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
Abstract
BACKGROUND

There are currently three coronavirus disease 2019 (COVID-19) vaccines approved by the United States Food and Drug Administration to prevent coronavirus infection. However, robust data are unavailable on the adverse events of the vaccines in patients with solid tumor malignancies undergoing systemic therapies.

AIM

To evaluate the safety of COVID-19 vaccines in patients with solid tumors undergoing systemic therapies.

METHODS

The study included patients with solid tumors treated in an academic tertiary care center who received COVID-19 vaccination between January 1, 2021 and August 15, 2021, while undergoing systemic therapy. Electronic medical records were accessed to collect information on patient characteristics, systemic therapies, type of vaccine received, and adverse effects associated with the vaccine administration. Adverse events (AEs) were graded according to Common Terminology Criteria for Adverse Events, version 5.0.

RESULTS

The analysis included 210 patients; the median age was 70 years, and 51% of patients were female. The most common chemotherapy, immunotherapy, and targeted therapy administered were taxane-based regimens 14.2% (30/210), anti-programmed death 1 (PD-1) agents 22.8% (48/210), and antiangiogenic agents 7.1% (15/210), respectively. The most common cancers were gastrointestinal 43.8% (92/210), thoracic 30.4% (64/210), and genitourinary 17.6% (37/210). Patients received the following vaccines: 2 doses of BNT162b2 by Pfizer 52% (110/210), 2 doses of mRNA-1273 by Moderna 42% (89/210), and 1 dose of JNJ-78436735 by Johnson & Johnson 5% (11/210). At least 1 AE attributable to the vaccine was observed in 37 patients 17.6% (37/210). The total number of AEs attributable to vaccines was 62: Fifty-three grade 1 and nine grade 2. Most adverse events occurred after the second dose 59.7% (37/62). The most frequent grade 1 AEs included fatigue 17% (9/53), fever 15% (8/53), injection site reaction 13.2% (7/53), and chills 9.4% (5/53). The most frequent grade 2 AEs were fatigue 33.3% (3/9) and generalized weakness 22.2% (2/9). Therapy was delayed by 2 wk because of the AEs possibly related to vaccine administration in 3 patients 1.4% (3/210).

CONCLUSION

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.

Keywords: COVID-19; Adverse events; Solid tumor; Chemotherapy; Immunotherapy; Targeted therapy

Core Tip: The current study evaluates the safety and spectrum of adverse events associated with coronavirus disease 2019 (COVID-19) vaccination in solid tumor patients receiving systemic therapy. While COVID-19 vaccination has been shown to be safe and effective in the healthy population, the data confirming the safety of COVID-19 vaccines in cancer patients are sparse. The lack of safety data in cancer patients has caused significant hesitancy to receive COVID-19 vaccination among the patient population with cancer. Our study showed that the administration of COVID-19 vaccines in solid tumor patients receiving systemic therapy is safe and should be encouraged.