基于数据库分析免疫检查点抑制剂相关不良事件在中国人群中的现状  

Landscape of immune checkpoint inhibitor-related adverse events in Chinese population based on database

作　　者：董安慧 李理 饶彬[1] 李刚[3] 吴耀忠[1] DONG Anhui;LI Li;RAO Bin;LI Gang;WU Yaozhong(Department of Breast Surgery,Wuzhou Red Cross Hospital,Guangxi Wuzhou 543002,China;Department of Radiotherapy,Wuzhou Red Cross Hospital,Guangxi Wuzhou 543002,China;Department of Oncology,Wuzhou Red Cross Hospital,Guangxi Wuzhou 543002,China)

机构地区：[1]梧州市红十字会医院乳腺外科,广西梧州543002 [2]梧州市红十字会医院放疗科,广西梧州543002 [3]梧州市红十字会医院肿瘤内科,广西梧州543002

出　　处：《现代肿瘤医学》2021年第24期4373-4380,共8页Journal of Modern Oncology

基　　金：广西省梧州市科技计划项目(编号:201902147)。

摘　　要：目的:描述中国人群中免疫检查点抑制剂(ICI)相关不良事件(AEs)的状况。方法:截止至2019年9月22日,检索PubMed、Web of Science和Embase数据库中所有ICI相关的临床试验,入组中国患者或主要是中国人群的试验将会被纳入本研究,汇总并比较治疗相关不良事件(TRAE)和免疫相关不良事件(irAE)的发生率。结果:纳入13个试验合计1063例患者,其中922(86.7%)例接受ICI单药治疗,141(13.3%)例接受ICI联合化疗或抗血管生成治疗。在所有患者中,任意级别的TRAE、1-2级TRAE、3-5级TRAE、任意级别irAE、1-2级irAE、3-5级irAE的累计发生率分别为84.1%、63.3%、20.9%、43.3%、40.0%、3.0%;与ICI单药治疗相比,ICI联合化疗或抗血管治疗显著提高了3-5级TRAE(46.1%vs 17.0%,P<0.001)和3-5级irAE(7.1%vs 2.0%,P=0.015)。通过比较不同ICI之间的毒性谱,我们发现了一些药物特异性不良反应。结论:ICI相关的不良事件一般为轻度,中国人群耐受性良好。但是,当ICI与化疗或抗血管治疗联合使用时,3-5级的TRAE和irAE会显著增加。Objective:To describe the landscape of immune checkpoint inhibitors(ICIs)-related adverse events(AEs)in a predominantly Chinese population.Methods:Online electronic data sets including PubMed,Web of Science and Embase were searched to identify clinical trials focusing on ICIs up to September 22,2019.Clinical trials that recruited Chinese patients or a predominantly Chinese population were included.Incidences of treatment-related AEs(TRAEs)and immune-related AEs(irAEs)were pooled and compared.Results:A total of 13 trials including 1063 patients were recruited,among which 922(86.7%)received ICI monotherapy and the others(13.3%)received combination of ICI with chemotherapy or anti-angiogenesis.The pooled incidence of any grade TRAEs,grade 1-2 TRAEs,grade 3-5 TRAEs,any grade irAEs,grade 1-2 irAEs and grade 3-5 irAEs in whole population were 84.1%,63.3%,20.9%,43.3%,40.0%and 3.0%.Compared with ICI monotherapy,combination therapy significantly increased grade 3-5 TRAEs(46.1%vs 17.0%,P<0.001)and grade 3-5 irAEs(7.1%vs 2.0%,P=0.015).A comparison of toxicity profiles between different ICIs revealed some drug-specific AEs.Conclusion:ICI-related AEs were generally mild and tolerable for a predominantly Chinese cohort.However,if ICI with chemotherapy or anti-angiogenesis as it could increase grade 3-5 TRAEs and irAEs.

关 键 词：免疫检查点抑制剂 中国人群 治疗相关不良事件 免疫相关不良事件 

分 类 号：R730.5[医药卫生—肿瘤]