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    SARS-CoV-2 infection and adverse events in patients with cancer receiving immune checkpoint inhibitors: an observational prospective study

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    Authors
    Mandala, M.
    Lorigan, Paul C
    De Luca, M.
    Bianchetti, A.
    Merelli, B.
    Bettini, A. C.
    Bonomi, L.
    Nahm, Sharon
    Vitale, M. G.
    Negrini, G.
    Di Croce, A.
    Ascierto, P. A.
    Rulli, E.
    Tondini, C. A.
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    Affiliation
    Unit of Medical Oncology, University of Perugia, Perugia, Italy
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    Background: In ambulatory patients with cancer with asymptomatic or pauci-symptomatic SARS-CoV-2 infection, the safety of targeted therapies (TTs), chemotherapy (CT) or immune checkpoint inhibitors (ICIs) therapy is still unknown. Material and methods: From the start of the first epidemic wave of SARS-CoV-2 in Bergamo, Italy, we have prospectively screened all consecutive outpatients who presented for treatment to the Oncology Division of the Papa Giovanni XXIII Hospital, Bergamo for SARS-CoV-2 antigen expression. We identified patients treated with ICIs and compared these to patients with the same cancer subtypes treated with TTs or CT. Results: Between March 5 and May 18, 293 consecutive patients (49% melanoma, 34% non-small cell lung cancer, 9% renal cell carcinoma, 8% other) were included in this study: 159 (54%), 50 (17%) and 84 (29%) received ICIs, CT or TTs, respectively. Overall 89 patients (30.0%) were SARS-CoV-2 positive. Mortality of SARS-CoV-2-positive patients was statistically significantly higher compared with SARS-CoV-2 negative patients (8/89 vs 3/204, respectively, Fisher's exact test p=0.004). All deaths were due to COVID-19. Serious adverse events (SAEs) were more frequent in SARS-CoV-2-positive patients compared with SARS-CoV-2-negative cases (Cochran-Mantel-Haenszel (CMH) test p=0.0008). The incidence of SAEs in SARS-CoV-2 positive compared with SARS-CoV-2 negative patients was similar in ICI and CT patients (17.3% and 3.7% for positive and negative patients in ICIs and 15.4% and 2.7% in CT, Breslow-Day test p=0.891). No COVID-19-related SAEs were observed in the TTs patients. Conclusions: The incidence of SAEs was higher for SARS-CoV-2-positive patients treated with ICIs and CT, mostly in advanced disease. No SAEs were observed in patients treated with TTs. SAEs were COVID-19 related rather than treatment related. Treatment with ICIs does not appear to significantly increase risk of SAEs compared with CT. This information should be considered when determining treatment options for patients.
    Citation
    Mandala M, Lorigan P, De Luca M, Bianchetti A, Merelli B, Bettini AC, et al. SARS-CoV-2 infection and adverse events in patients with cancer receiving immune checkpoint inhibitors: an observational prospective study. J Immunother Cancer. 2021;9(2).
    Journal
    Journal for Immunotherapy of Cancer
    URI
    http://hdl.handle.net/10541/623863
    DOI
    10.1136/jitc-2020-001694
    PubMed ID
    33593827
    Additional Links
    https://dx.doi.org/10.1136/jitc-2020-001694
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1136/jitc-2020-001694
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