Transcription:

Aimee Martin: Welcome to the Oncology Soundbite, a Podcast produced by the Seattle Cancer Care Alliance designed to offer bite sized audible oncology education from one of the top cancer treatment centers in the nation. I'm your host, Aimee Martin, a Senior Physician Liaison at the Seattle Cancer Care Alliance. During this episode, we'll focus on some rather timely news out of ASCO about the recent findings. The first new study on the impact of COVID-19 on patients with cancer. With us to detail these findings more, I'd like to introduce Dr. Petros Grivas, who serves as the Clinical Director for the GPU Cancer Program at SCCA. Welcome to the show Dr. Grivas.

Dr. Grivas: Thank you. It's a great pleasure to be with you.

Host: It's wonderful to have you, so I'd like to start with the first question. I'm very curious to find out how this study just got underway in the first place?

Dr. Grivas: That's a great question, Aimee, about I would say in the beginning of March when the pandemic was in the early steps in the United States, many oncologists including myself and others from other cancer centers were wondering how we can optimally treat our patients who have cancer, but also risk getting infected with COVID-19. And through that dialogue we found this unmet need to get answers, we formed this consortium called CCC 19, COVID-19 and Cancer consortium, and here at Seattle Cancer Care Alliance that has its own cancer research center and University of Washington we're part of the founding institutions for this consortium, aiming to ask and answer important questions about risk factors, treatment patterns, and other details and outcomes for patients with cancer who get a COVID-19. And that effort has led to a lot of information knowledge, and the recent publication, as well as an oral presentation of the ASCO meeting. And I'm very pleased to share some of the early results with you.

Host: Oh, fantastic. Yeah. I would love to learn more about what the results are and also what the methodology was that you used.

Dr. Grivas: Absolutely. This effort started, as I mentioned through this dialogue that we had with Vanderbilt University and other institutions, and we formed a red cap secure database that can be shared with multiple institutions, multiple cancer centers, where the local providers can access it. And usually they get some form regulatory approval in their local institution. And when they access the survey, they can fill out the different data variables that pertain to different clinical information. For example, what were the characteristics of the patients that had cancer and also was infected with COVID-19? What was the prior history of cancer? What was the cancer type? What were the treatment details for those patients? And also they fill out information regarding the diagnosis of COVID-19 chemical course these patients had, were they hospitalized or not? Did they require oxygen? Did they get to the intensive care unit? Did they need the ventilation support?

And ultimately, what was the clinical outcome? Did they do well, or did they succumb to the COVID-19? So we've got to cut from this clinical information in a very granular way. And we use this method of crowd sourcing - multiple institutions at the same time, fill out the survey. And we're able to in a very short amount of time collect a large number of cases that we then use to analyze centrally with our colleagues at Vanderbilt University with sufficient support we're able to analyze those surveys. And using very advanced statistical methods come up with particular physical analysis. And of course I can send the results with you in the bit. But all this effort was coordinated by a steering committee, consisted of 11 individuals. And we have very strong representations here in Seattle. Our institution SCCA, UW and Fred Hutch and myself were a part of the steering committee along with nine other exceptional colleagues to oversee this process and all this effort.

Host: Wow. That was certainly a very involved process and really impressive all the work that went into this study. What would you say, did you run into any challenges or limitations in your work to try to pull this together?

Dr. Grivas: Absolutely. Challenges and limitations were definitely part of this effort, but I have to say that we would try with perseverance and persistence to overcome these challenges. I think the challenges were of different nature, logistical challenges. How do we form the survey? Which questions are we going to add and how can we incorporate the literature and new findings that were published at that time from China, Italy, and other areas in our survey to make sure we ask relevant questions? And you know, how long could we continue, you know, updating the survey and which was the time point that we have to lock it and, you know, let the participants answer it? And then how do we go about regulatory compliance about the different centers? Do we need to get, you know, do the investigators need to get IRB approval, which was the case in most, if not all centers and then what about data transfer and data sharing? 

So we had to make sure we covered all this logistical and regulatory of course durations. And I think the steering committee worked really hard to go to work together and try to find solutions. And here at Fred Hutch, SCCA and UW were able to submit this protocol to the IRB and get an IRB approval very quickly, I would say in an expedited review fashion shared a lot with our research. So overall I would say that all the effort, it has been worth it and we keep going in this overall COVID-19 cancer consortium effort with increasing number of institutions joining us and of course, a lot of attention from the NCI from ASCO from European Society for Medical Oncology (ESMO) and other organizations, that actually help us partner with some of them, and try to of course generate important information for our patients and the contract provider.

Host: That's incredible work that you did, especially over such a short period of time. What would you say, where do you go from here? And as far as those main findings that you were able to identify, and then where do you take that information from here?

Dr. Grivas: So I will talk to Aimee, with the main findings, just to summarize the key findings that we presented this data at the American Society of Clinical Oncology ASCO, virtual meeting that took place about three weeks ago, virtually. And Dr. Jeremy Warner from Vanderbilt University presented this data. One of our early questions were had to do with what were the risk factors that could correlate with higher cancer deaths from COVID-19 in patients with cancer? And at the time of the first analysis, we had a little bit short of 1000 patients that we analyzed, and we tried to do a sophisticated statistical analysis accounting for different caveats and confounding factors. And we came up with some risk factors that were associated with higher 30 day mortality, meaning higher times of dying within a month from COVID-19 in patients with cancer, or specifically in this particular analysis, we capture any death, even if it was related to COVID-19 or not.

So we call this all cause mortality. So there's death of any cause. And we saw that older age, patients who are more senior, male sex, men versus women, history of smoking, also very poor performance status, which means more limited functional status of the patient. All of those factors were shown with higher risk of dying in patients who had cancer and COVID-19. Also, we saw that the presence of cancer itself as an active cancer versus history of cancer with no evidence of recurrence was a risk factor. So patients who have active cancer right now compared to those who have prior cancer in the past, and now they're in remission. The former category had higher risk of dying. Also the cancer was growing, was progressing, that was another risk factor. And also we looked at the different treatments that these patients received. 

And of course, who have to take the data with a grain of salt because of different selection, confounding factors here. But we know that patients who received the combination of hydroxychloroquine and azithromycin had the higher chance of dying compared to those who did not get this combination. But we cannot insert any causation between the treatment and the mortality, because patients who are more sick will have more severe COVID-19, they were probably more likely to receive this combination. So it's very hard to make any conclusions about that treatment and more data and more follow-up is needed, which brings me to the next steps here. I think we're planning for further analysis analyzing much higher sample size, much higher number of cases right now. I think we'll have probably exceeded 2,700, cases.

And we planned to do the analysis and report updated data in the near future. So we can inform the scientific community of the providers and the patients about important information, how to deal with treatment of cancer in COVID-19. We published the first analysis of the very prestigious journal called Lancet on May 28, 2020. That pretty much preceded the oral presentation by both of the Warner at ASCO meeting that we discussed before. One last finding I will highlight is that we looked at the potential association between what type of cancer treatment the patient received and whether that had anything to do with the chance of dying. And actually we found no significant correlation between cytotoxic chemotherapy versus not any other therapy versus not, and cancer mortality of 30 days, which means that if the patient needs treatment for the cancer, we feel comfortable based on the data so far, to still go ahead and treat the basin for cancer based on the treatment they need.

And that's an important message so far, and that's an important message to the patients that they have to have individualized discussions with their providers, their oncologist about pros and cons of particular treatments, chemotherapy, radiation therapy, surgery so on and so forth. But so far, I think we feel comfortable especially the COVID-19 pandemic is controlling the particular center that the patient who needs treatment for cancer needs to get treatment for cancer. And we should avoid delays because cancer itself can be a risk factor for death and complications. So I think that's an important component that we're able to, even in our center of SCCA and other centers to still go ahead with a sense of treatments. And we tried very hard to avoid delays on cancer therapy and these data support this notion of avoiding delays and still treat patients with cancers if indicated. And of course this requires individual discussions with the patient one by one with their providers to identify pros and cons and benefits for each treatment, each decision.

Host: Definitely. And certainly a lot of key takeaways from the study and still more information that you're gathering, where can providers find more information about the study and where they can go to, to get updates as well on future findings?

Well, of course, I think that's an important question. There's a website that I urge the providers to go and look at. The website is ccc19.org. The it's like a triple C19.org. And the website has a lot of information about the consortium frequently asked questions, collaborations, collaborators, COVID-19, and cancer different publications, resources, and other efforts. And each providers, you know, in different cancer centers want to join. They can become members of this consortium. They can reach out to us. They can reach out to Dr. Warner the contact information or listen to the website. And they become part of that, but anybody can contribute cases because the survey you know, can be accessed by different providers in different cancer centers.

Of course they can check with their regulatory body to get approval, but I think it would be great if we can capture as many cases that exist out there as we can, you know, to inform, you know, this knowledge need and cover this knowledge gap. As a matter of fact, I would say that more than 100 institutions, I have been a part of this consortium that were on having six institutions as of recently, and the list is growing. So the other great resource would be the Lancet publication, as I mentioned that was published on May 28, 2020, as well as the ASCO presentation by Dr. Warner. But the website that I mentioned, ccc19.org. It has a lot of information that can be useful for many providers again, it is ccc19.org.

Host: Thank you so much Dr. Grivas for that information and for all the work that you've been doing, we'll be sure to include that website link on our SCCA provider blog. And we really appreciate the time you've taken today to share more information about this study and all of the work that you've been doing.

Dr. Grivas: Oh, my pleasure, Aimee, and looking forward to more information from this consortium. One of the findings that I think it would be important to also quote, which we saw a mortality at one month, 13%, one three percent, that was higher than what we have seen in the literature. In other datasets, not necessarily in patients with cancer that thousands of this say high risk population. But as I mentioned, you know cancer itself requires treatment, which can be essential in this decision is going to be one by one made, and risks and benefits can be balancing individual providers. But we're here to answer questions and help providers and patients in this adventure.

Host: Thank you so much for joining me today, Dr. Grivas and thanks to our listeners for tuning in, for the Oncology Soundbyte. To hear more subscribe to the Oncology Soundbyte and your favorite podcast app, and to receive updates on our future podcast episodes, along with other news out of SCCA, go to Seattlecca.org/providerblog, and click subscribe. Until next time, thanks for listening and take good care.