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Dr Lyman and Dr Desai Talk COVID-19, Cancer Care, and the CCC19 Initiative

 

Transcript 

Aakash Desai, MD, MPH:  Hello everyone. I'm Aakash Desai. I'm currently an internal medicine final year resident at University of Connecticut. I'm soon to be an incoming hematology‑oncology fellow at Mayo Clinic Rochester.

I'm here with Dr. Gary Lyman to talk about our CCC19 initiative, and how COVID‑19 has affected cancer care in the United States.

Gary Lyman, MD, MPH:  I'm Gary Lyman. I'm Professor of Medicine at the University of Washington, here in Seattle, and also Professor of Public Health Sciences and Clinical Research at the Fred Hutchinson Cancer Research Center and also on the steering committee of the CCC19, which we'll be talking about. I'll turn it back to you, Aakash. You can take us through the agenda.

Aakash Desai, MD, MPH:  Absolutely. Gary, we all, in the cancer field, we've been looking at the COVID‑19 and how it has affected specifically the cancer patients. They are a uniquely vulnerable section of the population when it comes to COVID‑19.

Most of us now know that previous studies showed that with a diagnosis of cancer you have higher risk of severe events, including ARDS, mechanical ventilation, when you compare it to patients without cancer. Then patients with recent chemotherapy or surgery also were found to have a numerically higher risk.

This gives us a leeway into what really made us think about the CCC19 initiative. It is really a grassroots initiative which really began with a few Tweets and has its humble origins on Twitter.

Along with the cohort study tool, the web‑based CCC19 registry, this consortium now comprises more than hundred cancer centers and organizations all over the world. I'm going to ask Gary to talk us through a bit about the CCC19, being on the steering committee, and how the functionality works at the consortium.

Gary Lyman, MD, MPH:  Thank you, Aakash. As Aakash mentioned, this really grew out of a crowdsourcing effort emerging out of social media connections that have played a bigger part in medical research and just medical interactions, and particularly in oncology.

As the pandemic hit, particularly began to show up in the US, many of us, colleagues across the country, began to talk about, what can we do? We don't know much about this virus, about its impact on cancer patients. Can we begin to gather data quickly?

I think, Aakash, it was a spark that you lit and began to bring people together about the value of crowdsourcing in the setting of a crisis, like a pandemic.

This has happened in other crises situations, and fortunately, we connected and we're connected with the group at Vanderbilt, Jeremy Warner, who has led this effort, which is the home of the REDCap system, which collects clinical data at more than 4,000 institutions worldwide.

We thought, what a great opportunity if institutions are interested in jointly collecting data on cancer patients diagnosed with COVID‑19 and pooling that data, we could learn something fairly quickly and with much larger numbers than we would by normal clinical research methods.

Of course it was not intended to replace clinical trials, but it was to get some answers, some information quickly that could inform clinical practice, inform patients of course, and lay the platform for future clinical trials so that we really knew more about the diseases that we're dealing with here.

That has, within a matter of two or three weeks, a large survey registry was developed with Dr. Warner, Nicole Kuderer, myself, others, Brian Rooney, also at Vanderbilt. A number of people had input into this, and it was launched mid‑March, and within the first month, had accrued essentially 1,000 patients.

The first manuscript, which is just being published in "The Lancet" journal, reports on the data from that first 1,000 or so patients with cancer and COVID‑19. By the time you view this video, it will online or it will be published at The Lancet. It's very informative, and we can go into some of the details of what's there.

This is extremely timely, and I'll just add that since that time, over the subsequent months, since all that data was collected and submitted for publication, another 1,000 and closer to 1,500 patients have been gathered on site. We have well over 2000 patients with cancer and COVID‑19, mostly from the US, but some European and Canadian sites, as well.

Of course, the knowledge we're learning from this continues to grow. We can dive deeper into some of the important questions that clinicians and patients are still asking about this process, and trying to learn more about what are the risk factors to patients with cancer, for COVID‑19 and its complications.

What are some of the comorbidities that put patients at even greater risk of long term outcomes? A lot of this is discussed and analyzed in The Lancet Paper. This is just the first step. There will be a number of publications looking at more detail in certain aspects, certain cancers, and certain types of situations.

For instance, the thrombosis that we know is very prevalent in COVID‑19 patients in general, but we've seen also in the cancer patients affected. What's the role of this? Should these patients be managed differently? Should they be on anticoagulations?

This is just an example of some of the many questions we help to answer, or at least provide hypotheses that can then be tested in prospective studies for more definitive answers.

Aakash Dasai, MD, MPH: As a part of CCC19, I would really want to give a shout out to Jeremy Warren at Vanderbilt, Gary and Nicole at Fred Hutch, and others at Dana‑Farber, and other institutions. The rest of the steering committee, their dedication, I think we've been able to get this tremendous effort.

In such a short time, like Gary mentioned, we've been able to provide some preliminary answers to the public regarding cancer and COVID‑19. I think just to add to what Gary said, we are also very glad to be able to present that preliminary data at the virtual upcoming ASCO 2020, starting tomorrow. That will be very interesting to see what we find.

Moving over to how the pandemic has affected not just the patients, but also the healthcare system and talking about managing staff shortages, I think my personal experience has been as a trainee. I've known most of the residency programs moving to a flexible work schedule, trying to have residents, and fellows, or trainees participate in clinical patient care for a couple of weeks.

Have one or two weeks of backup, where they're able to in case if they are affected with COVID‑19 or have asymptomatic infection, they are able to isolate or quarantine themselves, and then return to patient care and clinical duties in the next couple of weeks.

I think that has been a tremendous effort from the healthcare system. At the three hospitals that I work at, The University of Connecticut, The Hartford Hospital, and St. Francis, we've seen a huge push from the administration to also be able to protect the physicians and the healthcare personnel at the same time, ensuring that adequate patient safety and patient care is maintained.

What has your experience been Gary, at Seattle?

Gary Lyman, MD, MPH:  It's been interesting, to say the least. Seattle, as you may know, in Washington State was the initial epicenter for this virus pandemic in the United States. The first case was diagnosed in a man who had returned from China, from Wuhan, just outside of Seattle. Unfortunately, the first death that was reported associated with COVID‑19, was reported here in Washington State.

This was a bittersweet experience, because although we identified very quickly, a fairly large number of cases, particularly in the nursing facilities here, we got the message very early that this was a serious problem, highly contagious, highly fatal, particularly in older and frail patients, patients with other medical problems.

Both at the University of Washington and the Fred Hutchinson Center and the other hospitals in the region, at the city level and at the state level, with Governor Jay Inslee implementing very prompt responses to information that they were receiving from us and the clinical frontline workers who were seeing these patients and seeing the devastation it was causing.

In addition, we had the benefit of extremely valuable effort at the university coming out of the virology department that very quickly...they were doing an influenza study, a seasonal flu study, and began in mid‑to late January to see a spike in upper respiratory illnesses that was somewhat unexplained.

Working with the laboratory scientists here and some sequencing data coming out of China, we were able to identify this as the coronavirus, the novel SARS‑CoV‑2 virus that had began to infect the population.

We did run into challenges with testing because, as you know, the CDC testing that was sent out had problems, and when we ran those tests and compared it to our own testing ability, we saw that there was a great deal of discrepancy, so it took the CDC of course several more weeks to correct that problem.

In the meantime, we had the capacity to do testing for coronavirus here, but the FDA held that up for about two or three weeks, saying that we could not use that test until they had fully validated.

Once they did, so we're into February here, later in February, early March, we immediately identified over 40 cases of COVID‑19 in the Seattle area, and of course the numbers have gone up very steeply from then.

As I emphasize, we were able to jump on top of this. We recognized the problem very early, took action, quickly implemented a variety of measures both at the university cancer center to monitor for patients, screen patients as they came in, and as well as at the city and state level, with serially implementing stay at home policies, essential business openings only.

That continues to be in place, although the state is gradually opening.

As a result, we have pretty good evidence that we were able to flatten the curve over what the projections had been, out of our own health metrics group that had projected thousands of cases rising very quickly here.

The implementations that have been taken, I think, are largely responsible for why we did not exceed the capacity of the healthcare system here in Washington State, and specifically in the Seattle Area.

Of course we're still going through the phased wind down and the emphasis on broad testing, including serology, to see who's been infected and might not even know about it, but many have antibodies that might partially protect them.

I'll just mention a recent study, and I'd be interested in a cautious take on this, that suggests that perhaps cancer patients who develop COVID‑19 may not mount as much of an antibody response as otherwise healthy patients who are infected with COVID‑19.

I think this resonates with our experience with cancer patients with other vaccinations, including pneumococcal vaccination, other common vaccinations, and probably the seasonal flu.

That's something I think we have to guard upon, that maybe the cancer population, either because of their disease or the treatments they've gone through, may not be as much protected despite having the illness and recovering as to the average population.

Aakash Dasai, MD, MPH: Yes, I definitely agree with that, Gary. I think some of the data that came out of the AACR also mentioned that they saw a higher risk of mortality among the hematological cancer population. I think your concern about having absence of mounting an immune response in cancer patients, maybe particularly hematological cancers, is very well placed.

It would be interesting to see whether we will be able to use these same antibody titers that we use in the normal population in our cancer population, or will there be need to change some of the practice or laboratory testing specifically for the cancer population.

I was very interested in that you mentioned that thankfully, we initially thought that we would be reaching our full capacity in terms of a healthcare system, but until now, it seems that we have been able to flatten the curve, at least keep ourselves from reaching that capacity.

I remember being on service for the last couple of months, especially in the hospital wards, and most recently in the intensive care unit. From two months on, initially when the pandemic hit us, we were really worried about having shortages in terms of the personal protective equipment, cleaning supplies, and medications.

I have witnessed everyone pretty much all over the country trying to preserve PPE, and I think there's been a lot of hue and cry about that in the media, but over the last couple of months, what I've seen is, we've been able to scale back and make sure that we're limiting exposure, we're limiting the usage of PPE.

Speaking from a trainee perspective, I've seen, when you would normally see four people go into a patient's room to examine and talk to a patient, we've limited it to one or two doctors, trying to limit the healthcare personnel's exposure, number two, also trying to conserve PPE.

Most recently, in the intensive care units, I've seen we're trying to recycle gowns and obviously resterilizing them. Also, a lot of push has come from the 3D printing side. I think I've seen a lot of 3D printed masks. I've seen a lot of 3D printed face shields, and I think all of that really has scaled up our capacity to produce personal protective equipment.

All in all, that has been, like you mentioned, I would say we are not as bad as we thought we were, but obviously we are not completely out of the woods.

Gary Lyman, MD, MPH: As mentioned here, basically the same kind of experience. We expected the worst, and that probably would have happened without some of these measures that you and I have discussed being put in place and have limited that.

It was such that while we have gotten some ventilators from the national stockpile, we were able to send those back last month, because we thought there were other parts of the country at that time, New York, New Jersey, and of course others coming up now that could use them more than us.

A field hospital was constructed by the military here, and that's been dismantled. We do think we're down the descending limb of that first wave.

That raises the question of whether, because the majority of the population remains vulnerable, susceptible to this virus, that if we don't reopen very carefully both our healthcare facilities and our civilian activities, and don't practice what's being recommended in terms of masking and social distancing, we clearly could have another wave.

If this occurred during the winter months when the seasonal flu is there, it could be extremely dangerous to cancer patients and the entire population.

Aakash Dasai, MD, MPH: Yes, absolutely. I think another interesting thing that has come out of this pandemic from a healthcare system perspective is the use of telemedicine and incorporation of telemedicine in routine patient care.

For ambulatory clinics that I've been part of, obviously telemedicine gives us a lot of exposure in terms of going to the patients, able to see and keep up their appointments.

I think it probably and hopefully should stay for some of the patients who are really debilitated and cannot make to their appointments. Especially I think in the field of oncology, it might be more relevant with those patients who are on a palliative care route. There's no point of exposing them bringing them into the clinic.

Interestingly, speaking with patients over the phones, and their families, I've seen that there is a lot of reluctance in going into the hospital and the emergency departments. I think there has been data published in "JAMA," where they've seen a fall in the number of acute myocardial infarction admissions or the admissions for stroke.

I have had a personal experience where a patient family member calls me saying that, "My mom is not responding on the left side since the last two days, and she had a recent stroke since the last two months," and this was new. What I saw, that the family member was really afraid of taking her to the emergency department, because they did not want her to be exposed to the coronavirus.

Even though that fear was well‑founded, but I think we are also seeing that this fear is trying to prevent patients from engaging me in their medical care when they need to be.

We've all discussed of how this might be a second wave, where the things that people have ignored and the things when we come out of the focus of the coronavirus, we have to focus on the other comorbidities and the chronic diseases that have probably been ignored in the past couple of months.

Gary Lyman, MD, MPH: Of course we've done the same thing, as have most centers. Telemedicine has really dominated our care for patients that don't need to be hospitalized and don't need to come in for perineural therapy. On any given day the use of telemedicine to monitor symptoms, evaluate changes has really been used broadly.

It's going to be interesting to see what happens in the post‑COVID era, whether we return to our prior life or perhaps embrace telemedicine more uniformly.

One of the biggest complaints I get from patients is the traffic in the Seattle Area. You probably do, people coming from New York or wherever. Patients love the idea of not needing to travel if it's not going to compromise their health and care.

Here, we have patients coming across the mountains in the middle of winter, so there's all sorts of reasons to suggest that telemedicine may have a rejuvenation, even after COVID‑19 subsides, in terms of oncology care and medical care in general.

I think there's a number of things that we're doing now that hopefully will be useful in that post‑COVID era, but I think also, at least I'm hopeful that there will be lessons learned here.

True, it's been a century since the last pandemic of this magnitude. We've had smaller ones, and we should have learned our lessons there, but I think it's going to be quite a while before this generation forgets what we've been going through and probably still going to go through over the coming months or year until there's a vaccine.

Hopefully, in terms of being prepared as health systems, as hospitals, and as a healthcare system more broadly, we'll be more prepared for what is probably not going to be another 100 years, my guess would be, with the globalization and the travel.

We've been very fortunate that so much time has gone by without this type of pandemic, and I think the next one could easily come with a new virus in a much shorter period of time. It behooves us to be very prepared as a society in the healthcare system for the eventuality, almost a certainty that we will be in this situation again, but hopefully much better prepared to save lives.

Aakash Dasai, MD, MPH: In terms of patient education, and in terms of the treatment protocols and changes, I've seen that this is largely obviously becoming more and more of a risk‑benefit discussions. A lot of oncology is already, but with COVID‑19, I think really there have been several efforts to objectively decide what needs to be done and what can do it.

I think there are institution‑specific guidelines and emerging consensus among the oncology community.

A thought process that I have seen, and I think it has been well‑received, is to think of the patients along a spectrum, where you have patients where you have a potential to cure, where you must treat them when their cancer mortality is going to be higher than the COVID‑19‑related mortality if they were to contract COVID.

On the other end of the spectrum is, you have patients where your goals are really palliative care, and so where you're trying to minimize their exposure to the health system.

In the middle of the spectrum, there's those patients where, with cancer therapeutics, you can have moderate effect on their quality of life and overall survival, or you can have a marginal effect on quality of life and overall survival.

How have you seen these specific guidelines or decisions being made in the oncology clinics?

Gary Lyman, MD, MPH: Certainly, I agree with everything you've said. I think one of the things that have come out of this initial CCC19 effort in the first paper reporting results, is that cancer treatment, the traditional cancer therapies probably don't increase your risk per se of serious complications.

What does increase the risk, in addition to comorbidities, other serious medical complications that are being treated beyond the cancer, is the status of your disease. If your disease is progressing, the risk, with or without any treatment, of mortality or serious experience with the COVID‑19 infection, is very great.

For me, this means maybe for those patients where we should be having these end‑of‑life discussions very early in the course of a cancer patient or any patient with a serious chronic disease, perhaps for these patients, faced with the pandemic and this serious risk of not leaving the hospital, we need to be having those discussions if we haven't already done that.

We need to know what the patient's wishes are, and make sure the family and the patient are aware of the serious possibilities and possible consequences in this particular time.

One the flipside, of course if the patient is in remission, they were treated in the past or receiving some type of adjuvant therapy, if they're not currently infected, they probably can proceed with therapy pretty much according to guidelines, and their risk is not going to be much different than that of those treated in other periods of time.

We do need to realize that there are particularly vulnerable patients. It's age, it's comorbidities, unfortunately, it's a bit of gender that weaves itself in there ‑‑ and we've seen that even in non‑cancer patients ‑‑ and the status of your cancer, whether it's progressing or not.

All these things need to be weighed in a combined fashion, to advise patients of what the risks are and what the possible time course of this could be, so that they can make these hard decisions.

I know this all happens in a rush. These patients often will deteriorate very quickly, and once they're ventilated, of course they can't communicate and the family can't visit them, so it's just incredibly challenging time.

The earlier these discussions, even if they don't go into effect because patient recovers and does well, should be had very early in this process in patients at risk.

Aakash Dasai, MD, MPH: Yes, that is definitely true. Even from my experience in the intensive care unit, I've seen not only cancer patients, but in any patients, it's an extremely difficult time for families, because most of the hospitals will not allow visitors because of the risk of coronavirus. As a family member, it must be very devastating for these people.

Finally, in terms of the clinical trial participation, I'm aware that NCI has put out guidelines about the interruption in clinical trials. Overall, worldwide we're seeing that, especially given the fact that this has been the pandemic has really taken over much of the healthcare system.

Where do you see the clinical trials and the progress, and what the priorities should be?

Gary Lyman, MD, MPH: Obviously, this has been one of the areas of oncology, other than the personal impact on patients, that's mostly profoundly impacted on our daily lives and our environment in the cancer academic setting or in the community setting.

I'm an executive officer with the SWOG Cancer Research Networks, and we're monitoring our trials there just like the other corporate groups in the larger cancer centers.

There's been a deliberate effort to try and not close trials. Some trials have been suspended because they're too complicated. They would mandate patients traveling or coming in frequently for visits, but to the extent that trials can remain open and potentially accrue, we've tried to do that.

Nevertheless, despite that, over the last two to three months, there's been a very dramatic downturn in accrual to most of these trials. I think that's partly due to patients' reluctance to come in and expose themselves to the cancer center environment, to get to come in for tests, blood tests, scans, and so forth.

Perhaps also the reluctance of the clinicians, because we're trying to do more telemedicine, we're trying to keep those patients out of the healthcare environment, where they get exposed or/and would consume some of the limited resources we have to care for other sick patients.

I think it's a combination of factors that have led to at least an 80, perhaps 85, 90 percent downturn in accrual over the last two or three months.

One of the things we're doing, we have a large trial we've just completed through the PCORI‑funded system, using the NCORP, which is the community cancer network for the Southwest Oncology Group, SWOG Cancer Research Network.

Fortunately, we had just completed the five years of this project, met our accrual goals just as the pandemic hit, and we're analyzing that data.

PCORI has reached out to us and said, "We want to find out what's happening to those patients as they go through the pandemic in terms of follow‑up survivorship, and also look at practices, how are the practices changing how they manage cancer patients?

"Are they using more aggressive supportive care if they're giving them treatment? Are we changing our thresholds for transfusions or other supportive care efforts, we using different regimens? Are we using more endocrine therapy for breast cancer and delaying the use of chemotherapy?"

We're going to be monitoring. Fortunately, the funding has been offered to continue to monitor through the remainder of the COVID experience, and over the next year, year and a half. Maybe again we can gather information for how much this pandemic has actually altered what we do in clinical practice, some of which might revert back.

As I said earlier, I think a lot of the things we found work in the setting of a pandemic might actually work just as well if not better once the pandemic is through. To a large extent, the patient experience might be better as a result. I like to look on the bright side of things, and so I do think there is a positive that may come out of this for all of us.

Aakash Dasai, MD, MPH: Finally, what I have personally found coming to the point of, a lot of talk has been focused on staff burnout and juggling home life on top of work. I think the flexible work schedules that have been worked out by different institutions has helped, but I think this is a very challenging and a stressful time for everyone, most of our patients.

What makes it difficult, it is also a difficult time for us as physicians and our families. Personally, I've seen a lot of us are separating ourselves from our families, those who are engaged in active patient clinical care, sleeping in the basement, working more than usual to see this through.

I think it's a remarkable effort from healthcare systems worldwide. This kind of a supportive healthcare system, caring equally for patients and physicians has really come out, like your point about this being probably a positive change, and there are some bright things to see from this pandemic I think makes that true.

Gary Lyman, MD, MPH: I could not agree more. The camaraderie, the support for each other I think has been enormous, been tremendous. We're all dedicated of course to our patients, but I think what this has done is made us also more dedicated to ourselves, and supporting each other through this entire process.

We've all seen some unfortunate...both our colleagues getting infected and some not surviving. We've had a couple of cases where the healthcare worker has become so depressed that they've taken their own life, so suicide has been an issue, but that can't detract from the vast majority that have just thrown themselves at this pandemic, supporting patients, supporting their colleagues.

I think, in the long run, there will be far more pluses that come out of this, despite the anguish and the heartache that we should never forget in terms of our colleagues and our patients, but hopefully we'll come out of this stronger as a profession.

The research that we've thrown ourselves into of course has been entirely a volunteer effort. No one's getting paid for the hours, the all‑nighters we're putting in on CCC19 and other research efforts, but it's because we feel such an urgency and such a responsibility to learn as much as we can, in addition to caring as much as we can for those patients in our charge.

Thank you Aakash, and I really have enjoyed this discussion.

Aakash Dasai, MD, MPH:  Same here, Gary. Thank you very much.

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