Results from an observational study revealed that patients with cancer who also were infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were treated with unproven, investigational therapies for the virus — and most of these drugs were administered outside of the scope of formal clinical trials.1 The only exception to this was remdesivir, which was administered to this population by way of a formal trial in 69% (86) of the 2186 individuals who were enrolled.
The investigators characterized “off trial” as any administration of a drug for coronavirus disease 2019 (COVID-19) through the expanded access route (compassionate use) prior to May 1, 2020, or through emergency use authorization (EUA) after May 1, 2020, and stated in the paper that “limits of temporal resolution in the [COVID-19 and Cancer Consortium; CCC19] registry do not allow for distinguishing between these 2 uses.” The data collection period was from March 17, 2020, to June 26, 2020.
In addition, the investigators determined that there was no statistically significant 30-day all-cause mortality benefit from treatment with hydroxychloroquine or high-dose corticosteroids alone or in combination in patients with active cancer. But, they determined that there may be a mortality benefit with remdesivir in this population. Compared with positive controls (of whom many got prior hydroxychloroquine), remdesivir alone was associated with decreased 30-day all-cause mortality (adjusted odds ratio [aOR], 0.41; 95% CI, 0.17-0.99). The analysis also looked at mortality with other anti–COVID-19 medications, including tocilizumab, azithromycin, high-dose corticosteroids, and other undisclosed therapies.
The study served as a follow-up analysis to a prior study by the CCC19, which found that individuals with cancer were at increased risk of COVID-19. But in the larger follow-up cohort, which involved 2186 patients (of whom 865 received some type of treatment for COVID-19), the researchers calculated that the mortality rate due to COVID-19 was higher than they had previously calculated: it was 16% in the newly published study compared with 13% in the prior study of 928 patients.
COVID-19 mortality rates have been found to be more than twice as high in Black, Latinx, and Indigenous cohorts as in White populations.2 Despite this statistic, in the CCC19 study, non-Hispanic Black patients had a decreased likelihood of receiving remdesivir (adjusted odds ratio [aOR] 0.56; 95% CI, 0.31-1.00). And based on data presented in a supplementary chart in the study, a higher proportion of Black patients received remdesivir off trial than did White patients (38% vs 32%, respectively). A higher proportion of Hispanic patients (36%) compared with White patients got access to remdesivir outside of formal trials as well. Dr Warner cautioned, however, against drawing any conclusions from what are “pretty small numbers overall for the patients receiving [remdesivir] off trial.”
Patients with renal comorbidities (aOR, 0.32; 95% CI, 0.16-0.61) and those with an Eastern Cooperative Oncology Group performance status of 2 or higher (aOR, 0.47; 95% CI, 0.24-0.90) were less likely to receive remdesivir, while those living in the US West were more likely to receive remdesivir (aOR, 1.85; 95% CI, 1.09-3.15).
Considering that Black patients are also more likely to experience severe disease, it would be rational to deduce that this population may potentially be better candidates for the receipt of remdesivir, as the US Food and Drug Administration EUA for the drug was granted specifically for “treatment of suspected or laboratory confirmed [COVID-19] in adults and pediatric patients hospitalized with severe disease.”3
However, it has also been said by the director of the National Institute of Allergy and Infectious Diseases, Anthony S. Fauci, MD, that remdesivir “has its most favorable effect in hospitalized patients with COVID-19 who have modest pulmonary disease.”4