key: cord-0985684-iuapkpty authors: Trojaniello, Claudia; Vitale, Maria Grazia; Ascierto, Paolo Antonio title: Checkpoint inhibitor therapy for skin cancer may be safe in patients with asymptomatic COVID-19 date: 2021-02-16 journal: Ann Oncol DOI: 10.1016/j.annonc.2021.02.008 sha: 480daac4004177ed77091e12b53f61376847a431 doc_id: 985684 cord_uid: iuapkpty nan Claudia Trojaniello, Maria Grazia Vitale, Paolo Antonio Ascierto. Department Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy To the editor: An ongoing area of uncertainty during the SARS-CoV-2 pandemic is the safety of immune checkpoint inhibitor (ICI) therapy for cancer, and the theoretical possibility of exacerbated immune-related adverse events (irAEs) secondary to COVID-19 inflammatory pathology (1) . Current guidelines from the European Here, we report that administration of ICIs was safe in these patients, with no increased incidence of irAEs or worsening of COVID-19 disease in patients with skin cancers incidentally discovered to be infected with SARS-CoV-2 through a median follow-up of 2.23 months (range 1-10 months). Although the prospect of delayed-onset irAEs remains a possibility, no new signals were reported during follow up and all of the patients recovered and are doing well. Importantly, among six patients who received ICIs one day prior to confirmed COVID-19 diagnosis by nasopharyngeal swab, no adverse events were observed, all infections were completely asymptomatic, and cancer therapy was reinitiated upon viral clearance. An additional 11 patients were found to be infected with SARS-CoV-2 within 10 to 30 days after their most recent cycle of immunotherapy, meaning that the effects of ICI were likely still present given known pharmacokinetics and pharmacodynamics of checkpoint blockade. Of these 11 patients, 6 developed mild COVID-19 symptoms, including fever, cough, and anosmia. Only one patient required hospitalization due to mild pneumonia, J o u r n a l P r e -p r o o f with findings of increased serum C-reactive protein (CRP) and d-dimer levels, all of which resolved. Patient characteristics, symptoms defined by CTCAE 5.0 (3), and outcomes are summarized in Table 1 . Although risk-benefit calculations during the pandemic must take into account several variables, including potential survival benefit, possibility of developing COVID-19 hyperinflammation (4) and patient risk factors and preferences, these data, along with other emerging evidence, suggests that the use of ICIs in the presence of SARS-CoV-2 infection may be safe for patients with mild or asymptomatic COVID-19 who are likely not at risk for developing hyperinflammatory disease. We found that of the 17 patients with concomitant ICI therapy and SARS-CoV-2 infection, only 6 (35%) developed symptoms, all of which were mild, and 15 (88%) resumed therapy. These findings are in line with initial results from the Thoracic Cancers International COVID-19 Collaboration (TERAVOLT) registry, which found that although mortality was high among patients with lung cancers, no evidence was found that COVID-19 outcomes were worse in the small subset of patients receiving immune checkpoint inhibitors compared to the overall cohort (5). A subsequent analysis at Memorial Sloan Kettering Cancer Center in New York similarly found that PD-1 blockade was not associated with increased risk of severity of COVID-19 (6). The outcomes we describe are also consistent with other reports of safe ICI therapy in patients with melanoma and COVID-19 (7, 8) . Larger studies will be needed to definitively establish safety and efficacy. Additionally, it will be important to take into account logistical concerns for isolating SARS-CoV-2-infected patients to prevent further spread and the potential for exposing vulnerable individuals, such as those living with cancer, to the virus. The oncology community mobilized and adapted to unprecedented circumstances during the past year, and efforts must continue to provide lifesaving care while minimizing risks for both healthcare workers and patients. COVID-19 and immune checkpoint inhibitors: initial considerations Managing cancer patients during the COVID-19 pandemic: an ESMO multidisciplinary expert consensus COVID-19-associated hyperinflammation and escalation of patient care: a retrospective longitudinal cohort study COVID-19 in patients with thoracic malignancies (TERAVOLT): first results of an international, registry-based, cohort study. The Lancet Oncology Impact of PD-1 Blockade on Severity of COVID-19 in Patients with Lung Cancers None Melanoma Metastatic Nivolumab 06/04/2020 16/11/2020 30/11/2020 None Yes Yes The authors thank the patients and their families as well as the front-line workers battling the COVID-19 pandemic. Additionally, the authors acknowledge Sam Million-Weaver, PhD for editorial assistance.