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


Journal

Journal for immunotherapy of cancer
ISSN: 2051-1426
Titre abrégé: J Immunother Cancer
Pays: England
ID NLM: 101620585

Informations de publication

Date de publication:
02 2021
Historique:
accepted: 06 01 2021
entrez: 17 2 2021
pubmed: 18 2 2021
medline: 2 3 2021
Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

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.

Identifiants

pubmed: 33593827
pii: jitc-2020-001694
doi: 10.1136/jitc-2020-001694
pmc: PMC7887862
pii:
doi:

Substances chimiques

Immune Checkpoint Inhibitors 0

Types de publication

Journal Article Observational Study

Langues

eng

Sous-ensembles de citation

IM

Commentaires et corrections

Type : ErratumIn

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Mario Mandala (M)

Unit of Medical Oncology, University of Perugia, Perugia, Italy mario.mandala@unipg.it.

Paul Lorigan (P)

Medical Oncology-Melanoma, The Christie Hospital NHS Trust, Manchester, UK.
Division of cancer sciences, The University of Manchester, Manchester, UK.

Matilde De Luca (M)

Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Lombardia, Italy.

Andrea Bianchetti (A)

Oncology, Fondazione per la Ricerca Ospedale Maggiore, Bergamo, Italy.

Barbara Merelli (B)

Unit of Medical Oncology, Department of Oncology and Hematology, ASST Papa Giovanni XXIII, Bergamo, Lombardia, Italy.

Anna Cecilia Bettini (AC)

Oncology, Department of Oncology and Hematology, ASST Papa Giovanni XXIII, Bergamo, Lombardia, Italy.

Lucia Bonomi (L)

Oncology, Department of Oncology and Hematology, ASST Papa Giovanni XXIII, Bergamo, Lombardia, Italy.

Sharon Nahm (S)

Medical Oncology-Melanoma, The Christie Hospital NHS Trust, Manchester, UK.

Maria Grazia Vitale (MG)

Unit of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.

Giorgia Negrini (G)

Oncology, Department of Oncology and Hematology, ASST Papa Giovanni XXIII, Bergamo, Lombardia, Italy.

Andrea Di Croce (A)

Unit of Medical Oncology, Department of Oncology and Hematology, ASST Papa Giovanni XXIII, Bergamo, Lombardia, Italy.

Paolo Antonio Ascierto (PA)

Unit of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.

Eliana Rulli (E)

Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Lombardia, Italy.

Carlo Alberto Tondini (CA)

Unit of Medical Oncology, Department of Oncology and Hematology, ASST Papa Giovanni XXIII, Bergamo, Lombardia, Italy.

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Classifications MeSH