Safety of mRNA-COVID-19 Vaccines in Patients With Thoracic Cancers

Our plain-English summary of Safety of mRNA-COVID-19 Vaccines in Patients With Thoracic Cancers, by G. Spitaleri, P. Trillo Aliaga, C. Catania, et al (Clinical Lung Cancer, 2023).

The study

• Authors: G. Spitaleri, P. Trillo Aliaga, C. Catania, E.D. Signore, I. Attili, C. Santoro, F. Giugliano, P.P.M. Berton Giachetti, G. Curigliano, A. Passaro, F. de Marinis
• Journal: Clinical Lung Cancer
• Published: 2023;24(1):e19-e26
• Cited by: 1 article, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

Background: Pivotal trials of COVID-19 vaccines did not include cancer patients with questions remaining in this population. Particularly in patients with thoracic malignancies receiving anticancer treatments, the safety of these vaccines has so far been little investigated.

Methods: This is a prospective trial of patients with thoracic cancer receiving anticancer treatments and COVID-19 vaccines at the Division of Thoracic Oncology of European Institute of Oncology between February and September 2021.

Results: A total 207 patients affected by thoracic cancers (199 lung cancers and 8 mesotheliomas) had received Covid-19 vaccines (206 mRNA vaccines and 1 virus-vectored vaccine). The majority of patients had at least one comorbidity (76.3%). They were concomitantly treating with targeted therapy (TT) (45.9%), immunotherapy (IO) (22.7%), and chemotherapy (CT) (14%). A total of 64 AEs (15.6%) were observed after administration of Sars-Cov-2 vaccine. The majority of AEs were grade 1 [G1] (6.3%) and G2 (8.8%), only two events were G3 (0.5%). The median follow-up was 9 months (range 1-22 months), during this follow-up 21 patients (10.1%) had a positive nasal swab, most of the patients were asymptomatic (67%) and the symptomatic ones (33%) had mild symptoms and fewer complications and hospitalizations.

Conclusions: COVID-19 m-RNA vaccines appear to be safe in the cohort of patients with thoracic malignances in active treatment, including those receiving immunotherapy. Considering the high morbidity and mortality associated with COVID-19 in patients with lung cancer receiving active treatments, our study supports the current vaccine prioritization, third and/or fourth dose, of all cancer patients with active treatment.

Copyright © 2022 Elsevier Inc. All rights reserved.

In plain English

This prospective study at the Division of Thoracic Oncology of the European Institute of Oncology in Milan, Italy, followed 207 patients with thoracic cancers (199 lung cancers and 8 mesotheliomas) who received COVID-19 vaccines between February and September 2021, nearly all during cancer treatment. It did not study asbestos exposure, and it did not report the mesothelioma patients separately. Of the 207 patients, 206 received mRNA vaccines, and 411 doses were given in all. Forty-three patients (20.7%) had a side effect. Of the 64 side effects recorded, most were grade 1 or 2 and two were grade 3 (fever and dyspnea). None were grade 4 or higher. Most began within 7 days and resolved within 3 days. One patient was hospitalized with grade 3 fever. Over a median follow-up of 9 months, 21 patients (10.1%) tested positive for the virus. The article's main text says 14 of them (67%) had symptoms. The authors concluded that vaccine safety in these patients did not seem to differ from that in the general patient population. They noted that the study was small, took place at one center, and did not measure immune responses.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Prospective single-center observational study (the authors call it a prospective trial) describing vaccine side effects; descriptive statistics only
• Who was studied: 207 patients with thoracic cancers (199 lung cancers and 8 mesotheliomas) treated or followed at the Division of Thoracic Oncology, European Institute of Oncology, Milan, Italy, between February and September 2021. They were 207 of 214 eligible patients; 4 refused vaccination and 3 postponed it. Median age was 67 years and 92.3% had metastatic disease at vaccination.
• Exposure: COVID-19 vaccination: 143 patients received Pfizer-BioNTech (BNT162b2), 63 received Moderna (mRNA-1273) and 1 received AstraZeneca (ChAdOx1 nCoV-19). 411 doses were given and 204 patients received a second dose. Patients were on targeted therapy (45.9%), immunotherapy (22.7%), chemotherapy (14%) or combinations. Asbestos exposure was not studied.
• Main results:
  • 43 of 207 patients (20.7%) had at least one adverse event after vaccination
  • 64 adverse events (15.6%) were recorded after the first dose (207 patients) and the second dose (204 patients): 26 grade 1 (6.3%), 36 grade 2 (8.8%) and 2 grade 3 (0.5%). No grade 4 or higher events occurred. 47 were systemic and 17 local.
  • The two grade 3 events were fever and dyspnea. One patient was hospitalized for grade 3 fever.
  • Most adverse events (62 of 64; 96.9%) began within 7 days of vaccination, and most (61; 95.3%) resolved within 3 days. Fatigue lasted beyond 15 days in two cases.
  • The 28 patients receiving chemotherapy had a lower incidence of adverse events (10.5%)
  • Over a median follow-up of 9 months (range 1 to 22 months), 21 patients (10.1%) had a positive nasal swab. From this the authors stated a vaccine efficacy of 89.9%; there was no unvaccinated comparison group.
  • The main text reports that 14 of the 21 infected patients (67%) had symptoms, most commonly fever (71%), cough (71%) and dysgeusia (29%). Symptoms were described as mild.
  • The authors compared these infections with 9 patients infected before vaccination. After vaccination there was 1 pneumonia versus 3 before, 1 hospital admission versus 4, and 0 intensive care admissions versus 1. The authors stated that this rough comparison is affected by significant confounding, including different virus variants in the two periods.
  • During follow-up, 22 patients (10.6%) died of cancer progression. The authors found no correlation with vaccine side effects.
• The authors' conclusion: The authors concluded that the safety profile of COVID-19 vaccines in patients with thoracic cancers, including those on immune checkpoint inhibitors and targeted therapies, does not seem to differ from that of the general patient population. They supported vaccine prioritization and recommended a booster (fourth) dose for patients in active treatment.
• Limitations the authors state:
  • Antibody and T-cell immune responses were not measured, for logistical and financial reasons
  • The population was heterogeneous, and confounding factors such as cancer type, cancer treatment and vaccine type could not be reliably accounted for
  • The small cohort limited the ability to detect rare or delayed toxicities
  • Almost all patients received mRNA vaccines, so results may not apply to viral-vector or inactivated vaccines
  • The study was carried out at a single center, which may limit external validity
  • The comparison of infections before and after vaccination is affected by significant confounding, especially the different virus variants circulating in the two periods

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer.

Medical terms in this study, explained in our Lexicon: Lung Cancer, Mesothelioma, Targeted Therapy, Immunotherapy, Chemotherapy.

Related studies

• COVID-19 vaccine effectiveness in patients with lung cancer: challenges in the Omicron era — S.M. Hosseini-Moghaddam, S. Swayze, et al. (2026)
• COVID-19 in patients with thoracic malignancies (TERAVOLT): first results of an international, registry-based, cohort study — M.C. Garassino, J.G. Whisenant, et al. (2020)
• The impact of COVID-19 on new mesothelioma diagnoses in Italy — L. Mangone, P. Mancuso, et al. (2022)
• Asbestos Exposure and Severity of COVID-19 — G. Granados, M. Sáez-López, et al. (2022)
• Pleural mesothelioma incidence and use of systemic treatment decreased during the COVID-19 pandemic in The Netherlands — I. Smesseim, L.H. Douma, et al. (2025)
• Mortality rates from asbestos-related diseases in Italy during the first year of the COVID-19 pandemic — L. Fazzo, E. Grande, et al. (2023)

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