Alicia Morgans: Hi, this is Alicia Morgans, Associate Professor of Medicine and GU medical oncologist at Northwestern University in Chicago, Illinois. I am so honored to speak today to Dr. Charles Drake, who is a Professor of Medicine and Urology, and the Head of GU Oncology at Columbia New York-Presbyterian in New York City. Thank you so much for being here with me today.

Charles Drake: My pleasure.

Alicia Morgans: Wonderful. So, Dr. Drake, we are talking to folks around the country and around the world about how the COVID-19 pandemic has influenced their practice of GU oncology, their practice of oncology generally, and how it's influenced clinical trials, patient care, all of these things. And we're so grateful to speak with you. Can you tell us a little bit about how you and your team have been influenced by COVID-19?

Charles Drake: Well, it's interesting. I mean, so in New York City, the pandemic came on fairly quickly and very much like a large wave. And it was interesting when it first started, it didn't look like the numbers were going to be so overwhelming. So we had a meeting where we decided which trials we would keep open. So at first, it looked like we were going to be allowed to keep some trials open to accrual. So what we did was we picked trials that were for patients who really didn't have other treatment options.

And the other thing that was clear was that they were going to be closing the operating rooms. And that's because they were going to need the operating rooms for patients who were going to be intubated. And so what we decided we would keep open our neoadjuvant trials to try to keep patients treated, right? And then we tried to keep open a couple of our end-stage trials so that patients who had no other treatment options could continue to get treated. That lasted a total of about seven days. And then the cancer center of the hospital, in fact from the top-level closed down all trials to any new accruals actually. So for a while, it looked like we would be able to maintain in a reasonable way, but that didn't last very long.

Alicia Morgans: I can imagine. And I'm glad that you and your group were able to pivot at that time. Certainly, when it came to trials, I think that that's probably, that is not unlike many, many sites across the country. When it comes to practice, did your team convert many teams to telemedicine, and if you did, are you thinking now about how to I guess move into the next phase now that New York is hopefully plateauing, and this may be a longstanding issue in terms of having social distancing and the risk in our clinics.

Charles Drake: Yeah. So we pivoted to telemedicine for nonessential visits. This works in my opinion really well for patients that you know and that you can get a sense by talking to them through your iPad or through your iPhone where they are clinically actually.

For new patients, it really works very, very poorly. But we do that actually. So we've switched all our nonessential visits to telemedicine, but we still have a lot of patients, a fair number of patients who are in active treatment, getting new adjuvant chemotherapy for bladder cancer, getting ongoing immune checkpoint blockade for kidney cancer and we actually kept our clinic open to treat those patients.

We put in place in the lobby, it was a fairly extensive effort, a screening team of nurses and NPs where they take everybody's temperature, they query them for COVID questions and then they can do a rapid COVID PCR so the patients can come back the next day if they have any symptoms. So I would say we had a two-pronged approach. One is to try to move nonessential visits to telemedicine, but also for the patients who had to come in, to do our very, very best to make sure that they were safe and not likely to infect each other or be infected in the cancer center.

Alicia Morgans: That's great. We are hearing from a few centers that they've been able to incorporate the rapid testing into their algorithms, which are largely for some centers that don't have as many tests really for patients who are going to be receiving chemotherapy or immunotherapy on the day of that visit. I imagine and I hope that our center will be moving in that direction. Have you found that test to be useful, and how commonly can we trust a negative on the rapid test? Do you know?

Charles Drake: So I guess I misspoke a little bit. The test that we're doing are the standard Roche PCR, the rapid test. So we have a lot of patients at Columbia and NYP. At one point we had 700 COVID patients in the hospital, greater than 200 on vents. And so our pathology department based on that got a lot of experience. And what they did was they first implemented the Roche PCR test. The Roche PCR test is very, very sensitive and specific. It's a very, very good test. The only reason you get a false negative on the Roche test is when you don't swab the brain, so the Roche test is very, very good if you swab very deeply.

All the other tests actually have a lot of noise. Honestly, at least in our experience, they've piloted about four or five of the different rapid tests, and eventually, they chose one. It's in the process of being certified with New York certification. So in New York, there's a second layer of certification beyond normal certification. So we'll have a rapid test soon, but actually what we have to do is we have to have patients come in, either be willing to wait for the four hours that the PCR takes or to just get that test and then come back on a subsequent day. But I can tell you that obviously my experience, the qPCR test is pretty accurate. The only time it gets a little dicey, I don't know if people know the science, but the way it reads out is by cycles, a CT, the threshold cycles and the number you choose for negative is arbitrary, right? So for us, it's 40, right? So say you have to have somebody who's 42, okay, well then they're negative. What if they're 38 and then 41 or something? So I think that's one of the challenges we have as we try to bring COVID patients back into the cancer center.

Alicia Morgans: That's really interesting. And I'm hopeful that as you and your internal team continue to use the test and more and more patients come through, you'll be able to, I guess identify, it sounds like you have identified 40 but really feel more confident in that threshold. But that's a really interesting issue that you raise and that all of us are going to have to deal with. It's also really important and exciting that you're able to turn that test, not the official "rapid test", but that test around in four hours.

Charles Drake: That's because they keep running it constantly. They just keep running it and running it, honestly.

Alicia Morgans: That's great. That's helpful for you because I think in many centers that are running PCRs, that's usually, at least the centers are saying it's a 24-hour turnaround and we know it doesn't take that long to run the PCR. But by the time they get enough samples to run the batch, maybe that's what it is. And unfortunate that they're running so many samples, that we would not wish for you, but I am glad that you're able to get that result in four hours give or take. That's not bad. So are you continuing to treat a number of patients then with chemotherapy and immunotherapies? Are you making any different treatment choices in your clinical day-to-day?

Charles Drake: Yeah. So patients who started a course of neoadjuvant chemotherapy for bladder cancer who are being treated with immune checkpoint blockade for kidney cancer or patients who were on chemotherapy for prostate cancer, we actually have continued to treat them using the precautions that I mentioned recently. Making sure that they're asymptomatic, afebrile, and if there's any chance of them being positive, being qPCR tested so that they're not positive actually. So we continue. The only one thing that we did actually use, the on-cell half-life of the anti PD1 antibodies is well known for nivolumab. It's not as well-described for pembrolizumab, but I'm sure it's the same. So some centers have increased their intervals for dosing as long as six weeks. We haven't gone quite to six weeks, but anybody who's on anti PD1, nivolumab, KEYTRUDA®, pembrolizumab, we switched them to a minimum of four weeks. So that's the main change we've made actually.

Also, when you're doing neoadjuvant bladder cancer, the standard is around four cycles. Sometimes if the patients, our surgical suites are not open, our surgical suites won't be open for another two to four weeks actually. And so, maybe considering another cycle of chemotherapy in that setting where you normally would feel pretty happy with three, maybe four. So that's how we've adapted it.

But I can tell you what's happened, it's interesting, is I suspect other centers have done this. So, Columbia has put into place this policy where there's no visitors, no guests, no visitors, no nobody, right? And this is for all the floors throughout the entire hospital and also in the cancer center. And so frankly, although it's a little bit tough for patients, what it does is it makes the place a lot more empty, a lot more streamlined, and we actually can get patients in and out a little bit quicker than we used to. So I know it's not as patient-friendly as it used to be, but frankly, in these times when you're trying to just get patients in, get them treated and get them out, it kind of works actually.

Alicia Morgans: Well, I'm really glad that you're finding efficiency. I imagine that many centers really are feeling the same. It's like a ghost town in waiting rooms at least where we are. And people, especially with telehealth visits intermixed, people are running, at least my clinic is running much more on time. So you're right. I do think the efficiency is better.

I'm sure it's hard for patients, especially inpatients who can't have people with them but finding a silver lining has always been a talent of yours. So I'm glad for that. So as you're looking to the future, you are really quite talented at taking, translating things that you're doing in your laboratory, whether it's immunotherapy or something else, and translating that into clinical trials to try to get treatments to patients rapidly. As you're looking forward, and understanding that COVID-19 may be with us in some degree or another for some time in the future, what are you thinking in terms of your trials and moving those discoveries from the bench to the bedside?

Charles Drake: That's a wonderful question. So we have opened a trial where we discovered in the lab that after castration prostate cancer cells, the ones that are left behind make interleukin 8, IL-8 for a long time. And this sets up a negative immunosuppressive tumor microenvironment. So we have a trial, it's a great trial where patients get anti PD1 and anti-IL-8, and a short course of hormonal therapy. And I have to tell you, it was going really, really well before the COVID crisis, right? We did convince the patients who are on trial and we kept enough of our clinical research staff open to continue to treat the patients who are on trial during the crisis. But we're looking forward to reopening the trial and completing it, right? But that's the part that's the challenge, right?

So it's easy to, maybe not that easy, but it's relatively easy to say, look, no visitors, no guests, we're closing down enrollment to trials, easy, right? But the other side, the ramping up side is a little bit more logistically challenging. So I'll give you a silly example, but it's true. So all our nurses, not all, but many of our nurses and NPs got redeployed to floors to take care of COVID patients, right? So as we go to open up our trials, we have to bring those people back. We have to get the physical plant, fire it up again, and things like that. So I'm actually concerned about what the pace will be about, reopening our clinical research and enterprise and then also, I mean this is not a secret, Columbia, Cornell, actually are the two of the hospitals in New York had the most cases. So we have to also convince the patients that it's okay, it's safe again.

I have to tell you though, in my experience in the outpatient setting with the testing procedures, the screening procedures that we put in place, we have really not any clear documented cases of patient-to-patient in the cancer center or patient-to-doctor or within the cancer center at least actually. So I think that our policies are good and I feel confident when I talk to patients and they say, "Can I come back in?" I'm like, yeah, wear a mask, wash your hands, wear gloves, and if you have any symptoms we're going to test you and send you home and come back the next day. But I think it's been okay so far, but I think getting back up to full strength is going to be a little bit of time. And I think it's going to be the same for everywhere. I mean when you talk to patients, I mean there are patients, they of course vary, but some patients are absolutely terrified. Like, "Oh my gosh, I'm not going to your place. It's a cesspool of COVID patients," right?

Other patients are like, "Talk to me, tell me what it's really like," and you say, "Listen, wash your hands wear a mask, be very careful, stay six feet apart," and they'll come in and do fine actually. So I think it's going to be a challenge, not only for us but also for other New York institutions. Maybe not as much, where the density of cases isn't as bad actually. But it is something we're worried about right now.

Alicia Morgans: I am so happy to hear that you have not had any patient-to-patient, patient-to-physician transition, and that your policies are working. And I get the sense that they're working where I am, and actually at many places around the country, if not the world. And I also, I was speaking with another GU oncologist just the other day. Oliver Sartor for example, about how our GU patients actually seem to be doing pretty well. And when we think about the risk-benefit, especially when patients don't have a lot of other good options, clinical trials are really recommended for a lot of our patients, as for some the best option in certain situations. And so recognizing the real risk-benefit ratio is something that I think we're going to get better at doing and will be able to hopefully communicate to patients. It's because like you said, it's not just us feeling comfortable and confident that we can move forward in these ways, but really the psyche of the patients is going to be critically important as we do that as well.

Charles Drake: I have to tell you that I totally agree with you actually. So this is a discussion I've had with patients at least three or four dozen times over the last couple of weeks. So they launch into this basically fear-driven discussion of COVID and basically based on what you see on television and things like that and numbers of cases, it's not unwarranted. But if you have a metastatic castrate-resistant prostate cancer, the chances of dying of that prostate cancer are very, very, very high. Even if the chances of contacting COVID, nobody knows the exact number, but it's certainly not 100% and even if you get it, the chances of dying are less than 50. I mean that's actually in the general population within the United States, the chances of dying, which if you contact them, COVID is going to be in the 1%, half a percent range actually.

And so, when you think about it numerically, the chances of your cancer being dangerous or hurting you versus the chances of COVID hurting you, for patients who have advanced disease, the equation is really in favor of treating your cancer, actually. And I've had this discussion many times and usually most patients, they get the logic, they understand the importance of that the cancer is really a thing, not a theoretical thing and they need to take care of it. But not always. Actually, there are patients who are just, I mean they use the word, they use the word terrified. I'm terrified of COVID. I'm like, okay, maybe you should be a little more terrified of your cancer, but it doesn't always work that way.

Alicia Morgans: Well, I wish you luck as you continue to try to counsel patients and I have a feeling they feel quite reassured when they talk to you, and as they see time go on and they see everybody having to get back into things, I hope that they're going to make it back to your clinic because I'm sure that they will. We don't always have a choice in these things. So I look forward to them returning, getting onto your trials, you helping them, and certainly everything getting back to wherever it needs to be to get the best outcomes for our patients. As we wrap up, do you have any, I guess parting thoughts for the listeners?

Charles Drake: Yeah. The one thing that I think that folks who are in this are listening to this from other cancer centers is that the one thing that we did well was a woman named Maura Abbott who's a nurse practitioner who's involved in managing the outpatient center. She was the one who pushed hard to put in place this screening process so that patients who are coming in for treatment to our treatment center or to our outpatient center are really very carefully screened. That was really a huge, huge plus and if people aren't doing that, I think that they should think about it.

I think that going forward the challenge will be how to understand what to do in the future as the whole hospital opens up again, but I think that that was, really on her part and on the cancer center's part, one of the few good strong policy moves that we made that worked.

Alicia Morgans: Well, wonderful. I'm glad that it worked. I'm glad that screening has been really working out well for you guys and as I said, that four-hour turnaround is phenomenal. I know it's driven by so many cases, or at least by so many tests, but I hope that we all can get it to a place where we can test patients and treat them if we need to on the same day. Because that's something that will make a really big difference in our decision making and our comfort with proceeding with some of these therapies. So I appreciate your time so much and I wish you all the luck as we try to get back to normal and continue to deal with COVID.

Charles Drake: Well, I thank you very much and thanks, it was great talking to you.