TY - JOUR
T1 - Safety of covid-19 mrna vaccines in patients with cancer enrolled in early-phase clinical trials
AU - Trillo Aliaga, Pamela
AU - Trapani, Dario
AU - Sandoval, José Luis
AU - Crimini, Edoardo
AU - Antonarelli, Gabriele
AU - Vivanet, Grazia
AU - Morganti, Stefania
AU - Corti, Chiara
AU - Tarantino, Paolo
AU - Friedlaender, Alex
AU - Belli, Carmen
AU - Minchella, Ida
AU - Locatelli, Marzia
AU - Esposito, Angela
AU - Criscitiello, Carmen
AU - Curigliano, Giuseppe
N1 - Funding Information:
This work was partially supported by the Italian Ministry of Health with Ricerca Corrente and 5 ? 1000 funds. The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Funding Information:
Funding: This work was partially supported by the Italian Ministry of Health with Ricerca Corrente and 5 × 1000 funds. The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2021/11/1
Y1 - 2021/11/1
N2 - 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.
AB - 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.
KW - COVID and cancer
KW - COVID-19
KW - COVID-19 vaccine
KW - Early-phase clinical trials
KW - Novel im-munotherapy
KW - Phase one trial
KW - SARS-CoV-2
KW - Solid tumors
KW - Targeted therapy
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U2 - 10.3390/cancers13225829
DO - 10.3390/cancers13225829
M3 - Article
AN - SCOPUS:85119376400
VL - 13
JO - Cancers
JF - Cancers
SN - 2072-6694
IS - 22
M1 - 5829
ER -