Episode Thumbnail
Episode 11  |  43:30 min

S1E11 | TAPUR Study: The future of cancer care

Episode 11  |  43:30 min  |  12.08.2020

S1E11 | TAPUR Study: The future of cancer care

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This is a podcast episode titled, S1E11 | TAPUR Study: The future of cancer care. The summary for this episode is: Like detectives working a cold case, scientists are using genes to unravel the mysteries of cancer’s origins and mutations, equipping doctors with new tools to target cancer at its source: the blunder coded in its molecular structure. Now, one groundbreaking clinical trial—the Targeted Agent and Profiling Utilization Registry (TAPUR™) Study—is revolutionizing our understanding of cancer at a cellular level. Led by the American Society of Clinical Oncology (ASCO), TAPUR is studying how commercially available anti-cancer drugs perform on a broader range of cancers, by matching the drugs to tumors with specific genomic mutations that the drugs are designed to target. Four years after the study’s launch, ASCO Chief Medical Officer Richard L., Schilsky, MD, FACP, FSCT, FASCO, sits down with our host, Pat Basu, MD, MBA, President & CEO of Cancer Treatment Centers of America® (CTCA), to share the strides TAPUR has made and how it’s impacted clinical trials on a global scale.
Takeaway 1 | 00:42 MIN
Intro to Dr. Richard Schilsky
Takeaway 2 | 01:51 MIN
Dr. Schilksy’s History with Cancer
Takeaway 3 | 01:16 MIN
What is ASCO?
Takeaway 4 | 02:55 MIN
Precision Medicine
Takeaway 5 | 02:13 MIN
The Mission of the TAPUR Trial
Takeaway 6 | 00:30 MIN
What TAPUR Does, Simply
Takeaway 7 | 02:06 MIN
The Results of TAPUR, So Far
Takeaway 8 | 01:25 MIN
TAPUR Patient Success Stories
Takeaway 9 | 02:16 MIN
TAPUR’s Clinical Practice
Takeaway 10 | 02:15 MIN
TAPUR’s Worldwide Effect on Clinical Trials
Takeaway 11 | 03:28 MIN
The Future of Clinical Trails
Takeaway 12 | 01:27 MIN
Cancer Prevention
Takeaway 13 | 01:42 MIN
The Evolution of Cancer Care
Like detectives working a cold case, scientists are using genes to unravel the mysteries of cancer’s origins and mutations, equipping doctors with new tools to target cancer at its source: the blunder coded in its molecular structure. Now, one groundbreaking clinical trial—the Targeted Agent and Profiling Utilization Registry (TAPUR™) Study—is revolutionizing our understanding of cancer at a cellular level. Led by the American Society of Clinical Oncology (ASCO), TAPUR is studying how commercially available anti-cancer drugs perform on a broader range of cancers, by matching the drugs to tumors with specific genomic mutations that the drugs are designed to target. Four years after the study’s launch, ASCO Chief Medical Officer Richard L., Schilsky, MD, FACP, FSCT, FASCO, sits down with our host, Pat Basu, MD, MBA, President & CEO of Cancer Treatment Centers of America® (CTCA), to share the strides TAPUR has made and how it’s impacted clinical trials on a global scale.
Guest Thumbnail
Richard Schilsky, MD
Chief Medical Officer & Executive Vice President, ASCO
Dr. Schilsky is the Chief Medical Officer (CMO) and Executive Vice President of ASCO. Formerly the Chief of Hematology/Oncology in the Department of Medicine and Deputy Director of the University of Chicago Comprehensive Cancer Center, he is a highly respected leader in the field of clinical oncology. He specializes in new drug development and treatment of gastrointestinal cancers. Dr. Schilsky is a Past President of ASCO, having served in the role during 2008-2009, and is also a Past Chair of one of the National Cancer Institute’s Cooperative Groups, Cancer and Leukemia Group B (CALGB).
Learn More About Dr. Schilsky

Dr. Pat Basu: Hi, I'm Dr. Pat Basu, president and CEO of Cancer Treatment Centers of America and the host of Focus on Cancer. I'm very excited for today's show where I welcome Dr. Richard Schilsky. Dr. Schilsky is a world renowned oncologist, over the past several decades has made tremendous contributions to cancer care, most recently serving as the chief medical officer, and executive vice president of the American Society of Clinical Oncology. And on today's show, he's going to share a lot of insights ranging from clinical trials and precision medicine to specifically one of the more exciting trials, the TAPUR Trial, which so many are excited to hear more about. So Dr. Schilsky, thank you for joining us. Welcome to the show.

Dr. Richard Schilsky: Thanks, Pat. Great to be here.

Dr. Pat Basu: Well, Dr. Schilsky, I'd be remiss if I didn't take the opportunity to focus on one of our many shared connections, the University of Chicago, the forefront of medicine where both you and I went to medical school had a profound impact on both of us, and certainly on cancer care, and frankly, medicine and science at large. Beyond U of C, you've had a tremendous career from the National Cancer Institute to your current role at the American Society of Clinical Oncology. I love to ask such giants in the field, to rewind the clock and take us back to the beginning. What got you interested in medicine and cancer care in the first place?

Dr. Richard Schilsky: Yeah. Well, it's a great question. I'm not sure I can pinpoint exactly what got me interested in medicine to begin with. But I knew from an early age that I wanted to go into medicine. I was able to uncover a little essay that my mother had tucked away in a scrapbook somewhere that I wrote when I was in sixth grade called My Ambition. And in it, I wrote not only that I wanted to be a doctor, but that I wanted to be a medical researcher, so that I could help to discover new cures and treatments for people who needed them. So it was clear to me from that age that I wanted to go into medicine, and then as I got into college, I was pre med. And that was at a time when my own grandmother, was going through an experience with breast cancer, which lasted a number of years, and really drove home to me what a serious illness cancer was. She went from having one breast removed to another breast removed and having radiation treatments that were very difficult for her and after each mastectomy, then the cancer spread to her bones. And eventually to her brain, there were very few treatment options that were available in those years, other than hormone therapies. And of course, after a lengthy illness, she succumbed to her cancer. So that really drove me to want to learn more about cancer and what I could potentially do to help improve cancer treatment. As I got into medical school, you may remember one of the iconic faculty members at the University of Chicago, John Altman. John was a mentor to me, and really opened my eyes to both cancer research and the challenges of caring for patients with cancer. I then had an opportunity after my first year of medical school, which was the only year we had off. And so I went home from Chicago to Manhattan, which is where I grew up, and had an opportunity to spend that summer working in the radiation therapy department at New York University Medical Center and Bellevue Hospital. And of course, I wasn't really qualified to do anything, I had just finished just my first year of medical school, but I did follow the doctors around and most importantly, I got a chance to talk to the patients. They were all cancer patients, many of them with fairly far advanced kinds of cancer and hearing their stories, understanding their hopes and their fears and their anxieties. And what they were going through, really grabbed me and really cemented my interest in going into cancer. And as I got to understand a little bit more about both the biology of it and all of the different ways that it could potentially affect a person's health, it really became clear to me that it was the perfect field for someone who wanted to care for people who have complex illnesses, but also have an opportunity to contribute to understanding those illnesses and developing new treatments for them. So that's what got me started. And it's been a great 40 years ever since.

Dr. Pat Basu: Thank you for sharing that. And obviously you and I are very familiar with the American Society of Clinical Oncology, ASCO. But for some of our audience who may not know as much about ASCO, you've been there now for, I want to say coming up on at least eight or nine years in this current role. Tell us a little bit more about ASCO and its mission and what you do there.

Dr. Richard Schilsky: So ASCO, as you said, the American Society of Clinical Oncology is the world's largest professional medical society that represents physicians and other members of the healthcare team who care for people with cancer. And fundamentally, our mission, when you reduce it to the very basic level, is to be sure that oncologists who are the doctors who take care of cancer patients have all the knowledge and tools and resources that they need to deliver the best possible care to people with cancer so that they can try to get the best possible outcomes for each patient. We're involved in all sorts of other educational activities in various strategies to help oncologists deliver the highest quality cancer care to their patients, and we do a lot of work in the advocacy world to advocate for those policies at the government level, that are important to our members, to enable them to have all the resources they need to deliver really first rate care to patients with cancer. So we do all of those things and more. And one of the interesting things about my job over the last eight years is that I've had my hand in each of those little buckets of work that we do.

Dr. Pat Basu: On a related note, I know we have a shared passion around precision medicine. This is a topic that a lot of our patients hear so much about. But it runs the risk of becoming one of those jargony words or terms that people overuse or misuse. So when you think of precision medicine, Dr. Schilsky, how would you define that for our audience?

Dr. Richard Schilsky: Yeah. Well, precision there really are two aspects to it. They both relate to understanding the biology of a person's illness, to the greatest extent possible, that allows us to prescribe a treatment that is unique to that person, and has the highest likelihood of benefiting them with the least toxicity. In cancer care, the two aspects of precision medicine really are understanding what is driving the tumor at the genetic level. So we know now that cancer is fundamentally a genetic disease. It is due to the accumulation of usually multiple mutations inside normal cells that then makes them behave and converts them to being cancer cells. And if we can identify those mutations that are driving the tumor, and that's why we call the driver mutations, if we can identify those mutations that are like stepping on the gas pedal, for the tumor and block those with drugs, we can get a very beneficial effect many times in many patients. So understanding at a molecular level, what's driving the cancer, and then introducing a therapy that blocks those factors that are accelerating the growth and spread of the cancer. That's one aspect of it. But another aspect of it that is equally important, is understanding the genetic variation between people. We are all essentially the same, but we all have important variations. That's why we don't all look exactly alike. We don't all talk exactly alike. And we also don't metabolize drugs exactly alike. And so any one person who is taking a medicine, that medicine may interact in their body differently than it does in the body of another person. And that variation can determine how well a drug works or what side effects it has. So understanding how the person's normal genetics and their normal physiology interacts with the treatments they take, that's another important aspect of precision medicine. And if we're successful in putting these two aspects together, then we can study the cancer, find out what's driving it, prescribe a therapy and then by studying the patient, be able to anticipate what side effects they might get from that therapy and how to minimize those. And it's those two factors that are coming together now, in the way we are practicing medicine, not only in oncology, but in many other areas of medicine, that is really making precision medicine come alive and resulting in more effective and less toxic treatments for patients.

Dr. Pat Basu: Such a great description. I am just so excited about what this means for patients. It makes so much sense, even outside of oncology and medicine I've had many patients ask me over the years, there is a male and a female, different height, different weight, but yet they're taking the same dosage. And yet when you really get into precision medicine, the actual interactions of how one's body and the genetic composition of the body can actually differ and have impacts in how a drug is metabolized, how a drug has various effects on the body. It's one of those complex topics that actually makes so much sense when you think about it. And I think that the work that leaders such as you and others have made in precision medicine, it's one of those very, very bright horizons for the future of our patients in this battle against cancer. It's also I think, a great segue into one of the main topics actually of today's show, which is the TAPUR Trial. This is really a groundbreaking trial in many ways, in terms of what it represents. You've really been one of the leaders in this. Can you share with us some more details about the TAPUR Trial?

Dr. Richard Schilsky: Sure. Well, first of all, let me explain where the name came from. So the name TAPUR, which is spelled T- A- P- U- R. There's an animal that's known as a tapir, it's not named after the animal. And it's spelled differently. So our name is an acronym. It stands for Targeted Agent and Profiling Utilization Registry. So that's a long mouthful. So you can see why we call it TAPUR. But it really came from our desire to try to understand what happens to patients who are prescribed some of these new targeted drugs, based on the molecular profile of their cancer, when the drug is used outside of it's FDA approved uses. And I can tell you a little bit about where the idea for the study began, it really came from the observation back in around 2012, 2013, that there were a lot of physicians oncologists who were now beginning to send off samples of their patients' tumor to have a genetic profiling test performed. And there were laboratories that were offering these tests, and they would be able to screen for, in some cases, 50 genes, 100 genes, 500 genes, depending upon the test, looking for these driver mutations, and maybe causing the tumor to grow and spread. In a significant number of cases, maybe 30% of the time, when the results came back it showed that in fact, there was a mutation in the cancer that could potentially be treated, oftentimes with a drug that was already FDA approved, already commercially available, or was being used for treating a cancer different from the kind of cancer that the patient actually had. So it might be that the drug was out there and was approved for treating breast cancer, but the patient had lung cancer. And the question then became, well, what would happen if I tried this breast cancer drug in my lung cancer patient, because it targeted the same mutation? Would the drug work or not? And doctors who were starting to prescribe these drugs, what we call off label, that is outside of their FDA approved indications. And the patients immediately ran into a problem with the fact that oftentimes your insurance would not cover the cost of those drugs because they were not yet proven to work outside of the FDA approved indication. So that was one struggle that many patients had, they would have an advanced cancer, they would have a genomic driver identified in their tumor, the doctor had an idea of the drug they wanted to give them, and would prescribe the drug, but then they couldn't get it reimbursed by insurance. What were they to do about that? And even if they could get the drug reimbursed, no one had any opportunity to learn anything from their experience. The only people who knew how they were doing were themselves and their doctor, and unless the information about their experience of taking that treatment was collected and reported in some way to the broader medical community, none of us would learn from their experience. So it's those two things that led us to conceive of and then launch in 2016, the TAPUR Trial. And in the study, we are providing drugs free of charge, they're donated by the pharmaceutical companies that make the drugs. And so the patient doesn't have to worry about whether they can get the drug covered or not. And importantly, we're collecting information about each patient and their experience with the treatment, their outcomes from the treatment, and then ultimately, reporting that information to the whole medical community. So we can all learn together from the experience of these patients. So that's how the study began. And it's about four and a half years in now. And we're really starting to learn quite a bit.

Dr. Pat Basu: One of the topics you just spoke about is such an important paradigm. Even when I was in medical school, or certainly other physician colleagues of mine, we often only separate cancers by their organ of origin, if you will. But combining with what you talked about in terms of precision medicine and the notion that there is a mutation, that there is something underneath that is driving it, irrespective of where that cell may be located in the body is again, one of those powerful concepts. And sometimes I've used the analogy with patients that, you might have an antibiotic that treats an upper respiratory infection, as well as a urinary tract infection. And it's not the organ of source that you're worried about, it's actually what you're trying to do to kill that bacteria in that case. And so the very notion that we have medicines that might work in a breast cancer, and also in another organ type actually makes sense. But as you said, the barriers to that whether they are insurance reimbursement, FDA, other things, have have certainly vexed us for a number of years. So I just applaud some of the forward thinking and barrier breaking of this TAPUR Trial. Give us the sense of number of centers, number of patients so far in the TAPUR Trial.

Dr. Richard Schilsky: Yeah. Well, when we started the trial back in 2016, I have to say, TAPUR is the first and still the only clinical trial that ASCO itself has ever conducted. So we weren't sure exactly how to do this, with the staff that we had available at the time. So we started off fairly slowly, we identified about 35 clinical centers that were really interested in doing genomic profiling of patient tumors. And they were located primarily in the states of Michigan, and North Carolina. So they were our launch sites. So we started the trial with those 35 sites in 2016, and then, as we gained experience, and we saw that the trial was proceeding well, we have progressively over the years, added more and more sites. So as of today, the trial is available at 123 locations in 23 states across the country. And we are continuing to add sites slowly but surely, as our resources permit. At this point, we have now enrolled and treated more than 2000 patients on the study. So 2000 people with cancer who have found a study drug treatment available for them and have received that treatment on the study. And we are going to continue the study as long as it continues to generate useful information, we hope for many years to come.

Dr. Pat Basu: Phenomenal. And again, unique in so many ways, including that this was the first that ASCO had conducted. So you've talked about some of these results and what you've learned so far. Share with us, it's been four years, what have we learned so far from this groundbreaking trial?

Dr. Richard Schilsky: Given the large number of types of cancer that there are, and the large number of types of mutations that exist, we are actually enrolling patients in about 400 different cohorts in the study. So we are essentially simultaneously conducting 400 clinical trials, all under the same protocol. Of those, we have so far reported out results in about 15 cohorts of patients. And there are about 30 additional cohorts that are enrolling in the expanded portion of the enrollment. And therefore, they will report out in the next few months. And when we look at the results so far, by these different cohorts, about half of them have turned out to be negative, about half of them have turned out to be positive. I want you to explain further what I mean by that. But we actually think that even a negative result is important for doctors and patients to know about because we are studying drugs that a doctor could prescribe tomorrow for a patient whose cancer has a particular genomic abnormality. And if we have data to suggest that that drug doesn't work in that setting, we want to get that information out there as quickly as possible so doctors don't use it, and instead, they look for an alternative treatment for their patients. Conversely, when we have a positive cohort, signaling that the drug actually has significant benefit to the patients who are receiving it, we also want to get that information out there as quickly as possible, because these are commercially available drugs, doctors can prescribe them, and if the drug is showing some potential benefit, we want that information to be known so doctors can pursue that treatment for patients for whom it's appropriate. So either way, we think that the results of our study are generating useful information. It's always a little bit more exciting to report a positive cohort, a positive finding than a negative one. But in this case, even a negative finding is informative, because it can steer a doctor away from prescribing something they might be considering, but, in fact, is not likely to work for their particular patient. So as we go along, we will be generating these data and we are hopeful that the positive results will inform guidelines and provide the information that doctors and patients and even insurance companies need to make decisions about whether to use these treatments and whether to cover them, so patients can get access to them.

Dr. Pat Basu: Terrific. I love that you mentioned the idea that the quote unquote negative results were still very valuable because you're exactly right, in such a cutting edge space where doctors are looking for new alternatives, the knowledge that something may not work can often be just as valuable as something that can work. And that being said, I agree with you some of the positives are things that we gravitate towards as men of science and data, I am often cautious to use anecdotes but at the same time they're so uplifting. As you and I have discussed, CTCA has been the largest accruer of patients to the TAPUR Trial. I've met several of these patients, and several stand out to me with their stories. I remember a woman, stage three uterine cancer had several rounds of treatments, including chemo and hysterectomy. Her cancer was relatively stable, and then she joined the trial in 2017. And had remarkable results. I talked to a firefighter in Philadelphia, who had really shared with me his story, he had been about I think 230 pounds and had lost weight on previous trials down to 130. Many times had thought about quitting on his current therapy. And he joined the TAPUR Trial and truly he's made it his life's mission now to talk about this because it has been such a not just life saving but just a transformational event for him. So again, I hate to single out a couple of cases but it's just been so heartwarming to see in a role like yours, Dr. Schilsky, in many cases you're helping lead this. But do you get to hear some of these patients' stories and still see some of these impacts? And if so, can you maybe share a couple?

Dr. Richard Schilsky: Yeah. Well, thanks Pat. I love to hear these stories. And I am a little bit removed from actually seeing the patients on the study myself, of course, because they're being treated all over the country. And I do want to again, compliment CTCA for really being such a fabulous partner in this study and rolling the largest number of patients, taking really good care of them, reporting really good quality data and really helping us advance what we're learning from this. And so it's great to hear the stories, I hear stories periodically from some of our other clinical sites. And oftentimes, it's exactly the same kind of story - a patient who had an advanced cancer, they were told there were no other treatment options, they were able to enroll in the TAPUR Study and get on a treatment that actually turns out to either have stabilized their cancer for a long period of time or actually make the cancer shrink. In rare cases, we've actually seen patients whose cancer has disappeared, they've obtained what we would call a complete remission. That's pretty uncommon, but it does happen from time to time. And when we report out our results, we look at our two major parameters. One is the percentage of patients where the cancer has shrunk or stabilized, but then also, how long that shrinkage or stabilization has been maintained. And that, to me, one of the most remarkable findings in the study, because we've had patients who have continued on their TAPUR treatment for months and in some cases years, when they have previously been told there were no other treatment options for them. I think there's very little doubt that those patients clearly have been benefiting from the therapy, which is great for them, but also great for us to be able to report their information for the rest of the medical community to be aware of.

Dr. Pat Basu: Absolutely. And along those lines, we often talk about the impact of the results of a clinical trial on the very direct sense, what was the result of a certain drug on a certain tumor type. But in this case, one of the things I love about the TAPUR Trial, it's actually the impact it's had on other clinical trials almost serving as a new paradigm or a new model, if you will. Can you share some of the aspects of how along that dimension, the TAPUR Trial potentially has changed some of the future trials that we'll see going forward?

Dr. Richard Schilsky: Well, I could talk about that in two different ways. But let me start with the fact that when we conceived the TAPUR Trial, we wanted it to be easy to implement in routine clinical practice. We wanted it to be as similar as possible, to the way usual cancer care is given. And we wanted it to be as accessible to as many patients as possible. So we did a few things differently from the way traditional clinical trials are run. One is, we really broadened out the criteria that are used to determine if a patient can qualify to participate or not. Typically, known as the eligibility criteria, and oftentimes, they're very restrictive, and they limit which patients can participate based upon how active the patient is, the patient's laboratory data, what previous treatments the patient may have had, did they ever have another form of cancer, all those kinds of things can exclude patients from participating in clinical trials. And we basically cut all those things out of TAPUR. So in our trial, there's no limit on the number of previous treatments a patient has received. It's okay, if they've had a previous different malignancy. It's fine if they have some modest symptoms from their cancer that limit their performance on a day- to- day basis. And we have other criteria that are pretty broad. So we're able to enroll a broad spectrum of individuals. And actually, that helps us gather data about how the drugs in our study perform in the typical kind of patient that gets seen in an oncology practice every day. We also limited the amount of data collection that's required for the study. So that we're only collecting the data that we really need to answer the questions about whether the treatment is working and whether or not it's safe. And that makes it just a lot easier on our treatment sites. It's less burdensome, they have to do less testing, it also makes it easier for the patients of course. So all of those things are wrapped up in our trial and many trials nowadays are beginning to embrace those same approaches. With the notion that clinical trials should be widely available, clinical trials should be embedded in routine practice, clinical trials should be able to enroll really, any patient who walks in the door, who wishes to participate in a trial as long as it's safe for them to do so. So we hope that the example that we set in the TAPUR Trial is really helping to reshape the way subsequent trials are organized. The other thing I'll say is that TAPUR has also inspired a number of other similar trials that are going on around the world. So there is a study going on in the Netherlands and with collaboration elsewhere in Europe that's known as the DRUP Study, D- R- U- P. Stands for Drug Re- utilization Protocol, I think, which is modeled on our study. There's another study going on all across Canada, called the CAPTUR Trial. CAPTUR is an inverted form of TAPUR with a C put into it for Canada. And these trials are enrolling patients in these other parts of the world. There are other similar trials that are launching, one just recently launched in Denmark, one has recently launched in South Korea. And we are reaching out to these other organizations to collaborate with them and to be able to share information across all these trials, so that we can all learn as quickly as possible about which treatments work or don't work for which particular patients. In some cases, we're studying very rare groups of people, either because the type of cancer they have is very rare, or more commonly, because the particular genomic driver is very rare. So the more we can collaborate across the country and across the world, the more quickly we can learn, and we can get answers that doctors and patients can use every day in the clinic.

Dr. Pat Basu: Absolutely. Well, I don't think there's any question about the impact that this is having on clinical care. And as you just articulated so well, on future clinical trials. I for one, I'm very optimistic about the continued growth and potential efficacy of each of these clinical trials. However, there has been a backdrop of so many years where there's statistics that show that 80, 90% of patients who could benefit from a clinical trial sometimes are not able to match into them and the like. But I believe it's a bright new future for clinical trials, and we're going to continue to increase that match rate. You've had such a personal impact on clinical trials, TAPUR included, what do you see as the next five years of the evolution of clinical trials? What should we as physicians and patients potentially be on the lookout for, as we look forward in the next several years?

Dr. Richard Schilsky: Well, as we've discussed, I mean - Clinical trials are and will continue to be the gold standard way in which we learn about whether new therapy is safe and effective or not. And of course, these days, where everybody's tracking the development of COVID vaccines, the general public is learning a lot more about clinical trials, because they keep hearing about the importance of demonstrating that a vaccine is safe and effective. And it's the same for developing a new cancer treatment. We have to be able to show in a rigorous way, with high quality data, that a new treatment is safe and effective in treating the cancer before we unleash it into general medical practice. And that's really the job of the FDA to evaluate new therapies according to those parameters. And there are various types of clinical trials that can be designed to demonstrate that, those endpoints. The traditional prospective, randomized clinical trial where patients are randomly assigned to one treatment, say a new treatment or a standard treatment. I think those are going to continue. But we're seeing a move away from those, in part driven by the successes of precision medicine. As we talked about earlier, when we can identify what's driving the cancer and then develop a treatment that specifically targets that, what we end up with is a treatment that generally is more effective and safer than the traditional kinds of cancer chemotherapy that we've had to work with over so many years. And when a treatment is more effective, it takes fewer patients to prove that it's effective. And we don't always need that randomized control group. Because if it's dramatically better, you can tell that without necessarily doing the randomized clinical trial. So the result of all that is that many newer therapies have been able to be introduced with smaller trials, fewer patients, they get completed more quickly, and we get the answers sooner. And that is moving those drugs more quickly into the clinic. We are seeing the expansion in oncology of what we call basket trials, TAPUR is an example of that, where we can treat multiple kinds of patients with multiple different therapies simultaneously, so that we learn as quickly as possible from all of the patients who are willing to participate in the study. And so I think that's the direction that clinical trials are going in. But I will also say that we have a lot to learn and we're not going to be able to learn everything that we still need to know from doing clinical trials. Because clinical trials are expensive to set up and to complete, and they take time to be done carefully and rigorously. And there are other ways we can get information. So of course, there's a lot of interest now in using what is referred to as real world evidence, where we actually learn by collecting information directly from the interactions that patients have with their doctors in routine care. And by collecting or obtaining information from their electronic health records, and other sources of data, we can learn pretty quickly about how an individual person or group of people is doing on a particular treatment. So I think what we're going to find in the years ahead, is we're going to continue to do clinical trials, they're going to be simpler, they're going to be hopefully more accessible, and maybe less expensive. But we're going to be able to supplement the information we get from clinical trials with real world evidence that is derived directly from patients' medical records, if patients and their doctors are willing to contribute that information to a data platform that then allows us to learn from it.

Dr. Pat Basu: As you mentioned, clinical trials are such a core piece of the future of cancer care, but it's not everything. So maybe we'll end on a similar question. You've had such a personal impact on the future of cancer care, I for one I'm very grateful for your service. For our audience, what excites you? Or what should patients look forward to for the next five to 10 years in terms of the evolution of cancer care at large?

Dr. Richard Schilsky: Well, I want to point to a couple of things. One is, I think many people may not be aware of the fact that there's a significant fraction of cancers that are potentially just preventable, either through lifestyle modification or through vaccination. It's estimated that 20 to 25% of all the cancers that occur each year in the world are caused by infectious agents, mostly viruses, but sometimes bacteria. And for many of those, we have vaccines already available or in development. So if everybody who is at risk of developing those viral infections, like hepatitis, like HPV infection, like other sorts of infections that are known to cause cancer, Epstein- Barr virus infection, that's the same virus that causes mono, also causes a form of head and neck cancer. So if we're able to actually vaccinate everybody in the world who has a viral disease that could potentially turn into cancer, we can eliminate various sorts of cancer, we could eliminate liver cancer, we can eliminate cervical cancer, we can eliminate many forms of head and neck cancer, just by vaccination. But on the treatment front, we've made a lot of progress. I've been in oncology now for 40 years. I've seen that progress with my own eyes over that span of time. Certainly, one of the most exciting things right now, that we are beginning to just see the emergence of, is so- called immune therapy for cancer. We have drugs now that are able to unleash the body's own immune system to fight the cancer more effectively. We have cellular therapies where a patient's own immune cells can be taken out of their body, genetically reprogrammed and put back into their body to fight the cancer. And I'm completely confident that we're going to see a lot more of these immune therapies coming along in the next few years. And one of the reasons they're so exciting, is because although they don't work in every patient, when they do work, they have the potential to produce very long- term remissions, and maybe even cures for patients with cancer. The whole landscape in cancer care has changed dramatically over the decades, it's really accelerated, I'd say in the last 10 or 15 years. And I would fully expect that it's going to accelerate even further as we begin to develop new treatments, new insights and deploying new drugs and technologies to make cancer care even more effective and safer for patients in the years ahead.

Dr. Pat Basu: Well, I certainly share your optimism and your passion. I think that's absolutely right. And immunotherapy is one of the more promising arrows in the quiver from the therapy end that I think, is really going to allow us to round that next corner in caring and taking care of cancer patients. I also love your comments around prevention, obviously timely in the sense that you talked about the importance of vaccines with everything that's going on, with the discussions around vaccines in general. But the more specific topic around how many cancers are indeed preventable, how many of those are preventable via vaccinations or other behavioral modifications is a profound number. I recall this story of these two doctors that are trying to save people down at the bottom of the river, they're pulling them out and one of the doctors runs upstream and the other doctor says, " Where are you going?" And he says, " Well, I'm going to stop patients from slipping into the river up in the first place." And so the power of prevention is something that has certainly taken hold in many other areas of medicine, including cardiovascular care, but I really agree that we will certainly make great strides in prevention and in just the public health aspect, if you will, of cancer care in the decade to come. So Dr. Schilsky, thank you so much for those insights. Thank you for the tremendous work that you've done across the gamut in the battle against cancer. Thank you for taking the time to come on the show today. I really enjoyed it and appreciate it.

Dr. Richard Schilsky: Always a pleasure, Pat. Thanks for inviting me on today. It was great.

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