基于真实世界的研究——646例肿瘤患者使用免疫检查点抑制剂相关不良反应的临床特征  

A real world research:the clinical characteristics of immune-related adverse events in 646 cases

作　　者：叶淑芳 刘苗兰 仇晓霞[1] YE Shufang;LIU Miaoan;QIU Xiaoxia(Renji Hospital,School of Medicine,Shanghai Jiaotong University,Shanghai,200127,China)

机构地区：[1]上海交通大学医学院附属仁济医院,上海200127

出　　处：《肿瘤药学》2024年第1期72-79,共8页Anti-Tumor Pharmacy

摘　　要：目的探讨免疫检查点抑制剂(ICI)在临床应用中的免疫相关不良事件(irAE)发生情况及临床特征。方法回顾性分析2020年5月—2022年6月接受PD-1和PD-L1治疗的晚期恶性肿瘤患者646例,观察并记录治疗期间irAEs的发生情况,包括发生率、发生时间、分级等。结果646例患者中,259例患者共发生370次irAEs,发生率为40.1%。1、2级不良反应266次(71.9%),3级以上不良反应104次(28.1%)。irAEs可累及全身各个器官系统,其中以皮肤毒性(15.6%)最常见。61例(23.6%)患者发生多系统irAEs。年龄≤65岁,联合用药,使用卡瑞利珠单抗、信迪利单抗、帕博利珠单抗的患者更易发生多系统irAEs。血液系统毒性、肝脏毒性、心血管毒性发生在早期,平均发生时间为治疗3个疗程内。年龄>65岁、合并自身免疫性疾病的患者行ICIs治疗可获得同等临床效益,具有良好的安全性。irAEs发生情况与患者的性别、年龄、合并症、用药方案、肿瘤类型、ICIs种类、免疫药物类型无关(P>0.05),与用药疗程有关(P<0.05)。结论ICIs临床应用广泛,严重不良反应发生率低,有一定的安全性,但不良反应可累及全身各个器官系统,应做好各类irAEs的早期识别、诊断及治疗。Objective To investigate the incidence and clinical characteristics of immune-related adverse events(irAE)in the clinical application of immune checkpoint inhibitors(ICIs).Methods 646 patients with advanced malignant tumors who were treated by PD-1 and PD-L1 inhibitors between May 2020 and June 2022 were retrospectively analyzed in this study.The occur-rence of their irAEs during treatment was observed and recorded,including the incidence rate,occurrence time,grade,etc.Re-sults A total of 370 irAEs occurred in 259 of 646 patients,with an incidence rate of 40.1%.There were 266(71.9%)irAEs of grade 1 and 2,and 104(28.1%)irAEs of grade 3 or higher grade.The irAEs could involve all organs and systems,among which skin toxicities(15.6%)were the most common.61(23.6%)patients experienced multisystem irAEs.Patients with≤65 years of age,drug combination,camrelizumab,sintilimab,or pembrolizumab were more likely to have multisystem irAEs.Hematological toxicities,hepatic toxicities,and cardiotoxicity occurred in the early time,averagely within 3 courses of treatment.Patients>65 years old and complicated with autoimmune diseases could also achieve clinical benefits with a good safety.Though incidence of irAEs was not associated with gender,age,complications,therapeutic regimens,tumor types,types of ICIs,and types of immune drugs(P>0.05),it was associated with the course of treatment(P<0.05).Conclusion ICIs are widely used in clinical practice,with a low incidence rate of serious adverse events and a relative safety.However,their adverse reactions can involve various or-gans and systems throughout the body,so it is important to get early identification,diagnosis and treatment of irAEs for these pa-tients.

关 键 词：免疫检查点抑制剂 免疫相关不良事件 临床特征 

分 类 号：R730.51[医药卫生—肿瘤]