Cargando…

Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis

Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgent...

Descripción completa

Detalles Bibliográficos
Autores principales: Nuzzo, Amedeo, Manacorda, Simona, Sammarco, Enrico, Sbrana, Andrea, Bazzurri, Serena, Paolieri, Federico, Manfredi, Fiorella, Mercinelli, Chiara, Ferrari, Marco, Massaro, Giulia, Bonato, Adele, Salfi, Alessia, Galli, Luca, Morganti, Riccardo, Antonuzzo, Andrea, Cremolini, Chiara, Masi, Gianluca
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9227366/
https://www.ncbi.nlm.nih.gov/pubmed/35746500
http://dx.doi.org/10.3390/vaccines10060892
_version_ 1784734157164773376
author Nuzzo, Amedeo
Manacorda, Simona
Sammarco, Enrico
Sbrana, Andrea
Bazzurri, Serena
Paolieri, Federico
Manfredi, Fiorella
Mercinelli, Chiara
Ferrari, Marco
Massaro, Giulia
Bonato, Adele
Salfi, Alessia
Galli, Luca
Morganti, Riccardo
Antonuzzo, Andrea
Cremolini, Chiara
Masi, Gianluca
author_facet Nuzzo, Amedeo
Manacorda, Simona
Sammarco, Enrico
Sbrana, Andrea
Bazzurri, Serena
Paolieri, Federico
Manfredi, Fiorella
Mercinelli, Chiara
Ferrari, Marco
Massaro, Giulia
Bonato, Adele
Salfi, Alessia
Galli, Luca
Morganti, Riccardo
Antonuzzo, Andrea
Cremolini, Chiara
Masi, Gianluca
author_sort Nuzzo, Amedeo
collection PubMed
description Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. Patients and methods: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27–87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. Results: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. Conclusions: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors.
format Online
Article
Text
id pubmed-9227366
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-92273662022-06-25 Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis Nuzzo, Amedeo Manacorda, Simona Sammarco, Enrico Sbrana, Andrea Bazzurri, Serena Paolieri, Federico Manfredi, Fiorella Mercinelli, Chiara Ferrari, Marco Massaro, Giulia Bonato, Adele Salfi, Alessia Galli, Luca Morganti, Riccardo Antonuzzo, Andrea Cremolini, Chiara Masi, Gianluca Vaccines (Basel) Article Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. Patients and methods: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27–87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. Results: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. Conclusions: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors. MDPI 2022-06-02 /pmc/articles/PMC9227366/ /pubmed/35746500 http://dx.doi.org/10.3390/vaccines10060892 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Nuzzo, Amedeo
Manacorda, Simona
Sammarco, Enrico
Sbrana, Andrea
Bazzurri, Serena
Paolieri, Federico
Manfredi, Fiorella
Mercinelli, Chiara
Ferrari, Marco
Massaro, Giulia
Bonato, Adele
Salfi, Alessia
Galli, Luca
Morganti, Riccardo
Antonuzzo, Andrea
Cremolini, Chiara
Masi, Gianluca
Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis
title Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis
title_full Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis
title_fullStr Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis
title_full_unstemmed Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis
title_short Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis
title_sort safety and tolerability of covid-19 vaccines in patients with cancer: a single center retrospective analysis
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9227366/
https://www.ncbi.nlm.nih.gov/pubmed/35746500
http://dx.doi.org/10.3390/vaccines10060892
work_keys_str_mv AT nuzzoamedeo safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT manacordasimona safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT sammarcoenrico safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT sbranaandrea safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT bazzurriserena safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT paolierifederico safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT manfredifiorella safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT mercinellichiara safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT ferrarimarco safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT massarogiulia safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT bonatoadele safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT salfialessia safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT galliluca safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT morgantiriccardo safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT antonuzzoandrea safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT cremolinichiara safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis
AT masigianluca safetyandtolerabilityofcovid19vaccinesinpatientswithcancerasinglecenterretrospectiveanalysis