SYSTEMATIC REVIEW article
Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Acetaminophen use and prognosis in cancer patients treated with immune checkpoint inhibitors: Evidence from a meta-analysis
Provisionally accepted
- 1Department of Pharmacy, Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
- 2School of Pharmaceutical Science, Guangxi Medical University, Nanning, China
- 3State Key Laboratory of Natural Medicines, China Pharmaceutical University, Nanjing, China
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Background: Emerging studies have investigated the association between acetaminophen (APAP) use and clinical outcomes in cancer patients receiving immune checkpoint inhibitors (ICIs), but their findings remain inconsistent. This meta-analysis aims to systematically synthesize available evidence to clarify this relationship and provide evidence-based guidance for clinical practice. Methods: A systematic literature search was performed to identify studies comparing prognostic outcomes between APAP users and non-users among cancer patients treated with ICIs. Eligible studies were required to report hazard ratios (HRs) for overall survival (OS) and/or progression-free survival (PFS) with 95% confidence intervals (CIs). Meta-analyses were conducted to derive pooled effect estimates. Funnel plots and Egger's test were used to assess publication bias, and sensitivity analyses via a leave-one-out approach were performed to evaluate the robustness of results. Results: Five studies encompassing 7 cohorts and 2,349 patients (1,306 APAP users and 1,043 non-users) were included. Pooled analyses revealed that concomitant APAP use was significantly associated with shorter OS (HR: 1.29; 95% CI: 1.16–1.44) and PFS (HR: 1.27; 95% CI: 1.12–1.43), as well as a trend toward a lower objective response rate (RR: 0.78; 95% CI: 0.60–1.00). No significant publication bias was detected, and sensitivity analyses confirmed the robustness of these findings. Conclusion: Current evidence indicates that APAP use is associated with poorer prognosis in cancer patients treated with ICIs. These results may inform clinical guidelines regarding concomitant APAP and ICI use. Further randomized controlled trials are warranted to validate these observations and establish causal relationships.
Keywords: Acetaminophen, Cancer, immune checkpoint inhibitors, prognosis, Meta-analysis
Received: 09 Aug 2025; Accepted: 06 Nov 2025.
Copyright: © 2025 Lin, Liao and Shen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Jinhai Shen, shenjh_pharm@126.com
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.