast cancer, and really dedicated your life to making inroads and positive changes for both of these communities. So I really am so grateful for you for that. We are sort of wrapping up this podcast. I wanted to give a little bit of space at the end to have any open topics, if there's anything that we feel is under-addressed or unaddressed in this topic. I know that we could probably spend, you know, five hours talking about it. Julia Maues:I will say one thing that is perhaps the most difficult decision. When I discovered my diagnosis, I was very happy to be pregnant, but I was faced with the question of, I now have a disease that is life-threatening. Am I going to be alive by the end of this pregnancy? And in order to be alive by the end of this pregnancy, do I need to terminate this pregnancy? I think that is a question that was the most difficult one during that moment and is one that I discussed with my team. And fortunately, in my case, it was possible to give me treatment during the pregnancy and still not harm my baby. But I think this is the first thing that we're faced with at that moment of the diagnosis. Dr. Fumiko Chino:And I think that concern is certainly even more relevant in the climate where, depending on where you live, that may not even be an option. And even, I have definitely heard some concerns about even chemotherapy while being pregnant could be potentially something that would be at risk. Erin, do you have anything to add? Dr. Erin Roesch:Yeah, no, I think that's a valuable point too, is that again, it's a very, very challenging, scary time at initial diagnosis. And just like Julia mentioned, many women are very happy they're pregnant. And even to Julia's point earlier about receipt of chemotherapy during pregnancy, you know, many women might not think that that's possible. We have data that has shown relative safety of certain chemotherapies during pregnancy, you know, after the first trimester. And so I think it's important that again, with the shared decision-making, that women know all of this information so they can process and come to the best decision for themselves. So, and I think also, not that we can predict the future—I always tell my patients I wish I had a crystal ball that I could tell what was going to happen in the future for people. But I think that we've had a lot of advances in terms of breast cancer treatment, and this includes for metastatic disease. And so our patients are living longer and living better. So I think that's important to remember too. And just again, make sure that we, as much as possible, have these conversations upfront with what we know and what we don't know so our patients can feel supported through this process. Dr. Fumiko Chino:That's a really good, positive note to end it on. So I'm so grateful for your time. Thank you for this wonderful conversation today. Thanks to Dr. Roesch and Ms. Maues, as well as our listeners, for your time today. You can find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put Into Practice's next episode. Until then, please stay safe. 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. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.     Conflicts of Interest: Erin Roesch: Honoraria Company: Intellisphere Consulting or Advisory Role Company: bioTheranostics Company: MDedge Company: Seagen    Julia Maues: No Relationships to Disclose
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  • Treatment De-escalation for Favorable Risk Breast Cancer
    Dr. Chino talks with Dr. Atif Khan and Dr. Lola Fayanju about the shift in breast cancer management from reducing locoregional recurrence and improving breast cancer mortality to deintensification, shared decision making, and improved quality of life. This discussion will be based off a JCO OP editorial published in late 2024 called “Contextual Framework for Understanding Treatment De-Escalation in Patients With Breast Cancer.” Transcript Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity. Breast cancer treatment has made significant strides in the past century, with the five-year survival rate rising from less than 5% in the early 20th century to around 90% in the present day. In today's episode, we'll be discussing the shift in breast cancer management from reducing local-regional recurrence and improving breast cancer mortality to deintensification, shared decision-making, and improved quality of life. This discussion will be based off of a JCO OP editorial published in late 2024 called "Contextual Framework for Understanding Treatment De-escalation in Patients with Breast Cancer." I'm excited to welcome two breast cancer experts as guests today: the first author of this editorial and radiation oncologist, as well as a health services researcher and breast surgeon. They're both engaged in research to improve outcomes for breast cancer, including treatment optimization. Dr. Atif Khan, MD, MS, is a full attending breast cancer disease site leader and Service Chief in the Department of Radiation Oncology at Memorial Sloan Kettering Cancer Center. He is also on the steering committee of the Clinical Research Innovation Consortium, as well as on the Research Council at MSK. Dr. Khan is the chair of the breast section of oral examiners for the American Board of Radiology and is active in NRG, helping develop and lead key clinical trials to optimize radiation delivery for breast cancer. Dr. Khan is also a translational science investigator of novel radiosensitizers. Dr. Oluwadamilola "Lola" Fayanju, MD, MA, MPHS, is the Helen O. Dickens Presidential Associate Professor and Chief of the Division of Breast Surgery at the Perelman School of Medicine at the University of Pennsylvania. She is also Surgical Director of the Rena Rowan Breast Center at the Abramson Cancer Center, Program Director for Implementation Innovation at the Penn Center for Cancer Care Innovation, and a Senior Fellow at the Leonard Davis Institute of Health Economics at Penn. Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today. Atif and Lola, it's wonderful to speak to you today. Dr. Atif Khan: It's a pleasure to be here. Thank you for inviting me, Fumiko. Dr. Lola Fayanju: Yeah, thanks for having me. Dr. Fumiko Chino: The topic today is treatment de-escalation for breast cancer, loosely based on the editorial that Atif wrote in JCO OP outlining a conceptual framework, which is primarily focused on local-regional therapies, i.e., radiation and surgery for breast cancer. The concept of rightsizing treatment has really been developing over the past three decades, spearheaded by surgical de-escalation. Lola, do you mind giving me a brief overview of surgical de-escalation as you have seen it throughout history and as currently realized in your practice? Dr. Lola Fayanju: Happy to. So, you know, it's one of those things where I think increasingly we recognize that breast cancer is a heterogeneous condition that shares an anatomical space. And with that refined understanding of treating breast cancer, we're no longer using a very blunt and large hammer to deal with what is actually a constellation of nails. So originally, when people used to treat breast cancer, the idea was that you wanted to take as much tissue as possible. And this originated the Halstedian mastectomy, which was a radical mastectomy that often involved removal of not only all the breast and axillary tissue but also the pectoralis muscle, even some accessory nerves, that really left people with incredibly deformed body habitus as well as compromised function. And in part, that was not an unreasonable approach given that disease was often presenting in a locally advanced fashion. However, as we have been increasingly able to detect disease at an asymptomatic, pre-palpable state, but also as our ability to treat disease at a systemic fashion has become more effective, we've been able to move from the Halstedian mastectomy to then the modified radical mastectomy, and then ultimately to even less axillary surgery, as well as less breast surgery, such that there was the advent of the lumpectomy pioneered by Bernie Fisher in the 1980s, as well as sentinel lymph node biopsy pioneered by Armando Giuliano and Don Morton in the 1990s and early 2000s. And what this allowed us to do, again, is to achieve similar if not better outcomes, because we were again catching disease at an earlier state thanks to screening mammography, but also able to provide more personalized, less morbid care that focused on just the cancer at hand with the additional adjuvant therapy of radiation to provide comparable survival to mastectomy. What this has allowed us to do is also think about the order in which we do treatment, that is allowing people to potentially get systemic therapy first in order to convert from a more morbid procedure to a smaller, less morbid procedure. So, we've made a huge number of strides both with regards to surgery in the breast as well as surgery in the axilla, and that's been facilitated by a combination of knowing more about disease, being able to be more systemic and holistic in its treatment, and also recognizing that more is not always more. The last thing I will say is that we've also been aided not only by the adjunct radiation and systemic therapies, but also by the ability of our radiologists to localize pre-existing cancer such that we can target the area and just the area of concern, whether it's through targeted axillary dissection or through sampling a previously positive area of the breast, such that we can again be more selective in terms of the surgery people get after systemic therapy. Dr. Fumiko Chino: Thanks for that great overview, and I really love it how you have highlighted that it's all of these advances that allow us to customize the treatment to the individual. So it's not one size fits all with cancer care. We're really trying to make a customized plan and really rallying all of the modern technologies to make sure that we're rightsizing the treatments for the individual. And I think that provides a lot of benefits for patients. Atif, can you highlight some of the key steps to de-escalate radiation for breast cancer? Dr. Atif Khan: I think thematically, we're seeing a very similar sort of trend in radiotherapy. Just as a reminder, radiotherapy is a critical component of breast conservation therapy and also in the post-mastectomy context for high-risk patients. Radiation has been shown to sterilize or reduce the risk of microscopic residual, reduce the risk of local-regional recurrence, and in high-risk contexts, you know, by extension, reduce the risk of all recurrences and even improve survival, for example, in the seminal post-mastectomy radiation therapy trials. Now, we existed in a time when there was perhaps only one right way to do radiation therapy, and that's not the case now. We have many different ways that we can deliver radiation therapy. And that's important because our, as Lola said earlier, our understanding of different risk strata of breast cancer has also improved, meaning we can stratify breast cancer patients into low risk, intermediate risk, high risk, maybe even very low risk. And therefore, we can tailor the intensification of our local-regional treatments to match the background risk that may exist for that particular patient. Now, if we consider five weeks of whole breast radiation or five weeks of post-mastectomy radiation to sort of be our historic norm, we now know that we don't have to protract the course of radiation out like that. We can treat that same target volume, for example, the whole breast, with a shorter course of radiation that generally is given over three weeks. Now, I do want to pause here for one second just to clarify for everyone listening: taking five weeks of whole breast and doing that over three weeks is not necessarily a de-escalation per se, because really the same biologically effective dose is being given. It's just being given faster. So it's not really a treatment deintensification or de-escalation per se. Now, it is less disruptive to patients, it might be less, say, financially toxic, for example, in terms of like missed days of work, etc., but it's not a de-escalation with respect to the intensity of the treatment. It's just the same treatment being given shorter, but we know that it's safe to do that. In contrast, partial breast radiation is, in fact, a de-escalation because now our target volume is no longer the entire breast, rather, we're just treating a part of the breast, that part of the breast where the risk primarily is, which is in the index quadrant where that original breast cancer was. And at the, let's say, at the low end of the risk spectrum, we now have very good evidence, you know, 14,000 randomized women, demonstrating that, in fact, partial breast radiation in those contexts is just as good as whole breast radiation. And I always sort of half-joke that whenever this treatment is possible, we should use it because for a fibroblast sitting in the breast somewhere minding its own business, a day without radiation is a good day, right? So if we can spare that treatment to uninvolved normal cells, we should try to do that. And then, of course, the ultimate de-escalation is to identify patients who don't need radiation at all and just omitting radiotherapy. And really across the risk spectrum, whether it's in breast conservation or whether it's in PMRT/regional nodal radiation, we are seeing the emergence of these different types of treatments, meaning kind of like the high-risk treatment, the intermediate-risk treatment, and then at the very low end of the risk spectrum, no treatment at all. But that's sort of the practice that we're living in now, and I think it's a good one. We're making progress. Dr. Fumiko Chino: I appreciate that. The whole idea is if we can potentially omit treatment to certain areas of the body or if we can omit it completely, we're certainly doing a favor for our patients if it's not going to increase their overall risk. We had talked, I think between the two of you, about some of the benefits of potentially omitting or reducing morbidities from, for example, surgeries or comprehensive treatments. Atif, do you want to take it first? What are the actual de-escalation risks? What are we potentially putting at risk when we talk about de-escalation or deintensification? Dr. Atif Khan: Yeah, great question. I mean, I think the primary risk, which is, you know, a scary thought, is that we de-escalate or we do it too quickly or we find that, in fact, reducing the intensity of treatment leads to an increase in the recurrence risk of breast cancer. That's a very scary thought. I will say that this process of creating options, you know, treatment options, de-escalated treatment options, has been quite successful. For example, I'll open it up to Lola and you, Fumiko, but I can't really think of a clear example in which the de-escalation trial went in the wrong direction. Like, they've all sort of gone in the same direction, which is that the de-escalation or deintensification studies have generally been successful, meaning that we were able to preserve the excellent oncologic outcomes that we are used to seeing with less treatment. That's a testament to kind of how careful, you know, the scientific process is with respect to these practice-defining trials. They go through multiple levels of scientific review. It's a multidisciplinary group of individuals that's looking at this. And I would say the endeavor overall has been quite successful. Dr. Fumiko Chino: Lola, anything to add? Dr. Lola Fayanju: Yeah, I think when we're thinking about the risk of de-escalation, I would put them into three categories of risk. So, there are risks to the individual, that is, you know, we're actually de-escalating in the wrong person because we have an insufficient amount of information about whether they meet the criteria for de-escalation. There's, I think, risk to the population in terms of are there groups of people who are systematically not benefiting from the de-escalation or who should not be benefiting from de-escalation because again of an underappreciation of how disease might work in that group or because the practice patterns where those people are getting care will not be amenable to de-escalation ultimately being of a good thing for them because they're not getting the other components of care that frankly are needed for de-escalation of one modality. And then three, I think there's a risk to our collective knowledge about cancer because when we're not collecting information about what happens after six weeks of radiation or how many lymph nodes are positive, we just know a little bit less about the natural history of the disease and the natural sequelae of treatment. Again, that knowledge may be worth forgoing given the morbidity to patients and the non-benefit with regards to recurrence and survival, but it's real. It means that our retrospective reviews look different. It means our ability to have preliminary data for other types of things look different. With regards to the populations, it means that whenever we're thinking about de-escalation, we need to think hard about how to translate what we see on the podium at San Antonio or ASCO into clinical practice. And that requires, I think, more care than is often administered. Dr. Fumiko Chino: Yeah, I'll quote directly from the manuscript of the editorial that we are basing this podcast on, and it said basically, "American women ascribe a high utility to remaining without evidence of disease." And that really sticks with me in that, even though there may not be a survival benefit, an increased risk of recurrence is not without a personal, financial, and physical burden on patients, even if that difference is small, it may be meaningful for the person in front of you. Now I'll also shift focus slightly and just mention that we're primarily talking about local therapy here, but I'd be remiss to not highlight that there are gains in de-escalation for systemic therapies from, for example, RxPONDER, allowing us to safely omit adjuvant chemotherapy for many node-positive patients; B21, showing that monotherapy with radiation may be actually even better than tamoxifen monotherapy with no metastatic or survival differences; and of course, the PERSEPHONE trial that demonstrated that six months of trastuzumab was non-inferior to 12 months, although, granted, there were many caveats leading to poor adoption of this in practice. Now, Lola, I know you've already mentioned this, but there are maybe some concerns that you see about broad adoption of these practices into, for example, surgical de-escalation. Based on what I know is stark disparities in clinical trial enrollment in certain populations or in maybe even clinical trial protocol adherence, are there any specific populations that you want to highlight that might be hesitant to apply this clinical trial podium data to? Dr. Lola Fayanju: That's a great question. So, as an example, when we think about the SOUND trial, which was recently published and demonstrated that in women with early-stage breast cancer who were undergoing breast-conserving therapy and had normal axillary evaluation prior to surgery, that sentinel lymph node biopsy could be safely omitted without detriment with regards to long-term outcomes, you need to think about the context in which that preoperative ultrasound is being done. So, at different institutions, whether or not an ultrasound is routinely done, whether or not that ultrasound is done prior to biopsy, all of these things have implications for how likely you are to have a false positive after biopsy (so it's preoperative, but it's post-biopsy) and also what you're going to do about it, whether you're going to act on it, whether you're going to go ahead and proceed with sampling that node if it looks enlarged, putting something in it that means you retrieve it. If it demonstrates a small amount of cancer, potentially consigning someone to either an axillary dissection or preoperative systemic therapy that they might have forgone had you had the full picture of surgical pathology. So that's just one example of how the context in which implementation occurs is really important because you have to take into account local practice patterns and what that means with regards to how we interpret the data that was used in the trial to then implement this practice in real life. With regards to populations that need to be considered, I think in terms of centering equity, both domestically but also at a global level, thinking about, for instance, how we stage the axilla, how we map the axilla. What's the facility for lymphoscintigraphy as well as for localization of a previously positive node? So, there are many countries, many quite wealthy countries, in which use of radiocolloid is not routine, where it is primarily that people are using some type of tracer blue dye, for example, and therefore would not strictly be meeting the criteria for optimal sentinel lymph node mapping that would allow for a low false negative rate after neoadjuvant systemic therapy. In the United States, we might be in places where you have patients who are having surgery with people who don't do that much breast surgery and who are less likely to have a successful and correct yield of lymph nodes at time of sentinel node biopsy. And so, you know, these are people for whom there might be actually clinically significant disease that's being left behind if not being done by someone who has a lot of experience working with dual tracer as an opportunity to localize a preoperatively positive lymph node. So again, thinking about both the availability of materials as well as the expertise of the local practitioners means that people in less or differently resourced settings may not benefit from implementation in a way that actually leads to appropriate outcomes. Dr. Fumiko Chino: Yeah, I love it how you highlight that there's global differences, but there's also just in the US differences in capacity and skills within doing these, some of these presurgical and surgical evaluations. All three of us work at world-leading cancer centers, and I recently just transitioned from two top cancer centers in the United States, but I was actually kind of shocked about the differences even between the two major centers about how we do ultrasounds, for example. Now, Atif, I've noticed that some providers don't really feel comfortable combining the information from various de-escalation trials in practice, i.e., so for some patients that might have had sentinel lymph node biopsy omitted per SOUND, they may be less likely to actually get PBI and instead, you know, prefer to treat whole breast radiation to cover the axilla. So, in this respect, it seems like we're kind of taking like one step forward, one step back. And are we de-escalating surgery to just escalate radiation? Dr. Atif Khan: Fumiko, I agree with you. It'd be very counterproductive if we found that de-escalation in one domain was leading to escalation in another domain. I think the example you cite is a good one. If we are moving to a world without sentinel node biopsy and let's say clinical staging only, does that then mean that we have to, for example, give up on partial breast irradiation and treat everybody with whole breast radiation on the notion that low axilla, for example, is going to get some therapeutic effect? And I would submit for everyone's consideration that no, we in fact should not do that. We spent years developing the partial breast irradiation literature. We know that PBI has less acute toxicity. In every single trial, it has less fatigue, and it actually has less late toxicity in some studies, which is not surprising because remember, you're treating less tissue, you're treating less stuff, and that's a good thing.   Now, coming to SOUND and INSEMA, on the sentinel node arms of both of those studies, the rate of additional positive nodes is very- around, 10%, and that's pretty low. So I would submit for everyone's consideration the idea that if your patient is node-negative by SOUND criteria, let's say, right? They're very likely to be pathologically node-negative. And you can actually treat them as if they were pathologically node-negative. And that's kind of how we've adopted the findings of both SOUND and now also INSEMA from San Antonio, meaning that if a patient is eligible for PBI based on everything else, and she is node-negative by SOUND criteria, then we will offer them PBI in exactly the same way as we were before these trials were reported. I also wanted to make one observation on your prior comment, Fumiko, if I may, about the de-escalation of systemic therapy. One thing that has been on my mind quite a bit is, particularly with, let's say in the elderly group where we have been struggling with kind of like the best monotherapy, right? Should it be five years of endocrine therapy? Should it be a short course of radiation, or do patients really need both of these treatments? And this is topical because the EUROPA trial, one of the endpoints was reported at San Antonio, the quality of life endpoint. Not surprisingly, a short course of radiotherapy was sort of associated with better quality of life than the endocrine therapy. But I think we may be missing one potential opportunity in this sort of idea of like, we have to either do the radiation or the endocrine therapy, which is we might be able to give a little bit of systemic therapy and a little bit of radiation therapy. This line of investigation or line of thinking doesn't really exist right now. Like that conversation is interesting. So for example, can we give, for number one, can we go from AI back to TAM, right? Because AIs are just, there's just, the quality of life is worse. And can we give a lower dose of the TAM, monitor for compliance, and then give a little bit of radiation, you know, let's say PBI or something? And maybe that's the way to do that. And you could take that idea and you could apply it across different contexts even in breast cancer. And I'll note that that is how kind of the Hodgkin's lymphoma treatment evolved over time. At the low end of the risk spectrum, they kind of said, “Okay, a little bit of chemo and a little bit of radiation is better than just giving a lot of chemo or certainly a lot of radiation.” And you know, that worked. And I think at the low end of the breast cancer risk spectrum, we might start thinking about that kind of line of investigation. Dr. Fumiko Chino: You want to ‘Goldilocks’ this situation. You want to try to find something that's just right. And I love that. And I think that sort of out-of-the-box thinking is very helpful when we think about how omission seems very clean, "you just don't get this," but deintensification, simultaneous deintensification, I think has a lot of appeal there. Lola, do you have anything to add about that? Dr. Lola Fayanju: I have to acknowledge the bias of three local-regional therapists on this podcast, I’m outnumbered by our two rad oncs. But just wearing my medical oncology ally hat, I think one of the challenges is also that for many of them, the ability to prescribe effective forms of systemic therapy, including CDK4/6 inhibitors, for example, is sometimes predicated on information we obtain at surgery. So, when we think about implementation, which is really, you know, an area of research for me, whether it's trying to implement the SOUND trial, again, in an institution where everyone's getting an ultrasound prior to biopsy, absolutely. But in an institution where either it's completely ad hoc, so it's kind of the ‘wild, wild west’, you have no idea from radiologist to radiologist who's doing ultrasound before or after biopsy, and also frankly, what is the kind of false negative rate at that institution, recognizing not everyone's working at the kind of places we work at. Are we doing patients a disservice? But then, in addition, thinking about working with insurance companies, right? If we're trying to say, “Okay, we are no longer going to do sentinel node biopsies,” but that's actually required for the administration of certain medications, we put our medical oncology colleagues in a bad position in terms of their ability to actually get certain types of treatments paid for and approved. And so again, thinking about the consequences of our choices for patients, I think it really points to the fact that multidisciplinary consultation is increasingly going to be needed because we can't de-escalate everything. I think we all agree most cancers need to be treated in some fashion. But, you know, if we take away surgery, we take away radiation, we take away systemic therapy, suddenly we have a cancer that's just sitting there. And for some people, that's the right thing. Again, thinking about shared decision-making, for some patients with other morbidities and/or older age where they're unlikely to have any kind of meaningful threat from disease being left in place, well, that is the right thing potentially. But for a majority of our patients who actually want some form of treatment, I think we do need to think about the implications for our other prescribing providers, what that means, how we can help them, even as the clinical trial data suggests that there aren't major changes in adjuvant therapy or radiation prescription when you omit sentinel node biopsy, at least in the trials that have so far been shown. Dr. Fumiko Chino: This is a nice segue to my last point, which is to talk about how these discussions of de-escalation, these decisions should really be made after the full multidisciplinary input. And yet, I feel like I've seen our specialties get increasingly disconnected in this kind of era of Zoom conferences. There seem to be less face-to-face meetings. There seems to be decreasing space for our co-shared clinics. And I just wanted to ask both of you what you think our responsibility is to each other and to our field to ensure that we're really working on these things synergistically. Lola, you just mentioned some of your thoughts, but do you mind speaking about the multidisciplinary conversation or even how we're designing research? Dr. Lola Fayanju: I think, with regards to the research, I'll start with that first, it means that, I think we're less going to have trials that fit in certain kind of cooperative groups that are more geared towards radiation or what have you. I think, increasingly, we should be having MPIs, you know, co-PIs who are from different modalities. I think that that's going to allow us to bring our different lenses to constructing the trial, to ultimately interpreting the result. I think we'll only grow from that. I think the era of having a bunch of medical oncologists or surgeons or radiation oncologists as the primary authors really should probably shift. I think we need to think more globally about multidisciplinary care and what those, quote unquote, “tumor boards" should look like. And thinking beyond our own institutions, again, we're relatively privileged in terms of being at places where we all have at least weekly, if not bi-weekly multidisciplinary tumor boards. Most cancer care in the United States is happening in the community where a patient walks into, often a general surgeon's office, and that person will get surgery upfront whether they need it or not, or whether they should be getting systemic therapy or not first. And then from there, they will then be referred to a medical oncologist who may have had no input as to which procedure should have been omitted or discussed or vetted prior to meeting that person. And so, I think our greater challenge is how to bring in the global oncology community, and by global, I mean truly across the globe, across the United States, across the world. And it might be that ASCO and JCO, places like this for discussion, is an opportunity for us to connect people, connect our communities, and not having us work in silos, both at the institutions in which we currently are employed, but also at a broader level. Dr. Fumiko Chino: Wonderful statement. Atif, anything to add to that? Dr. Atif Khan: Yeah, I think you're pointing out an important thing, Fumiko, which is, you know, we are somewhat more fragmented since the pandemic, and we're kind of in our own spaces, and that is potentially a problem. I think in breast cancer, the different specialties are often existing in kind of a very cooperative matrix, and I think that ends up meaning that we're able to really provide high-level care to our patients. I think there are other specialties, I know, where the specialists may be existing in a somewhat more competitive matrix with each other, and I think that ends up potentially being counterproductive for patient care. So I think this is probably a thing that we need to have more conversation around and sort of thinking about how do we bring the different vantage points together in the interest of the patient and not lose that multidisciplinary care that we'd become so used to and that's provided such excellent outcomes. I think on the research side, I don't want anyone to sort of be left with the idea that there's just one specialty that's sort of driving, you know, the design of these trials. From my own first-hand experience, both at Alliance and NRG, there's a lot of scientific review that happens, and I spent quite a bit of my energies over the past decade and a half kind of convincing medical oncologists that a certain local-regional question is warranted. And, and you know, that's part of the process. I appreciate that because they're not just experts in their field. You know, we all eat, breathe, and live breast cancer. So, you know, they have keen insight into the local-regional management as well. Dr. Lola Fayanju: Yeah, I have to say I love the cooperative group meetings. That's kind of where the sausage gets made. And I think it is really exciting that you have people from different disciplines sitting together, proposing trials, vetting them. It feels like you're seeing the future in the present, which is really exciting. And, you know, I think what we're all striving to do. Dr. Fumiko Chino: I love that hopeful conclusion, and I really am so grateful for both of you for this wonderful conversation today. Many thanks to both Dr. Khan, Dr. Fayanju, as well as our listeners for your time today. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put into Practice's next episode. Until then, I encourage everyone to continue doing the work that they find meaningful for their patients, for their community, and for themselves. Dr. Atif Khan: Thank you. Dr. Lola Fayanju: Thanks so much. 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. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Disclosures: Atif Khan: Stock and Other Ownership Interests: Novavax, Xtrava; Research Funding: Clovis Oncology, Merck KGaA, Varian Medical Systems; Patents, Royalties, Other Intellectual Property: Use patent for the drug riluzole awarded to Rutgers University with me as inventor.   Oluwadamilola Fayanju: Research Funding: Gilead Sciences  
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JCO OP: Put Into Practice highlights new research published in JCO OP related to cancer care delivery, quality, disparities, access. Host Dr. Fumiko Chino, MD FASCO interviews thought leaders in oncology to give listeners practical knowledge that can be used in day-to-day practice along with solution-oriented discussions and care innovations.
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