ORIGINAL RESEARCH article
Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1655724
Predictive Factors and Outcomes of Immune-Related Adverse Events in Chinese Patients Treated with Immune Checkpoint Inhibitors: A Real-World Retrospective Study
Provisionally accepted
- 1Tongji University, Shanghai, China
- 2Shanghai Tenth People's Hospital, Shanghai, China
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Background: The widespread clinical application of immune checkpoint inhibitors (ICIs) has brought immune-related adverse events (irAEs) to the forefront of oncology management. However, systematic investigations focusing on the efficacy and irAE profiles of ICIs locally developed in China (Chinese ICIs) in real-world settings remain limited. This study aimed to explore predictive factors and outcomes of irAEs in patients predominantly treated with Chinese ICIs. Methods: In this single-center retrospective study, 206 patients with solid tumors treated with ICIs between 2020 and 2024 were included, with 87.9% receiving Chinese ICIs. Multivariate regression analyses were conducted to identify predictors of irAEs and factors associated with progression-free survival (PFS). Clinical characteristics, inflammatory biomarkers, cytokine levels, and cardiac function parameters were comprehensively evaluated. Results: Younger age (p=0.04) and the brain metastases (p=0.03) were associated with a higher incidence of irAEs. Organ-specific irAEs showed distinct predictors: hepatitis with younger age, hepatitis B virus (HBV) infection, hepatic malignancy, multisystem irAEs, and elevated IL-10; myocarditis with multisystem irAEs, systemic inflammation markers (white blood cell count, WBC; neutrophil-to-lymphocyte ratio, NLR; systemic immune-inflammation index, SII; systemic inflammation response index, SIRI), and cardiac function indicators (left ventricular ejection fraction, LVEF; QRS duration); thyroiditis with multisystem irAEs and reduced IL-6; while pneumonitis with elevated platelet count (PLT) and IL-6. The type of irAEs was not associated with PFS. Conclusions: Younger age and brain metastases were associated with a higher incidence of irAEs. Organ-specific irAEs were characterized by distinct sets of clinical and laboratory predictors. Inflammatory markers correlated with poorer PFS. The type of irAEs was not associated with PFS. Chinese ICIs were not independently associated with an increased risk of specific organ toxicities.
Keywords: Immune checkpoint inhibitors (ICIs), Immune-related adverse events (irAEs), Predictive factors, efficacy, Chinese agents
Received: 28 Jun 2025; Accepted: 04 Sep 2025.
Copyright: © 2025 Kong, Xie and Liu. 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: Haodong Kong, Tongji University, Shanghai, China
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