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May 30, 2020

In today's episode, we hear from Dr. Derek Raghavan, an internationally renowned cancer researcher and medical oncologist.  He is President of the Levine Cancer Institute in North Carolina and professor of medicine at UNC Charlotte.  Dr. Raghavan discusses the critical decisions that his institution took regarding clinical trials, and safeguarding patients and staff during the pandemic.



ASCO Daily News: Welcome to the ASCO Daily News Podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. It's an honor to welcome Dr. Derek Raghavan to the podcast today. He's an internationally renowned medical oncologist, and President of the Levine Cancer Institute in North Carolina, and Professor of Medicine at UNC Charlotte.


Dr. Raghavan is here to talk about swift and comprehensive action that the Levine Cancer Institute took to safeguard patients and their treatment during the pandemic, and the critical decisions that were needed regarding clinical trials and other issues in cancer care.

Dr. Raghavan reports no conflicts of interest relevant to this podcast. Full disclosures relating to all Daily News podcasts can be found on our episode pages. Dr. Raghavan, it's great to have you on the podcast today.


Dr. Derek Raghavan: I'm happy to be with you, Geraldine.


ASCO Daily News: You wrote a very interesting editorial in JCO Oncology Practice recently about the Levine Cancer Institute's approach to caring for patients during the pandemic. What aspects of your approach have proven to be the most successful, and what have been the most difficult areas to manage?


Dr. Derek Raghavan: That's a complex question, Geraldine. What I would say is that we've done a lot of things all in synchrony. And maybe I could back up and say that the way we formulated this was starting with the literature search, which, back in January, was pretty empty. But then we were able to develop teleconferences with physicians in Wuhan and in Taiwan, and then participate in international conference calls for people from around the world.


And then in addition, one of my colleagues, Laura Musselwhite, who, prior to becoming an oncologist to work with Tony Fauci and Doctors Without Borders in pandemic and epidemic management, they all-- all those factors came together in helping us to formulate a game plan. So essentially, what we did was recognize that the object should be protection of patients, families, and hopefully staff as well.  And that we should maintain our management of cancer, but keeping in perspective that there was a new big kid on the block, meaning coronavirus, that we had to be very mindful of. And so our strategy was predicated on social and physical distancing, ensuring that our staff and patients were masked early, that we did a very careful cost benefit analysis on each treatment that we did, and if there were treatments that would have modest gain, if there were visits that wouldn't really require patients to be here.


So, for example, the well follow up visit for a potentially cured patient with prostate cancer, that might easily be done on the telephone, at least for a short period of time. Our surgeons looked at their caseload and identified cases that had been scheduled largely for convenience or to get it done. And, you know, you obviously don't want to leave cancer sitting around, but there are primary cancers that are relatively low malignant potential.


So we deferred some of those surgical procedures. In my particular area of interest, invasive bladder cancer, one of my areas, we decided that we'd work on local control first. So we would get a quick cystectomy done and be prepared to use adjuvant chemotherapy at a later time, rather than our conventional approach, which is to use frontline intravenous chemotherapy first.


So the whole concept was predicated on the idea that if we did this well, the coronavirus would be around for a couple of months, would hit a peak, and then start to diminish. And we were hoping that perhaps an active treatment would come up, perhaps a vaccine would become available. So it was basically a question of deferring and delaying as long as it was reasonably and safely possible.


ASCO Daily News: Right. And how about clinical trials? That is a very complex area to manage with some critical questions that have been asked very quickly after the pandemic struck. How has the Living Cancer Center handled clinical trials?


Dr. Derek Raghavan: Yeah, that was probably one of our most challenging areas. As a baseline, I should say, we see about 18,000 new patients to the year at 25 sites. And we put patients into various trials at the level of about a little more than 1,000 patients a year, so we're pretty active in the clinical trial space.
So the way we thought through this was a number of things. Number one, you have a responsibility to the conduct of the trial. All the patients who have already subjected themselves to that trial, we owe them for having done that, and we can't muck up the trial.
On the other hand, there's a responsibility to the new patients to ensure that you're not putting them in harm's way unnecessarily. The bang for the buck for many phase 1 trials is rather modest. So we thought very carefully about whether patients should be entered in phase 1 trials, and we've actually run those down very substantially.


We have a couple of phase 1 trials where patients have been showing good response in the hematological malignancies. We've seen some dramatic improvements among patients in the 50 or 60 CAR T treatments that we've done. And so where patients are unequivocally benefiting, and our CAR T menu has mostly been for pre-treated disease, we have continued on putting in as many protections as we possibly can.


Where there's been the need for a clinical trial violation for patient safety, our approach has been to contact the sponsor of the study and the principal investigator, discuss with them the options of treatment, and, of course, always be fully transparent with the patients so that they know and understand what's doing.
The coronavirus will be with us indefinitely. It will be problematic until we identify either a treatment that takes care of it or an immunization or a vaccine that prevents against it. And the thing that's scary is there is no known immunization or vaccination available, and there's no defined treatment.


Remdesivir is a drug that is being trumpeted as potentially a good drug, and maybe time will prove that to be the case. One of the less pleasing aspects of this recent three month period is the number of false claims that have been made starting at the White House and meandering out through the medical profession. People are claiming all sorts of silly things that are just not proven by data.


ASCO Daily News: Well, as you say, the health crisis looks like it could go on for months in the absence of a vaccine. What are the longer term concerns for cancer care?


Dr. Derek Raghavan: Well, I think, you know, it depends how you think about it. If you go back to 2008 when there was a huge financial crisis and lots and lots of people were losing employment and being unemployed for a lengthy period, what has been published and is quite clear is that for a period of about a year in 2008 and thereabouts, people deferred and deflected early diagnosis and treatment of cancer.


And there was no question that there was a worldwide substantial increment in deaths from cancer. In this situation. It's a little different. Hopefully, the fact that America is gradually opening up its economic situation will mean-- and I'm not an economist, so I'm not predicting, I'm hoping, that the economy will start to rally, and the people will be employed, and we'll be able to continue on with the best type of healthcare.


There is, of course, the risk that people being frightened of coronavirus will cease coming to the hospital, will stop having treatment, and that, in people with dangerous malignancies, will probably result in increased deaths. I think what the medical profession is trying to do as assiduously as possible is to encourage patients with risky disease to follow our lead and let us treat them when it's important to do so.


We've reassured people without dangerous forms of cancer that a little delay is reasonable. But the truth is, this has been with us for only four months. We actually don't know what the long term consequences will be. I think it's fair to say that there will be a second surge and maybe a third.


Hopefully we'll be a little bit more ready this time than we were over the last months. And hopefully politicians on both sides of the House will learn that truth telling is important for the benefit of the population. The lies about availability of testing, the lies about the lack of shortage of personal protective equipment were egregious and were harmful.


I think America has recognized that antigen testing is important and we need to have the equipment available, that personal protective equipment is essential, and that we need to have a game plan. In Charlotte, in Atrium Health, I'm glad to say that we thought through this. We benefited from the experience of other centers.


And so we were ready for a crisis that, to this point has not yet materialized. We are surrounded by several southern states that I believe are opening way too soon, and I'm concerned that that may, in fact, have an impact on the health and well-being of the population in North Carolina.


The good news for us is that we are continuing to observe social distancing and masking. We're paying careful attention to testing as much as we can. And at Levine, we've actually started a project looking at the significance of positive antibody tests. So I hope that all of these things put together and all the other centers that are working in this space will lead to a safer environment if a second or third surge occur this year.


ASCO Daily News: Well, speaking of the health and well-being of patients, how have your patients responded to the increased anxiety caused by the pandemic?


Dr. Derek Raghavan: Well, I think they've responded generally well. I think we've been very careful to try to do as much wraparound to support our patients as possible. So one of the things that we've done is to create an on/off system. And the thinking was that we didn't want to get in a situation where all our workforce could be potentially off work with COVID virus.
So we set a two team system approach where my teams rotate for 14 days on the line and 14 days working from home. In the bone marrow transplant setting, the 14 days consist of a week on the BMT unit and a week in the clinic, and then they rotate to be at home.


And then at home, they're actually doing virtual consults and phone calls, Skype interactions with patients who have been discouraged from coming to the hospital. So in doing it that way, we're providing an awful lot of social support. Atrium Health, my healthcare system, is a big system. We see about 12 million encounters a year. We have, I think, 40 hospitals and about 60,000 staff.


So what we've done is created a hospital and home system. No credit to me whatsoever. This was the Atrium Health team. And so they have level one, which are people with known coronavirus on testing who are well. And they have a hospital nurse who just checks with them by phone each day.


Level two is people who have clinical symptoms and known coronavirus, and they have a paramedic who visit them, check them, do pulse ox, and various other tests each day. And then level three, they're in the hospital. So with that planning structure in place, we've done an awful lot of virtual work, and in so doing, have been able to provide additional support.


Our supportive oncology team, we have a very heavy commitment to cancer rehab, support of oncology, survivorship activities, integrative cancer medicine. All of those people have been doing their work virtually. And interestingly and unexpectedly, we've found that if you talk to people around the country, the cancellation rate for supportive oncology is higher than most other active treatment domains.


What we've found is, offering virtual consultation, the cancellation rate has plummeted. And so our thinking is that we'll probably do a lot more virtual work in the field of supportive oncology, because patients seem to love it. They like the fact that they can have the interaction without having to jump into a car and go to the hospital and so on.


ASCO Daily News: Right. So that's very interesting. You know, in terms of telehealth, do you think this is a practice that has been adopted during the pandemic that will outlive the coronavirus and potentially change cancer care in the future?


Dr. Derek Raghavan: Yeah. I actually do, Geraldine. And I think the new normal will be quite different. And I think the piece that we need to be careful about is, virtual consultation will not be the answer to a maiden's prayer. It's going to be terrific for some people. It'll be a wonderful way of following well patients.


Let's imagine someone who does well patient visits three times a year. I think you could very reasonably do two of them virtually. But I do think that physical proximity and contact, as part of the medical service delivery, is important. You know, it is important to examine the contra lateral breast of a woman who has been treated for breast cancer surgically.


It is important to be able to analyze, clinically, a prostate, or to do a rectal exam in someone with colorectal cancer, and to actually auscultate for the patient who's had lung cancer and listening for wheezes. You know, CT scans are amazing, and so are mammograms, and all of the tests that we have. But there is still a relevance of clinical examination.


And we don't yet know, nobody does, the amount of misdiagnosis that will happen from a virtual consult. The assumption that it's only a good thing, I think, will be a mistake. And so what I hope will happen is that people will do structured evaluations of virtual consultation to learn what sort of things happen that lead to mistakes. How much of the virtual consult ultimately leads to the patient feeling abandoned? We don't know any of the answers to that, and it's work that will need to be done.


ASCO Daily News: Right. So let's focus on staff. How are you supporting staff and addressing the issue of burnout? We've all heard about the very distressing news of a doctor, an ER doctor in New York, who very tragically, sadly, took her own life. And there are similar stories, and there will surely be more stories like this in the future. How are you addressing issues of burnout and distress among your staff?


Dr. Derek Raghavan: That's a crucial issue. And you're absolutely right that that has been nationally an issue. So I think I'll take my answer in degrees. The first thing I would say is I edited a broadsheet called HemOnc Today, and my recent editorial was entitled, "How Many Mistakes Does it Take to Kill a Population."
And the point of that editorial was to say-- it was really a rallying cry to the politicians on both sides of the House to say, tell the truth, and support the population, and don't do stupid things that will kill people. At a more local level, I think societies like ASCO are doing a wonderful job in providing information, providing support sites, giving information about how to manage burnout and how to manage COVID.


And so I tip my hat to the professional societies for doing exactly what they need to do, and would encourage people to take a look at the ASCO website, because there's a lot of great information there. And then at the very local level, what we've been doing is a bunch of stuff. My clinical leaders have all stepped up to the plate.


Every one of us is in the hospital. We're there with the frontline staff. We're seeing patients. We're taking the same level of risk. And I think that's very important for the troops to feel like they're part of a team that's working in an integrated fashion.


My leadership group does a weekly video session that is sent to every member of the Levine Cancer Institute that gives them an update on the statistics on what's happening, how much longer, when are we going to reentry, why we're doing the things we're doing. We provide copies of information that's out there. So our paper in JCO Oncology Practice on the sort of standard approach that we've taken is available to all our staff.


We've actually run-- and this has been done, actually, through Atrium Health, rather than just through Levine, we've run explicit sessions on burnout run by a clinical psychologist, whose focus for the last 20 years has been burnout in professionals, Dr. Wayne Sotile, who happens to live in the Charlotte area, and he's run some really useful sessions on burnout, both for medical staff and their family members.


People need to know what's happening. They need to know that you have their back. So when we first heard that there was going to be a shortage of personal protective equipment, my team, led by Dr. Jane Chai, one of our oncologists, actually developed a 3D printing enterprise where we produced thick plastic facial masks to add to the production of the kind of second rate floppy masks that we had.


People felt terrific about having that available, and they scaled it up. They actually developed these with help from a high school 3D printing unit and a local university unit. We were able to supply the ICUs of the medical center with some of these masks.
So when people know that they're taking their fate into their hands, it actually helps a lot with the fear and burnout. And I also think that the rotational system, two weeks on, two weeks off, has helped a lot of the fatigue. Because while the people at home have been working hard and doing virtual consults, they're not sitting. They're experiencing the danger of contracting a virus that could end you up in the ICU.


ASCO Daily News: Well, I want to thank you, Dr. Raghavan, for sharing your excellent insights with us today on the ASCO Daily News Podcast. Please stay well and we will check in with you again soon.


Dr. Derek Raghavan: Nice to talk to you, Geraldine. Thanks very much.


ASCO Daily News: And thank you to our listeners for joining us today. If you're enjoying our content, please rate and review us on Apple Podcasts.

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.

COI Disclosure: 

Dr. Derek Raghavan

Consulting/Advisory Role: Gerson Lehrman Group, Caris Life Sciences