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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Bibliographic Details
Published in:Cancers 2021-11, Vol.13 (22), p.5829
Main Authors: Trillo Aliaga, Pamela, Trapani, Dario, Sandoval, José Luis, Crimini, Edoardo, Antonarelli, Gabriele, Vivanet, Grazia, Morganti, Stefania, Corti, Chiara, Tarantino, Paolo, Friedlaender, Alex, Belli, Carmen, Minchella, Ida, Locatelli, Marzia, Esposito, Angela, Criscitiello, Carmen, Curigliano, Giuseppe
Format: Article
Language:English
Subjects:
Adverse events
Breast cancer
Cancer
Cancer therapies
Cancer vaccines
Chemotherapy
Clinical trials
Coronaviruses
COVID-19
COVID-19 vaccines
Disease
Drug development
Drug dosages
Fever
Immune checkpoint inhibitors
Immunosuppressive agents
Immunotherapy
Metastasis
mRNA
Pain
Pandemics
Patients
Population
Safety
Severe acute respiratory syndrome coronavirus 2
Tumors
Vaccines
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Summary: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.
ISSN:2072-6694
2072-6694
DOI:10.3390/cancers13225829