#ASCO21: Addressing Challenges in Cancer Care With Dr. John Sweetenham

Dr. John Sweetenham, associate director for clinical affairs at the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern and editor-in-chief of ASCO Daily News, discusses compelling approaches in cancer care featured at the 2021 ASCO Annual Meeting, including key studies on financial toxicity, drug prices, disparities in clinical trial accrual, and the impact of the COVID-19 pandemic on cancer screening.   Transcript ASCO Daily News: Welcome to the ASCO Daily News podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. My guest today is Dr. John Sweetenham, associate director for clinical Affairs at UT Southwestern's Harold C. Simmons Comprehensive Cancer Center. Dr. Sweetenham also serves as editor-in-chief of ASCO Daily News. He joins me to discuss compelling approaches in cancer care featured at the ASCO Annual Meeting, including key studies on financial toxicity, trends in oncology drug revenue, disparities in clinical trial accrual, and the impact of the COVID-19 pandemic. Dr. Sweetenham reports no conflicts of interest relating to our discussion today. Full disclosures relating to all episodes of the podcast are available at asco.org/podcasts. Dr. Sweetenham, it's great to have you on the podcast again. Dr. John Sweetenham: Thanks, Geraldine. It's good to be here. ASCO Daily News: There's been a lot of interesting research on the impact of the COVID-19 pandemic on patients with cancer. Sadly, the pandemic caused the postponement or cancellation of countless screening procedures. Abstract 6501 looks at the impact of the pandemic on stage presentation of breast and colorectal cancers. What can you tell us about this study? Dr. John Sweetenham: I think this particular study is very important because it is a confirmatory study of observations that have been made in other environments. But in this case, it's a single institution study from UC San Diego. The implication, the basis of this study, obviously, is that screening programs have really been critical in reducing death rates from certain cancers. And breast and colorectal cancer would probably be the best examples of that. And as we know, during the pandemic, many people postponed or cancelled their screening procedures. And so there have naturally been concerns about what that will do to stage at presentation, and an anticipation that we will see more patients eventually showing up for our services with more advanced stage of disease. So in this study, the workers at UC San Diego looked at their patients who had been treated in the years 2019 and 2020. And the treating clinicians used stage at presentation, which was determined by standard AJCC staging modules pulled out of their electronic medical record. And they did a pretty straightforward comparison of the stage distribution for their patients between 2019 and 2020. And they focused especially on colorectal and breast cancer because those are diseases where screening is known to have a significant impact. The interesting data from this study are that the total number of new patient visits for cancer during 2019 and 2020 were actually remarkably similar. And if you look at the stage distribution across all cancer types and compare 2019 and 2020, there really isn't very much difference. But what's disturbing is that for patients with breast cancer, they observed a lower number of patients with stage I disease, which reduced from 64% in 2019 to 51% in 2020, and a higher number of patients presenting with stage IV disease, which went from 2% to 6%. And very similar trends were seen for the patients with colorectal cancer, where they saw a decline in stage I presentations and an increase in stage IV presentations. So these are, again, confirmatory data which highlight the problem with delayed screening. The investigators mentioned that they're going to continue to follow these numbers closely and are planning to present data from their experience in 2021 as well. I think that what this does is really--it emphasizes the need for us for ongoing efforts to encourage our patients to return to care, to return to their screenings, and frankly, to get vaccinated so that they will have more confidence in coming back and returning to care. ASCO Daily News: Thank you for sharing these data. There are a lot of financial toxicities associated with cancer care. And there's an interesting study, Abstract 6504, that uses data from patients' credit reports to measure the relative risk of adverse financial events in cancer patients after diagnosis compared to individuals without cancer. Can you tell us more about this? Dr. John Sweetenham: Yes. And my first disclaimer would be that I'm certainly not a health economist. But as someone who is a non-expert in this domain, I found this to be a very interesting study which looked at the relative risk of adverse financial events in patients with cancer compared with a control group. And it did this by using data that they pulled from the patient's credit reports, which, from my perspective, is a really interesting way of looking at the financial hardship. And the way they did this was they used the Western Washington SEER cancer registry for their cases who they investigated in this study. And they used the voter registry to identify their control patients or control cases, I should say. And then they used data from one of the credit reporting agencies to look for signals for what they describe as adverse financial events in the patients with cancer compared with the population. And they were able to identify levels of severity of adverse financial effects within this analysis. So to cut to the chase here, what's interesting is they identified more than 300,000 individuals, of whom just over 84,000 were patients with cancer. And the remaining 250,000 or so were control patients. And they looked at the available line of credit for these patients, and then also looked for signs of what they described as severe, or more severe, or most severe adverse financial effects. And the most severe would have been, for example, foreclosures on homes or repossessions of homes and properties. So obviously, pretty significant and very serious adverse financial effects. And if we just look overall at their results, so for example, severe adverse financial effects, there was a highly significant difference which demonstrated that these were significantly more common in the population of patients with cancer, the same being true for both the more severe and the most severe adverse effects. And so, in a way, you could argue not surprising. But I think it put some numbers around the fact that there are long lasting effects financially for our patients with cancer, for a significant proportion of them, as a direct consequence of their diagnosis and compared in quite a robust way against a non-cancer population. And these are real life and very long term consequences, so something that we just have to keep uppermost in our minds as we're planning the financial advice and the financial navigation that we provide to our patients during their cancer journey. ASCO Daily News: Absolutely. Well, let's focus on the price of cancer drugs. Abstract 6505 looks at trends in oncology drug revenue among the world's major pharmaceutical companies. The study's authors cite a 70% increase in the number of clinical trials for cancer drugs over the past decade, and a substantial increase in the price of cancer drugs. In fact, the study found a 96% increase in sales revenue from cancer drugs among the world's top pharmaceutical companies over the past decade. So what are your thoughts about this? And why, in your opinion, is this study important? Dr. John Sweetenham: Thanks, Geraldine. Yes, I think that this study is important on a number of levels. I think when one first looks at the results of this study, it would be easy to conclude that, well, this is just one more piece of data that shows that the cost of cancer drugs is rising and is too high. And that's reflected in the extraordinary financial toxicity that we see in our patients with cancer. And you know, I think that there are elements of that which are probably true. But I do think there are other interesting observations from this. For example, as you mentioned, they demonstrated that sales revenue from cancer drugs has increased by more than 96%. And interestingly, revenues from non-cancer drugs among the same companies have actually decreased during that time. I would also mention, because it may be relevant, that although the analysis primarily included true antineoplastic drugs, they did include a number of supportive care drugs in this analysis as well, which are primarily used in patients with cancer. And so, certainly, I think in addition to the antineoplastic drugs, probably, the supportive care drugs have been part of the driver of this increase in revenue. The other interesting part of this is that during the study period, oncology revenues have grown, whereas revenues for other non-oncology drugs across all of the companies involved have remained stagnant. So what can we draw from this? First of all, as I said, I think the message about the cost of drugs is familiar to all of us and is not a new one. I think it is very interesting that there's been a 70% increase in the number of clinical trials of cancer drugs. And I think what that's telling us is that clearly, there has been enormous activity and substantial opportunity for the development of new cancer drugs. So as we look at these numbers, I think one of the positive spins to put on this is the fact that there are a lot more anti-cancer drugs coming online, a lot more trial activity. And in the long run, I think that has to be good for our patients. And we should be, to some extent, reassured by the fact that there are so many more drugs. I think also, what's interesting, although I certainly wouldn't editorialize over this, is the fact that this apparent explosion in activity and revenue around anti-cancer drugs has apparently been at the relative disadvantage of patients with other diseases, not really a thing for us to comment on that from what I classify as an editorial perspective. But I think the message for us and for our patients from this study is mixed, that, yes, there does seem to be some imbalance in terms of the amount of revenue generated out of these drugs. On the other hand, there are many of these agents now in clinical trials and on the market that weren't there a number of years ago. And overall, I think that that indicates the positive side of this story. ASCO Daily News: Well, I'd like to address a very important and timely topic, access to care. Abstract 100 reports the outcomes of a 5-year initiative of community outreach and engagement to improve enrollment of adult Black patients in clinical trials. How would you assess this initiative? Dr. John Sweetenham: I think this initiative and the results that they've produced really underlines, more than anything else, number one, the complexity that is involved in addressing this issue and the sort of multifaceted approach one has to minority accrual. And secondly, it underlines to me that there's no quick readout. One has to wait a while to see the effects of this kind of intervention. And there have been successful attempts to improve minority accrual to clinical trials. There are many ongoing initiatives. What struck me as being interested about this study from the University of Pennsylvania was the kind of multi-pronged approach they took to this. So they report that in 2014, Black residents comprised 19% of their population, [and] 16% of the cancer cases seen in the Philadelphia area. But only 11% of patients at the Abramson Cancer Center at the University of Pennsylvania were Black. And the number of Black participants who were recruited onto their treatment and interventional studies were relatively low, ranging between 8% and 13%, depending upon the type of study. So they developed a center-wide program with a number of key elements, which included tailored marketing. They had plans within each individual protocol for how they were going to enroll African American patients. They developed partnerships with faith-based organizations and conducted educational events. They provided Lyft and Ride Health to address transportation barriers. They had patient education by nurse navigators and an improved informed consent process. So they really approached this addressing several of the factors that play into the disparity in clinical trials accrual. And what they found is after 4 to 5 years of taking this approach, the percentage of Black patients seen at their center had increased to 16.2 from 11.1. And when they looked at the percentages of African American patients who they accrued onto their trials, it was really quite substantially increased. So if you remember, prior to this intervention, the range was from 8% to 13%. At the conclusion of this study, the rate was from 22% to 33%. So they had seen a 1.7 to 4-fold increase in 5 years. So I think that this persistent multi-pronged approach addressing many of the factors that play into these disparities was really interesting. And it demonstrates that to really make a significant impact on some of these disparities requires a lot of work over a long period of time. And as I said, the readout may not come immediately. It takes a while for the effects to truly be seen. ASCO Daily News: Exactly. Some great approaches there for people to look at in Abstract 100. Well, my final question relates to concerns from health insurers, that clinical trial participation can increase the total cost of care for patients. So in this study, Abstract 6513, investigators looked at the impact of clinical trial participation on total costs paid by Medicare during the oncology care model program in a large community-based practice. Can you tell us more about this study? Dr. John Sweetenham: Yes. This is an interesting study which is based on patients enrolled into the oncology care model. For those who may not be aware of this model, it's an alternative payment model which has been developed by the Centers for Medicare and Medicaid Innovation to address improvements in quality of care, as well as address issues of cost of care for patients with cancer. This study is based out of the community-based practice of 90 oncologists who practice [at] over about 30 sites of care. And what they did in this study was to link trial data and electronic medical record data with data generated from the oncology care model for patients undergoing treatment for various cancers between 2016 and 2018. And important to point out that the OCM includes patients who are Medicare beneficiaries only, so represents patients over age 65. And what they were trying to address in this study was whether the entry of patients onto clinical trials actually results in increased costs, which is, I think, some of the sort of received wisdom that's out there, that clinical trials are expensive. The OCM provides a slightly more controlled environment in which to study that and find out whether costs of care associated with clinical trials actually do overall increase the cost of care, something which clearly will be of great interest to insurers. So in addition to exploring this from the perspective of antineoplastic treatment, the group also had the opportunity to look at some non-trial episodes, and in particular, study the impact of the receipt of active treatments in the last 14 days of life as well as hospice use and hospitalizations. So these are other kind of issues which are important to us now which the OCM provides a window on. So the study was conducted and included just over 8,000 OCM episodes which met criteria for the study. And of those, 459 of the episodes included patients who were on a clinical trial. And interestingly enough, on average, episodes when the patient were on a clinical trial cost almost $6,000 less than matched non-trial episodes. And it was independent of whether it was an early phase or a late phase study. And interestingly, but perhaps not surprisingly, the primary reason for these lower costs was because of the increased drug costs. Because typically, the cost of the drug would have been covered by the trial. Interestingly, there were no differences in the rates of treatment within the last 14 days for the patients who were on the study. And there was no difference in rates of hospitalization or hospice use for the patients who were on the studies either. So the take-home message from the study was that the inclusion of patients in a clinical trial actually, overall, led to a reduction in Medicare costs for Medicare beneficiaries. And so it didn't support the concern that many third party payers have, that entry of their covered patients onto clinical trials actually cost more. Just one possible note of caution is that this was a community oncology-based practice. And it's possible that the breakout of patients on early phase versus late phase clinical trials might have been very different from what we might encounter in a more academic oncology setting. But nevertheless, I found this to be an important study which, to some extent, explodes a misconception that putting patients on studies costs a lot more money. ASCO Daily News: Absolutely. Well, Dr. Sweetenham, thanks for highlighting some really interesting studies on a range of very important issues impacting the cancer care community. Dr. John Sweetenham: Thanks, Geraldine, a pleasure as always. ASCO Daily News: And thank you to our listeners for your time today. If you enjoyed this episode, please take a moment to rate and review us wherever you get your podcasts.   Disclosures:  Dr. John Sweetenham: None disclosed.  Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.