Alicia Morgans: Hi, my name is Alicia Morgans, Associate Professor of Medicine, and GU medical oncologist at Northwestern University. I am so happy to have here with me today, a colleague and friend, Dr. Matthew Galsky, who is a Professor of Medicine at the Mount Sinai hospital and the Tisch Cancer Institute, and a GU medical oncologist of course as well. Thank you so much for joining us, Matt.

Matthew Galsky: Thank you.

Alicia Morgans: Wonderful. We have been talking to a lot of people around the world about how COVID-19 has affected their clinical practice, their research enterprises, and all that lies in between. And I'm just wondering from your perspective, how have you seen things change in your clinic? And we can focus, I know you do a lot of your work in bladder cancer. We can kind of focus on that population.

Matthew Galsky: So we've seen things change dramatically and quickly as have I think a lot of centers. We had started to experience changes in our outpatient volumes I think around the second week of March as patients correctly so became increasingly concerned about traveling in for visits and the risk of exposure. And so at around that time, we started to ramp up our telehealth capabilities and started to do a lot of visits through telemedicine. So that's been one major change.

A second change has been the impact on treatment decisions. And we can talk about that more specifically, but in patients who are making the trip into the center, weighing the risks versus benefits of systemic therapy, of course, is complicated in this environment.

And then the third major change that we've seen on our impact has been on clinical research. And we had decreased or put a lot of our accruals on hold, a lot of our trials on accrual hold for a period of time where we kept open some select studies that we thought were really important to have open to limit the burden in terms of our clinical research teams. And maintaining those studies in minimizing exposure of our clinical research team to potential infected patients. So those have been really the three major areas of impact.

Alicia Morgans: And those are huge areas. And one I really want to dig into a little bit more is the change in treatment choice and maybe you haven't changed, but some of the changes in treatment selection for systemic therapies for bladder cancer, both in the muscle-invasive setting. So when we think about things like neoadjuvant chemotherapy and certainly trials that are doing neoadjuvant immunotherapy. And also in the metastatic setting where we have options for treatment. How have you noticed that any of your conversations around treatment choice have changed with your patients?

Matthew Galsky: So the neoadjuvant treatment discussions are at baseline complicated discussions as you well know. Speaking about the theoretical risk of micrometastatic disease and weighing that against the potential risks of systemic therapy itself. And so at baseline, those are complicated conversations when you throw in this variable in terms of the potential for increased risk of poor outcomes, should someone get infected in an immunocompromised state that obviously makes the discussion even more complex.

And then you throw in the variable that for patients with muscle-invasive disease, there could potentially be an impact on delays to surgery while operating rooms are not being used or not being used at their full capacity. So these conversations have become much more complex in a very short period of time. And I would say that the ultimate decision to pursue neoadjuvant therapy in the muscle-invasive setting has been variable based on how a patient views those individual variables in the risks versus benefits although we have continued to recommend that treatment, acknowledging that there could be some increased risk if one were to get infected with COVID. And I think the proportion of patients who have opted to proceed with neoadjuvant therapy in that setting has decreased a little bit, but not markedly so.

Alicia Morgans: I think that's really important for everyone to hear and to think about. And I would say the risk of delaying surgery because you don't have access to an operating room may also be offset by proceeding with systemic therapy or at least in patients' minds that may be, "I can't get into the operating room now anyway." I might as well do this. And certainly, we would advocate for neoadjuvant chemotherapy anyway.

As I think about the metastatic setting for cisplatin patients at least we've still encouraged patients to move forward with their chemotherapy. I'd love to hear your thoughts there, but I wonder also about that conversation around patients who maybe are borderline eligible for carboplatin, but then also may stay in high for potentially having high PD-L1.

What are your conversations there or are they affected by COVID or not? So what are you thinking about in the metastatic setting?

Matthew Galsky: So there's been this narrative evolving that immune checkpoint blockade is safer in this context than chemotherapy. I think we're really operating in a minimal data zone. I don't know that we know that definitively. On the flip side, there have been concerns raised about the potential long toxicities of immune checkpoint blockade, difficulty differentiating that from COVID at least initially. And then the potential complexities of getting an infection in the context of compromised lung function or being on steroids. So again, very complicated, a lot of variables involved and no data.

In that patient population at baseline, I feel that immune checkpoint blockade is really an appropriate treatment. So it hasn't really changed my discussion for a patient like that. I will say that for patients who are considering chemotherapy versus immune checkpoint blockade, you might have a rationale to pursue either approach.

That has been a discussion in terms of the impact specifically of the viral pandemic on the potential morbidity and mortality that might be incurred with one of those treatments versus the other. So I've had some patients really come in wanting immunotherapy instead given the concerns about being immunocompromised in this context from chemotherapy, rightly so.

Alicia Morgans: It is really a complex decision though because we know that chemotherapy for patients who are eligible ignoring the potential response or ignoring the PD-L1 status for example. Chemotherapy is what we try to advocate for. When cisplatin is an option for patients, we definitely advocate for that. And we don't know what the implications are of checkpoint blockade complications in the setting of COVID-19 infection.

We have, as far as I know, no evidence on that at all. We do have some information that steroids don't seem to help and may potentially be harmful. And severe colitis and hospitalization in a patient who has COVID-19 to me sound like a very complex and challenging clinical situation to potentially deal with.

So I think it's really important and I appreciate you acknowledging that we just don't have data to guide us and sometimes our fears help to make those choices. But right now these are not choices that we can make that are entirely data-driven.

Matthew Galsky: And I would say that as a whole, despite those nuances that we discussed, as a whole, I think most of the treatment discussions and ultimate decisions are similar to prior to the viral pandemic. So as a whole, I would say perhaps the bigger concern is the patients that we're not seeing in the potential delays in diagnosis, in the potential advance stages of disease at diagnosis that we might be encountering over the next six months. And I think that might have even a bigger impact than some of these more nuanced treatment decisions that we're making today.

Alicia Morgans: I completely agree with that also. And I don't know what your clinic has looked like, but our volume of patients being diagnosed with muscle-invasive disease has gone down pretty dramatically. So I'm making very few of these choices and metastatic disease the same way. And I do worry that in the next six months we're going to see people come to light who have had delays with that diagnostic algorithm because of fears of engaging with the healthcare system.

Because these patients don't necessarily present very rapidly in the first place. And we know that there are delays, particularly in women who develop hematuria that people think, "Oh, it's a urinary tract infection." Or in men, it could be a kidney stone. So there might be a lot of expectant management that's happening in the outpatient setting with primary care with other providers, which ultimately will lead to these patients coming to light later. And so I think that is really an important thing to acknowledge.

Matthew Galsky: And it's this really tight balance in this tight rope that we're walking right now in that we can't minimize the risk of this infection. It's killing way too many people still on a daily basis. At the same time, our patients who have advanced neurologic cancers are still going to be there after this infection, ideally is in the past.

And we're still not going to have the definitive answers in how to address those illnesses in the best way that we can. And so I think that we have to be very careful not to divert all of our attention away from our cancer patients and our cancer clinical trials, and continuing that progress.

Alicia Morgans: So speaking of clinical trials, we know that there have been many trials in bladder cancer, neoadjuvant setting, muscle-invasive disease, very advanced disease, all kinds of combinations. You have been very, very involved with the rapid rate of progress in this setting. And as you mentioned, one of the things that has been so affected by COVID-19 has been our trials and really having to potentially in some settings close all new accrual to trials or to a few trials for patients who may not have other good options, and minimize the trial portfolio overall generally in most centers if not all centers.

So how do you see this affecting progress in bladder cancer specifically and how is your center thinking about trying to get back into the swing of things as we see things peak and resolve a little bit knowing that we probably will have some level of COVID-19 simmering with us for the foreseeable future?

Matthew Galsky: So I think things have been and will be impacted in a negative way, which I'll touch on. But I do think that there's a potential silver lining here as well. So the silver lining first, I think that this has shown us that doing things differently is possible. And what I mean specifically are things like the rapid adoption of telehealth. We published a small pilot clinical trial about three to four years ago where the trial was completely done by telemedicine. Aside from the first visit, it was a trial in patients with rising PSA with prostate cancer. And at the time we really did that study because of recognized geographic barriers to clinical trial accrual. But I think that there are much broader implications adapting those sorts of technologies to do things in a new way.

And so I think that we can take some lessons away from this and not do things simply business as usual. Understand what regulatory practices and procedures are absolutely necessary and contribute to patient safety and which ones don't. And perhaps adapt some technologies that make the process more efficient both for patients and for physicians. So that's a silver lining part.

The downside, of course, is the impact on trials that are ongoing, in which the timelines will likely be off. And the second of course is trials and development, which will potentially start later, potentially not started all in some circumstances based on the shifting landscape, financial considerations, et cetera. So I do think that there's going to certainly be a negative impact in the short term.

We held accruals on a large number of our cancer clinical trials as things were really reaching the peak. And as we passed the peak, at least here locally, we're really looking to ramp back up and do so slowly. And so we're just discussing which trials are the priorities to reopen to accrual within the next week. And we'll probably look at this on a week-by-week basis and ramp-up in that way.

And as we ramp up both our clinical operations and our clinical research operations, it's going to be doing that in a new way, of course. Making sure that the waiting rooms have adequate space for social distancing. Making sure that our clinical trial procedures are such that we minimize visits that aren't absolutely required, these types of things.

Alicia Morgans: Well, I think that they all seem like good strategies and I wish you and your team a lot of luck in the progress that you're going to make reopening gradually over time. And certainly, luck to those patients who are engaging in those trials.

So thank you so much for sharing your perspectives and your thoughts on COVID-19 in your clinical practice. Stay safe and we wish the best to you and everyone there in New York.

Matthew Galsky: Thank you, you too. Stay safe.