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

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

doi:10.3390/cancers13225829

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

Cancers (Basel). 2021 Nov 20;13(22):5829. doi: 10.3390/cancers13225829.

Authors

Pamela Trillo Aliaga^{1

2}, Dario Trapani¹, José Luis Sandoval^{3

4}, Edoardo Crimini^{1

2}, Gabriele Antonarelli^{1

2}, Grazia Vivanet^{1

2}, Stefania Morganti^{1

2}, Chiara Corti^{1

2}, Paolo Tarantino^{1

2}, Alex Friedlaender⁴, Carmen Belli¹, Ida Minchella¹, Marzia Locatelli¹, Angela Esposito¹, Carmen Criscitiello^{1

2}, Giuseppe Curigliano^{1

2}

Affiliations

¹ Division of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.
² Department of Oncology and Hematology, University of Milan, 20122 Milan, Italy.
³ Unit of Population Epidemiology, Division and Department of Primary Care Medicine, Geneva University Hospitals, 1205 Geneva, Switzerland.
⁴ Department of Oncology, Geneva University Hospitals, 1205 Geneva, Switzerland.

Abstract

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.

Keywords: COVID and cancer; COVID-19; COVID-19 vaccine; SARS-CoV-2; early-phase clinical trials; novel immunotherapy; phase one trial; solid tumors; targeted therapy.