Safety of COVID-19 mRNA Vaccines in Patients with Cancer Enrolled in Early-Phase Clinical Trials

Pivotal trials of COVID-19 vaccines did not include cancer patients, with questions remaining about their safety and efficacy in this population. Patients enrolled in early-phase clinical trials receive novel treatments with unknown efficacy and safety profiles. Studies on the safety of COVID-19 vac...

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Autores principales:	Pamela Trillo Aliaga, Dario Trapani, José Luis Sandoval, Edoardo Crimini, Gabriele Antonarelli, Grazia Vivanet, Stefania Morganti, Chiara Corti, Paolo Tarantino, Alex Friedlaender, Carmen Belli, Ida Minchella, Marzia Locatelli, Angela Esposito, Carmen Criscitiello, Giuseppe Curigliano
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	SARS-CoV-2 COVID-19 COVID and cancer early-phase clinical trials novel immunotherapy COVID-19 vaccine Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/276687d39d9d44b594058b4f7472fd6a
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spelling	oai:doaj.org-article:276687d39d9d44b594058b4f7472fd6a2021-11-25T17:04:30ZSafety of COVID-19 mRNA Vaccines in Patients with Cancer Enrolled in Early-Phase Clinical Trials10.3390/cancers132258292072-6694https://doaj.org/article/276687d39d9d44b594058b4f7472fd6a2021-11-01T00:00:00Zhttps://www.mdpi.com/2072-6694/13/22/5829https://doaj.org/toc/2072-6694Pivotal trials of COVID-19 vaccines did not include cancer patients, with questions remaining about their safety and efficacy in this population. Patients enrolled in early-phase clinical trials receive novel treatments with unknown efficacy and safety profiles. Studies on the safety of COVID-19 vaccines in these patients are urgently required. This is a retrospective, real-world, cohort study of patients receiving anticancer treatments and COVID-19 vaccines between 1 February and 25 June 2021 at the Division of New Drugs Development for Innovative Therapies of the European Institute of Oncology. One hundred thirteen patients were enrolled, 40 in early-phase clinical trials, and 20 under novel immunotherapy agents. Nearly three-quarters of the patients experienced at least one adverse event (AE) after the first dose (1D) (74.3%) and second dose (2D) (72.6%). Most of the AEs were local (67.3% 1D and 61.9% after 2D), while 31.8% (1D) and 38.1% (2D) of the patients had systemic AEs. No AEs above grade 2 were observed. Therefore, COVID-19 vaccines appear to be safe in patients enrolled in early-phase clinical trials, including patients receiving novel immunotherapy compounds. All cancer patients should be prioritized for COVID-19 vaccination, regardless of ongoing treatments or enrollment in early-phase trials.Pamela Trillo AliagaDario TrapaniJosé Luis SandovalEdoardo CriminiGabriele AntonarelliGrazia VivanetStefania MorgantiChiara CortiPaolo TarantinoAlex FriedlaenderCarmen BelliIda MinchellaMarzia LocatelliAngela EspositoCarmen CriscitielloGiuseppe CuriglianoMDPI AGarticleSARS-CoV-2COVID-19COVID and cancerearly-phase clinical trialsnovel immunotherapyCOVID-19 vaccineNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancers, Vol 13, Iss 5829, p 5829 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	SARS-CoV-2 COVID-19 COVID and cancer early-phase clinical trials novel immunotherapy COVID-19 vaccine Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	SARS-CoV-2 COVID-19 COVID and cancer early-phase clinical trials novel immunotherapy COVID-19 vaccine Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Pamela Trillo Aliaga Dario Trapani José Luis Sandoval Edoardo Crimini Gabriele Antonarelli Grazia Vivanet Stefania Morganti Chiara Corti Paolo Tarantino Alex Friedlaender Carmen Belli Ida Minchella Marzia Locatelli Angela Esposito Carmen Criscitiello Giuseppe Curigliano Safety of COVID-19 mRNA Vaccines in Patients with Cancer Enrolled in Early-Phase Clinical Trials
description	Pivotal trials of COVID-19 vaccines did not include cancer patients, with questions remaining about their safety and efficacy in this population. Patients enrolled in early-phase clinical trials receive novel treatments with unknown efficacy and safety profiles. Studies on the safety of COVID-19 vaccines in these patients are urgently required. This is a retrospective, real-world, cohort study of patients receiving anticancer treatments and COVID-19 vaccines between 1 February and 25 June 2021 at the Division of New Drugs Development for Innovative Therapies of the European Institute of Oncology. One hundred thirteen patients were enrolled, 40 in early-phase clinical trials, and 20 under novel immunotherapy agents. Nearly three-quarters of the patients experienced at least one adverse event (AE) after the first dose (1D) (74.3%) and second dose (2D) (72.6%). Most of the AEs were local (67.3% 1D and 61.9% after 2D), while 31.8% (1D) and 38.1% (2D) of the patients had systemic AEs. No AEs above grade 2 were observed. Therefore, COVID-19 vaccines appear to be safe in patients enrolled in early-phase clinical trials, including patients receiving novel immunotherapy compounds. All cancer patients should be prioritized for COVID-19 vaccination, regardless of ongoing treatments or enrollment in early-phase trials.
format	article
author	Pamela Trillo Aliaga Dario Trapani José Luis Sandoval Edoardo Crimini Gabriele Antonarelli Grazia Vivanet Stefania Morganti Chiara Corti Paolo Tarantino Alex Friedlaender Carmen Belli Ida Minchella Marzia Locatelli Angela Esposito Carmen Criscitiello Giuseppe Curigliano
author_facet	Pamela Trillo Aliaga Dario Trapani José Luis Sandoval Edoardo Crimini Gabriele Antonarelli Grazia Vivanet Stefania Morganti Chiara Corti Paolo Tarantino Alex Friedlaender Carmen Belli Ida Minchella Marzia Locatelli Angela Esposito Carmen Criscitiello Giuseppe Curigliano
author_sort	Pamela Trillo Aliaga
title	Safety of COVID-19 mRNA Vaccines in Patients with Cancer Enrolled in Early-Phase Clinical Trials
title_short	Safety of COVID-19 mRNA Vaccines in Patients with Cancer Enrolled in Early-Phase Clinical Trials
title_full	Safety of COVID-19 mRNA Vaccines in Patients with Cancer Enrolled in Early-Phase Clinical Trials
title_fullStr	Safety of COVID-19 mRNA Vaccines in Patients with Cancer Enrolled in Early-Phase Clinical Trials
title_full_unstemmed	Safety of COVID-19 mRNA Vaccines in Patients with Cancer Enrolled in Early-Phase Clinical Trials
title_sort	safety of covid-19 mrna vaccines in patients with cancer enrolled in early-phase clinical trials
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/276687d39d9d44b594058b4f7472fd6a
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Safety of COVID-19 mRNA Vaccines in Patients with Cancer Enrolled in Early-Phase Clinical Trials

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