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Shah MA, Mayer S, Emlen F, et al. Clinical Screening for COVID-19 in Asymptomatic Patients With Cancer. JAMA Netw Open. 2020;3(9):e2023121. doi:10.1001/jamanetworkopen.2020.23121
As the coronavirus disease 2019 (COVID-19) pandemic continues across the United States, a critical issue for practicing oncologists is how to continue cancer care while protecting patients.1 To continue care for patients while also minimizing exposure to health care staff, the Weill Cornell Medicine Division of Hematology and Medical Oncology created separate units for patients with confirmed COVID-19, patients with symptomatic but unconfirmed COVID-19, and asymptomatic patients with no known high-risk COVID-19 exposures.2 Patients were contacted prior to their appointment and triaged based on their COVID-19 risk status. To understand the success of our clinical screening and triaging procedures, we implemented a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing protocol in asymptomatic patients who required cancer care across the Division of Hematology and Medical Oncology.
This quality improvement study, approved by Weill Cornell Medicine, follows the Standards for Quality Improvement Reporting Excellence (SQUIRE) reporting guideline. Informed consent was waived because data were deidentified, per institutional policy.
Patients were considered asymptomatic if they had no recent fever (defined as body temperature ≥100.5 °F for ≥5 days); no COVID-19 symptoms, which included cough, headache, loss of taste, and shortness of breath3; or high risk exposure (eg, contact with an individual with confirmed COVID-19, nursing home stay, or hospitalization) within 14 days. Diagnosis of COVID-19 was confirmed using SARS-CoV-2 nasal swab polymerase chain reaction (PCR) testing (Cobas 6800; Roche Diagnostics) and SARS-CoV-2 IgM and IgG serological tests (Pylon 3D; ET HealthCare).4 Patients were retested every 1 to 2 weeks. Rates of positive SARS-CoV-2 PCR and COVID-19 serological tests and 95% CIs are reported, using the 2-sided Clopper-Pearson (exact) 95% CI. Statistical analyses were conducted using Stata statistical software version 13.1 (StataCorp).
From April 30 through June 2, 2020, we performed 621 SARS-CoV-2 PCR tests on 537 asymptomatic patients (272 [50.7%] men) with hematologic or solid tumor malignant neoplasms (Table 1). Our patients were geographically representative of New York, New York, and surrounding areas, and more than 90% of patients were receiving active cytotoxic or targeted therapy. The rate of SARS-CoV-2 positivity was 0.64% (95% CI, 0.18%-1.64%). This includes 84 patients who had repeated SARS-CoV-2 tests, all of which were negative. Only 4 asymptomatic patients had test results positive for COVID-19, 2 each for hematologic and solid tumor neoplasms. We also performed serological tests from May 18 to June 2, 2020, on 238 asymptomatic patients. The rate of COVID-19 prior exposure in our asymptomatic cancer population was 4.23% (95% CI, 2.05%-7.65%) (Table 2). Notably, during this period, the SARS-CoV-2 PCR positivity rate in New York City in early May was 20%.5
The findings of this quality improvement study have several important implications. While it was clearly prudent to postpone elective procedures and delay care when possible, it is also clear that the risk of COVID-19 is likely to persist for some time. Cancer care will need to continue, given that further delays will lead to significantly worse outcomes for individual patients6 and other health care crises. We observed that the rate of past infection in our clinically screened asymptomatic cancer population was exceedingly low, at approximately 4%, and the rate of SARS-CoV-2 PCR positivity was less than 1%. This is in contrast to the COVID-19 prevalence in New York City at that time, which was close to 20%. While we do not know the reason for this low prevalence rate, it is likely that these highly motivated patients abided to social distancing recommendations, masking, and hygiene. We found that patients whose test results were negative for COVID-19 could receive chemotherapy without increasing the risk of contracting the disease, further bolstering the argument that clinicians may resume anticancer therapy in asymptomatic patients. Our quality initiative study was limited by the relatively small sample size of our patients in racial/ethnic minority groups and relatively short patient follow-up. However, we found that with proper patient education and clinical screening for symptoms or viral exposure, we maintained the outpatient clinical arena largely free of SARS-CoV-2. These data provide some reassurance to health care workers and patients that oncological treatment may safely continue.
Accepted for Publication: August 17, 2020.
Published: September 29, 2020. doi:10.1001/jamanetworkopen.2020.23121
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 Shah MA et al. JAMA Network Open.
Corresponding Author: Manish A. Shah, MD, Department of Medicine, Division of Hematology and Medical Oncology, Weill Cornell Medicine, 1305 York Ave, Y1247, New York, NY 10021 (email@example.com).
Author Contributions: Drs Shah and Mayer had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Shah, Emlen, Hidalgo.
Acquisition, analysis, or interpretation of data: Shah, Mayer, Sholle, Christos, Cushing, Hidalgo.
Drafting of the manuscript: Shah, Sholle.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Shah, Sholle, Christos.
Administrative, technical, or material support: Shah, Mayer, Emlen, Sholle.
Supervision: Shah, Hidalgo.
Conflict of Interest Disclosures: Dr Christos reported receiving grants from Clinical and Translational Science Center (1-UL1-TR002384-01) during the conduct of the study. Dr Cushing reported serving as a consultant for Octapharma and Instrumentation Laboratory outside the submitted work. Dr Hidalgo reported receiving personal fees from Inxmed, Agenus, Biooncotech, Takeda, Oncomatrix, and Sumitomo; research support from Bioexcell and Bioline; owning stock in Pharmacyte, Agenus, and Biooncotech; and serving as founder and owning stock in Nelum outside the submitted work. No other disclosures were reported.
Funding/Support: This study received support from NewYork-Presbyterian Hospital, Weill Cornell Medical College, and the Joint Clinical Trials Office.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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