Differences in the Pattern of and the Response to Treatment Not Just Race - Elisabeth Heath

June 27, 2021

In an educational session at the 2021 ASCO annual meeting, Elisabeth Heath, MD, FACP, discussed the variability of treatment options offered to patients with prostate cancer based on patients’ race and geographic location. In this conversation between Charles Ryan, MD, and Dr. Heath, the topic of clinical trial inclusion biases is brought to the forefront. The blindly accepted idea that Black men fare worse on prostate cancer treatments is addressed by providing evidence that they may actually have equal, or better, treatment responses. This conception within the medical community leads to exclusion of Black, and minority, groups on new clinical trials. Dr. Heath also points out that the discussion about race and cancer treatment is not just Black vs White, there are many more sub-groups that go into that discussion. She expounds on the idea that utilizing “Hispanic” as one group is clumping together a group that contains a massive amount of heterogeneity. Both Dr. Ryan and Dr. Heath agreed upon the idea that to get rid of these inclusion biases, you need to get whichever patient may be the victim of the bias onto the clinical trial. Once they are on the clinical trial, there will be a set protocol that will be followed which will dispel any possible biases. Dr. Heath wrapped up her discussion with a call to doctors, to ask more questions and consult more resources on these difficult topics, saying that it is okay to not have all the answers. 

Biographies:

Elisabeth Heath, MD, FACP, Associate Center Director of Translational Sciences and Leader of the Genitourinary Oncology Multidisciplinary Team, Karmanos Cancer Institute. 

Charles J. Ryan, MD, The B.J. Kennedy Chair in Clinical Medical Oncology at the University of Minnesota and Director of the Division of Hematology, Oncology, and Transplantation, Minneapolis, Minnesota


Read the Full Video Transcript

Charles Ryan: Hello, Chuck Ryan here from The University of Minnesota, and I am joined here by Dr. Elisabeth Heath, who is a friend and colleague, and she is an Associate Center Director for Translational Sciences and the Hartmann Endowed Chair for Prostate Cancer Research and a Professor of Oncology at the Karmanos Institute in Detroit, Michigan. She was recently part of a really interesting ASCO effort to look at differences in the pattern of and the response to treatment in prostate cancer, "Not Just Race" was the title of the talk. Dr. Heath, Elisabeth, great to see you. Thanks for joining us.

Elisabeth Heath: Gosh, thanks for having me, Dr. Ryan, Chuck, it's always fun to have a conversation with you, especially on a really important topic.

Charles Ryan: Super important topic and you put out as your learning objective to examine the variability of treatment options offered to prostate cancer patients based on risk factors and other factors such as geographic location, race, and disease spectrum. Before we get into what you presented, what prompted this analysis and this discussion?

Elisabeth Heath: A lot of it is I think that we are so grateful that Dr. Pierce made the whole ASCO thing about every patient everywhere, and in doing that, we have to be aware of the representation all around the globe, and honestly, we do a terrible job. Chuck, we try and try and try, but until there are these dedicated sessions at a national meeting like this, I think it's hard to have the conversation.

Charles Ryan: There is a lot going on right now regarding the comparison, for example, of outcomes to Black men, to White men, to Asian men, and others with prostate cancer. And there's a lot of controversy about whether there actually are adverse outcomes, for example, for African-Americans, because it sort of depends where you look, correct?

Elisabeth Heath: Yeah. What's hard is you almost do not want that to be the topic, whether you feel that race is a social construct, whether there are biological differences, I'm sure the answer is yes, to yes, to yes, to yes. It's just where you are looking at the data. I think the fact that we are having a conversation thrills me because many of us have been doing this for 20, 30 years. You say to yourself, "Wow, people are starting to pay attention. How awesome is that?" There are actual analyses and intentions with getting more patients on study or even having it as a topic like right now with UroToday, how great is that?

Charles Ryan: Well, it is great. But you also identified in your talk, for example, various parameters that are associated or that could be explored. You've already touched on a little bit, ethnicity, rural versus urban, academic versus community centers, socioeconomic status, and really, the idea is I think you are constructing multi-variate determinants of potential outcome that you wanted to study.

Elisabeth Heath: Yeah, because we know no matter how you tease it out, each one man always has all those factors going on. Whether you're looking at race, the next thing you know they are in a rural area, or you're looking at a particular factor, but they're in a different country. I would say all-in-all, kind of recognizing what those parameters are, I think, is what makes it important. Every time we think disparity, we think black, white. I look at the sort of Latino, Hispanic, just the ethnicity question is so under-explored, that the heterogeneity there is tremendous and we just kind of clump everybody. Well, I don't know? Hispanics. What is that? That is a giant group depending on where you are on the globe, and we don't even think about that.

Charles Ryan: Right.

Elisabeth Heath: So, just that alone is overwhelming. But I tell you, where we, I think, see a lot of change in the last couple of years is where you live. There's this idea of just based on zip code, I mean, are you just going to do worse based on zip code? And I think we are recognizing, especially here in the state of Michigan, you're in Minnesota, there are pockets in our states that really have a lot of rural patients. And you're like, "Gosh, we are not doing right by them."

Charles Ryan: Yeah. Well, I've heard outside of the context of cancer that the most important number that determines your fate in life is your zip code, where you were born.

Elisabeth Heath: Yeah, yeah.

Charles Ryan: Let's talk about a couple of things that you went through with a little bit more detail. In response to prostate cancer treatment, you had the statement here that Black men with prostate cancer have equal or better treatment response. Tell us about that.

Elisabeth Heath: A lot of the times you think they are going to do terrible. I don't know if that's implicit bias, I don't know if that's just where you're trained or you are just automatically putting a sort of parentheses around their history, going, "Oh, boy, based on X, Y, and Z," of no data, by the way, you think they're going to do worse. So, when it comes to trials, you just make these suppositions. You don't offer. "No, no, no. There's no way he's going to go on."

But, when you really cut down on it, a lot of the time, that's not the case. And if you look at the treatments, whether it's sipuleucel-T or radium or chemo or abiraterone, the answer is Black men do just as well, if not slightly better, than their white counterparts, and meta-analyses after meta-analyses, it's there. So, I think in some ways the great equalizer, which is getting them on a trial, really works.

Charles Ryan: Well, once you've put somebody on a clinical trial, you've sort of eliminated the variable of the treating practitioner and his or her biases, right?

Elisabeth Heath: Yeah.

Charles Ryan: Because they're following a protocol.

Elisabeth Heath: Yeah, exactly.

Charles Ryan: And as you identify, the bias may come in with who goes on the protocol, but once they're on, as we all know, we put a patient on a protocol and we are not in charge anymore, the protocol is, so to speak.

Elisabeth Heath: That's right, that's right.

Charles Ryan: So, there are a number of registries and other things that are being explored. You talk a little bit about the sipuleucel registry and I think there are others using radium and docetaxel and the IRONMAN that are looking to explore this. Tell us about the state of that research right now.

Elisabeth Heath: I think most of it because, if it's not something done prospectively, it ends up being like that. But I'll tell you what, just based on the other sessions at ASCO, part of this looking at, let's say, claims data, and you're looking at metastatic hormone-sensitive patients, you recognize, number one, even though we go through all this trouble with clinical trials, you don't implement the data, so how are you going to get the actual answer? But for Black men, it's actually worse. So, even when you do get the answer after you do all that, you still will have a disparity if you don't actually execute the actual treatment the way it's meant to. So, that's another struggle.

But I think there is a lot of values for different registries. I just saw that the IRONMAN paper, that talks about all these trials is the number one downloaded or number one cited paper now. That's exciting because it's showing that people around the world who are thinking about this topic, hopefully from this ASCO meeting, is they are looking to look at more evidence. What do others think about it? What's out there now?

Charles Ryan: Yeah, absolutely. And you highlighted a couple of things. You highlighted the Partnering Around Cancer Clinical Trials effort, PACCT, which is an effort to improve, increase the participation of African-Americans in prostate cancer. How long have these types of efforts been around and how effective have they been so far?

Elisabeth Heath: I would say this is a terrific project from Dr. Susan Eggly at our center, that we are collaborating also with Dr. Mike Carducci and Dina Lansey from Hopkins, and it's the idea that it's got to be, this multi-level deal. It can not just be one investigator or one trial, it's got to be a multi-pronged approach. The interesting thing is that even at centers like ours, where we pay attention, we really try to do this right, we can improve. And the improvement has led to better communication, better trust, and next thing you know, you're like, "We've done better, even in a center where we think we're doing okay." So, I think that's one part of this PACCT approach.

The other part is making sure that patients know that, in a lot of ways, mistrust is probably the number one reason that they say, no, but when people get asked the general answer is, yes. So, you have to almost formally study that to say, "Why am I going to not ask when the studies that we have done internally say, they're going to say, yes." There is an occasional no, and when they happen, it's usually due to mistrust. But in general, if you ask and you endorse, it's a thumbs up.

Charles Ryan: Yeah. It is a really important point. In my past experience working on an IRB, we tried to stick to the principles of fairness and justice in an ethical framework for clinical trials. The idea was that it was almost unethical to not offer a clinical trial to a patient who is eligible because you think that they wouldn't go on the trial, because, to your point, you don't know if they're going to answer yes or no. And maybe that's, as you point out, one of the bigger challenges we face, is not the patients, but the doctors or the clinical trial enrollers getting over their own biases and offering the trial to a patient.

Elisabeth Heath: Absolutely. And unless that is done with intention from the institution, from the organization, it won't change. When we did the training, I would say my own experience and looking at implicit bias training, for example, I was shocked at how things are looked at, that perhaps my own lens on how I view things could be modified or expanded. It was an exciting thing and I see it now with many different organizations. We get asked to do surveys and modules. Can we learn more about a particular subgroup? There is so much out there that people are starting to do, it's really getting our whole community to rally behind it.

Charles Ryan: Very good. Well, I want to congratulate you for your efforts and your leadership in this area and certainly the educational work that you've done around this point. What's your advice, in closing, for a community doctor or somebody who is participating in clinical trials and how they might approach these questions, and what types of pieces of knowledge they should have as they move forward in their own practices and academic centers in terms of accrual?

Elisabeth Heath: Yeah, I think recognizing there are a lot of resources. I hear this from our own community partners who, if they are stuck or just have questions, they will call their investigator colleagues, either at the NCI cancer centers or nearby cancer centers. I think the answer is if you're not 100% sure, just pick up the phone, text somebody, email when you're home and just ask that question.

I think the idea of other things you can do institutionally, the National Cancer Institute has lots of resources. You do not have to reinvent the wheel. In the United States, we all belong to a region of sorts where there are educational information, webinars, things that can really help you in active practice, but you have got to want it. And I think the reason to do that is, again, getting on a trial is a great equalizer. If you're not sure how to help advance health equity, maybe it's not to get another committee, maybe it is just getting your patient on a trial.

Charles Ryan: I should also point out, one of the things we don't talk about enough in our field is how well we adhere to a protocol-based therapy once a drug is approved. So, for example, abiraterone, a drug I know a lot about. Clinical trials are done where the protocol is followed, the drug is given to a specific point of the disease progression, but then the drug gets approved and nobody follows how individual physicians will start or stop the therapy or make those reductions, et cetera. The point I'm getting at is, you've eloquently said, that when people are treated according to the same protocol, we equalize disparities. And so the question is not, should we put them on a clinical trial? We should. But the question is, should we then follow what we did on the clinical trial in everyday life? That's kind of where I'm going with that. Does that make sense?

Elisabeth Heath: Oh, absolutely. Just again, those real-world registries. You just look at that Medicare data that Steve Freedland presented right there, disparity is right in front of us. Not only do we not do it as a global whole for everybody, so that is really kind of shortchanging half the men or a third of the men that should be getting that, but it's actually worse for African-American men. These are things, again, every day. You have the information. As you said, if trials are not it and that's not your deal, just do what is actually guideline-based, because that also ensures equity.

Charles Ryan: Correct. So, if you are treating a patient from whatever background and you decide to follow what was done in the PREVAIL study with enzalutamide, you can rest assure that you are allowing that patient to have the best potential outcome that that therapy can offer because that was what was demonstrated.

Elisabeth Heath: Absolutely.

Charles Ryan: All right. Well, any other final thoughts on this really important topic? Advice to clinicians or others?

Elisabeth Heath: I just want to thank you, and I think for UroToday, you guys really keep it on the frontlines and practical. A lot of this data, just so much information, and when we have a moment to maybe share some of our thoughts and what we would do in our own practice in addition to, yes, trials are the right thing, just know what it really means, how that transcends that. And also, if it's not trials, just do what is guideline-based and keep going.

Charles Ryan: All right. Well, Dr. Elisabeth Heath from Karmanos Cancer Center in Detroit, always a pleasure to talk to you and I look forward to seeing you in person again someday.

Elisabeth Heath: Same here. Thank you so much.

Charles Ryan: All right. Take care.
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