摘要
背景
据报道,免疫检查点抑制剂 (ICI) 引起的不良事件 (AE) 几乎影响所有人体器官。然而,关于眼部AE的研究很少。进行了一项荟萃分析,以评估与化疗相比 ICI 相关眼科 AE 的风险。
方法:符合条件的研究选自调查 ICI 的 II/III 期随机对照试验。数据通过R软件和Stata进行分析。
结果
PD-1/PD-L1 抑制剂治疗相关 AE (trAEs) 和非特异性眼科 trAEs (NS-trAEs) 的比值比低于化疗 (OR 0.44, p < .05; OR 0.28, p < .001; OR 0.18,p < .05 ;或:分别为 0.18,p < .001)。与单一疗法相比,PD-1 加 CTLA-4 抑制剂增加了免疫相关 AEs (irAEs) 的风险 (OR 4.52, p < .01);ICI 加化疗增加了 trAE 和 irAE 的风险(分别为 OR 2.82,p < .001;OR 3.63,p < .05)。
结论
PD-L1/PD-1 抑制剂发生 trAE 和 NS-trAE 的风险低于化疗;与单一疗法相比,联合疗法发生眼科 trAE 和 irAE 的风险更高。
缩写
PD-1:程序性细胞死亡蛋白 1;PD-L1:程序性细胞死亡蛋白配体1;CTLA-4:细胞毒性 T 淋巴细胞相关蛋白 4;ICI:免疫检查点抑制剂;AE:不良事件;trAE:治疗相关不良事件;irAE:免疫相关不良事件;NS-trAE:非特异性眼科治疗相关不良事件;RCT:随机对照试验;PFS:无进展生存期;OS:总生存期;ORR:客观缓解率;MM:黑色素瘤;NSCLC:非小细胞肺癌;SCLC:小细胞肺癌;HNSCC:头颈鳞状细胞癌;PICOL:患者、干预、比较和结果;对比:VS;化学:化疗;95%CI:95%置信区间;FEM:固定效应模型;REM:随机效应模型;NA:不适用;MeSH:医学主题词
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Risk of Ophthalmic Adverse Events in Patients Treated with Immune Checkpoint Inhibitor Regimens: A Systematic Review and Meta-analysis
ABSTRACT
Background
Immune checkpoint inhibitors (ICIs) -induced adverse events (AEs) have been reported affecting almost all human organs. However, studies about ocular AEs are few. A meta-analysis was performed to evaluate the risks of ICI-related ophthalmic AEs compare to chemotherapy.
Methods: Eligible studies were selected from phase II/III randomized controlled trials investigating ICIs. The data were analyzed by R software and Stata.
Results
Odds ratio of treatment-related AE (trAEs) and nonspecific ophthalmic trAEs (NS-trAEs) were lower for PD-1/PD-L1 inhibitors than chemotherapy (OR 0.44, p < .05; OR 0.28, p < .001; OR 0.18, p < . 05; OR: 0.18, p < .001respectively). Compared with monotherapy, PD-1 plus CTLA-4 inhibitors increased the risks of immune-related AEs (irAEs) (OR 4.52, p < .01); ICIs plus chemotherapy increased the risks of trAEs and irAEs (OR 2.82, p < .001; OR 3.63, p < .05 respectively).
Conclusions
PD-L1/PD-1 inhibitors had lower risks of trAEs and NS-trAEs than chemotherapy; Compared with monotherapy, combination therapy had higher risks of ophthalmic trAEs and irAEs.
Abbreviation
PD-1: programmed cell death protein 1; PD-L1: programmed cell death protein ligand 1; CTLA-4: cytotoxic T-lymphocyte-associated protein 4; ICI: immune checkpoint inhibitor; AE: adverse event; trAE: treatment-related adverse event;irAE: immune-related adverse events; NS-trAE: nonspecific ophthalmic treatment-related adverse event; RCT: randomized controlled trials; PFS: progression-free survival; OS: overall survival; ORR: objective response rate; MM: melanoma; NSCLC: non-small cell lung cancer; SCLC: small cell lung cancer; HNSCC: head-neck squamous cell carcinoma; PICOL: patient, intervention, comparison, and outcome; Versus: VS; Chem: chemotherapy; 95%CI: 95% confidence interval; FEM: fixed-effects model; REM: random-effects model; NA: not applicable; MeSH: medical subject heading