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Medicine Matters oncology

And TERAVOLT, which was presented at ASCO, is a global consortium that was actually started from an email from Dr. Marina Garassino from Milan who was worried about how COVID would impact lung cancer patients and also what would be the impact, not only of the illness, but also on the pandemic in terms of the outcomes, in terms of delays in care. So she sent an email out to about 50 investigators around the world. I emailed her back straight away and said, we'd love to help you, and we can set up this database here at Vanderbilt. And within one week, we had a case report form set up and had IRB approval, both locally at Vanderbilt and nationally in Italy, for investigators around the world to enter their data on their lung cancer or thoracic cancer patients with COVID-19.



And it's not restricted to lung cancer. It also includes mesothelioma, and thymoma, and carcinoid patients, and both small-cell and non-small-cell patients. The criteria for enrollment in COVID is that the institutions have to have local IRB approval. A patient has to have a COVID diagnosis, either through RT-PCR, a suspected case with a known contact with someone who's COVID positive, or based on radiographic images and symptoms suggesting COVID.



The median follow-up of patients that were included in the data cutoff for ASCO was 33 days. And we presented data on the first 400 patients who had complete information entered in the case report forms. It included patients from both the US, Europe, South America, Canada, as well as parts of Australia and Asia. We found that the median age of patients was around 70 years of age. The majority of patients were male and were either current or former smokers.



In terms of underlying comorbidities, we found that the patients were classified into three groups-- those who had recovered from their COVID diagnosis, those patients who had died, and those patients with ongoing infections. We found that in the patients who had recovered from their COVID diagnosis, that more of those patients were likely to have no comorbidity-- around 18%. Compared to the patients who died-- only around 9% of patients had no comorbidities with the majority of patients having one or more comorbidities.



The most common comorbidities-- and we've heard a lot in non-cancer populations about hypertension and diabetes, as well as vascular disease being risk factors for mortality from COVID. We found that these were common risk factors in our case cancer patients. But didn't find that any of these specific comorbidities were associated with increased mortality from COVID.



We also looked at therapies in the last three months. And we were surprised to find that the majority of patients either had no therapy-- so around 25% of patients-- or had only had one line of therapy at the time of their COVID diagnosis. Common complications from COVID were pneumonia or pneumonitis, ARDS, sepsis, coagulopathy.



When we looked at risk factors associated with mortality from COVID, we used something called the Grays Test, which looks at the cumulative incidence of a specific-- of death, basically, from COVID. And we compared death to recovery. And we found that, in patients, the risk factors for death were age over 65 years old, presence of a comorbidity-- but we could not figure out which one specifically-- as well as an ECOG performance status of one or two.



We also found that patients who were on steroids greater than 10 milligrams of prednisone equivalent or more who were on anticoagulation, which could have included heparin and any of the DOACs such as rivaroxaban, or patients who were on warfarin were at increased risk of mortality. And we also found that patients who who received chemotherapy, either alone or in combination with immunotherapy, were at higher risk for mortality. Surprisingly, we found 35% mortality in our patient population with about 80% of patients' deaths being attributed to COVID. 78% of patients required a hospitalization. But only 8% of patients were actually admitted to the intensive care.



When we looked at the therapies the patients were given, there's been a lot in the media about different agents. And CCC19 presented at ASCO and found combination use of hydroxychloroquine and azithromycin were associated with increased risk of mortality in cancer patients. We didn't find such affiliations between the therapies that were administered to our patients. In the multivariate analysis, it was age, ECOG performance status of one, prior steroid use, and chemotherapy that, again, held up as being increased risk of mortality from COVID-19.



So this database is ongoing. At ASCO, we had 400 patients presented. We're now up to over 550 patients entered into the database. We're continuing to look at risk factors for mortality. We're also looking at therapies that could potentially improve patients' outcomes later on down the line.



We're also looking at, importantly, how does having a COVID pandemic affect lung cancer treatment in general? And so what are the delays in patients' cancer care? And then we will soon have a patient-related survey launching on our website, which is teravolt/consortium.org, looking at patient factors or what the patients are thinking in terms of how COVID is impacting their daily lives and how it's impacting their care.



What can patients do to minimize their risks?

So I don't think that we should stop offering care. We're doing a few things at our institutions. So first of all, anyone who starts chemotherapy, we're testing them for COVID. And if they come up as positive for-- or we're testing them for SARS-CoV-2. If they come up as positive, we're potentially delaying their therapy until they clear. And so I don't think that we should be stopping therapy.



I think we should be just very careful about how we're giving therapy to our patients-- so advising our patients to take those neutropenic precautions even further, telling people to stay away from crowds, to stay away from other people. This is a serious virus that is going to continue to spread and be with us for some time. But I don't think that we should be stopping care in our patients. But it may require, at some point, a delay in initiation of care if a patient tests positive prior to starting the therapy.



How long do you plan to run the study?

In the study, we're going to continue to collect data. I think that there are two things that we're looking at. One is a lot of the patients who are in this initial analysis were patients who are hospitalized and who were sick. And I'm hoping that we find more asymptomatic cases with time. And maybe we find that there's a better outcome for our thoracic cancer patients. The mortality in the CCC19 was less than 20% in an all-comer patient population. But for as long as the pandemic is ongoing, we'll continue to collect data.



I was on a conference call with other steering committee members-- Heather Wakelee and Solange Peters. And we were talking about looking at different outcomes in the study. And we said something about a live meeting. And as Dr. Peters said-- Solange said, a live meeting will mean that we have a vaccine, and so the pandemic is over. And at that point, we'll close the database.



What we'd like to do is also figure out, what does the prototype of that at-risk patient look like, so that we can potentially help as the pandemic continues. And everybody's worried about that second wave. And say, if you have lung cancer patients with these specific risk factors and this specific age, you need to be even more cautious.



Again, don't stop therapy, because lung cancer is a pandemic. And it's not going to go away either. But rather, be really cautious in how you're giving therapy, and monitoring these patients, and minimizing their interaction with both society during that therapy as well as the health-care field.