Treatment-related adverse events, immune-related adverse events and discontinuation in patients with solid tumors adding adjuvant immune checkpoint blockade: a meta-analysis of 38 randomized controlled trials

作者：Wangcheng Zhao, Zhi Yang, Quanming Fei, Xinhang Hu, Yifan Ouyang, Xuyang Yi, Shouzhi Xie, Li Wang, Xingchun Huang, Yu He, Juan Luo, Xiao Ye, Zhe Zhang, Fenglei Yu · 发表于：International Journal of Surgery · 年份：2025 · DOI：10.1097/js9.0000000000002480 · 被引用次数：5 · 研究领域：Cancer Immunotherapy and Biomarkers、Cancer, Stress, Anesthesia, and Immune Response、Inflammatory Biomarkers in Disease Prognosis

BACKGROUND: The safety profile of immune checkpoint blockade (ICB) in the adjuvant setting has not been well characterized. This study aims to summarize the incidences of adverse events (AEs) in patients with solid tumors receiving ICB in adjuvant setting, and evaluate the effect of ICB addition on incidences of these adverse events. METHODS: We searched public databases and relevant international conference proceedings up to 20 September 2024, to identify eligible randomized controlled trials evaluating the ICB-based treatments in adjuvant setting for patients with solid tumors. The primary outcomes included treatment-related death, treatment-related adverse events (TrAEs), immune-related adverse events (IrAEs), serious AEs, and discontinuation due to AEs. The GRADE approach was used to evaluate the certainty of evidence for primary outcomes. RESULTS: Thirty-eight trials with 25 852 participants were included. Single-arm meta-analysis showed that combination therapies had a higher incidence of grade 3-4 TrAEs than PD-1/PD-L1 monotherapy, while anti-CTLA-4-based therapies exhibited higher discontinuation rates (49.7% [39.4-60.0] for anti-CTLA-4 monotherapy) versus other ICB strategies. Treatment-related death was rare, occurring in 63 of 16 272 participants receiving adjuvant ICB-based treatments. The pairwise meta-analysis revealed that the addition of ICB was associated with increased treatment-related deaths (OR [95% CI]: 1.713 [1.117-2.628]), although this association was...