At the American Society of Clinical Oncology’s (ASCO) virtual annual meeting, a late-breaking abstract, which used data from the COVID-19 and Cancer Consortium (CCC19) registry, showed that treatment with the combination of hydroxychloroquine and azithromycin to treat COVID-19 in cancer patients was associated with a 2.89-fold greater risk of 30-day mortality than use of neither drug.
In this exclusive MedPage Today video, principal investigator Jeremy Warner, MD, of Vanderbilt University in Nashville, discusses the study.
Following is a transcript of his remarks:
So we came together on March 15th, 2020. Really at that time there was no major impact of COVID-19 in the United States. There were less than 100 cases, but a large number of us came together through social media, at first and then through networks of academic institutions, and other practice settings to create a registry of patients with cancer and COVID-19 to try to learn about what the impact of this disease was going to be on patients with cancer. And really by the end of one month into this work, we had over 90 participating institutions and we’re now at 110. So we reported on our first results at the ASCO meeting this past weekend. And those first results consisted of 1035 cases reported to the consortium by the end of the first month. We reported only on those patients who had laboratory confirmed SARS-COV-2, which turned out to be about 930, or precisely 928 patients.
And so looking at those patients the first basic things that we looked at were demographics. We found that the patients were about 50/50 female male. We found that there were more African American patients than might be expected from census distributions. And we found fewer white or Caucasian patients than expected. We found that there were primarily ECOG 0/1, so good performance status, although substantial proportion of these reported cases had a ECOG of two or worse. We also found that many different cancers were represented with breast cancer being the most common at over 20% of the reported cases followed by prostate cancer, followed by GI, and several others. And about half of the patients had active cancer, and about half were on active treatment. Notably these populations don’t necessarily overlap because a patient can be receiving adjuvant therapy while being in remission. And a patient with active cancer can not necessarily be on treatment. So these were separate variables that we collected.
So we found overall, that 13% or 121 of these patients had died. And all of the patients that had died died within 30 days of their COVID-19 diagnosis. When you think about this number, one number you can compare it to is the global average for mortality or the United States average. Either of those it’s around 6%. So either way you look at it, this is about twice those averages. One thing I forgot to mention earlier is that these patients were substantially older, with a median age of 66, and actually 30% of the cohort was over the age of 70. And certainly when we started to look at subgroups, the older patients had the highest rates of mortality.
One thing we noticed that patients who have no comorbidities and have an ECOG performance status of zero, and this constituted 86 patients out of the 928, there were no deaths reported in that particular group. Whereas on the opposite end of the spectrum, if you look at patients with an ECOG performance status of two or worse, who ended up on mechanical ventilation, the death rate was 85%.
Looking at specific factors as we conducted multi-variant logistic regression analysis with partial adjustment to see if we get account for a specific risk factors, and the ones that emerged in particular were, male sex, older age, being a former smoker, having more than two or more comorbidities, these were the what you might call general risk factors that we found associated with a worse outcome.
And then when we looked at cancer specific risk factors having that ECOG performance status of two or worse, was highly associated with mortality, as was having a progressing cancer, which was associated with a five fold increase in mortality relative to patients who were in remission.
Some notable findings that did not reach statistical significance were having undergone recent surgery or being on an active treatment in which we defined as having chemotherapy or other treatments within four weeks. Those were not independently associated with mortality as independent risk factors.
So one last finding that we had was that the treatment with the combination of hydroxychloroquine and azithromycin was associated with a threefold increase in mortality. Although there are many factors that go into that finding, including potential confounding indication.
So our conclusions from the study were that the overall outcomes for patients with cancer are worse than the average population, and that’s looking at the primary outcome of death, but as well as secondary outcomes with nearly half of the population hospitalized. We found independent risk factors, as I mentioned previously, and we found a signal for the treatment with hydroxychloroquine and azithromycin, but we strongly recommend that these drugs be in a prospective setting to evaluate whether they have a risk or a benefit.
So I think there are two main takeaways from this study. One is that for healthy populations, that probably they should proceed with their treatment and that delaying treatment when we know that there are life saving or life extending treatments, for these populations, might not be needed. So with caution, they could proceed with surgeries, chemotherapy, and so forth. On the other hand, what we were seeing with older patients and those with progressing cancer and poor performance status really suggests that treatment needs to be really carefully considered when weighing the risks and the benefits and advanced care planning, which should always take place with any patient diagnosed with cancer or really any patient. But advanced care planning, both with patient and family really needs to happen ideally well before a COVID-19 diagnosis, and those patients in particular should do everything they possibly can to avoid infection with SARS-COV-2.
Source: MedicalNewsToday.com
