Retrospective Cohort Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Oncol. Jul 24, 2022; 13(7): 599-608
Published online Jul 24, 2022. doi: 10.5306/wjco.v13.i7.599
Short term safety of coronavirus disease 2019 vaccines in patients with solid tumors receiving systemic therapy
Ronald E Cox, Marie Parish, Carolyn Oxencis, Edward Mckenna, Bicky Thapa, Sakti Chakrabarti
Ronald E Cox, Student, Medical College of Wisconsin, Wauwatosa, WI 53222, United States
Marie Parish, Carolyn Oxencis, Pharmacy, Froedtert & the Medical College of Wisconsin, Wauwatosa, WI 53222, United States
Edward Mckenna, Bicky Thapa, Sakti Chakrabarti, Department of Hematology and Oncology, Medical College of Wisconsin, Wauwatosa, WI 53222, United States
Author contributions: Cox RE, Parish M, Oxencis C, McKenna E, Thapa B, and Chakrabarti S contributed equally to this work; All authors have read and approved the final manuscript.
Institutional review board statement: The study was reviewed and approved by the Medical College of Wisconsin Institutional Review Board (Approval No. PRO00040038).
Informed consent statement: Per institutional review board approval, consent forms were not necessary since the project did not include direct contact with subjects.
Conflict-of-interest statement: Sakti Chakrabarti has received fees for serving as a speaker for Natera. Sakti Chakrabarti has received Honoraria from Haliodx and QED Therapeutics. Ronald Cox has no conflicts of interest. Marie Parish has no conflicts of interest. Carolyn Oxencis has no conflicts of interest. Bicky Thapa has no conflicts of interest. Edward McKenna has no conflicts of interest.
Data sharing statement: No additional data are available.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Sakti Chakrabarti, MD, Associate Professor, Hematology and Oncology, Medical College of Wisconsin, 8701 W WATERTOWN PLANK RD, Wauwatosa, WI 53222, United States. schakrabarti@mcw.edu
Received: January 11, 2022
Peer-review started: January 11, 2022
First decision: February 15, 2022
Revised: February 27, 2022
Accepted: June 13, 2022
Article in press: June 13, 2022
Published online: July 24, 2022
Processing time: 191 Days and 18.1 Hours
ARTICLE HIGHLIGHTS
Research background

In the wake of the coronavirus disease 2019 (COVID-19) pandemic, the United States Food and Drug Administration approved 3 vaccines to prevent coronavirus infection. The rapidity of vaccine approval and the limited scientific inquiry into vaccine-related adverse events notably expanded apprehension towards vaccination in patients with malignancies. Our study reports real-world data on the severity and spectrum of adverse events in solid tumor cancer patients receiving systemic therapy.

Research motivation

The motivation behind this project was to promote awareness regarding the short-term safety of COVID-19 vaccines in cancer patients with solid tumor malignancies. Our results help lessen the societal apprehension and hesitation surrounding the safety of COVID-19 vaccination.

Research objectives

The main objective of this study was to evaluate the short-term safety of COVID-19 vaccines in patients with solid tumors undergoing treatment with systemic therapies. Through rigorous analysis, we were able to document the incidence and spectrum of vaccine-related adverse events in our patient cohort. Our research forms the groundwork for future studies on long-term adverse events secondary to vaccination.

Research methods

Our study was a retrospective analysis of cancer patients who received COVID-19 vaccination between January 1, 2021 and August 15, 2021. Eligible patients were identified using the EPIC SlicerDicer tool in the Froedtert and the Medical College of Wisconsin Cancer Center database. Once identified, patients were further screened based on study inclusion/exclusion criteria. Electronic medical records for the final patients were examined to collect information on patient characteristics, tumor characteristics, details of systemic therapy, type of vaccine received, and any adverse events associated with the vaccine administration.

Research results

Analysis of our 210 patients revealed at least 1 adverse event attributable to vaccination in 17.6% of our study cohort. Of these adverse events, fifty-three were grade 1 and nine were grade 2. Our data further bolsters the sparse scientific literature regarding COVID-19 vaccination in patients with cancer.

Research conclusions

The present study demonstrates that the adverse events associated with COVID-19 vaccination are infrequent, mild, and rarely delay treatment in patients with solid tumors receiving systemic therapies. This knowledge further begs the question of whether or not patients receiving systemic therapies are mounting an appropriate response to immunogenic antigens. Further scientific inquiry exploring vaccine efficacy and adverse events in our patient cohort vs a healthy control group could elucidate the role of systemic therapy in vaccine-related adverse events.

Research perspectives

Future research will be focused on increasing study enrollment and exploring the long-term adverse events secondary to COVID-19 vaccination.