Zhang You-Cheng, Zhu Tian-Chen, Nie Run-Cong, Lu Liang-He, Xiang Zhi-Cheng, Xie Dan, Luo Rong-Zhen, Cai Mu-Yan
State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou 510060, China.
Department of Pathology, Sun Yat-sen University Cancer Center, Guangzhou 510060, China.
J Clin Med. 2023 Jan 17;12(3):736. doi: 10.3390/jcm12030736.
Immune-related adverse events (irAEs) are side effects that reflect the activation of patients' immune systems after treatment with immune checkpoint inhibitors (ICIs). However, there is no meta-analysis on the effect of early irAEs on patient survival. Thus, we assessed the association between early irAEs and the survival of patients treated with ICIs.
PubMed, Embase, and Web of Science were searched from May 2010 to May 2020 for all the retrospective and prospective comparative studies to evaluate the hazard ratios (HRs) for death. A random-effects model was used to calculate the pooled HR for death, and heterogeneity was assessed using I² statistics. The main outcomes were overall survival (OS) and progression-free survival (PFS).
A total of 11 reports with 2077 patients were included. A significant association was observed between early irAEs and a favorable clinical outcome. Patients with early irAEs had prolonged OS (HR: 0.62, 95% confidence interval (CI): 0.53-0.74, < 0.001) and PFS (HR: 0.53, 95% CI: 0.41-0.66, < 0.001) compared to those without; these results were confirmed using a sensitivity analysis. The irAE types, malignancy types, and sample size were correlated with patients' clinical outcomes.
Early irAEs, especially cutaneous irAEs, correlated with a better clinical outcome in patients treated with ICIs.
免疫相关不良事件（irAE）是免疫检查点抑制剂（ICI）治疗后反映患者免疫系统激活的副作用。然而，尚无关于早期irAE对患者生存影响的荟萃分析。因此，我们评估了早期irAE与接受ICI治疗患者生存之间的关联。
检索2010年5月至2020年5月期间PubMed、Embase和Web of Science数据库，获取所有回顾性和前瞻性比较研究，以评估死亡风险比（HR）。采用随机效应模型计算合并的死亡HR，并使用I²统计量评估异质性。主要结局为总生存期（OS）和无进展生存期（PFS）。
共纳入11篇报告，涉及2077例患者。观察到早期irAE与良好的临床结局之间存在显著关联。与无早期irAE的患者相比，有早期irAE的患者OS延长（HR：0.62，95%置信区间（CI）：0.53 - 0.74，P < 0.001），PFS也延长（HR：0.53，95%CI：0.41 - 0.66，P < 0.001）；敏感性分析证实了这些结果。irAE类型、恶性肿瘤类型和样本量与患者的临床结局相关。
早期irAE，尤其是皮肤irAE，与接受ICI治疗患者更好的临床结局相关。
