JCO Oncology Practice Podcast

Dr. Chino welcomes Dr. Jennifer Miller and breast cancer survivor Megan-Claire Chase to discuss Dr. Miller's recent OP article, "Representation of Women, Older Adults, and Racial and Ethnic Minoritized Patients in Pivotal Trials for U.S. Food and Drug Administration Novel Oncology Therapeutic Approvals, 2012-2021: Bright Spot Trials and Trends Over Time," highlighting new research about how we are doing with diversity in key cancer clinical trials
TRANSCRIPT
Dr. Fumiko Chino: Hello and welcome to Put into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an associate professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.
There are known problems in enrolling a representative sample on cancer clinical trials, with stark disparities within certain demographic groups, including age, sex, and race and ethnicity. Patients who are female, non-White, and at the age extremes, either younger or older, are known to be less likely to participate. With skewed patient participation, the validity of randomized data may be questioned, with some asking whether clinical trial results based on a charmed enrollment sample can truly be applied in routine practice.
I'm happy to welcome two guests today to discuss new research highlighting how we are doing with diversity in key cancer clinical trials. Dr. Jennifer Miller, is Co-Director of the Program for Biomedical Ethics and an associate professor at Yale School of Medicine. Her research focuses on ethics, equity, and governance in research, development, and accessibility, as well as in the ethics of healthcare data sharing. She is the first author of the manuscript, "Representation of Women, Older Adults, and Racial and Ethnic Minoritized Patients in Pivotal Trials for US Food and Drug Administration Novel Oncology Therapeutic Approvals, 2012 to 2021: Bright Spot Trials and Trends Over Time," which is featured in JCO OP's March print issue.
Megan-Claire Chase is a 10-year breast cancer survivor, patient advocate, and a current program director at SHARE Cancer Support, a national nonprofit that provides free education, assistance, and navigation services for people with breast and gynecological cancers. Since her treatment for stage 2A lobular cancer, she has worked to fill the gap of knowledge and advocacy for young patients with cancer, including through her blog, Life on the Cancer Train, and through the podcast, Our BC Life.
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.
Jen and Megan-Claire, it's really nice to speak to you today.
Dr. Jennifer Miller: Thank you for having us.
Megan-Claire Chase: Thank you.
Dr. Fumiko Chino: Jen, before we dig into the specific research, do you mind giving us a little bit of background about your work in bioethics and what led you to start this specific work on clinical trial diversity?
Dr. Jennifer Miller: Yes, thank you so much. So, as you mentioned, I'm the Director of Bioethics for Yale School of Medicine and a professor of internal medicine at Yale. And then also in 2005, I co-founded a nonprofit called Bioethics International and direct a project called the Good Pharma Scorecard. In all of those roles, I'm focused on one big question: How can we help the 7 billion people around the world live a good life, a flourishing life? And in order to even talk about that bigger concept, we need to think about some basic things: access to clean water, housing, food, education, among other things, and a level of health.
And there are so many determinants of health, but one of them is access to medicines and vaccines. And when you think about access to medicines, you have to think about the role of the pharmaceutical industry, given that it sponsors 75 to 90% conservatively of the clinical research supporting FDA approval of our new medical products. What's interesting is while the industry has a very stated noble mission, right, to 'cure, heal, and advance people's health', when you survey Americans in particular, 91% think that companies put profits before people and patients, so money before people and patients. And when you look at the media and the court cases, they're covering mostly scandals and outright ethics failures ranging from concerns about whether companies are telling you the truth about the safety and efficacy of new medicines and vaccines and worries about outright price gouging.
And what's interesting is when I host a meeting every year with C-level executives from pharma, when I get them together and show them all of the concerns that stakeholders have about their patient centricity, I often hear the same two things: one, "Those are old issues that we fixed. If only you academics looked at more up-to-date data, you'd see that that is no longer a problem," right? And so they called the pricing problem a 'hoodie' problem because Martin Shkreli, he wore a hood, a black sweatshirt with a hood. But as we know, there's a widespread current and genuine pricing problem with medicines and vaccines.
And then they said it was an outlier company, right? "That's one company in an otherwise sound industry or rogue employee in an otherwise good company, not the industry as a whole." And so when I walked away it's, wow, there's a black box. We actually don't know the ethical or patient centricity performance of pharma companies, of an individual company, of a product, of a trial, or of the whole industry as a whole, and it's really important to know this.
And so, I got together a multi-stakeholder group and I said, "Hey, fine, I'm neutral. It's either a misperception, you're doing great and we need to build merited trust, or there really are some problems and we need to fix them and get them right for patients around the world." That's how I started the Good Pharma Scorecard, which is really designed to set ethics goals for the pharmaceutical industry and turn them into metrics so we can benchmark the performance of trials, products, and companies and then rate and rank them. What that does is it recognizes where there are good practices so we can study how they did it, but importantly to catalyze reform and change where needed for patients.
We started by looking at the transparency of clinical research, right: do pharma companies tell you all the safety and efficacy data about new medicines and vaccines? And we were able to measurably move the needle. In other words, pharma companies really changed their practices as a result of getting their Good Pharma Scorecard ratings and rankings. And so we turned our attention and said, "What else should we tackle?" And the next thing we tackled was representation in clinical trial enrollment, for exactly the problem that you mentioned. We tend to test our new medicines on healthy, young, White males that don't represent the patient population in the US or other countries who end up taking products post FDA approval.
Dr. Fumiko Chino: What a great narrative of how you kind of reached the point where you are doing this research. And again, I think you've highlighted that diversity in clinical trials is only one aspect of everything that could potentially be improved in healthcare in the United States. So I am so excited about what you're going to do next to address the next issue.
But let me ping over to Megan-Claire. I know a little bit about you personally, but can you share with our listeners a little bit about your background and just discussing for example, the multiple hats you wear in life? You have a cancer survivor, you're a cancer caregiver, you're a patient advocate, and obviously you work at SHARE. So what is your origin story for Warrior Megsie?
Megan-Claire Chase: Well, first of all, I always knew I would get cancer, and when people hear that, they're like, "Why would you say that? Like, why would you even, like, mention that out into existence," right? But it's no, like, I know my family medical history, at least mainly on my mother's side. And I'm an IVF result. It took my parents 8 years to even get pregnant, and then during the third month, my mother was diagnosed with ovarian cancer. And so, I like to say I'm literally a cancer because I was born in July. I was born 3 months early. I was supposed to be born the last week of October, and I was born July 3rd.
And so the joke in the family is, I look nothing like my mother externally, but internally, I got all the issues. And so we really are both walking miracles, the fact that we did both survive this, but I knew, I just knew I would get ovarian or cervical cancer because that's where all of my issues were. So I had been monitored since I was 16. And then, of course, having other health issues, being born premature and all of that, and then ultimately, I had very strange symptoms. We hear the guidelines of breast cancer, and I had none of those. But I also was an advocate. So in my family, my parents are divorced, so I'll mainly be talking about my mother's side. My maternal grandmother, my Nana, she was the first biracial registered nurse at St. Vincent's in Bridgeport, Connecticut. And my grandfather was a mortician, so we're like, "Boy, aren't they like the perfect couple, you know? She helped you in life, and he helped you in death."
But all of that to say, I was raised to know my patient right to change doctors, my patient right to ask questions, and my patient right to get pushy. And I did all the things. So we often hear, "Hey, you need to advocate for yourself." Well, even when you advocate for yourself, sometimes you're ignored because I'm a woman, then I'm a Black woman, and then I was under 40. So I wasn't even old enough to get a mammogram. And because there is that correlation between breast and ovarian, I was able to get one early and covered by insurance 100%, and they were like, "Hey, you're good. Come back when you're 40."
But I kept having all these other strange symptoms, and I just kept pushing and pushing for close to two and a half years, and then it wasn't until the cancer was like, "Okay, we're going to have to just make a grand entrance because no one's believing you." Then everyone sprung into action, and it was because of all that, and I thought to myself, "Oh my God, if I'm being ignored and I am someone who's pretty darn vocal, what if English wasn't my first language? What if I didn't know my family medical history?" Like, I just went down the rabbit hole, and my background is in media and marketing, and I'm also a writer. And so I was very open with my diagnosis because I'm an only child too. So this is like huge. It was just too big for me to deal with alone, but also I wanted to like amplify the barriers that I was experiencing and then also losing my fertility. I mean, it was just so many things at once, and it was through that, I ultimately realized, "Hmm, this cancer journey, it's never really over." And that was how I came up with the name "Life on the Cancer Train" because I was like, I keep waiting to get off the stop permanently, and that's not happening.
And though I am now in double digits of 'no evidence of disease', I call it my boyfriend NED. We've been in a long-term relationship now for 10 years and we're going to continue going strong. I've had so many other issues that no one prepared me for. And so I was doing a lot of advocacy work while I was in media and marketing, and then I was like, "Hmm, what would happen if I actually worked in this space? Like, imagine what I could do." And that's ultimately how I ended up finally working at SHARE Cancer Support remotely because I live in Atlanta, Georgia, so you may hear a slight twang every so often. And I am the Breast Cancer Program Director and host of Our BC Life podcast.
And, you know, through all of that, I am known in Cancerland as Warrior Megsie because my hair came back curly. And, you know, so many people are like, "Oh, I would have loved for my chemo to turn my hair curly," and I'm like, "Well, I wanted my hair." Every time I look at myself, it's traumatic. Yes, do I rock it? Sure. I mean, when it was coming in looking like a chia pet, I was a little concerned, but every day I'm reminded of what I've gone through and what I continue to go through. And that's ultimately how I made my grand entrance into Cancerland.
Dr. Fumiko Chino: Thank you for sharing that with us, and I know that this is not kind of how you wanted to find your mission in life, right? You would have been much happier to just live your previous existence without cancer, or just being a cancer caregiver, or just being an advocate, or just being a communicator and not being a cancer survivor on top of all of that. So, I do appreciate though that you took it for what it was, which is this is the path that you're walking down, and so let's try to make that path better for everyone, more comfortable, clearer, more outlined. And so I appreciate that.
Now, Jen, do you want to walk us through your actual JCO OP study, what you did, what you found, why it matters?
Dr. Jennifer Miller: Sure. Second plug for St. Vincent's in Bridgeport. My mom works there as well on Nine North, so I was so excited to hear that, that common touchpoint. So when we added the representation challenge to the Good Pharma Scorecard, we, obviously unsurprisingly, found abysmal representation of a variety of different groups or pretty much everyone. And we stepped back and we said, "What more can we do to measurably move the needle?" Because there have been 40-plus years of policy efforts to try to improve representation of women, older adults, and racial and ethnic minoritized patients among other groups, and we haven't measurably moved the needle for any group in cancer over the last 10 years.
And that's shocking not to see any improvement in 10 years. That's a lot of time and there's been a lot of investment on this issue. And so, what we settled on was this idea of doing a bright spot analysis. The bright spot approach assumes that somebody, somebody's getting it right, and if we could find that bright spot and study how they do it, we might be able to develop generalizable guidance for everyone else to be able to repeat that positive behavior. That bright spot analysis was done with the FDA Oncology Center for Excellence with their support. And so, while the 10-year data looked abysmal, right, we hadn't seen any improvements overall, when we started to look by sponsor, it turns out there were some bright spots. There were some sponsors who were able to consistently adequately represent one group. They couldn't represent everybody, but they were getting one group, right, and we decided to focus on Black or Latino identifying patients. And we found 33 bright spots.
So I'll tell you the overall data and then I'll talk a little bit about the bright spots. So we looked at a 10-year sample, novel oncology products approved by the FDA between 2012 and 2021, which was 111 novel cancer therapies sponsored by 70 different companies based on 121 pivotal trials enrolling over 50,000 patients around the world. And what we found was zero trials, zero trials adequately represented all the demographics we were looking at, which was sex, age, and racial and ethnic identity. And we were comparing enrolled participants to the patient population with each targeted indication.
However, 99% of trials were able to at least represent one group. 80% adequately represented women, 44% adequately represented older adults, age 65 and older. However, only 2% were able to adequately represent racial and ethnic minoritized patients. And we were only looking at a small group of race and ethnicities. So rather than focusing on the negative, we looked at those 33 bright spots and we said, "Let's go interview them. How did they do it?" And we heard some common practices that were now debating some processes that are likely to drive that outcome we're looking at that we're debating whether to add to the Good Pharma Scorecard. We'll add some, we're just trying to figure out which ones are most associated with success.
Dr. Fumiko Chino: I love this idea that you really wanted to go on a fact-finding mission, which is, "We know that things are bad. Let's document they're bad." But then for the few people, institutions, companies, whatever that are actually doing well, how do we learn lessons from them to then try to actually do a guide map for other places to run clinical trials in a more equitable fashion? If there's specific things that they're doing that actually helps them get more, for example, Black patients to enroll. So I love that, that you're like, "Let's go on a fact-finding mission, let's really, let's categorize it, let's share this knowledge so that we can then actually improve everyone - a rising tide floats all boats."
Now, Megan-Claire, are the findings that we just talked about - the 0% of trials were adequately represented for every different demographic - are they actually surprising to you? Because I still remember in 2022 when Stephanie Walker from the Metastatic Breast Cancer Alliance highlighted the 'ask gap', which is that Black women may be just as likely to enroll on clinical trials if they're actually asked, but they're just not asked. So I'd love your thoughts and how you see this kind of play out within the patient advocacy community, and then, you know, if we're really thinking about is this an ongoing problem reaching diversity of patients?
Megan-Claire Chase: Well, I was not surprised at all. And huge shout out to Stephanie Walker. Love her. She's amazing. I am someone who used to be totally against clinical trials. I was one of those that was like, "You're not going to use me as a guinea pig." And then I went through my own cancer experience, and my mother also now has a blood cancer, and watching her go through the clinical trial process also and I actually experienced medication not working in my body. And honestly, it was from that moment on where it really clicked for me. And I, you know, it makes me sad that I had to wait for myself to get sick in order to fully understand the importance of representation in clinical trials.
But it was in that moment where I was like, "Wait a minute, how many people were on the trial for this medication that looks like me? And I don't just mean like one or two." And then the fact that it kept happening over and over again, and I started thinking, "Oh my gosh, this is a really huge issue because if we're not represented, that means we don't know how those medications are going to work in our bodies." And the fact that I was intolerant of eight different medications that we kept trying and putting my body through, it was really eye opening for me. And then in my advocacy work, I've had a chance to look, at what is it called, the paperwork that you look at - the consent forms. I'm reading all of this terminology, and I'm like, "That's racist," or, "that's going to come across wrong to the community that you're trying to reach."
And so, after experiencing that, walking through it with my mother as well and then I was like, "We need to talk more about this." And so, I often hear over and over again, "Yeah, we're not getting enough representation in clinical trials, we're not being asked," but also we're not talking about it in a way that resonates. So like even the words "clinical trial" is problematic. And so, here's the way I started talking about clinical trials after my own experience is I think of it like dating, and I am trying to find the perfect trial. Now, was I ever offered a clinical trial or even told that could be a potential option? No. All of the information I found out was all on my own. And I was like bringing in research to my oncologist who at that time, my active treatment oncologist, I ultimately divorced her, and I said that to her face. I was like, "I divorce you because you're not listening to me. Thank you for getting me to this point, but now we're talking about medications are not working for me, and you're telling me, 'Oh, just get off it for two weeks and then get back on it.' And I'm like, 'I am not going to keep putting my body through this.'"
And so, I started thinking of it like, yeah, this is kind of like dating. You're trying to find the perfect trial. You're trying to help do something wonderful and healthy for your body. You're trying to improve your quality of life. But then when I was getting rejected from all these clinical trials because I'm not 'pristine', so to speak, I was like, "Okay, this is really hurtful." And I really like was taking it personally, and I thought to myself, "How many others stop at that first 'no' and they don't think, 'Hey, maybe I should try another one or maybe this one wasn't the right fit?'" So I started talking about it in a different way, and I think one of the big things that's missing is, right, the lack of trust with pharma. We're not really addressing that. Like, what are they doing to show they are trustworthy? Like we need it in like those kind of clear terms.
And then I'm seeing other great nonprofits like Touch, The Black Breast Cancer Alliance, what they're doing and trying to help educate the Black community about clinical trials. But it's also too, how do we talk about it with our elders in the community, right? And we have to first acknowledge the stain on our history. And when we have, you know, a lot of times they are White doctors, you know, maybe they are saying, "Hey, you might be eligible for a clinical trial," but are you actually like saying to the patient, "Hey, I acknowledge there's a huge stain on history when we think of Black bodies and Latino bodies as well. We acknowledge that. Let me tell you the changes that have been made. Did you know, like, if you're in an oncology clinical trial, you will not be getting a placebo. You will either be getting your standard of care treatment or the clinical trial medication." So many patients don't know that. And so, I really feel like there's a huge communication gap between providers and pharma and getting that kind of information to patients and talking about it in a way that resonates. So I was not surprised when Dr. Miller was going through her findings, but I'm also really appreciative of, okay, what is one thing that's going right and how can we build off of that? That's encouraging.
Dr. Fumiko Chino: No, I really appreciate that narrative for you. And again, it strikes back to me sort of knowledge I already know, which is immunotherapy might have worse side effects. It might be worse for women, for example, or an Oncotype score may be actually less prognostic for Black women. You know, we have some retrospective analysis showing these things because again, who was tested in these trials may not be representative of the people who are actually receiving these treatments.
Now, Jen, there was a recent qualitative analysis published in JCO OP called, "Why I Said No," and it evaluated why eligible patients with breast cancer declined clinical trial participation. They highlighted fear, mistrust, and also logistical challenges as key barriers. And you had mentioned previously that Bioethics International, your nonprofit that you helped found and lead, it seeks to, and I quote, "raise the bar on ethics, patient centricity, and social responsibility in healthcare." And of course, I see a lot of overlap in terms of what we need to improve. So outside of having better conversations and relationships with our patients like Megan-Claire outlined, how can the pharmaceutical companies have better standards to start addressing these concerns? You mentioned earlier just like at least one win that you had obtained.
Dr. Jennifer Miller: Yeah, and let me just go back to something Megan-Claire said. I found it really impactful. You said, you wanted to hear what pharma companies are doing to be trustworthy, and that's sort of the question behind the Good Pharma Scorecard. And what we do is we first engage patients to hear what do patients need to see from pharma companies, not just to trust them. You can trust a used car salesman who sells you a lemon, right? I am not interested in that. What do we need pharma companies to do so that we can advance our health, right, and yes, appropriately trust them? And so, we do a lot of dialogue with patients and also clinicians and other stakeholders, and that informs the development of our areas of focus and also the metrics that we build in.
And then Fumiko, I think you asked what success have we had with the scorecard in improving practices? Yes. So, we initially started with that concern that pharma companies are not telling us all the safety and efficacy about new medicines and vaccines. So we figured out how to measure that. So, for every product that the FDA approves, there's an approval package that the FDA releases. It's hundreds and hundreds of pages of PDFs. It's not machine readable, but if you were to be a crazy person and read all of those PDFs over and over again for every product that's approved, you could pick out all of the trials that are conducted and that the FDA reviews to decide whether to approve a product or not. There's a median of like 26 of them. You cannot use AI or any kind of natural language processing to pull out the trials because there's no pattern in the naming of the trials. It doesn't say in the FDA approval package, "Trial number XYZ." So we have a team, we manually go and read all those, and we pull out a denominator. We know all the trials that were conducted, and then we just go and see, we measure what proportion of them are registered in a registry like ClinicalTrials.gov run by the NIH. What proportion have reported results in that same registry? What proportion are published? What proportion are publicly available, meaning published or registered and reported?
The first study, it was such a low number that it was embarrassing. But I'm happy to say that at least for large companies, year after year, the score started going up. And then we created an amendment window where we said, "Here, companies, you have 30 to 60 days to improve things. We will publish a pre-score, but we will also publish a post-score." And half of the low scoring large companies took us up on the amendment window and improved things in data sharing. And so that is what emboldened us to start doing more. That's when we went to representation in clinical research, and then now we're looking at access to medicines in low-middle income countries. A new FDA approved product is tested in a median of 26 different countries if you're a large company, or 16 if you're all sized company. And generally speaking, the countries that participate in that research for FDA approvals never get market access to the products they helped test, and from an ethics perspective, that's considered exploitation. You go in, you use a population, and you don't give anything back. So now we've measured that extensively, so now we want to try to fix that.
Dr. Fumiko Chino: I love what you've done, and it really, I see a natural correlation with like for example, the Leapfrog Group who rate hospital quality and safety. And when you give a hospital an F and they're able to rate it, you know, to increase it to like an A score, it really shows that they're committed to the process. We can't improve anything unless we measure it. I know that sounds insane. Like, I'm sure every company that you had previously talked to for the pharmaceutical companies thought they were doing great, and then you were like, "Actually, not so great." And you have to highlight it, and then you have to give them something to do to improve their score. And so I, I really appreciate that it seems very no-brainer. So, thank you for your work on that.
Megan-Claire, our last formal question is to you, which is, there was this fantastic ASCO Education Book chapter from last year. It presented a practical guide to clinical trial accessibility, including a collaborative overview and highlighting that, quote, "a shared responsibility across sectors to modernize clinical trial design, to reduce access barriers, and to ensure that clinical trial participation becomes a standard and equitable component of cancer care - we all share responsibility in this." So in your mind, are there some low hanging fruit that we should work to start addressing first in our patient-facing interactions, or does kind of everything get equal weight in terms of what you think is important?
Megan-Claire Chase: Again, that communication, how do we talk about it? If you're going to tell me about a clinical trial, because a lot of times we're feeling the onus is on the patient, and we're like, we really need our providers to suggest, "Hey, why don't you look at this?" Or I feel like there needs to be like a middle person between the provider, have a middle person, and then the patient because a lot of that terminology we're hearing for the first time or we need a minute to even process. And then also, is this in Spanish? Is this in other languages? So we want to make sure that we're understanding it, and we really need some of that language not to be talked down to or anything like that, but just in a clear, simplified way. And also, where are the images? Like, I want to see the people who have been on these trials. And a lot of times we're getting materials where the faces don't look like ours.
Then I am someone who was diagnosed under 40, so I was getting materials of old White women and White men on there. And so it feels like, okay, you keep trying to say you're including us, but you're not really showing- we're not seeing those efforts like visually or on the page. And so, I understand that a lot of times when we're talking about clinical trials that it's the medical community and the researchers, they need to understand all of that. But why don't we have like a patient side where it's been like, "Hey, here's what they're saying in their scientific way. As a patient, here's what you need to know." And honestly, like, we need more voices like mine, quite frankly, that can bring in like the creativity to it because to me, again, that's what's missing.
And I also think too, again, if we can talk about it in a way where we're saying, "Look, we know it's problematic. We have to keep acknowledging the history," and that just never gets done. And so, you know, I want to actually bring up different ways to talk about clinical trials. So something that we do at SHARE Cancer Support, we actually have a novella, and this one in particular, I'm really proud of, helped to write and come up with the characters along with our Spanish speaking program. And it's about a Black woman and then a Latina woman and then an Afro-Latina, and they have triple negative breast cancer. One has metastatic, and we go into it in like, you know, with those cultural nuances and talking about, "Hey, this one, she decided to look into a clinical trial."
Well, also too, the other issue is access. Where are those clinical trial sites? Who's going to pay for daycare? And you're asking us to come during the daytime when a lot of us work. And if you're trying to really reach deep into the communities where maybe they are not white collar careers that they have and maybe they need to be close to a bus line, it feels so teeny tiny, so to speak, but they're major parts on the path to getting that representation in clinical trials. So I feel like we have a long way to go. Yeah, we can talk about it, but if we're not putting those little pieces to lead a nice pathway into the trial, then, then what are we doing? We just keep talking in circles.
Dr. Fumiko Chino: Yeah, no, I love it. You've actually outlined all of these different breadcrumbs that we could follow the trail to track clinical trial diversity that we're so far making, I would say, small to minimal efforts towards. And it's just some things that you mentioned that I wanted to highlight is that we already know that if you actually want to enroll a diverse sample, open the trial closer to that patient population where they live, where they receive cancer. Like we have at this point, pretty good research. You bring up the idea of like, we need something like a clinical trial ombudsman. I've been kind of shouting this idea out for a while for financial toxicity. We need a financial toxicity ombudsman, but it's- we need someone who's impartial who can communicate between providers who may have some bias, you know, they're trying to enroll on clinical trials. The thing that they're offering you may not actually be the best clinical trial for you. So we need kind of an impartial person to kind of interface. So 100%, I agree with all of that.
We are wrapping up the podcast. I want to leave just a little bit of extra time at the end if you think that there's something important that we didn't cover, if we want to talk about how the shift away from DEI is going to change the future of cancer research, or if that's just too depressing to talk about in the last couple of minutes of our conversation. I want to leave it open. Jen, anything from you in terms of wrapping up?
Dr. Jennifer Miller: I want to put a plus one on everything Megan said and her work as a trial navigator because in the bright spot analysis, when we went in and interviewed the bright spots, we came up with 14 shared factors that are associated with success, and one of them is navigators. The critical importance of navigators from symptom onset through diagnosis, through testing, through access to care and clinical trials. So just want to thank Megan for her work and amplify that in any way possible.
Dr. Fumiko Chino: Wonderful. And Megan-Claire, last thoughts from you because I think it's very fitting to leave it with a patient advocate for the last word.
Megan-Claire Chase: Well, thank you so much. It's only because of conversations like this and trying to reach different audiences that we are able to continue to have these conversations, but more importantly, have some action behind it, right? And so, I do think it's important to acknowledge, okay, we have made some great steps, but there's more. And quite frankly, the patient community and those in minoritized communities, we deserve more, and we just really need to make sure that we're trying different ways to communicate that clinical trials are safe and here's why you should consider one, and even if one is not right for you or even if you don't even need one, it's still important to know.
Dr. Fumiko Chino: Thank you so much for this great conversation today. Many thanks to Dr. Miller and Ms. Chase as well as our listeners. 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 hope your winter is starting to thaw.
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
Jennifer Miller
Employment Company:
Company: YALE UNIVERSITY
 
Consulting or Advisory Role
Company: GalateaBio
 
Research Funding
Company: Bristol Meyers Squibb
Other Relationship
Company: Bioethics International
Company: CSL Bioethics Advisor

Dr. Chino welcomes Hari Raman, MD, MBA, author of "End-of-Life Care for Older Adults With Blood Cancers With Medicare Advantage Versus Medicare Fee-For-Service Insurance," to discuss new research highlighting how insurance type may affect receipt of quality end-of-life care for patients with blood cancers.
TRANSCRIPT
Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for the JCO Oncology Practice. I am Dr. Fumiko Chino, an associate professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.
People with blood cancers may have prolonged clinical courses lasting years or decades and requiring specialty care. Prior research has shown that end-of-life care in this population may be suboptimal with higher hospitalization and lower hospice enrollment. Capacity for receiving appropriate specialty care has been a known concern with Medicare Advantage plans, but paradoxically, there may be unique advantages for those at the end of life. I am excited to welcome a guest today to discuss new research highlighting how insurance type may affect quality of end-of-life care for patients with blood cancer.
Dr. Hari Raman, MD, MBA, is a clinical fellow in hematology-oncology at Dana-Farber Cancer Institute. He got his MBA from Harvard Business School in 2023 while doing his internal medicine residency at Brigham and Women's. His research focuses on quality care delivery and value in healthcare with a focus on hematological malignancies. He is the first author of the manuscript, "End-of-Life Care for Older Adults With Blood Cancer With Medicare Advantage Versus Medicare Fee-for-Service Insurance," which was featured in JCO OP's February print issue.
Our full disclosures are available in the transcript of this episode, and we have already agreed to go by our first names for the podcast today.
Hari, it is really wonderful to speak to you today.
Dr. Hari Raman: Thank you so much, and I really appreciate this opportunity to join you.
Dr. Fumiko Chino: I have been hosting this podcast for over a year, and I think you are actually our first guest who is still in their training. So, I love this, I am excited to have you here. Do you mind giving us an overview of kind of where you are in your career and what got you interested in this topic?
Dr. Hari Raman: Yeah, no, of course. And again, I am really grateful to be here in training. I knew I wanted to care for patients, but as I continued training, particularly in my residency, I came to realize how many considerations around care delivery and the administration of healthcare actually exerts a significant influence on the patient care itself. And so while I was in training, I was really fortunate enough to receive an MBA while in residency to gain kind of a foundational understanding of how the business and financing of healthcare in the US, particularly, impacts care delivery and access. And as a clinical fellow at Dana-Farber, I have just been incredibly grateful to join Dr. Oreofe Odejide's lab here at Dana-Farber. She is actually the senior author of this study, where we have been able to examine care delivery and outcomes research for patients with blood cancers. This is really the intersection of both my clinical and academic interests given that my clinical focus will be caring for patients with lymphomas.
Dr. Fumiko Chino: And you are at the tail end of your training, right? So, you are, you know, out the door, correct? Or maybe you are not out the door.
Dr. Hari Raman: No, exactly. You hit it right on the head. I will actually be staying on as faculty here at Dana-Farber next year, and I am really excited to continue our research and also be able to care for patients with lymphoma starting quite soon, actually.
Dr. Fumiko Chino: That is so exciting. So, within this calendar year, you will be setting up shop on your own.
Dr. Hari Raman: That is the plan.
Dr. Fumiko Chino: Wonderful. And it is amazing to have built this large group of collaborators again within the same hospital system and academic world where you did your MBA and your additional training, so that is phenomenal. Hopefully, you will continue working with the same people.
Dr. Hari Raman: Yeah, exactly. You are exactly right. It is really so inspiring and also really we are really quite lucky here to be able to go down the hall and ask experts in healthcare policy what they think about some of our findings and really be able to get a rich discussion even within the walls of our own institution. So, I have been really grateful for that.
Dr. Fumiko Chino: Now, before you discuss this specific new research, do you mind giving our listeners a little bit of an overview of what you see as the key differences between the traditional fee-for-service Medicare and Medicare Advantage? I know personally and, you know, I think within oncology we really commonly encounter problems with the MA plans. We have network restrictions, we have coverage limitations, we have obviously prior authorization burdens. But there is obviously a lot of advantages, otherwise, it would not have proliferated at such a rapid rate in sort of the modern era.
Dr. Hari Raman: So crucially, the payment model for Medicare has been what we call fee-for-service, where the government or the Centers for Medicare and Medicaid Services, in this case, pays providers a set amount per service that they provide to their Medicare patients. In Medicare Advantage plans, private plans are actually paid on a risk-adjusted basis by the government or CMS to assume the total cost of care for patients. Theoretically, this would allow the government to have a somewhat predictable cost of care given that they are paying these monthly or bimonthly payments on a risk-adjusted basis and then also incentivize private plans to essentially limit the overall cost of care through various levers that they may be able to pull. I think you alluded to a really good point that part of these levers include things like restrictions on networks as well as potentially allowing patients to only go to certain providers or have certain hospitals in network.
While this is something that we think about from a restriction perspective, the other part of this to note is that Medicare Advantage is a voluntary program that patients choose to go onto. As you can imagine, the way in which these payers are able to get patients to go onto their plans is through other offerings, such as lower premiums, more add-ons such as dental or vision insurance, including other things such as care coordination, which is really important for oncology patients, or even access to lifestyle things such as gyms and other services.
Dr. Fumiko Chino: Yeah, I know that at least based on my own prior research that the populations that have traditional Medicare and the populations that have Medicare Advantage really are a little different. Do you mind commenting on that?
Dr. Hari Raman: Yeah, and I think this also speaks to the offerings that Medicare Advantage plans often provide. What we have seen, particularly in the last decade, has been that Medicare Advantage plans tend to have enrollees that are more likely to be of a racial and ethnic minority group. Also, these patients tend to have lower incomes and are frequently dually eligible for Medicaid as well. I think this is both in part to the populations that Medicare Advantage payers are deciding to roll out to, but also in part because of the offerings that may be provided and may be disproportionately more attractive for patients who may have lower sociodemographic means.
Dr. Fumiko Chino: One thing that has always struck me with some of the literature and the research around Medicare versus Medicare Advantage is that Medicare Advantage offers more to patients when they are well, but it may be more challenging to use if you have serious and complex medical conditions, and ironically, it is actually more expensive to CMS than traditional Medicare. It is a little push-pull with the sort of the rapid proliferation of the program. There is more than 50 percent of enrollees are now in Medicare Advantage as opposed to traditional Medicare.
Now, do you mind walking us through your actual JCO OP study, what you did, what you found, why it matters?
Dr. Hari Raman: So, I think as you astutely pointed out early on the podcast, we know that for patients with blood cancers or hematologic malignancies, they really face significant challenges at the end of life. This is even in comparison to patients who have solid cancers. This primarily manifests as having increased rates of hospital admissions, ICU stays, and even dying in the hospital near the end of life. This really detracts from the ability for patients to be able to spend more time with their loved ones at home, which is something that they frequently voiced when folks have done studies examining patient preferences. Furthermore, we have seen that patients with blood cancers actually have decreased hospice utilization. We know that hospice, which is a multidisciplinary support service that is really tailored to offer maximal comfort and support and care for both patients and their caregivers at the end of life, is quite diminished in patients with blood cancers, particularly in comparison to whether it is patients with heart failure or solid cancers and any other really end-of-life illness.
And lastly, along the same piece of hospice, patients with blood cancers are also uniquely situated in a situation where they are required to have blood transfusions to support their quality of life, but also their blood counts. Oftentimes patients who are near the end of life require access to these transfusions, and the problem right now in our current models of hospice care is that hospice agencies are not equipped to provide access to palliative transfusions. This is primarily due to a mismatch in the financial reimbursement that they receive and the cost of providing access to transfusions. And so patients with blood cancers at the end of life are often forced to make really difficult tradeoffs between preserving access to blood transfusions versus enrolling onto hospice and then receiving all the benefits of hospice care that they may be able to receive once they enroll onto hospice.
Our question really was to understand whether there may be modifiable risk factors, such as insurance type, which I mentioned in Medicare is optional in terms of either enrolling onto Medicare Advantage or fee-for-service, and see if that may impact the quality of care patients at the end of life, particularly with those with blood cancers. We performed a retrospective analysis using data from the Centers for Medicare and Medicaid Services. Our data spanned about five years from 2016 to 2020, and we really focused on patients who had insurance coverage by either the traditional Medicare fee-for-service or Medicare Advantage plans. Patients had to have had coverage for at least 15 months in a continuous fashion prior to their passing. In terms of how did we assess quality of care at the end of life, we focused on administrative metrics that have previously been validated both in surveys as well as focus groups of both patients and providers. This really focused on three key aspects: hospice use, rates of high-intensity healthcare utilization, which is broken up into things such as emergency department visits, ICU stays, as well as rates of in-hospital death, as well as rates of advanced care planning to see whether patients and their providers have had these discussions about what is important to them at the end of life before they ended up dying. We had access to about 70,000 patients in our study, about two-thirds of whom had fee-for-service insurance and about a third of whom had Medicare Advantage.
When we thought about these individual metrics of quality of care at the end of life, we saw that about a little bit more than half of patients were enrolled in hospice across both cohorts. However, the Medicare Advantage patients tended to have higher odds of hospice enrollment with a nearly 11 percent increase in the odds of receiving hospice before they passed, as well as a decreased likelihood of having a very short hospice stay, which meant that patients who enrolled onto hospice with longer stays were able to more fully capture all the benefits of hospice. In terms of healthcare utilization, we also again saw that patients with Medicare Advantage plans were less likely to have two or more ED visits, less likely to have any ICU admissions in the last month of life, and had a nearly 25 percent reduction in the odds of dying in the hospital compared to those patients who were enrolled onto fee-for-service plans. In general, we found that overall that patients with Medicare Advantage seemed to have at least met administrative metrics for higher quality of end-of-life care compared to those with fee-for-service insurance across patients with blood cancers.
Dr. Fumiko Chino: One thing I think that was really compelling about your research was that it actually showed a sort of flattening out of what are very large gaps in health equity in terms of different patient populations that may be more likely to die in the hospital, be more likely to receive aggressive care, and it did not seem that you were able to find a difference, which is, I think, good. Do you mind speaking more about that?
Dr. Hari Raman: Yeah, exactly. To your point, we know that prior research has shown that patients who are particularly of racial and ethnic minority backgrounds tend to have higher rates of high-intensity healthcare utilization at the end of life and decreased hospice. As you mentioned earlier, similar to what we have seen in the national cohort, our Medicare Advantage cohort was also more likely to be from a racial and ethnic minority background. And so we then asked the question, well, do we see any differential changes in the benefits of Medicare Advantage, particularly at the end of life, across different racial and ethnic groups? We found that across our entire study, patients who were white versus patients who were non-white were equally as likely to receive benefits with regards to the kind of differential impact of Medicare Advantage versus fee-for-service, which I think was really interesting for us because we know that these patient populations are at very high risk for poor quality end-of-life care.
Dr. Fumiko Chino: Now, your findings are really consistent with some other research that I have seen that shows that Medicare Advantage may really improve some metrics of end-of-life care, and I think this is mostly likely due in part at least to the hospice carve-out for MA plans where Medicare steps in to actually cover hospice payments and that kind of makes it free for MA plans to deliver. I would love your thoughts on this and please correct me if I am misunderstanding this situation.
Dr. Hari Raman: I think you are exactly right, and I think this is a really interesting example of how policy can actually drive behavior. You see that as you mentioned, there is a financial incentive for Medicare Advantage plans to have patients enroll onto hospice. Just briefly to review, once patients enroll onto hospice, these Medicare Advantage plans are no longer responsible for the cost of care associated with that terminal diagnosis, and they stop receiving the risk-adjusted payments from CMS. However, they still receive rebates from CMS for the minimal amount of care not related to the terminal diagnosis. A study actually that came out of Brown earlier this year found that CMS may be spending up to 50 million dollars a year in extra payments to these Medicare plans after patients enroll onto hospice. I think the flip side really is that, you know, there is also a theoretical benefit for patients if we think that we are increasing access and enrollment to this valuable service. But I think it is very important to not ignore the fact that this is definitely incentivized from a financial perspective for Medicare Advantage plans to have patients enroll onto hospice.
Dr. Fumiko Chino: There is one thing you mentioned in your manuscript that I actually thought was really great in that, in thinking about how the money monies, because MA plans, they have that financial incentive to enroll people in hospice, they actually invest more into things like coordination of services and navigation. Do you mind speaking a little bit about that?
Dr. Hari Raman: Yeah, of course. And I think this kind of came out of the question that we had when we were discussing and we said, when we are in the clinic, we do not necessarily know what insurance a patient has and we do not really use that to drive a lot of our decision making. And so we thought, how are we seeing these differences? I think one thing that came up was that, you know, there is a lot of communications and interactions that patients have outside of the clinic with their payers and with other ancillary service providers. I think one key piece is that with Medicare fee-for-service, patients are not given additional services by default, and there is no real exposure to other services unless patients ask for it. However, in these Medicare Advantage plans, when you have things like care coordination and navigation, patients may be having these discussions with other providers where either things such as hospice enrollment or end-of-life care planning are reinforced and these ideas are kind of explored further at home. I think partly what we are seeing is that while we may not see a difference in the provider behavior whether patients have Medicare Advantage or fee-for-service, there may be exposures to things like care coordination that are driving a lot of these patient and caregiver behaviors in terms of thinking about when to enroll onto hospice or when we think about focusing more on the quality of life rather than extending life through hospital visits and ED admissions.
Dr. Fumiko Chino: There was a recent JCO OP analysis looking at switching from MA to traditional Medicare after a new cancer diagnosis because switching can be challenging if patients did not actually sign up for a gap plan at their initial enrollment, i.e., some people actually end up being trapped in an inadequate MA plan for their cancer needs and that has been unfortunately well-covered in the media at this point. There is a very limited number of states that actually have Medigap consumer protections. So the study that just recently came out found that people are more likely to switch if they live in these states. And so kind of in my mind, that means that clearly MA plans are not just wine and roses at the end of life; some people really do have a lot of problems with them for their cancer diagnosis. So I am not actually sure if there is a clear answer to the friend or foe question, but I wanted to ask you what the kind of nuances that you pulled out of this, you know, doing this type of work.
Dr. Hari Raman: Yeah, I think you are exactly right. I think it is, it is hard to know if there is a clear answer to the friend or foe question. But I do think what is really helpful here is that our analysis at least somewhat adds to the broad body literature that demonstrates that there are certain policy levers that we may be able to isolate from different alternative payment models such as Medicare Advantage or other new innovations that may be playing a significant role in impacting the quality of care that patients receive at the end of life. But I do think the important part you mentioned is something that our study was not structured to examine, was that we did not look at the quality or access to care for these patients prior to the end of life. And so we really focused on that last year period. And I think a key question here and a key concern for a lot of us is that we really need to ensure that patients have access to high-quality care across their entire cancer treatment journey from the diagnosis and ultimately to their end of life. I think our study here was focused at the end of life, but we really need more information as to the restrictions that patients may have when they get a diagnosis or when they start seeking treatment because these are all things that patients are concerned about and may not necessarily be focused on at the end of life.
Dr. Fumiko Chino: It is ironic because I thought about after reading your piece that we know historically it is hard to switch from MA to traditional Medicare, but if traditional Medicare has better access concerns for active treatment and Medicare Advantage has better end-of-life metrics, maybe, you know, we should be advising people have traditional Medicare for their treatment and then switch over to Medicare Advantage for their end-of-life needs, which seems insane, but weirdly could help, question mark?
 
Dr. Hari Raman: I think that is something that you bring up is a really good point. And I think, you know, the one thing I would say particularly in patients with blood cancers is that their disease trajectories are often quite unpredictable. And I think to your point, you know, it would be really nice if say we have these modifiable factors where we can things like switching insurance can allow us to either get more access at the beginning and then towards the end have different forms of insurance that give us more access to palliative care services. But I think the key nuance here is that patients and their providers may not know when that end-of-life phase occurs.
 
And so one thing that we are thinking about is, well, how can we incorporate some of these policy levers that are more pervasive throughout all insurance forms so that patients are not necessarily having to take that upon themselves while they are sick to think about insurance coverage? Because I think as I can attest for my patients, the last thing patients want to think about is insurance coverage when they are facing things such as a terminal diagnosis or even advanced cancer. And so I think you bring up a really interesting point and it often almost seems like the burden is on the patients to figure out a workaround while there may be an opportunity for us to think about implementing new policies to kind of ease that burden for patients.
 
Dr. Fumiko Chino: Very well said. We are at the tail end of our conversation, but I want to leave a little bit of space if there is anything that you feel like we did not address. I know for example that you also evaluated advanced care planning conversations and I was kind of sad to see that they were not had that often or at least not documented as being had.
 
Dr. Hari Raman: Yeah, I think it is kind of a quirk of the data a little bit. And so we used claims-based data and I think what we saw was that patients who enrolled onto hospice may not have had an advanced care planning documented. And so it did not really make sense to us right away. And I think part of this is due to the capitated structure of Medicare Advantage where providers are not getting reimbursed for having additional claims for advanced care planning and things like that. And so I think it is safe to assume that if patients were thinking about enrolling onto hospice they would have had some form of advanced care planning discussion. And I do think from a fee-for-service perspective this speaks to potentially the incomplete penetration of some of these billing codes that were initially designed to capture quality of care and quality of discussions at the end of life but may not necessarily be as disseminated throughout all these practices.
 
And so I am not entirely sure that the low rates of advanced care planning that we saw in our claims analysis necessarily reflects actual treatment patterns because it may just be that the providers are not enrolling onto these relatively new billing codes or billing for these new codes. But I do think it is a good point that you are making and I think one piece is that we do really need to capture that information through other means if possible, things such as large language models as well as NLP processing is starting to come out of there where they are looking at the actual notes that providers write for patients and we are starting to see some of these conversations really be able to be measured and calculated in a more accurate way.
 
Dr. Fumiko Chino: Yeah, that is such a good summary of it, which is that if I am not going to get paid more for documenting the conversation or specifically filing a claim for it, why would I do that? Because it is just extra paperwork on my part.
 
So, do you have a next step in terms of where you want to go? I mean you are going to start your faculty career within this year. Do you know what your first project is going to be?
 
Dr. Hari Raman: Yes, we shared some of our work at ASH earlier this year, but we examined-  we tried to take a similar approach looking at insurance coverage to try to focus on a younger population. So we did an analysis on patients aged 18 to 64, and the really neat thing in that population is there is kind of a natural experimental cohort because the majority of patients are either covered under Medicaid or commercial insurance plans. And we tried to ask some similar questions asking, you know, are there differences that we see in the quality of end-of-life care that patients receive with regards to Medicaid and commercial insurance? I think this is particularly relevant in this current time because of upcoming federal legislation looking at limiting access to Medicaid. And we actually found that, similar to what we have had here, patients under Medicaid were actually more likely to have higher quality end-of-life care compared to those with commercial insurance.
 
And I think again, a lot of this could be driven by many factors, but one key piece is that most of Medicaid around the country nearly 70 percent is actually in a managed care fashion and it is contracted through accountable care organizations. And so again we are seeing that some of these policy levers may actually be driving a lot of behaviors on both patient and providers particularly at the end of life in this very vulnerable population.
 
Dr. Fumiko Chino: I am excited to read more about that work, maybe even in the pages of OP.
 
Dr. Hari Raman: We are looking forward to working on that, thank you.
 
Dr. Fumiko Chino: Thank you so much for this great conversation today. Many thanks to Dr. Hari Raman as well as our listeners. 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 will join us next month for Put into Practice's next episode. And 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.
 
 
 
 
 
Disclosures:
 
Hari Raman
No Relationships to Disclose
 
 
Fumiko Chino
Employment
Company: MD Anderson Cancer Center
 
Consulting or Advisory Role
Company: Institute for Value Based Medicine

Dr. Chino welcomes Dr. Erika Moen and Dr. Dan Zuckerman to discuss new research highlighting how specialist scarcity is felt by oncologists practicing in rural environments. Dr. Moen is the first author on "Rural Oncologists' Perceptions of Specialty Scarcity and Repercussions for Care Delivery: A Qualitative Study," which is featured in JCO OP's January 2026 issue.
TRANSCRIPT
Dr. Fumiko Chino: Hello, and welcome to Put Into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an Associate Professor in Radiation Oncology at MD Anderson Cancer Center, with a research focus on access, affordability, and equity.
Rural oncology care has many challenges, including travel distance, limited specialty care, sparse clinical trial infrastructure, and financial barriers leading to worse outcomes and access for patients from diagnosis through survivorship care. Oncologists practicing in rural areas often have difficulties coordinating care with geographically distant providers and limited availability. This is made worse by known workforce gaps.
I'm happy to welcome two guests today to discuss new research highlighting how specialist scarcity is felt by oncologists practicing in rural environments. Dr. Erika Moen, MS, PhD, is an Assistant Professor of Biomedical Data Science at Dartmouth. She is a health services researcher and leads a multidisciplinary team working to leverage network analysis to optimize cancer care delivery and patient outcomes. The long-term goal of Dr. Moen's lab is to improve equitable access to coordinated cancer care with a particular focus on rural populations. She is the first author of the manuscript, "Rural Oncologists' Perceptions of Specialty Scarcity and Repercussions for Care Delivery: A Qualitative Study," which was featured in JCO OP's first issue of 2026.
Dr. Dan Zuckerman, MD, FASCO, is the director of GI oncology and staff medical oncologist at St. Luke's Cancer Institute in Boise, Idaho. The center encompasses eight locations and is the region's largest provider of cancer care, treating a catchment area of over 20 counties. He is past president of the Idaho Society of Clinical Oncology and has been active in ASCO, including past chair of the Clinical Practice and Innovation Committee.
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.
Erika and Dan, it's really wonderful to speak to you today.
Dr. Erika Moen: Hi, Fumiko and Dan. It's great to meet you both, and I'm looking forward to this discussion.
Dr. Dan Zuckerman: Me as well. Thanks, Fumiko. Nice to meet you, Erika.
Dr. Fumiko Chino: Erika, do you mind starting us off on how you got interested on how to try to optimize multidisciplinary care and why your focus is specifically in rural populations?
Dr. Erika Moen: Yes, absolutely. When I was a new assistant professor, I knew I wanted to focus my research program on bringing together my methods expertise in patient-sharing network analysis, which involves using healthcare administrative data to identify networks of physicians who share the same patients, with my research interest in cancer care delivery.
I remember reading an oncology workforce report published by JCO OP, and in that paper, there was a map visualizing county-level metrics of the number of oncologists per capita. And one of the things that immediately struck me was what I was seeing in rural areas. There would often be one county that had a relatively high density of oncologists, and it would be surrounded by counties with none. I wondered what the multidisciplinary referral networks of those physicians looked like and how physician departures or retirements would impact those patients and care teams. And because rural areas have known workforce shortages, and the delivery of high-quality cancer care depends on relationships between multidisciplinary specialists, these networks of physicians seemed critical to study and to support to maintain access to care for rural communities.
Dr. Fumiko Chino: What a great summary about how you got interested in this and trying to marry the data science of it all with the actual care delivery, like what matters to patients on the ground, which is: "Am I going to be able to see a specialist focused on melanoma or am I just going to have to see a general oncologist?" So that's a phenomenal narrowing in on "this is the reason why I'm doing the research that I want to do."
Now, Dan, congratulations on your recent nomination for the ASCO Board of Directors. I know that you have been passionate about improving quality care delivery for decades. Can you speak to your efforts in your home state and within ASCO to ensure that the science and technology and practice pattern advancements that we see at academic centers actually make it into the community?
Dr. Dan Zuckerman: Yeah, I think about the 44 counties in Idaho, and I'd have to guess that most of us are concentrated in three or four of those. But you know, a great example: so I've been practicing out here for 18 years, when I left fellowship, we came to a center where we had autologous stem-cell transplant but not allo. And so you sort of ask about one of the greatest innovations recently in oncology has been CAR T-cell therapy. And we were thinking about and watching our patients with leukemias and lymphomas being sent to places like Seattle or Salt Lake and thinking about, as Idaho grew and our population, urban and rural, how could we provide for that?
And so, really back in 2015, when I was director of our Cancer Institute, we got buy-in from our leadership, thankfully, to start building an allogeneic stem-cell transplant program with an eye to do allo, but also with an eye to know that we needed sort of that expertise in cellular therapies, all the way from lab to processing, to having the physicians and APPs and pharmacists to do that, so that we could deliver CAR T-cell within Idaho. And it took three years to build an allo program, and then we had planned to deliver CAR T-cell in 2020 and the pandemic happened. That delayed us by a year or two. But, you know, it's an example we're proud of, but it took a massive lift. I think originally it was close to a two-million-dollar pro forma with 19 FTEs, and we were fortunate to have leadership at St. Luke's and also a group of physicians who were willing to make that lift because we're not an academic center. But that's sort of one example where we've been successful in being able to bring some subspecialty care to a rural area, but it is incredibly difficult. And we still have gaps. So obviously I'm highlighting a place where we've been successful.
Dr. Fumiko Chino: No, I love that you mentioned CAR T-cell because I know we did a recent podcast episode about access to CAR T and how providing CAR T within the community is obviously the next step, and yet it's so challenging. There's these logistic challenges, but you also have to have actual buy-in from the institutions to build the programs because they will not build themselves. And I think: Oh, you don't have CAR T-cell in your community within your county, within 10 counties? You didn't even have it within your state! And so, that's a phenomenal effort, and it required so much investments in people and dollars and just time. So, I completely respect that.
And it dovetails really nicely into the next question to Erika, which is: the manuscript on deck that we're talking about really talks about the access to specialty care and how that can be very challenging in rural areas. Do you mind giving us an overview of the manuscript, kind of what you did, what you found, what you're excited about in terms of the next steps?
Dr. Erika Moen: Sure. So, our study conducted and analyzed qualitative interviews from 20 oncology physicians across five sites that served a rural catchment area. And it was part of a larger project evaluating patient-sharing networks for cancer care. And we identified three major themes. The first was participant experiences related to the effects of physician shortages on care team expertise, collaborative relationships, and patient volume. The second related to the strategies that oncologists use when facing physician shortages, including referrals to outside health systems or generalists practicing outside their subspecialization, and reallocating time from other responsibilities. The third theme described the unintended consequences of these adaptive strategies, including greater patient travel burden, less optimal or delayed treatment, reduced access to clinical trials, and increased physician burnout and lower job satisfaction.
We then developed a conceptual map showing the connections between these themes in the broader context of an oncology physician's departure. And I think I'm really excited about the effort to map some of these themes together because I think it can be informative depending on the adaptive strategies that are being used to try to manage a workforce shortage; different interventions might be more or less effective to ensure that the care teams and the patients are supported.
Dr. Fumiko Chino: It's really interesting. It reminds me of, you know, I grew up in Indiana, and not a tiny town, but a small-town Indiana. My mom was practicing oncologist, and her referral patterns, so, for example, when she retired, her referring physicians had to figure out, "Well, who do we trust now? Who are we going to reroute our consults to now that you are no longer in service?" As it turns out, as someone who started a practice and then actually ultimately hired my sister, it was a very easy dovetail.
Dr. Erika Moen: No, but I think that's exactly right. And the importance of trust really came through as a prominent challenge that was faced by physicians that did have someone depart. And I think it's just a human experience we can all relate to.
Dr. Fumiko Chino: So Dan, I'll ping it right over to you because I would really love your thoughts about how the themes outlined in this study is something that you may find in your practice. So, for example, I know that you work at a large center, but with many referral in the community. For example, in GI oncology, I could imagine if someone retired who was a gastroenterologist in the community, that you would have this whole cascade of potential difficulties for you. Do you mind speaking about that?
Dr. Dan Zuckerman: Yeah, no, for sure, Fumiko. And on a personal note, it's funny that we both have parents who are oncologists. So I, unlike your sister, I'm actually practicing with my dad here and he's imminently retiring. And what you mentioned about that legacy and that expertise and that trust in the community and what that means and who he'll hand his practice off to certainly resonates.
But certainly talking about subspecialty care, and I think, you know, Erika and her group's paper really honed in on a key linchpin physician is often the surgeon. And so I do mostly GI medical oncology and for us, you know, we had two HPB surgeons for, you know, sort of the middle part of my career. And then the senior surgeon, who we had poached from Seattle and was, you know, sort of towards the tail end of his career, retired. But he was doing quite a bit of volume, but also was the sort of respected physician, was sort of the leader for that. And that definitely for at least a year or two was a challenge for us in terms of replacing his expertise, of putting more volume on his junior physician.
Probably more pointedly, and I think Erika's paper points this out, is that we for a long time had a urologic oncologist who was just the key person for our GU program, was doing all the RPLNDs, the cystectomies. He was just 55, had a background in the military, and realized that he could go to the local VA and dial down for quality-of-life purposes because he was exhausted, because he was that key physician. So, he was seeing so many patients, he was the heart of the program, and then all of a sudden he left. And right in the midst of it now, we're scramble- literally scrambling in terms of are we sending these patients down to University of Utah, which is sort of our closest partner academic center? Is it the community urologist, who you know, haven't done that many cystectomies in a while and haven't done an RPLND in a decade, that we rely on?
And so, yeah, we definitely feel it as a concrete example in our GU oncology program with just the departure of one physician has caused quite a bit of scrambling and quite a bit of changes in practice patterns. You know, Erika's paper also mentions possibly suboptimal care, so our patients not doing the standard neoadjuvant immunotherapy-chemotherapy with followed by cystectomy; are we doing more bladder preservation simply because we just don't have a surgeon to do it and patients don't want to travel? And so, the downstream impacts from the loss of expertise when you already have a scarce physician population are deeply felt every day.
Dr. Fumiko Chino: Erika, one thing that really struck me from your work is that there was real difficulty, it seemed like, recruiting a truly rural sample provider. So, for example, all of the physicians in the study were at centers who had large rural catchment areas, but almost all of them worked at NCI-designated cancer centers. And I do typically think of those as being pretty well-resourced. So, it's very different than, for example, again my mom's community practice, where she was at one point the only radiation oncologist. So, I would love to hear from you about that perspective of sometimes even getting the voices of the people you want to hear from, how challenging that is.
Dr. Erika Moen: Yeah, I agree completely. I'll start off by giving a big thanks to the physicians who did participate in our study, and perhaps some of them are listening. We did have more success recruiting when we were able to leverage a personal connection or a local champion, and these were often at other NCI cancer centers. We did try to recruit at outreach or community sites within those larger health systems and we had some success there. But I think it's going to be really important to understand which of our findings can generalize to community-based practices that aren't part of a larger integrated health system and identify the challenges that are more unique to care delivered outside of the context of a large health system. So yeah, I mean our sample is what it is, and I think some of the challenges will be universal but probably even greater or amplified in the places with fewer resources.
Dr. Fumiko Chino: And I'll just say even for, for example, my mom's practice, which she, you know, was an independent practice, since she retired it has now been part of this sort of large conglomerate oncology practice. That may be also just how the wind is blowing in America in terms of consolidated care.
Now Dan, there was a recent JCO OP analysis that was about the use of telemedicine oncology, and it highlighted that even after the telehealth boom of the pandemic, rural patients were still less likely to use telemedicine. They continued to have, for example, higher utilization of emergency services. And I'd really love your perspective on this. I know that you had recently helped transition your benign hem program to be an e-consult-based workflow. So I assume you're pretty familiar with some of the access issues that rural patients face.
Dr. Dan Zuckerman: Yeah, that's a great point, Fumiko. And I think there's sort of two parts to that. The telemedicine piece is interesting. On face value, I think- I and I think my colleagues had assumed that rural patients, especially because of travel distance, really just, you know, time in the car and gas money, that there might be a higher uptake. And I actually was surprised to see that it's not as high. And I think the reasons for that are manifold, but you know, some of them are technological, just is simply that patients don't have adequate Wi-Fi access or maybe predisposed also I think culturally to not want to engage with the technology. Rural populations often tend to be a little bit older and patients who just prefer, you know, to give me that line and say, "Hey, I'm sort of old-school, I just want... I'd actually rather spend three hours in the car and drive down to see you than log on," because of that experience.
That's an interesting point that we've definitely seen even in Idaho, that there has not been widespread uptake. You know, that said, there are some patients who do fine with the technology and prefer the convenience, but it's not as penetrant as I thought it might be.
In terms of the e-consultation, that's been a great way for us to be able to handle classical hematology, which, you know, probably comprises 20, 30 percent of all our volume, simply to make room and improve access for patients. And that's sort of been a win all around in the sense that we've been able, you know, getting questions about, you know, macro-cytosis in people with alcohol history or somebody who has a thrombocytosis and the PCP didn't appreciate that they'd had a splenectomy. I mean, you know, sort of stuff that I think we would might label garbage or just not even rising to the point of requiring even a hematology, we can handle on the back end. And that way the primary care provider, they get an answer quicker, the patients don't have to get in the car. I mean, that's super frustrating when you see a patient and they've driven three hours to see you and then you're sort of trying to not exactly cover for the PCP, but just make it clear this is just a nothing burger. I'm sorry you had to come here and spend all this time and money and find someone to watch your kids and then get a bill from my health system because it's a, you know, billable encounter.
So, from the e-consultation perspective, actually the biggest barrier, I'll just tell you Fumiko, as you can imagine, is we weren't interested in doing work for free. And so, the biggest barrier was really just: how do you get credit to the physicians? And so, finally - it's not that complicated but finally someone agreed on the back end to have a dummy RVU. So, that's the system we use. A note goes into Epic, the provider can read it, the patient can see it, they don't have... the patient doesn't have to do anything, and they don't get a bill, but the physician who took, you know, four to seven minutes to review something pretty easily gets a quote dummy RVU credit. And I don't know if I'm embarrassed or just honest to admit that that was actually the sort of final barrier to getting that program up and running. And it's worked well to improve access.
Dr. Fumiko Chino: That's such an interesting workaround that you've created within your health system, and I think it really actually is very telling, which is when we think about how to truly generate better integrated care, less wasteful care, truly important, like meeting of the minds of this specialist for this specialty problem, reimbursement is so important. Trying to figure out how do we get things paid for - it's actually one of the major concerns about, for example, the current environment in which reimbursement for even telemedicine might go away, which could create huge access problems in rural populations.
Dr. Dan Zuckerman: You mention that, Fumiko, and I don't think we're alone, but unfortunately, you know, I think it had to do with something with the government shut-down and lack of funding, but that we, I think we're not alone as a health system that put a moratorium on allowing for telemedicine visits, simply because they weren't being reimbursed. And patients were scratching their head because, like, a week before they could do it and the week after they couldn't. And yeah, that's been a terrible thing for access for those patients who do want to take advantage of telemedicine.
Dr. Fumiko Chino: We're kind of at the tail end of the podcast. I want to leave a little bit of space at the end to talk about any issues that you feel like we haven't covered. We've talked a lot about the potential problems related to providing specialty care in the rural environment, but we haven't really talked about any solutions. You know, I'd love to hear any thoughts as we walk out the door in terms of thinking about - I know, for example, in the paper, Erika, you mentioned something like a community-based virtual tumor board, and I certainly can think about that as being really nice to bring a community together to actually talk about difficult cases and actually so for people to actually meet each other and to become familiar with each other and to start trusting each other. I can imagine that's actually a very compelling solution.
Dr. Erika Moen: That would be a good solution for the issues around losing someone you trust and someone who you are familiar with in terms of the way that they think about cases or the way they think about their workflow. And so I thought that could be a way to manage that, but it's not going to solve all the problems. So that's why I do think solutions have to be multi-level and multi-faceted, whether there can be navigation when you're now spanning two health systems that don't share electronic medical records. Can there be some proactive work there? But I think sometimes it does come more as a shock to the system, in which case maybe, you know, you're in a reactive mode, and then it gets to be harder in terms of managing those challenges in real time.
Dr. Fumiko Chino: Any last thoughts from you, Dan?
Dr. Dan Zuckerman: Well, I'd just like to say, you know, reading Erika's paper and thinking about rural- you know, oncology in rural America, I appreciate that it captured some of the qualitative aspects of the fact that your group interviewed oncologists in rural areas, taking care of rural patients, that a lot of it was the loss of expertise and camaraderie and trust that can be leading to burnout as much as volume issues, which I tend to agree with. Yeah, I mean, it sucks when you lose a partner and you have to increase your volume and your workload and you're seeing 24 instead of 20. But, like one of your participants had said, it's just like you can sort of just turn up the dial or order... get another APP, and yes, we all know how to work harder. And that does contribute to burnout, but it may not be as appreciated how much we still value, as oncologists, caring about our colleagues and the expertise and the lack of penetrance of expertise into rural areas. And so, I thought that was a useful point that one of your participants said: "Okay, we have more volume, but I'm exhausted, but I survive." And I often feel that way, and I'm sure, Fumiko, even in academic center, we all feel that way, but getting the expertise and getting distribution of expertise into rural areas is really, really difficult and is an ongoing challenge. And I think your paper highlighted that well.
Dr. Fumiko Chino: Absolutely, you really have to have a passion for the work, and that is what carries you through.
So, on that note, I want to thank you so much for this great conversation today. Many thanks to both Dr. Moen and Dr. Zuckerman for your time as well as for our listeners' 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 you'll join us next month for Put Into Practice's next episode. Until then, I hope your 2026 is off to a wonderful start.
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
Dan Zuckerman
Leadership
Company: OncoHealth Medical Group, PA
 
Consulting or Advisory Role
Company: Oncology Analytics
Company: AstraZeneca
Company: Revolution Medicines
 
Erika Moen
No Relationships to Disclose


Fumiko Chino
Employment
Company: MD Anderson Cancer Center
 
Consulting or Advisory Role
Company: Institute for Value Based Medicine
 
Research Funding
Company: Merck

Dr. Chino talks with Dr. Talya Salz, the first author of the JCO OP manuscript "Impact of an Electronic Patient-Reported Outcome–Informed Clinical Decision Support Tool on Clinical Discussions With Head and Neck Cancer Survivors: Findings From the HN-STAR Randomized Controlled Trial (WF-1805CD)" which was published earlier this year simultaneous to the ASCO Quality Care Symposium. Jeff White, the Director of PR and Strategic Communications for the American Society for Radiation Oncology, also joins the conversation to provide the patient advocate perspective.

TRANSCRIPT
Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an Associate Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.
Incidence of head and neck cancers is rising, primarily driven by HPV-positive oropharynx cancers, which are commonly diagnosed in younger people with overall excellent disease outcomes. Patient-centered cancer survivorship is a key evolving area of study, with the goal of improving quality of life after cancer treatment. This is particularly important for people in head and neck survivorship given large post-treatment symptom burden, including speech and swallowing problems, dry mouth and dental concerns, neck fibrosis, and pain.
I'm happy to welcome two guests today to discuss new research on how to improve communication in cancer survivorship. Dr. Talya Salz, PhD, is an Associated Attending Outcomes Research Scientist at Memorial Sloan Kettering. Her research aims to improve the quality of life for cancer survivors, focusing primarily on late effects after cancer treatment. She is the first author of the JCO OP manuscript "Impact of an Electronic Patient-Reported Outcome-Informed Clinical Decision Support Tool on Clinical Discussions With Head and Neck Cancer Survivors: Findings From the HN-STAR Randomized Control Trial." This publication was simultaneously presented with the 2025 ASCO Quality Care Symposium.
Mr. Jeff White is the Director of PR and Strategic Communications for ASTRO, the American Society for Radiation Oncology. He focuses on media outreach and manages ASTRO's social media channels in a way to expand knowledge and awareness about radiation oncology and its critical role in curing cancer. He was diagnosed and treated for an HPV-positive tonsillar cancer in 2023 and shared his story on RT Answers to help other patients understand the role of radiation, surgery, and chemotherapy in head and neck cancers.
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.
Talya and Jeff, it's really great to speak to you.
Dr. Talya Salz: Thank you for having me.
Jeff White: Great to be here.
Dr. Fumiko Chino: Talya, do you mind starting us off on how you got interested in trying to improve survivorship care, and specifically what gaps your research can fill?
Dr. Talya Salz: My research is really shaped by my experiences trying to navigate the health care system. I had some health issues in my 20s, and as a recent college graduate in a new job with my brand new health insurance, I was really shocked at how hard it was for me to find doctors that I trusted. It was hard to communicate what I needed and to get insurance to cover my care. That experience really steered me toward a career that addressed reasons why patients, and we're all patients at some points in our lives, have difficulty getting care that's appropriate, that's needed, and that's patient-centered.
So when I started doing health services research in cancer almost 20 years ago now, there was a growing consensus that after cancer treatment is over, after patients are told there's no evidence of disease, that they're cured, there are so many more health issues that can arise that had historically been neglected. And late effects of cancer treatment can last long after treatment is over, or they can pop up months or years later. All the distress and anxiety from cancer, that doesn't just vanish once the treatment is complete.
One problem is that there's no agreement on who should manage late effects of cancer treatments after treatment is over. Survivors have fewer appointments with their oncology team, and these visits traditionally focus on monitoring for recurrences and new cancers. Many oncology providers feel that late effects of cancer are realistically difficult to manage in the brief post-treatment visits or that these issues are out of their purview. So survivors are typically expected to return to the primary care they were getting, or maybe they weren't even getting it, before their cancer. And a lot of research has shown that primary care providers feel ill-equipped to address all the health issues stemming from cancer and cancer treatments.
Cancer survivors can feel a real burden by this transition from oncology-focused care to more general preventive care. In my survivorship research, I hope to understand and improve how cancer survivors' long-term health issues are managed as they navigate from cancer-focused to ongoing survivorship care.
Dr. Fumiko Chino: What a great and thorough answer to that question. I love the idea that you took the kernel of your own experience and then translated that into an entire career to try to improve the lived experience of cancer survivorship and outlined so many key friction points that survivors really face when they transition into this long, hopefully, road of survivorship.
Jeff, I think I've known you since the entirety of the eight years you've been at ASTRO, and I immediately thought of you as the perfect guest for this podcast focused on improving head and neck survivorship communication, as you are a communication specialist. Do you mind speaking a little bit about your role within radiation oncology and then how this became both the best and the worst background to have when you were yourself diagnosed with cancer?
Jeff White: Sure. Yeah, as you mentioned at the intro, I've been with ASTRO for about eight years and was brought in to kind of elevate the specialty as much as possible, either through media relations, social media, and partnerships and other things like that. When I came to ASTRO, a lot of people were saying to me like, "Wow, how are you and why are you working in cancer every day? Like, that's pretty heavy and that's pretty intense." And my answer was always, "You know, cancer is not really an issue within my family." So I didn't feel a huge connection. I was concerned about health care and access and things like that, but I wasn't really personally connected to it. So I thought, you know, I've been working day in and day out reading about cancer, understanding the different types of treatments for the different types of cancers. There were a couple of moments, and I distinctly remember working with Dr. Paul Harari when he was the ASTRO president, who happens to be a head and neck cancer specialist. He was talking me through kind of the whole process for treatment, and I distinctly remember saying to myself, "I don't ever want to get head and neck cancer. That looks pretty rough."
The irony is that here we are in 2023. I had a lump in my neck right after I had a physical, so I'd gotten all my... everything was good, my blood work was clean. And just this random lump appeared one day. So I went to my primary, and he was immediately concerned, "I think that you should go get it biopsied." And so that kind of started me down the path.
The good news was is that when I had the lump examined, it was a benign cyst. So I breathed a sigh of relief, and the doctor was like, "Great." He's like, "If you want to get it removed, you might want to go see a surgeon." So I kind of casually made an appointment to see a surgeon just to kind of get this little annoyance removed. And within two minutes, the surgeon was like, "I don't think that's what that is." He's like, "I think you have tonsil cancer." So that kind of started me down the path to kind of learn more about it, and obviously was biopsied and it was confirmed that it was cancer.
You know, that just took me down a whole path that I wasn't prepared for in any sort of way. I knew enough to be scared, but I also had no concept for what it really was until I kind of experienced it myself.
Dr. Fumiko Chino: I know you're so well integrated into radiation oncology through your role within the society. Do you feel like that gave you a leg up, at least in terms of getting a second opinion or facilitating the actual care?
Jeff White: I was able to connect with a radiation oncologist right away. I initially was told it was going to be three weeks to get a biopsy, and I just about fell apart because that was like... I couldn't possibly wait that long. So I will... you know, that was a blessing to have a connection in that respect. But I did, I shopped around. I live in Washington, D.C., so I am very fortunate that I have access to three top-notch facilities within a pretty close radius. I recognize that not every patient has that, but I was able to kind of find a place that kind of worked for me, that I felt comfortable with the team, I felt comfortable with the machines that I was going to be interacting with.
I also distinctly remember being in a waiting room looking at the patient materials, kind of reading it and thinking, "I've got to use this experience for good. Like, it's the only thing that could kind of calm me down a little bit because I was so panicked." And I thought, "I've got to use this as a learning experience and something that I can share with other people, and that might make this whole odyssey feel like there's a purpose to the whole thing."
Dr. Fumiko Chino: That's a lovely sentiment, the idea that you would use your lived experience to try to improve knowledge and education for other patients down the road once you got through it yourself.
Now, Talya, just to feature a little bit on the actual manuscript, do you mind giving us an overview about what you did, what the HN-STAR trial found, and what are you excited about in terms of the next steps?
Dr. Talya Salz: The goal of our trial was to improve the management of late effects for people who had finished treatment for head and neck cancer. As you talked about before, people with head and neck cancer can experience many ongoing challenges after treatment's complete. It's really sensitive anatomy, and there can be really aggressive treatments that can cause challenges with eating and breathing, speaking, movement, not to mention ongoing distress, fatigue, insomnia. There are comprehensive guidelines for the care of head and neck cancer survivors which include recommendations for monitoring and managing more than 20 of these late effects. The problem is integrating these recommendations into clinical care, and it may be hard to identify all the relevant concerns that survivors have and then manage them in a brief clinic visit.
We've learned from research among people undergoing active cancer treatment that asking people about their symptoms with standardized surveys, what we call patient-reported outcomes, can improve their symptoms, their quality of life, their communication with their providers, and even survival. So my team hoped that we could use patient-reported outcomes in the post-treatment setting for head and neck cancer.
To do this, we developed a web-based interface so that head and neck cancer survivors could complete surveys online, these are the PROs, about their symptoms before routine oncology visit. Those survey responses were used to identify concerns that reached a threshold that we deemed burdensome. We used that information to personalize a clinical decision support tool that the oncology provider could use in clinic on a computer or on a tablet. The clinical decision support tool presented each health concern and how burdensome it was to the oncology provider, and the provider could click on any of the concerns to see the guideline-based recommendations for management, whether the management was further testing, referrals to other providers, medications, or self-management.
There's more to the web-based tool. This tool is called HN-STAR, but those are the pieces of HN-STAR that are relevant to today's discussion. We hoped that when oncology providers used HN-STAR, clinic discussions could focus on relevant symptoms and concerns. Basically, the goal was to streamline and tailor care based on survivors' concerns.
In our trial of HN-STAR, we randomized 28 community oncology practices to either use HN-STAR or to provide usual care to head and neck cancer survivors in their practice. We enrolled 357 survivors at these practices. Survivors in both arms were asked to complete PROs for 26 concerns prior to a routine post-treatment follow-up visit, and after the visit, survivors in both arms were asked which concerns were discussed in clinic.
What we found was that these were very symptomatic patients, with an average of seven and a half burdensome concerns. In both arms, an average of five concerns were discussed in clinic regardless of whether the survivor reported the concern as burdensome. However, in the HN-STAR arm, an average of four of survivors' burdensome concerns were discussed compared to an average of three burdensome concerns that were discussed in the usual care arm. So importantly for survivors in the HN-STAR arm, 59% of their burdensome concerns were discussed in the clinic visit compared to 45% of burdensome concerns for survivors in the usual care arm.
This means that clinic discussions did not have a broader scope. The same number of concerns were discussed, but the discussions in the HN-STAR arm were more tailored to salient survivor concerns. This is not actually the main endpoint of our trial. We hope that these more tailored clinic discussions translate to improved care and improve health-related quality of life after a year, and we're still collecting these data. But we think it is really promising that this clinical decision support tool can streamline discussions between providers and head and neck cancer survivors.
Dr. Fumiko Chino: Now, Jeff, I would really love your thoughts on this trial and then about your own, sometimes maybe bumpy, transition into survivorship. So for example, what has worked for you to facilitate good conversations with your oncology team? And I would imagine given your active role within cancer education and communication that you actually have a leg up on some other survivors, but I would also still guess that there's a lot of opportunities to improve.
Jeff White: Oh, you'd be right on that. So the one thing that popped into my head as you were talking about this, Dr. Salz, was the timing of this. It really... getting my input or getting a patient's input at a certain point within the timeline is important, and it also... I like the idea that I could do it on my schedule versus feeling the pressure of being asked a question in person at the appointment because there's a lot of anxiety. You want to get the appointment over with, but like, if you have the time to really think through like, "You know, this actually is more problematic. I do want to kind of talk about that." I think that's very important.
I'm a communicator by nature, and so I feel pretty comfortable sharing. Plus I knew my doctor before I became his patient. But I will also be honest that I was hesitant to do too much research into what was going to happen for me long-term. I was overwhelmed, and I could only take in so much information, and that even included looking at my scans. And one of the things that I appreciated the most from my radiation oncologist was he was going to show me a scan after a PET scan, and I immediately froze because I did not want to see my body on that screen. And before he turned the light on, he said, "Do you even want to look at this?" And I said, "Nope. I don't. I really don't. You can talk to me about it, but I can't handle it." I just appreciated that he had the sensitivity to ask me that question because had he not, I would have been forced into a situation that I probably would have kind of fallen apart a little bit to see dark spots, you know, within my body and things like that. So…
The other thing I will say is that I didn't do a lot of  research, as I mentioned, kind of post-treatment of what to expect, so it actually was kind of a surprise to me the troubles I was having with swallowing. I literally just came from the doctor's today because I have these neck spasms. You know, I'm about 2 years out but I have these fibrosis issues and things like that. I can only take in so much content a time before I get overwhelmed.
 
Dr. Fumiko Chino: Do you think that the information that you were given, much less the information that you did or did not research for yourself, but that what was given to you was actually sufficient to help prepare you for survivorship?
Jeff White: I'm going to say 'no'. I went to a number of different facilities for surgery at one place and radiation and chemo at a different facility. I was looking to see what sort of education they were going to give me because I was curious, like, what do patients get? I knew what I had access to, and I was a little surprised at how little I was given. There was some talk about things. I will say that especially, I'm going to say on the surgery side, they kind of breezed through the bad stuff very quickly, verbally, and that was it. If I missed it, I missed it. On the chemo side, I was given a multi-page document that I actually did read before it all started because I didn't know much about chemo, so I did read that. And then obviously on the radiation therapy side, you know, I knew enough to know kind of what was happening.
But I also chose to take it day by day. That just worked for me. I just was like, "Today is Tuesday. This is what's happening today." Because I couldn't think about... you know, and this was Day 7 of 33, and I just kind of went day by day by day and just took it as it came.
Dr. Fumiko Chino: I appreciate what you said about the idea that the provider really needs to tailor the level of information and the delivery to the patient, right? Which is you got... he got the signal that you did not want to look at your PET scan just either by non-verbal communication or by the look on your face. He said, "You know what? We'll skip this part." And again, I think that is a really important part of the cancer survivorship, treatment survivorship journey.
Talya, a recent JCO OP article, other than your own, from your colleagues within MSK used a patient portal document to try to elicit patients' core health-related values to better inform medical decision making. Amongst other things, they found that almost all providers found that the answers, when they were available, were quote-unquote "worth the time to review," although less than half, 42%, found them always or often helpful. And I'd actually love your perspective on this because one of the key points of improving how we implement patient-reported outcomes is that providers need to actually respond to them and change their behaviors.
Dr. Talya Salz: Yes. I have two thoughts about this. I love this study because it actually integrated this assessment of values into clinical care to see how it was used in practice. And this value assessment is another version of a PRO, just like we used in our study, and it was used to inform an upcoming clinic visit. There was a built-in use for it. And actually, just to make the point, in our study we didn't just provide the PROs to the providers; we actually gave them some actionable information, and we'll see in future analyses whether they used it.
The second point about this is that feasibility is a huge piece of this puzzle to improve patient-centered care. Patients have to complete the PROs, and they're sick, they're busy, they're inundated with surveys, they're inundated with other forms, billing, etc. And then at the same time, oncologists have to use the information. They can find the information valuable and helpful as these providers did, but they have their own constraints. Their clinics are busy, and having something be worth the time spent is a real struggle. So if a new process isn't woven into the workflow, it's unlikely to change care. So new processes have to be considered worthwhile and made easy to use. Implementation science, which is research to understand how we can implement research findings into practice, is really critically important here when we think about making changes to care delivery.
Dr. Fumiko Chino: Absolutely. We can't just do a study and then just assume it's going to happen because time and again, decades of research has not translated into actual benefit to patients if not implemented. So 100%.
Jeff, there was a recent JCO OP Art of Oncology Practice piece called "Patient Empowerment through Shared Decision-Making," and it speaks about the balance of, and this is a quote, "between beneficence which can be paternalistic and patient autonomy that requires a carefully crafted art." And I obviously think we still need to improve tailored communication within oncology to talk about the things that actually matter to patients, not just what we think is important as providers. This was one of the highlights for the HN-STAR intervention to me; it really helped facilitate those patients discussing the things that mattered the most to them.
Jeff White: Yeah, I actually really loved that study. I felt that the empathy that kind of came through in that piece was really impressive. And, you know, I 100% believe that each of my physicians, you know, had nothing but empathy for me. But they also were seeing multiple, multiple, multiple patients per day. And there was a line in there that really resonated. It said, "Cancer wreaks havoc on human lives." And I can't... I mean, I'm going to get emotional because it's like... that is so incredibly true. It throws everything in your world off, and you feel completely out of control. The next line said something, "but we can afford some control."
I have kind of reflected on like my anxiety levels which were extremely high in the process of getting the diagnosis and figuring out the treatment. Once I was in treatment, I think my anxiety went down a little bit because I was actively doing something and I was actively, you know, seeing doctors every week. Once I finished my radiation, my radiation oncologist was like, "Okay, see you later. You're going to now meet with the nurse practitioner." And I was like, "What? What do you mean? Like..." That was really jarring to me. And, you know, as much as I loved her, I was like, "What do you mean? Like, I'm still struggling here." And the struggle was real for many, many months. I didn't feel as prepared in that respect for kind of what was going to happen in the weeks and months afterwards and the anxiety of waiting for my first post-PET scan.
I don't think I answered your question in any way other than to say that like, I feel like there are so many different touch points for the patient to kind of check in and kind of see how they're doing. And I felt connected to my team, and I'm obviously not a shy person, so I was sending messages through the portal even just saying like, "I'm really struggling here. You know, this is way harder than it was... you know, was presented to me. Like, these mouth sores are no joke, man. Like, that was rough."
Dr. Fumiko Chino: Did you feel like you had to advocate for yourself to get speech therapy, occupational therapy, to see the right specialist to treat your ongoing concerns?
Jeff White: I was lucky because I was at a cancer center that was multi-faceted, so I had access to... I even had access to mental health support. At first I said, "No thanks, I'm good." My best friend is a therapist, so I felt like I had a person that I could kind of talk to. But after a while I was like, "You know what? I think I need to talk to an outside, like, third party that, you know, doesn't know me to kind of help process all this." And so I do feel thankful that I had access to acupuncture and massage and all that, you know, lymphedema treatments and things like that. I didn't know I was going to need all that, but it certainly is something that I've used over the last months and year.
Dr. Fumiko Chino: Now in survivorship, do you know the full span of what we can do, and +/- how it could help you? Because I've actually talked to some survivors that are like, "I didn't even realize that there was a sexual health specialist that I could have talked to about my ongoing concerns, because no one ever thought that my treatment for X cancer could affect my sexual health or my whatever."
Jeff White: Well, what have you heard about me? What has my partner told you? No, I'm just joking. I do feel like the cancer center I went to is so comprehensive and there was a range of services that I could tick off if I was interested. So, I do feel thankful for that. I also remember that, when I was undergoing radiation therapy, I was the only head and neck cancer guy. It was all prostate cancer. So in our little men's waiting room it was me and like 6 guys that were all undergoing prostate cancer treatment. And so we kind of built a little cohort in that respect.
The other thing I'll say is that I didn't realize the online community was so strong. I did actually have access to a support group through the cancer center that didn't work for me. It just wasn't... these were people that had very severe post-treatment issues, and I, you know, was just like a little newbie and they were like, "We don't have time for you." Like, "We've got bigger fish to fry." But Reddit has been amazing. So I locked into Reddit post-treatment, and I kind of wish I'd known about it while I was in treatment because it's patients talking to each other. No one's pretending to be a doctor. There's no fake stuff out there. There's no misinformation. And it's really people that are like, "I have the, you know, I have this similar cancer and here's what kind of worked for me." So I've been pretty active on there in the last year.
Dr. Fumiko Chino: I love what you brought up, this idea that the communities can be really tailored to the individual, how they best receive information. So for an online community that worked better for you than like the quote-unquote "authorized" patient support group. And what works for one person may not work for another person. So I think it actually harkens back to the trial, which is that, hey, patients should actually say "This is the thing that bothers me most. Can we talk about this?" Because for some people it might be neck spasms, for other people it might be dental caries, and for someone else it might be how they look and feel about themselves.
We are at the end of the podcast. I do want to leave a little bit of space for anything that you feel like we haven't covered yet. If we want to talk about surveys, if we want to talk about the community site research NCORP of it all, because I think there's a lot of opportunities to think about, for people who can't be treated at cancer centers that have all of the bells and whistles. For community practices, how do they actually improve survivorship care? I'd love to just open it up. Any last thoughts?
Dr. Talya Salz: I was thinking about what you said, Jeff, in terms of all the opportunities that were available to you at your cancer center. And I also come from a... work at a cancer center where all of these services and opportunities are broadly available, at least they're in place whether or not people use them and can afford them. But it was really important to our team that we make sure that our intervention works for people in community oncology settings.
And we worked with the NCI's Community Oncology Research Program, or NCORP, through the Wake Forest Research Base. The NCORP is dedicated to enrolling cancer patients who are treated at community oncology practices across the country into clinical trials, including cancer care delivery research trials such as the one that we did. And it was really important to us to be able to create a tool that would work in these settings. There was a real range of services that are available at these community oncology practices. I mean, some of them did have mental health services on site, some of them did not; speech and swallow rehabilitation therapist - some sites have them, some sites do not. And so it was a real challenge building a tool that could be flexible enough that providers could select options that were realistic for their patients. So I'm really grateful we had the opportunity to work with them. It was a great experience, and we ended up with a pretty racially, ethnically diverse group of cancer survivors, including a significant minority from rural areas of the country too. That was a real strength for us.
Dr. Fumiko Chino: I would be remiss not to mention that NCORP is funded by the NCI, and the research that comes out of NCORP is not possible without strong federal government funding, which is the thing that is exactly at risk right now in the current restrictive funding environment.
Dr. Talya Salz: I hope that my vocalizing my support while you were talking did not get in the way, but that is extremely important that this kind of research continues to be funded by the NCI and actually the American Cancer Society funded a lot of this research as well.
Dr. Fumiko Chino: Thank you so much for this amazing conversation today. Many thanks to both Dr. Salz and Mr. White, as well as our listeners. 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 hope your winter is warm and bright.
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
 
Talya Salz
No relationships to disclose
 
Jeff White
No relationships to disclose

Dr. Chino talks with Dr. Navneet Majhail and patient advocate Laurie Adami about CAR-T therapy, an advance cancer treatment that biologically engineers a patient's own T-cells to recognize and kill cancer cells. This discussion will be based off the JCO OP article, "Outpatient Administration of Chimeric Antigen Receptor T-Cell Therapy Using Remote Patient Monitoring," on which Dr. Majhail served as lead author.
TRANSCRIPT
Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an associate professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.
CAR T-therapy is an advanced cancer treatment that biologically engineers a patient's own T cells to recognize and kill cancer cells. It has shown remarkable benefits, leading to long-term remission or even cure for select patients with hematological cancers that have not responded to other treatments. Primary trials were exclusively conducted in the inpatient setting due to high risk of quick onset and life-threatening toxicities requiring close monitoring and immediate treatment. Advances in symptom monitoring and care delivery have allowed the introduction of outpatient CAR T, which is cost saving and more patient centered. I'm happy to welcome two guests today to discuss this promising operational shift.
Dr. Navneet Majhail, MD, MS, serves as the Physician-in-Chief of Blood Cancers at the Sarah Cannon Cancer Network, where he oversees 10 transplant and cellular therapy programs that collectively perform over 1500 transplants and cellular therapies each year. He is the first author of the JCO OP manuscript, "Outpatient Administration of Chimeric Antigen Receptor T-Cell Therapy Using Remote Patient Monitoring," which was published earlier this year.
Ms. Laurie Adami was President of the LA-based Interactive Data's Fixed Income Analytics Division when she was diagnosed with stage four follicular lymphoma at age 46. From 2006 to 2018, she was in continuous treatment and received multiple lines of therapy, including three clinical trials. In 2018, she received treatment number seven, a clinical trial of Kite CAR T-therapy. Thirty days later, she was in complete remission, where she remains today. She is an active patient advocate and legislative policy advocate for several not-for-profits.
Our full disclosures are available in the transcript of this episode, and we have already agreed to go by our first names for the podcast today.
Navneet and Laurie, it's so wonderful to speak to you today.
Dr. Navneet Majhail: Thank you. Looking forward to this conversation.
Laurie Adami: Thank you, Dr. Chino. I guess I'm supposed to call you Fumiko. Great to be here today. Great to be alive, first of all, and great to be here on this call. Thank you for having me.
Dr. Fumiko Chino: I think with everything you've gone through, Laurie, we all go on a first name basis.
Now, Navneet, do you mind starting us out with a short history of CAR T in the US, including the side effects and the precise care delivery needs that were the initial reasons why care was limited to the hospital?
Dr. Navneet Majhail: So, Fumiko, you laid an excellent background as to why these therapies are done in the inpatient side and what they are. I mean, it's really exciting, right? These are what we call transformative therapies in oncology or medicine as a whole. You're taking patients with very, very advanced diseases who traditionally would have gone on to hospice, where you can potentially put around half of these patients into very deep remissions, and maybe some of them might be cured of their underlying malignancies.
Now, having said that, as you alluded to in the introductions, most of the trials early on were focused entirely on the inpatient space for a few reasons. One was the unknowns. These were early therapies, unknown side effects, you needed to have that monitoring. The second, some of the very early work that was done with these therapies, it was clear you can have some potentially severe and fatal side effects, like cytokine release syndrome, what we now call ICANS, or immune effector cell-associated neurotoxicity syndrome. You have issues such as HLH, hemo-phagocytic lymphohistiocytosis. These are some really fatal, potentially fatal and severe side effects, which really needed close monitoring on the inpatient side.
As things have evolved, obviously we've gotten smarter at selecting patients. The constructs have improved as well, where the incidence and the severity of these toxicities has gone down. And as we become smarter overall, both from a supportive care, patient selection and technology perspective, certainly there are opportunities now for us to look at delivering these care where patients can access these therapies better.
Dr. Fumiko Chino: That's a wonderful summary, and I know at this point, I believe over 300 sites are Foundation for the Accreditation of Cellular Therapy accredited to deliver CAR T-cell therapy. So, we really have gone very much into the space where we're trying to expand access to these therapies.
Now, Laurie, I know that your CAR T was in 2018 on a phase two trial at UCLA, but your treatment started in 2006. Do you mind walking us through what that was like for you? How did it go? What was required in terms of travel, time, for, I know, again, just not just yourself, but also your family, and it's through the treatment and then also the recovery? I'm presuming that you had to be in the hospital, for example, for your CAR T for at least a week, if not longer.
Laurie Adami: Yeah, I was diagnosed in 2006 and spent 12 years in continuous treatment, all in Los Angeles where I live. When I did my CAR T, I was also in Los Angeles, so that made it easier for me, as well as my family, because when I went in for CAR T, I was just at the UCLA main hospital, which is about 20 minutes drive from my home.
The process for 12 years was difficult at every level, both physically as well as emotionally and mentally. My son was only in kindergarten when I was diagnosed, and I was given horrible statistics up front in terms of my survival likelihood, but I was determined to stay alive, and thankfully for me, I was able to get into CAR T really at the end. And like Navneet said, I would have been going to hospice if the CAR T trial hadn't opened because I had literally burned through six other treatments, none of which worked.
Dr. Fumiko Chino: It's truly a transformative treatment, and I can only imagine that for you yourself, the burdens must have been immense. I know that you were an executive flying, it sounds like around the world. How did that change your life?
Laurie Adami: So I lost my career as a result of my illness because it was clear after my first relapse, after the only treatment that existed at the time, which was 19 years ago, that this was going to be a battle that wasn't just going to go away. And so, I was really seeking things constantly, and I would do a treatment, it would fail right away. It was really, really difficult at every level. So I had to go out on disability from my work, and then I was never able to go back, because by the time I finally got CAR T, then COVID hit, I couldn't start traveling around the world with my special immune system. Yeah, it was costly at so many levels, but thankfully, thanks to science and all of you doctors on this call for administering these therapies, I am so grateful to be alive.
Dr. Fumiko Chino: Well, that segues really nicely in terms of the next advancement of science, which is to take CAR T out of the hospital. Now, Navneet, do you mind giving us an overview of your JCO OP article, outlining key considerations for outpatient administration of CAR T, so discussing things like remote patient monitoring and what is really required in terms of the investments from the cancer center?
Dr. Navneet Majhail: Certainly, Fumiko. At the end of the day, as we considered moving these therapies to the outpatient setting, there were two big problems we were trying to solve. One was the capacity issues. I mean, again, we've had increase in the utilization of these therapies, at least across our network, at the rate of like 15 to 20% per year, right? So that's your trajectory where it's heading, and there's a lot more indications coming down the road, and there's no way our health system or any other health system in the US has enough beds on the inpatient side to accommodate this, right? So one was, how do we address the capacity issues that are happening today and that we foresee happening in the future in an innovative way? And the second was, how do we make this therapy more financially sustainable? These are expensive therapies, just by the cost of the product and the care that's given around it. And the more we can do this in the outpatient setting, the less we use inpatient resources, everything that comes with the hospital stay, and would certainly make this more financially sustainable.
And I think as we think about moving this to the outpatient side, of course, across our network and for any other place that's considering it, a big component is patient experience and patient safety, right? Because as we discussed early on, there are some potentially really lethal toxicities that are associated with these products. They've gotten better. They are seen less often, and it's not very often that we see those severe toxicities, but they can come up very suddenly. We've got to make sure that you've got the pathways and everything else in place to manage those patients in a safe way.
So, we have a multi-site network. We currently have 10 centers that are a part of the Sarah Cannon Transplant and Cell Therapy Network. It's physician driven, and what we do is we like to standardize things as much as possible, so all sites can do the same thing, and we can monitor outcomes, data, and what's happening to patients in that context. So, where we ended up with is using a remote patient monitoring platform to essentially care for these patients in the outpatient setting. It's actually a pretty cool technology and a cool thing our teams came up with. I'm talking about this, but to be honest, I cannot take any credit for what our teams have done.
At the end of the day, we currently have a contract with an organization called Current Health. So, they have these kits, which include a remote patient monitoring device. It's an FDA cleared device, and it's essentially something that you slip onto your arm. It's a small, round, an inch-wide monitor. And what it does is it sends data on your vitals, your temperature, your pulse ox, your pulse rate, a whole variety of things, through Bluetooth technology to a central command center that's manned by trained nurses. And what we did was we worked with Current Health to essentially come up with the algorithms for what is a true indicator, potentially true indicator for complications like CRS, right? So if you're sleeping at night, guess what? Your pulse rate goes down, right? If you've just come back from a run, you'll be tachycardic, right? So if you're sleeping with three blankets on you, your temperature will go up, right? So how do we come up with these algorithms which take out the noise and really help us focus on what might be potential CRS? And I'll confess, we are always working to refine these algorithms, make them better as we go forward.
Once the nurse sitting in that central command center identifies a potentially true alarm, then we work with them to come up with the triage pathways and the clinical pathways for management so that the patient is triaged to the right care at the right time. So if they end up in the ER, what are the pathways for the ER to give tocilizumab very promptly, right, within 60 minutes of showing up there and so forth.
So that is what we have developed across our network from an outpatient care platform, and what we've seen in this context is that we still have around two-thirds of our patients who end up getting admitted in the outpatient setting. So we typically start as a start with the lymphodepleting chemo, and we'll keep it going through at least day 14 after the infusion of the CAR T-cells. And during this time period, around two-thirds of our patients will still end up getting admitted because with the slightest fever, we don't want to take a chance. We'll triage them quickly to the ER or the hospital. But then the median length of stay was only four days compared to our historical data where, as you can imagine, we would keep these patients in for a median of 16 days. So that's how we are managing these patients as we go forward. And like I said, we are doing a lot of research to see how can we make things better, how can we manage some very, very early CRS in the outpatient setting, for instance, and how can we keep refining the alarms and so forth?
Dr. Fumiko Chino: That sounds amazing, and it sounds like it's truly something that would not have been capable without some more advanced technologies in terms of remote patient monitoring. So we're truly galvanized by our technologies, telemedicine has really revolutionized, at least during COVID. So I'm assuming you're capitalizing on some of those advancements.
Dr. Navneet Majhail: We certainly are, and one of the interesting things I'd like to share, and maybe Laurie can comment on this or may validate this, right? So we collect the survey data, and we talk to the patients about their experience. And one interesting thing that came across these conversations was the fact that many patients and their caregivers felt more secure that there was someone potentially watching them 24/7 for these alarming signs. As you can imagine, as these patients come in, we scare them, right? "Hey, this is very, you know, innovative therapy. This might fix your lymphoma or myeloma, but hey, what, I mean, you got this bad CRS, you know, X number of people will die because of CRS and severe ICANS where you may get seizures and whatnot. But yeah, go home and sleep over it, right? So you can go home, you can stay in the outpatient setting, and come back tomorrow to see us, right?" So it was very interesting to us, that theme where patients felt that, okay, they had a level of reassurance that there was someone watching them. And that to me was very interesting as we collected that data together.
Dr. Fumiko Chino: Laurie, is that something that you've heard of from other patients, at least treated in the outpatient setting?
Laurie Adami: So I have not actually spoken to a patient who's had the monitoring on them. I've spoken to numerous patients who've done it outpatient and have been very scared, and their caregivers have been even more scared, because you know, not all caregivers are created equal. Some of these patient populations are older, and you know, there can be confusion. So, you know, I think the fact that these monitoring devices are going to become available will be immensely helpful, not only for the patient's well-being, but for their caregiver who's right now on the hook. If they fall asleep and miss the patient spiking a fever, I mean, this is the scary stuff. So, I think this is fantastic. I do wonder how you manage, how you figure out the ICANS part of it, because I know the symptoms you're talking about are primarily CRS. So does the monitor do anything that can gauge the mental activity or no?
Dr. Navneet Majhail: We are spot on that the monitoring is mostly focused around CRS. Now, for example, our program here in Nashville, the process we've set up is, so the kit that the patients use also has a tablet, through which you can have a video conference capability, right? So the process that we've set up here at the Nashville program where I practice is that one of our nurses will do a video call at 8:00 p.m. And again, I mean, you can imagine, I emphasize the team effort because you've got the outpatient clinic team, they'll have patients, as you know, there's a whole assessment that patients do, where they write their name, you know, a sentence and, you know, everything else. And at the end of the day, all that is basically passed on to the nurse who's on at night to do those assessments for patients. And around 8:00 p.m. or so, she'll or he'll connect with the patient through that video conference capability. They'll have them write that sentence and then show it on that video to see what it looks like. And then he or she can compare as to what it was 12 hours earlier at 8:00 in the morning. So it is not around the clock ICANS monitoring, but at least patients don't go 24 hours or more before getting that assessed.
Dr. Fumiko Chino: No, that's so helpful to kind of have that clarity. And I love what Laurie said that patients and patient caregivers actually kind of want this, the idea that there's more eyes on them and they're getting this sort of continuous monitoring. So, it sort of meets the brief in terms of optimizing time at home, but also reassurance for patients and caregivers.
Dr. Fumiko Chino: Now, Laurie, I had watched your interview on The Patient Story, and you had said something I thought was quite striking. You had gone to four different large cancer centers for various treatments, that ultimately led to your cure with CAR T. Do you mind speaking about how access to specialty care can be really a barrier for patients? I know that you had said previously that you felt lucky to live in LA. And I'm assuming that's not just for the nice weather.
Laurie Adami: No, it's not. I'm from the Northeast, and I'm still a Northeasterner, but being in LA where I could get to so many care centers so easily within an hour was a real bonus for me. The other thing that I was lucky to have was good insurance. So I had PPO insurance when I was employed, and that allowed me to see specialists. And I talked to many, many patients now, you know, probably over 50% of patients get diagnosed in community oncology settings and/or community hospitals, and oftentimes those settings don't have specialists. So I speak to patients being treated at Kaiser where they don't even have a lymphoma specialist. And so they're not being given necessarily the best information about the available treatments, and they may never even hear of CAR T.
So, it's a real problem for a lot of patients to get to specialists, and unless you're seeing a specialist, you're unlikely to hear about these newer modalities of treatment, immunotherapies, small molecule drugs, CAR Ts, much less likely if you're seeing a general oncologist. They're not going to know about it. And what do they know about chemotherapy, auto stem cell transplant, and allo stem cell transplant, which is being done for over 50 years? And so I'm still speaking to many patients who can't get CAR T because their insurance either won't pay for it, or they live in a state where there are no CAR T centers, which believe it or not is still the case in the United States today. There's still a small number of states where you have to travel two or three states to get to a CAR T center, and you have to get a referral from your community oncologist, and there's no easy mechanism for that happening back and forth. And I'm working on a couple initiatives with some focus groups to make that better, but it's a real struggle.
And that's why I was lucky. I had good insurance, I lived in LA, I was treated at four big cancer centers, and within an hour, I could fly to San Francisco or San Diego to see more specialists. So it's really a function of when you're diagnosed, what is your insurance? What assets do you have? What benefits do you have? I speak to patients who if they don't go to work today, they don't get a paycheck. They can't miss a day to travel eight hours to go see a specialist. So there's a real problem with access in the United States and a real problem, I think, with bifurcated health care.
Dr. Fumiko Chino: I love that you have used the privilege that you did have, even in the context of a stage four diagnosis, and then used that energy that you kind of came out of it to continue to advocate aggressively for other patients. So I, you know, I applaud you a thousand times for that.
Now, Navneet, can you talk about the access barriers from the provider perspective? I know that you had mentioned capacity building in the OP paper and about how outpatient treatment facilities programs development in the community oncology practices could certainly help ease some of these geographic barriers to care that Laurie just so eloquently brought up.
Dr. Navneet Majhail: So, Fumiko, to put this into context, let me start with some numbers first. So if you look at the number of patients in the United States who can potentially benefit from a CAR T-therapy for the currently approved indications, one in five patients gets it. So I'll let that sink in. Despite all these transformative therapies we've talked about, only one to in five to one in four patients who needs a CAR T-therapy will get it. And some of the research that we have done and others have done, once you get to a treatment center, right, so once you get to a treatment center - so you've bypassed all those geographic, insurance, many of these other access barriers to a CAR T-therapy - once you get to a treatment center, two out of the three patients will end up getting an infusion or treatment. So there's still a third of these patients who will not get an infusion once they hit a CAR T center, mostly because their disease is too advanced by the time they show up. So these are the high-level numbers that put into perspective what the delta is, right? What the gap is that we need to solve as we go forward.
So now, as you think about the access barriers, I think Laurie, you were spot on some of the education gaps across many of our colleagues in the community where they may not be aware of the indications, the advances, and the opportunities around CAR T-therapy. So, obviously, I think that's a big issue. Even on the provider side, even though they are patient-centric access barriers, I mean, we feel it too, geography, trying to get patients into see us, right? Some of the insurance barriers you talked about, I mean, the health disparity issues that I think Fumiko, you're very familiar with. And as you can think about a therapy which is expensive, is limited to select sites, all those access barriers that we face across oncology just get accentuated. They get multiplied.
As we think about the community practices, as, and you're spot on, I mean, how do we increase access? A big opportunity is getting these to the community sites. I think provider education is a big one. The capacity pieces, how do we build capacity is a big one. And I think the third one is what I call the economics of care delivery. What that means is not just the cost of these therapies, but things like the infrastructure that needs to be built up, the people you need to hire, train, get to a good place, all those pieces, apheresis, for example and so forth. And then all the reimbursement, revenue cycle pieces that as a practice you have to deal with. So these are some of the barriers at the community practice levels people feel as you consider accessing these therapies.
Dr. Fumiko Chino: Absolutely. You know, Laurie, did you have anything to follow up with that?
Laurie Adami: I just wanted to comment on this financial issue because I know Navneet talked about the high cost of these therapies, which is completely valid, but if you look at the treatment that I had prior to my CAR T, I had over $3 million in costs billed to my insurance. That was before CAR T. So, one of the therapies that I was on in a clinical trial, where I was actually the long tail in the trial, was a PI3 kinase inhibitor trial that I was on for almost six years. And while it never got rid of my cancer, it bought me stable disease. I stayed on that pill for almost six years. It bought me stable disease to allow me to get to CAR T. But that drug got priced for $180,000 a year, and I was on it for six years. Right there, that's almost $1.2 Million.
So, I think if you look at the alternatives, you find out that really CAR T is not, I mean, yes, it is expensive, for sure, but you know, if you look at something like an allo stem cell transplant, which was being tossed at me over the 12 years as an option, that's far more expensive than CAR T, because not only is it a very long time in the hospital - they were telling me to expect up to three months in the hospital - but then a lot of patients have terrible graft-versus-host disease, so you spend the rest of your life in medical care. So, I just wanted to raise that point, and to the extent we can reduce the hospital costs by taking these treatments to patients outpatient, that will be a huge benefit, because that can be half of your cost in hospital stays. When I was in the ICU, I think it was $38,000 a night for one ICU night. So these hospital stays are very costly. But I did want to just point out that it's kind of painted as black and white, so expensive, but I think we have to contrast it for all the other options patients are getting. You know, if you're on a drug for many, many years, a small molecule drug, those drugs are very expensive. And if you can do a one time, one and done, you're far better off financially.
Dr. Fumiko Chino: Absolutely. And I think, and this is not to put it in such stark terms, but I'll say this as a cancer widow, dying in the hospital is very expensive, and it is a terminal diagnosis and then in the ICU, we're talking about incredibly expensive and by definition morbid and mortal. So if we're saving lives and creating cures, that's a high-value proposition.
Now, Laurie, it is very clear that you're a very engaged patient, and I know you've spoken before about how you were very active in your care in terms of researching new treatment options, going to clinicaltrials.gov. Can you speak a little bit from your experience both as a patient and an advocate about how access and knowledge has improved a little bit over time? For example, the Leukemia and Lymphoma Society was recently renamed to the Blood Cancer United, but I know they have a clinical trial support center, and I know that you have played a role as a peer mentor for some other patients, so I would love to hear more about that.
Laurie Adami: Sure. Yeah, so when I was diagnosed 19 years ago, there were very few tools, and it was really a struggle for me to get information. And yes, while I use clinicaltrials.gov, I found it was full of false information. It wasn't updated promptly, and I was very concerned, and then I found out the FDA didn't approve what goes into clinicaltrials.gov. So there's a lot of junk in there. And when patients say, "Oh yeah, I'm looking at clinicaltrials.gov," I'm always encouraging them to reach out to a nonprofit that is focused on their area because that's the best place to get valid information.
Now, the problem is most people don't know about nonprofits because outside of the American Cancer Society and Susan Komen, very few nonprofits spend any money at all advertising because their mission is to cure the disease they're focusing on and to make sure patients get the financial help they need. So the money that they're raising is going to research and helping patients. So you don't see advertisements on TV, "Oh yeah, if you need to find a clinical trial for pancreatic cancer, call PanCAN Action." You just don't see it.
So I had to figure that out on my own, and now it's amazing what organizations like LLS or Blood Cancer United are doing because you can call them, and I've called on behalf of many patients, I've provided all the pathology information and the treatment history. Within 48 hours, they return a list of all the trials that you qualify for in whatever geographic region you request, and it's at no cost at all. And Blood Cancer United will actually call - I just hooked a patient up with a trial at the National Institutes of Health, thankfully a trial that didn't get shut down yet - and they actually called on behalf of that patient to make sure that they were still accepting enrolling patients.
So that's something that I think most patients don't know about, and I wish physicians, when they diagnose their patients, I wish physicians would provide resources. You know, "You should reach out to Blood Cancer United or Lymphoma Research." But the problem is most of these big academic research centers are also doing their own fundraising. So they don't really want to connect you with another nonprofit that's raising money. So it's kind of a conflict a bit. I mean, I know they want to do the best for patients, but they're restricted in terms of what kind of information they can hand out to the patient. And I've always wanted to put like pamphlets in my oncologist's office because when you get diagnosed, no one ever expects to get diagnosed, and 40% of people in the United States are going to get in their lifetime diagnosed with cancer. So you are going to have that bomb go off, a lot of people are, and you don't know what to do. And if someone had told me back when I was diagnosed, these nonprofits have resources, reach out, there are support groups, there are patients you can talk to, it would have saved me so much time and aggravation, and I just had to figure it out on my own. And sadly, that's still the case in large part.
Dr. Fumiko Chino: I love this siren call to be an activated patient, but also for providers to really think about the full dynamic of care for the patient in front of you and to not be narrow in your institution, but to really think about what are all of the resources that we can marshal around everyone.
I do want to leave a little bit of space at the end if there's anything that you feel like we didn't cover.
Dr. Navneet Majhail: Yeah, again, I think, Fumiko, we're still evolving in the field. As we think about where the field is going, we'll have constructs hopefully in the solid tumor space. Autoimmune diseases are coming. We're all excited about that. But I think going back to the fundamentals, so how do we take care of patients well? It's not just the care that happens in the context of the first few weeks before and after infusion, but then how do you watch these patients lifelong to look for late effects, survivorship issues, and so forth as you think about it. And I know we didn't get a lot of time to talk about this, but especially since your focus was how do we take this to the community, a big piece is ensuring the quality of care these patients receive in the community. You mentioned FACT early on and its role in ensuring high-quality care, it becomes even more relevant in the context of outpatient care as we think about these therapies.
Dr. Fumiko Chino: Absolutely.
Now, Laurie, last thoughts from you?
Laurie Adami: So I did want to add that we talk about CAR T and all the risks of CAR T and the long-term follow-up because I understand it's a genetic tool, right? This is not just chemo pills coming off a factory line. This is using your own immune system, modified, etc. But I think we also need to remember, if we contrast it to the brutal treatments I had before CAR T - CAR T, I'm not worried at all about that. If I get secondary cancers down the road, because I was so heavily treated, and most patients as of right now have been heavily treated. They've had radiation, they've had chemotherapy. We know those cause secondary malignancies. All of my side effects have to do with my prior six lines of treatment, not with CAR T. So I just want to remind everybody that, you know, we look at this in a vacuum, but the old stuff wasn't so great either. And maybe we should talk about how these patients are doing after those therapies. Anyway, that was it.
Dr. Navneet Majhail: Laurie, I was going to say, thank you so much. I'm going to take so many of your quotes and enlarge them and put them in my clinic. You've been incredible.
Laurie Adami: Reach out anytime, and if I ever get to Tennessee, I'll come see you. I'll buy you dinner.
Dr. Navneet Majhail: Looking forward to that.
Dr. Fumiko Chino: I love the idea that every single provider will have quotes enlarged from a patient advocate who was treated for their disease site in their clinic, because if there's anything that we can learn outside of the science, it's from the lived experience of cancer treatment and survivorship. I want to thank you so much for this great conversation today.
Many thanks to Dr. Majhail and Ms. Adami, as well as our listeners. 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, 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
 
Fumiko Chino
Consulting or Advisory Role
Company: Institute for Value Based Medicine
Research Funding
Company: Merck
  
Laurie Adami
Stock and Other Ownership Interests
Company: Gilead, Merck, Pfizer and Universal Health Services
  
Navneet Majhail
Stock and Other Ownership Interests
Company: HCA Healthcare
Consulting or Advisory Role
Company: Anthem, Inc