There is often a disconnect in toxicity assessment between what is reported on clinical trials as being “well tolerated” and the lived experience of taking a treatment for patients. Toxicity minimizing language including “safe” and “tolerable” are subjective and can downplay quality of life limiting side effects from treatment. A recent paper published in JCO OP reported that less than half of phase 3 clinical trials had “complete” toxicity reporting including total adverse events, deaths, and discontinuation due of toxicity. Dr. Chino welcomes two guests to discuss patient-centered clinical trial design with a focus on side effect profiles of treatment.
TRANSCRIPT
Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.
There is often a disconnect in toxicity assessment between what is reported on clinical trials as being, quote-unquote, "well tolerated" and the lived experience of taking a treatment for patients. Toxicity-minimizing language includes words like "safe" and "tolerable." They are subjective and can downplay quality of life–limiting side effects from treatment. A recent paper published in JCO OP reported that less than half of phase 3 clinical trials had complete toxicity reporting, including total adverse events, deaths, and discontinuations due to side effects.
I'm overjoyed to welcome two guests to the podcast today to discuss patient-centered clinical trial design with a focus on side effects from treatment.
Dr. Ethan Ludmir is an Assistant Professor at MD Anderson Cancer Center with a primary appointment in GI radiation oncology. He is a prolific researcher on topics encompassing clinical trials, cancer outcomes, and the integration of biostatistics in oncology. He has a specific interest in improving clinical trial design, including designing patient-centered endpoints and complete reporting. He led collaborators in the manuscript that will frame our discussion today called, "Incomplete Toxicity Reporting and the Use of Toxicity-Minimizing Language in Phase III Oncology Trials," which was published earlier this year in JCO OP.
Stacey Tinianov is the executive director and co-founder of Advocates for Collaborative Education, a global advocacy organization uniting patient, research, and policy advocates through pan-cancer collaborations, basic and advanced advocacy education, and the sharing of leading practices to change the narrative in cancer outcomes. Following her diagnosis and treatment for early-stage breast cancer 12 years ago, Stacey has become a leading national voice for patient advocacy and empowerment via collaborative education, community building, shared decision-making, health data access, and person-centered design.
Our full disclosures are available in the transcript of this episode, and we've already all agreed to go by our first names for the episode today.
Ethan and Stacey , it's wonderful to speak to you.
Dr. Ethan Ludmir: Terrific. Thank you so much for having us, Fumiko. It's a pleasure to be here with friends and colleagues of many years to be able to talk about this important topic.
Stacey Tinianov: Yes, thank you. Delighted to be invited, delighted to be part of the conversation.
Dr. Fumiko Chino: Our specific topic today is toxicity minimization, either by underreporting or by language and framing that downplays the lived experience of treatment. Ethan, do you mind starting us off by telling us how you got interested in toxicity reporting and then briefly discussing what your study team did and the findings?
Dr. Ethan Ludmir: Absolutely. Thank you, Fumiko. I have the privilege and luxury of being able to present research that is 100% the brainchild and terrific work of colleagues and friends, including the first author, a terrific graduate student named Avi Miller; colleagues like Alex Sherry. So I think it's always important to acknowledge I'm here mostly for window dressing. They really did the lion's share of the work and really have reported this fascinating story.
Our lab works primarily on issues related to the optimization of clinical trial design and reporting. One of these key topics that has come up more and more over the course of time is how are we presenting toxicities? And so we gave this project the sort of cute name of "The Table 3 Fallacy." Right? When you present a clinical trial report, usually Table 3, just by the way things end up getting numbered, is generally where you find these toxicities. You see a massive Excel sheet of reported toxicities, and invariably it ends up kind of culminating in a sort of pithy couple of sentences saying, "Toxicity was manageable."
So we wanted to really drill down on this with sort of two features in mind. One of them was, how well are we doing at objectively reporting physician-assessed toxicity? And of course, that comes with the itinerant kind of limitation that all three of us have both written about and talked about, that is physician-assessed toxicities are very different than patient-experienced toxicities - and maybe we'll put that to a side for one second - but objective toxicities on one hand and then subjective characterization of those toxicities on the other.
So for this project, we looked at, we've sort of cultivated over the years an actively updated database of every phase 3 trial that's been completed in clinicaltrials.gov since the website's inception. And so in this report, we looked at over 400 trials representing over 300,000 patients enrolled. And we wanted to assess objectively how many trials reported in their manuscripts serious adverse events, treatment-related deaths, study therapy discontinuation, and an emerging area that really bears some emphasis, which is reporting of lower-grade toxicities. And I know we're going to discuss this as this moves forward, but especially in the last few years, this has entered visibility as an area that we really ought to be emphasizing more. As a sort of anecdotal point, it's very easy to characterize a single grade 3 episode of toxicity that potentially is self-limited. But on the other hand, if you've got a patient who has the misfortune of having grade 2 nausea day in and day out - sure, that's grade 2, but that can be much more impactful on somebody's quality of life. So being cognizant of these kinds of differences is important.
So we went through these 400 trials and objectively categorized using pre-established guidelines how many reported serious adverse events, treatment-related deaths, study therapy discontinuation. And the answer is only 44% of trials consistently do this. We added and created sort of our own guideline - everyone comes up with guidelines these days, so we said we're going to do our own guideline - and add into the mix reporting of lower-grade toxicities. And if you call "complete toxicity reporting" doing what's been done before and reporting lower-grade toxicities, then only 32% of trials report out these complete toxicities.
And perhaps the most interesting covariate there is that our industry-supported trials, which increasingly dominate the scene, those tend to do a better job at reporting toxicity profiles than cooperative group–sponsored studies. And we can kind of dissect that, perhaps, on the back end.
And the final point is we looked at how often investigators are using language like, "Study therapy had toxicity that was acceptable or tolerable." These subjective languages that fundamentally minimize the experienced toxicities. And the answer is nearly half of trials report- have that language in the study text itself, often in the discussion section or the abstract. And this is what's picked up, right? This is what our patients read. This is what news outlets read. And I think this really fundamentally undermines a lot of the nuances here. But if you let me keep talking, I'll just keep talking forever, so I'll stop talking.
Dr. Fumiko Chino: That was a really excellent summary of what your team did, and I agree 100%. Give credit where credit is due. It is a whole team that brings research like this to publication, and so I really always respected the fact that you have worked in very large teams and have given due credit to people like trainees along the way that are doing some really elegant work under the auspices of the- I'll just call it ‘The Ludmir Lab’.
Now, as you mentioned, patients may really consider side effect profiles very differently than what investigators determine could be, quote-unquote, "clinically relevant." Stacey, I'd really love your take on the toxicity topic and how you've seen this play out in both the advocacy space and in your role as a scientific advisor.
Stacey Tinianov: First of all, I am truly thrilled that all of this is being examined. We know that words matter. We know that we've managed to change our collective language in the oncology space and our understanding significantly of that impact in the last 10 years. We've modified phrases like, you know, "patients failing treatment" and we've moved to what is kind of more “what actually failed patients”. So, you know, I think the key piece there is when we describe things like "manageable" and "tolerable" in scientific publications or in that Table 3, we are looking at “clinically relevant". And so I want to acknowledge that when you talk to people in clinic, you know, "manageable" means that there's a way to clinically manage a side effect. "Tolerable" means that treatment can continue. So we understand where these phrases originated from. However, as Ethan mentioned, these terms have very different meanings in day-to-day living.
I spent some time actually quite recently at the FDA talking about the gratitude I have that, you know, safety and efficacy is a primary concern for the FDA because as advocates and certainly as patients, we care about safety and efficacy. But we also are incredibly concerned with quality of life, and it's particularly important to say because all of these great therapies are only great therapies if individuals can stay on them. And if these so-called "manageable" and "tolerable" side effects, as they start to accumulate, people have to come off treatments, well then all of that incredibly hard work and all of those resources to bring something to market are for naught.
The other thing I think it's highly dependent on individuals, and I think that, again, when we quantify and when we, you know, qualify something, we have to do it kind of in a population setting. And yet I think we need to acknowledge that all individuals are different, and something that may truly be "manageable" and/or "tolerable" in one individual might not be in another. And so I think we need to make room for that. And the reason the language is so important is so we can make those choices. We can weigh the benefits to the risks, not just on a cellular level, but on an impact level. So again, so excited to have this conversation.
Dr. Fumiko Chino: I love that personal take on it, which is that it is personal. You have your own experiences, obviously, with toxicities, but that individuals may not be comparable across each other and aggregate number on a spreadsheet is very different than lived experience.
Stacey Tinianov: When you look at those hundreds of thousands of individuals, those were the cancer Olympians. Those were the individuals that qualified for a clinical trial because even though they were sick and in some cases very, very, very sick, they were the best of the best. And so that toxicity profile is on a population that has actually made it into a clinical trial. But once a drug is approved and once it's put into market, it's potentially available to anybody, and so we see those side effects, you know, sometimes in a much more complicated situation. But too, you know, again based on the individual, even if this drug gets out and it's the same diarrheagenic profile for one individual as another, the impact of that on a quality of life is very, very different. Somebody who really enjoys sitting outside and birdwatching and hanging out with friends and reading books, as long as they’re within ten feet of a bathroom, the diarrheagenic effects of a drug are going to impact that person probably far less than somebody who rates their quality of life on how many summits they can peak.
Dr. Fumiko Chino: 100%. I can even say for my own lived experience, when my father-in-law received cancer treatment, they actually chose one of his treatments based on the fact that he is a guitar player, and so they really wanted to minimize his risk of peripheral neuropathy. And so, you know, instead of cisplatin, they chose cetuximab for his treatment, even though it is maybe suboptimal in a straight numbers comparison, but the toxicity was very meaningful.
Now, there was another recent JCO OP study published this year focusing on patients with melanoma on immunotherapy. It found that of the 70% of patients with any toxicities, about half of them were, quote-unquote, "only" grade 1 or 2. But in this so-called "low-grade toxicity," 15% were hospitalized, 31% had treatment stopped because of toxicity, 33% needed to go on an immunosuppressive medication. Now, Ethan, do you mind putting this into perspective from the kind of clinician and clinical trialist standpoint?
Dr. Ethan Ludmir: With pleasure. And this is a terrific piece and really highlights and informs a lot of the reasons that complete toxicity reporting is crucial. Right? We need to know about the grade 1-2 side effects because invariably, as much as we like to relegate those to second-class status in how we've to date been characterizing physician-reported toxicities, clearly, there's a dramatic impact in many of those toxicities on people's ability to tolerate therapy, their ability to require additional intervention like immunosuppressives, and it's really quite central in the way we think about things.
The other facet, I think, that's increasingly relevant here is the treatment discontinuation aspect of things is one that increasingly from a statistical perspective comes to the fore. We've written about this before in a couple of different pieces, but it's something that I'm not always sure gets enough billing, which is that study therapy discontinuation is often not considered an event. And so when you design Kaplan-Meier curves and you report these out, those patients are censored rather than marked as having an event. And so you get weird statistical effects of how those curves are perceived because you're almost ignoring the folks who had the toughest time with the therapy when those are among the most informative patients when you're thinking about things from both a large-scale regulatory perspective to Stacey 's point, and again to Stacey's point, the individual in front of you.
So I mean, it's a terrific piece of work and also speaks to, as we think about the era of PROs really getting more and more mature in how we analyze them and integrate them into our trials, it also speaks to the challenges of just objectively quantifying toxicity from a physician perspective as tick mark “That is one grade 3 toxicity.” Can we make this multidimensional? Are we thinking more about the time perspective? How long is the grade 2 toxicity going for? Are you having a day of nausea or continuous nausea for a month? These are the things that I think are relevant as we think about optimization of our endpoints going forward.
Dr. Fumiko Chino: Patient-reported outcomes has entered the chat. I love it.
Now, Stacey, do you have anything to add from a patient perspective?
Stacey Tinianov: I absolutely do, and I think the discontinuation piece is critical. But again, I also want to add that once things get approved and are in market, it's not a digital discontinuation or continuation. We have, obviously, dose reductions that tend to be led by clinical expertise. But what we're seeing in the community, especially with some of these newer targeted therapies, is individuals medicate themselves. For instance, diarrhea, you know, fatigue, there's a lot of very, very clinical side effects, but I think diarrhea is the one I like to focus on because I don't think I've ever talked to anybody who has not experienced diarrhea. So I think there's a level of understanding and empathy there. But when we look at some of these diarrheagenic, especially in the CDK4/6 space, we have individuals who, one, because it's manageable and tolerable, are given an over-the-counter prescription for an antimotility drug, and that drug then causes another side effect, and this side effect isn't measured. This is not in the toxicity profile of a therapeutic. It's in the toxicity profile of the supportive care medication. And so what we're seeing is this incredible cascading effect of diarrhea, constipation, diarrhea, constipation, diarrhea. And so patients say, "You know what, enough is enough. I'm about to go on a vacation. I'm going to take two weeks, and I'm not going to take my meds." And whether they communicate to their doctor or not probably depends a lot on their relationship. But from a drug standpoint, with these drugs, we don't know what that does, right? And so we know that we have people not taking the therapy as it was intended and approved, and this is directly a result of the side effects.
The other piece is, I think it's important to note that when we think about side effects, I think oftentimes we think about a finite period of time, but some individuals are on drugs forever. They're on it forever until it stops working. And so, if you say that, okay, fatigue is really, really a challenge, but if it's your new regular, you're never going to feel better than this, that's a really hard decision to make.
The other piece is, again, I think that when we think about these grade 1 and these grade 2 side effects, we don't necessarily visualize what that actually means. And so going back to poop, because we all like talking about poop, you know, a grade 2 side effect - and one of the things you already know - is defined as four to six loose, watery stools as baseline. So one of my favorite conversations or favorite phrases or questions, I guess, is to say, “You know, just take a second. Where in your busy day would you put four to six extra loose, watery stools?” And then, you know, you're like, "Oh my gosh, that's not tolerable." So it really is just this like huge, huge, huge consideration for people, and I'm not saying that these drugs shouldn't be on the market, but what I am saying is when you publish the results of how these drugs affect individuals, that needs to be part of the conversation so it can be part of the shared decision-making.
Dr. Fumiko Chino: 100%, 100%.
Now, Stacey and I both just returned from ASCO 2025, where the so-called "latest and greatest" new treatments were showcased. There were at least a handful of times where I heard that X new treatment was both efficacious and tolerable without any patient perspective presented. And it's been over four years since I heard the incredible Jill Feldman speak about the importance of patient-reported outcomes, including her famous slide highlighting the difference between how you look and how you feel. Stacey, you've been in the advocacy space for over a decade. Do you think we're making any progress over time on this issue?
Stacey Tinianov: I should probably lead with the fact that I am an optimist. So my answer, my answer is ‘yes’. And I mentioned earlier that I've watched the focus on words and and our language is starting to change based on the recognition that words matter. I think for the most part we don't call individuals who decide to join clinical trials, we don't call them ‘subjects’ anymore. We're recognizing them as humans. We're also incredibly excited about what is starting to be presented on the main stage. I know that, you know, at this past ASCO, we had, you know, many individuals who were on stage as advocates in conjunction with the luminaries in the clinical and the research space. And so I think that's progress because I don't think there's one advocate who wasn’t on stage to kind of share, you know, some of these similar concerns.
But we're also seeing it in the research space itself. So Advocates for Collaborative Education decided that quality of life was something that was not being well studied and not being well represented. So a couple of years ago, we actually did an advocacy-led study, "More Than a Diagnosis: A Quality of Life Survey for Individuals with a History or Diagnosis of Cancer.” We did it because we knew it needed to exist. We also created our own survey because the current validated measurement tools that look at quality of life, one, they're administered by a clinician, right, so you're not necessarily getting that- they're not necessarily looking at the things that we as patients care about. So we created this survey with patients and with advocates. And the most exciting thing is once we accrued - we had 516 responses across a variety of cancers, and we did this in a matter of five weeks - and we submitted abstracts to SABCS, to ASCO, to ASCO Quality, and we've had posters or presentations at every one. We are talking about these words "manageable" and "tolerable," but more importantly, I think we're talking about being able to integrate quality of life into the decision-making process in clinic and also integrate quality of life into how we evaluate from a patient-reported outcomes standpoint in the clinical trials. And so it's a process. I recognize it's a process, and I also recognize for those who are struggling now, it is moving too slowly. But ultimately, and I know the three of us can agree, when choosing cancer therapies, people should not have to choose between being alive and living. So living, really, really living is what we're focused on.
Dr. Fumiko Chino: Absolutely. I would say quality of life and quantity of life are both equally important. Ethan, do you have anything to add to what Stacey just eloquently said?
Dr. Ethan Ludmir: Candidly, she framed it exactly the way I would want to if I were more eloquent myself. So no, I think that's exactly where we're at. I live in my own little pond of statistics, so a lot of things that I'm worried about deal with how we're measuring quality of life, how we're analyzing it. The devil is usually in the details there, but on one hand, like, that's something I feel is a direction that, kind of behind the curtain, the statistic- statisticians really have to do a lot of work and education to get there. But in a certain way, that's a much easier challenge than what both of you are describing now as we see sea change at the level of who's talking at ASCO, who's being brought into the conversation and trial design, whose voices are being heard and propagated. So I think the math is much easier to work out than the vision. And so kudos to both of you for spearheading that vision and seeing it realized, I think, in real time, which must be very, very rewarding.
Dr. Fumiko Chino: I've been so enthused about how many patient advocates I've seen on both big ASCO and then, of course, ASCO Quality, the health services meeting. I know that at least the session that I had at ASCO had a patient advocate as a speaker. So I think, again, our sort of ideal world is that every single session has a patient advocate to help frame the research and the data from the perspective of the lived experience of someone on cancer treatment or a survivor of cancer.
Stacey Tinianov: It's so important for me to acknowledge that none of that would have happened without people like you that are embracing it. We recognize, advocacy recognizes that we needed champions on the inside to be able to come in and share those perspectives. We so, so recognize that. So, thank you for that.
Dr. Fumiko Chino: We have a mole in ASCO, and it's a patient-centered mole. Thank you for that.
All right, switching tack just a little bit for our last little bit of the podcast. Ethan, I know you've been on really a mission to improve clinical trial design and really have a growing body of meta-research or, you know, "research about research." Why is meta-research important, and how do we learn from it to refresh and reinvigorate clinical trials so that they provide better information to providers but also more meaningful outcomes to patients?
Dr. Ethan Ludmir: That's a terrific question. A little bit loaded in the life and times in which we live right now, but a terrific question. So I think clinical trials are fascinating. I think there's tremendous avenues of opportunity in how we design them, how we execute them, how we interpret them, how we analyze them. So that gets me up in the morning. That really puts a skip in my step. I love JCO OP. I will put in the very smallest of plugs for a different journal in which we just published a report two days ago that was presented concurrent at ASCO on how many clinical trials in the last 25 years have actually moved the needle in quantity of life or quality of life. And I know all three of us can share this perspective, you know, each with different words, but at the end of the day, that's what matters. We need to know that whatever we're doing, we're improving somebody's quality of life, their quantity of life, or ideally both. And so my trainees kind of hear me say this repeated often and often and often. And I think it's very important because in many ways, for a little while now, we've lost the thread at the regulatory level, at the sponsor level, and that's nothing new. There's a lot of ink that has been spilled about this. But the beauty of meta-research in a certain way, and to be clear, I'm a clinical trialist in my day job too, and I think there's a key role of not just being there and being an armchair quarterback, but then living it yourself and running your own trials and having to work with sponsors and partners, ensuring that you involve patient advocates and hearing their voices, not just ticking a box off on a checklist.
Meta-research gives us this separate avenue to really sort of think about things, trying to see the forest through the trees. What really does evidence-based medicine show us? Where are we doing well? Where are we not doing well? There's a tremendous body of literature that, in our small way, we've contributed to some of those conversations, and we're incredibly proud as a group about that.
But especially in an era and a time when the structure of evidence-based medicine is being called into question, the validity of evidence is being called into question, I think in many ways, it is easy to be on an extreme. It is easy to take a flag and plant it on a hill and say, "I believe X or I believe Y," and the other side, another view, is completely wrong. And as I tell my trainees, many of these people are also in that meta-research space, and I try to spend a lot of effort to say, we might not get the flashiest headlines, and a lot of journals, and I'm very grateful that JCO OP is not among this number, will specifically want papers that are almost trying to be inflammatory. And we very much want to paint an even-handed picture. Here's what we're doing well, here's what we suck at, here's how we can move forward. Do you make changes through editorial policies or regulatory policies? Do you make changes just by, as both of you have done, keeping that conversation alive, using the media and the forums you have at your disposal to just say, "This is something we need to be talking about more and focusing on"?
And I think the the important thing that I carry forward, especially as we see changes at the regulatory and the administrative levels, are that use the data in front of you, analyze them with integrity, present them with integrity, and say, "Here's what we're doing well, here's what we're not doing well, here's the believability of our data, here's where we think we're weak." And invariably, the truth is somewhere in the middle. President Eisenhower said, "The middle is a very lonely place to be," but invariably, it's right. And I'm definitely butchering that quote, so you'll forgive me, but that's very much kind of how I think we should be approaching things, is that even-handed, "What are we doing well? What do we need to work on? And how do we find the right partners to get us there?"
Dr. Fumiko Chino: Absolutely. I know that Dr. Sherry, who presented that research you mentioned that was simultaneously published in JAMA Oncology, relayed the research showing that very few trials are powered to an overall survival benefit and so they're not showing that. Very few trials are showing a quality of life benefit, and even fewer than few trials are showing both an overall survival and a quality of life endpoint. What was striking to me is that one of the people who came up to the microphone said something along the lines of, "Well, if you have this, you don't need to measure quality of life," and I was like, "Hold me back," because quality of life no matter what is one of the most important endpoints. If you live two months longer but it's in pain, I'm not sure what the living is. I say this as a cancer widow.
Now, Stacey , anything to add given your role as a patient advisory for new treatment testing, for development, for patient education? Anything to add? I know you have an opinion about this.
Stacey Tinianov: Well, I have opinions about a lot of things. But I want to, you know, thank you for bringing up the divisiveness that exists, and I think that the divisiveness that exists in society is obviously impeding our work. But in advocacy, we're there for every individual, and we're there to advocate for the best possible outcomes and the best possible experience for every individual. And cancer's incredibly nondiscriminatory. It really doesn't matter if you're a, "I did my own research," or if you're kind of leaning into evidence-based medicine. And so I don't know that I live in the middle, but I definitely think that there's a lot of value in being the bridge. Just sitting in the middle and observing, I think, maybe it's just not enough action for me, but really trying to figure out what are the things that we can agree on. I think we can agree on quality of life. I think we can agree on ‘we need to do better.’
I will say I'm excited because I do feel like things are changing. And again, change is hard and sometimes change is slow. But we do have groups, you know, the Patient-Centered Dosing Initiative, a group that was started by a few metastatic breast cancer patients that said, "You know what? We are overdosing people," and we kind of know that because the way we approve drugs is to get to the maximum tolerated dose, a little over, and then pull back. That's where we then go through the rest of everything else. So of course these toxicities are high. I, and I can’t quote the source, but this week, I learned that approximately 1% of payload in some of these large ADCs actually gets through. And a lot of that depends on, you know, how much is going to be able to filter through, but what that means is we are giving such a high load that of course these toxicities are high. And so I think the more we know, the more we can address. There will be situations where it is what it is and people will just need to decide what's right for them.
But I think from a clinical trial standpoint, I think, you know, again I'm preaching to the proverbial choir here, advocacy and helping making trial designs, trial protocols much more friendly to the individual who's going to sign up, it's a win-win for everybody because we're going to be able to accrue. We're going to actually be able to do the research and we're going to be able to get people who understand why they're participating, what the potential benefits and risks are, and that's going to really help with reducing the attrition rate. It's really going to help with people who are committed to making sure that we can see this through. So I love this. I think, you know, a goal for me is to see more lay summaries on our research. I think let's communicate what we're doing and the impact of what we're doing so that the rest of - on both sides of this bridge - so that the rest of society has a better understanding.
Dr. Fumiko Chino: One thing that you said really stuck at me as a treating physician is that I've had patients on, let's just say a CDK4/6 inhibitor, who really were underplaying their toxicity to their medical oncologist because they did not want to get a dose reduction. And I have to be, "You know what, on that clinical trial," I have it here, "70% of the people on the clinical trial, the Olympians of clinical trial participation, they needed a dose reduction, and we still get this benefit from 70% of those people had a dose reduction." So it is okay for you to have a dose reduction as well. And I, you know, I have to emphasize that to patients fairly frequently how important it is to balance the what you're getting out of it and what it's putting you through.
Stacey Tinianov: With regard to that, and I think that's a fantastic topic, the way that dose reduction is often communicated and especially communicated in meetings like ASCO and all the other meetings, is it's de-escalation. And de-escalation, it's a technical term, and it also, especially to individuals who are new to the oncology space and new to treatment, it feels like they're getting less than. You're de-escalating, you're getting less than. And so I think when it's framed as "right-sizing," "Yes, this drug was approved in a population, and right now what we're doing is we're right-sizing it for you as an individual," I think the comfort level in individuals is much, much higher for that. So, and I know you do because I know you.
Dr. Fumiko Chino: That's funny. As a radiation oncologist, we're constantly de-escalating. I put that in quotes, but I have shifted it to “right-sizing” more recently because I think I might have heard you say that, and I thought, "Well, that is actually great language, and it's very patient-centered language."
As we wrap up our time on this podcast, I want to just give a little bit of space at the end. Is there anything that we missed, any large topic that is uncovered, or any last thoughts before we close out? Ethan, anything from you?
Dr. Ethan Ludmir: I echo Stacey entirely. I think there's a tremendous opportunity space, even in today's slightly politically charged environment, to be robust and earnest in our research, to maintain continuously the focus on patients, right-sizing rather than de-escalating, talking about toxicities in a meaningful and appropriate way, understanding the validity of not only the results for the individual but now taking again a big step back, the results at the population level, the results for clinical trial populations, and the general population.
As much as we live through chaotic times and and these are tough times, I think this is in certain ways an important opportunity for us to continue focusing on what matters. And I remain just as Stacey, ever the optimist, that we're going to maintain the positive direction, address the things that we need to address. And sometimes I always feel a little guilty writing papers like this because the purpose is not to say that we're doing something wrong or bad, but rather, here are areas of easy, layup opportunities for improvement. And I think those remain sort of the important things to keep in mind, even in a divisive environment. There are easy ways to bring everyone again back together and improve where we're at.
Stacey Tinianov: So well said, Ethan, and I just want to acknowledge that everything that happens in this conversation and kind of the larger academic medical world, we need to be having these conversations in community because we were just with 44,000 of our closest friends in Chicago, but how many other thousands and thousands of oncology professionals, advocates, and patients were not in the room and actually won't actually receive any of this information for potentially years. So as we start to think about how we can right-size and reorient in the clinical trials space and in the reporting space, we also need to be thinking how we can start to right-size and reorient in clinical care, not only in these large academic medical centers that are so plugged in, but in these smaller rural community settings where, I promise you, they're having the same adverse event experiences, just maybe not as wonderfully supported.
Dr. Fumiko Chino: It's a great way of ending the podcast. Thank you so much for this wonderful conversation today. Many thanks to both Dr. Ethan Ludmir and Dr. Tinianow, as well as our listeners for your time today.
You will find the links to the papers that we have discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope that you will join us next month for Put into Practice's next episode. Until then, I encourage you to think deeply before saying that a treatment was "well tolerated."
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Conflicts of Interest
Fumiko Chino
Employment
Company: MD Anderson Cancer Center
Consulting or Advisory Role
Company: Institute for Value Based Medicine
Research Funding
Company: Merck
Stacey Tinianov
Consulting or Advisory Role
Company: Blue Note Therapeutics
Company: ARTIDIS
Company: Napo Pharmaceuticals
Travel, Accommodations, Expenses
Company: ARTIDIS
Company: Napo
Ethan Ludmir
Employment
Company: Alaunos Therapeutics
Recipient: An Immediate Family Member
Honoraria
Company: Nanobiotix
Consulting or Advisory Role
Company: Xerient
