A Systematic Review Assessing the Underrepresentation of Cancer Patients in COVID-19 Trials.

BACKGROUND: The new severe acute respiratory syndrome coronavirus 2 has emerged as a global pandemic that threatens thousands around the world. Observational cohort studies have demonstrated that cancer patients have inferior outcomes due to underlying malignancy, treatment-related immunosuppression, or increased comorbidities. We aimed to examine the representation of cancer patients (hematological malignancies and solid tumors) in COVID-19 therapeutic and prophylactic interventional trials. METHODS: In this review, all randomized controlled trials (RCTs) published between December 2019 and August 2021 were included. We included only trials evaluating medications that were recommended by NIH guidelines: steroids, tocilizumab, remdesivir, and REGN-COV2. RESULTS: The search yielded 541 potentially relevant RCTs, 22 of which were considered suitable. All trials included patients with solid cancer and hematological malignancies in the formal reported inclusion criteria. However, only two trials reported the accurate number of cancer patients included. Ten trials excluded neutropenic patients and seven trials excluded thrombocytopenic patients. Eleven trials excluded patients that were treated with any immunosuppression treatment. None of the two trials that included cancer patients reported separate outcomes for this population. CONCLUSION: Our systematic review shows that cancer patients are underrepresented in COVID-19 interventional therapeutic trials, and evidence regarding outcomes are lacking.