Le Jiayuan, Sun Yuming, Deng Guangtong, Dian Yating, Xie Yanli, Zeng Furong
Department of Dermatology, Xiangya Hospital, Central South University, Changsha, Hunan, China.
National Engineering Research Center of Personalized Diagnostic and Therapeutic Technology, Changsha, Hunan, China.
Hum Vaccin Immunother. 2025 Dec;21(1):2458948. doi: 10.1080/21645515.2025.2458948. Epub 2025 Feb 2.
The utilization of immune-checkpoint inhibitors (ICIs) in cancer immunotherapy frequently leads to the occurrence of immune-related adverse events (irAEs), making it generally not recommended for patients with preexisting autoimmune diseases. Hence, we conducted a meta-analysis on safety and efficacy of ICIs in cancer patients with preexisting autoimmune diseases to provide further insights. PubMed, EMBASE, and Cochrane Library were systematically searched until December 20, 2024. The main summary measures used were pooled rate and risk ratio (RR) with 95% confidential interval (CI), which were analyzed using R statistic software. A total of 52 articles were included in the study. When cancer patients with preexisting autoimmune diseases received ICIs treatment, the overall incidence was 0.610 (95% CI: 0.531-0.686) for any grade irAEs, 0.295 (95% CI: 0.248-0.343) for flares, 0.325 (95% CI: 0.258-0.396) for de novo irAEs, 0.238 (95% CI: 0.174-0.309) for grade ≥3 irAEs, and 0.143 (95% CI: 0.109-0.180) for discontinuation due to immunotoxicity. Compared with those without autoimmune diseases, cancer patients with autoimmune diseases experienced a higher risk of any-grade irAEs (RR: 1.23, 95% CI: 1.12-1.35) and discontinuation due to immunotoxicity (1.40, 95% CI: 1.11-1.78). However, no statistically significant differences were observed in the incidence of grade ≥3 irAEs, objective response rate (ORR), disease control rate (DCR), overall survival (OS), and progression-free survival (PFS) between the two groups. During ICIs treatment, irAEs are common among cancer patients with autoimmune diseases, but severe irAEs is relatively low. ICIs are effective in this population, but should be strictly monitored when used to avoid immunotoxicity.
免疫检查点抑制剂（ICIs）在癌症免疫治疗中的应用常常导致免疫相关不良事件（irAEs）的发生，因此一般不建议用于已有自身免疫性疾病的患者。因此，我们对ICIs在已有自身免疫性疾病的癌症患者中的安全性和疗效进行了荟萃分析，以提供进一步的见解。系统检索了PubMed、EMBASE和Cochrane图书馆，检索截止至2024年12月20日。主要的汇总指标为合并率和风险比（RR）以及95%置信区间（CI），使用R统计软件进行分析。该研究共纳入52篇文章。已有自身免疫性疾病的癌症患者接受ICIs治疗时，任何级别irAEs的总体发生率为0.610（95%CI：0.531 - 0.686），病情复发率为0.295（95%CI：0.248 - 0.343），新发irAEs发生率为0.325（95%CI：0.258 - 0.396），≥3级irAEs发生率为0.238（95%CI：0.174 - 0.309），因免疫毒性停药率为0.143（95%CI：0.109 - 0.180）。与无自身免疫性疾病的患者相比，有自身免疫性疾病的癌症患者发生任何级别irAEs的风险更高（RR：1.23，95%CI：1.12 - 1.35），因免疫毒性停药的风险更高（1.40，95%CI：1.11 - 1.78）。然而，两组在≥3级irAEs发生率、客观缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）和无进展生存期（PFS）方面未观察到统计学上的显著差异。在ICIs治疗期间，irAEs在已有自身免疫性疾病的癌症患者中很常见，但严重irAEs相对较低。ICIs在该人群中有效，但使用时应严格监测以避免免疫毒性。
