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ORIGINAL RESEARCH article
Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Volume 16 - 2025 |
doi: 10.3389/fimmu.2025.1508512
This article is part of the Research Topic Clinical Pharmacist Service Promotes the Improvement of Medical Quality Volume II View all 41 articles
Predictors of Severity and Onset Timing of Immune-Related Adverse Events in Cancer Patients Receiving Immune Checkpoint Inhibitors: A Retrospective Analysis
Provisionally accepted- 1 Department of Pharmacy, Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
- 2 College of Pharmacy, Chongqing Medical University, Chongqing, China
Objective: To identify predictors of all-grade, grade ≥ 3, and onset time of immune-related adverse events (irAEs) in cancer patients undergoing immune checkpoint inhibitors (ICIs) therapy.Methods: This retrospective analysis included cancer patients treated with ICIs at Chongqing Medical University Second Affiliated Hospital from 2018 to 2024. Logistic regression and Cox regression analyses were used to identify predictors of all-grade and grade ≥ 3 irAEs and the time of irAE onset.Results: Among the 3,795 patients analyzed, 1,101 (29.0%) developed all-grade irAEs, and 175 (4.6%) experienced grade ≥ 3 irAEs. Multivariate logistic regression revealed that female (OR = 1.37, p < 0.001), combination therapy (OR = 1.87, p < 0.001), pre-existing autoimmune diseases (AIDs) (OR = 5.15, p < 0.001), pre-existing cirrhosis (OR = 1.34, p = 0.001), antibiotic use during ICIs treatment (OR = 1.51, p < 0.001), and a higher baseline prognostic nutritional index (PNI) (OR = 1.23, p = 0.01) were significant predictors for the development of all-grade irAEs. The predictors for grade ≥ 3 irAEs included age ≥ 60 (OR = 1.49, p = 0.023) and pre-existing AIDs (OR = 2.09, p = 0.005), For the onset time, predictors included female (HR = 1.26, p = 0.001), combination therapy (HR = 1.80, p < 0.001), pre-existing AIDs (HR = 2.25, p < 0.001), and pre-existing infection (HR = 1.20, p = 0.008).Conclusions: Females, combination therapy, pre-existing AIDs and cirrhosis, antibiotics, and a higher baseline PNI are associated with a higher risk of developing all-grade irAEs. Those aged ≥ 60 and with pre-existing AIDs face a higher risk of severe irAEs. Females, undergoing combination therapy, with pre-existing AIDs and infection generally experience a shorter time to irAEs onset. Multicentric prospective studies are warranted to validate these findings.
Keywords: immune checkpoint inhibitors, Immune-related adverse events, predictor, severity, onset time
Received: 09 Oct 2024; Accepted: 03 Feb 2025.
Copyright: © 2025 Fang, Qian, Xie, Zhao, Zheng and Li. 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:
Di Li, Department of Pharmacy, Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
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