A prospective testing SARS-Cov-2/COVID-19 in cancer patients with antitumor treatment

ABSTRACT

Background: The oncology community faces unprecedented challenges in balancing a delay in cancer treatmentagainst the risk for a potential COVID-19 infection and associated complications. An early retrospective analysisreported that cancer patients with COVID-19 infection have a much higher death rate than those infected but withouta cancer diagnosis, likely because of their immunocompromised disease from cancer and treatment. Even thoughCOVID-19 is known to have a long incubation period (∼14 days), there were no clear guidelines for screeningasymptomatic cancer patients who are planning to have and having antitumor treatment as of April 2020. Methods: We developed a protocol to screen asymptomatic cancer patients for COVID-19 who are scheduled toreceive cancer-directed treatment (i.e., chemotherapy, targeted therapy, immunotherapy, anticancer monoclonalantibody, endocrine therapy, or investigational agent). The protocol was developed and activated within 2 weeksthrough the Cancer Center Investigator Initiated Trial Program. FDA-authorized CDC 2019-Novel Coronavirus(2019-nCoV) Real-Time RT-PCR Diagnostic Panel EUA kit was performed at Sinochips Diagnostics. The primaryobjective was to determine COVID-19 status in participants prior to initiating anticancer treatment. The secondaryobjective was to evaluate COVID-19 related adverse events (AEs) in recovered COVID-19-positive participants for30 days after initiation of anticancer therapy. Results: We enrolled 507 patients and tested for COVID-19 from 4/28/20 to 5/8/20 through coordinated efforts within the CTO and Biospecimen Repository Core Facility. The research study was stopped when the KU HealthSystem was able to test this population as standard of care. Median age was 65 years, 110 patients (22%) wereaged 75 years or older, and 274 (54%) patients were female. 387 patients (76.3%) were Caucasians, 35 (6.9%)African American, 7 (1.4%) Asian, and 437 (86.2%) non-Hispanic. Based on the catchment of zip codes, 7% oftested patients came from more than 60 miles and 1.6% from more than 100 miles. Zero patients had a positiveCOVID-19 test. Conclusions: The prevalence of COVID19 in asymptomatic cancer patients is low, likely because of goodcompliance with the social distance policy. Screening for COVID19 may help reduce AEs related to COVID-19 inpatients receiving cancer-directed treatment. Studying COVID-19 test results in a larger patient pool is warranted. Asimilar study to test asymptomatic patient-facing oncology staff is pending.