真实世界中肺癌免疫检查点抑制剂治疗的安全性及有效性

Safety and efficacy of immune checkpoint inhibitors for lung cancer in the real world

目的:探索应用在真实世界中免疫检查点抑制剂(immune checkpoint inhibitor,ICI)治疗肺癌患者的安全性及有效性。方法:本项多中心回顾性研究,分析了4家医院从2018年1月1日—2022年9月31日接受ICI治疗的1022例肺癌患者的临床资料。结果:本研究纳入的人群中,有577例(56.5%)患者发生了不同程度的免疫相关不良事件(immune⁃related adverse event,irAE)。发生比例较高的为内分泌系统(41.4%)、肺部(14.5%)、心脏(13.5%)等。比较2组患者的临床特征,结果显示:美国东部肿瘤协作组体力状态评分(Eastern Cooperative Oncology Group,ECOG)、程序性死亡配体⁃1(programmed death ligand 1,PD⁃L1)表达情况、肺癌病理类型、表皮生长因子受体酪氨酸激酶抑制剂(epidermal growth factor receptor⁃tyrosine kinase inhibi⁃tors,EGFR⁃TKI)治疗史、烟酒嗜好以及既往慢性病史的组间差异具有统计学意义(P均<0.05)。与未出现irAE患者相比,出现irAE的患者有更高的疾病控制率(95.8%vs.89.6%,P<0.001)和更长的中位无进展生存期(11.1个月vs.9.4个月,log⁃rank P<0.001)。结论:真实世界中,应用ICI治疗的肺癌患者irAE发生率较高,累及广泛,影响因素较多,但多以轻症为主;且irAE的发生可能与更好的疾病控制率及无进展生存期有关。

Objective:To investigate the safety and efficacy of immune checkpoint inhibitors(ICIs)received by real⁃world lung cancer patients.Methods:In this multi⁃center retrospective study,the clinical data of 1022 lung cancer patients treated with ICIs from January 1,2018,to September 31,2022,in four hospitals were analyzed.Results:Among the included population,577 patients(56.5%)experienced varying degrees of immune⁃related adverse events(irAEs).The most common systems affected were the endocrine system(41.4%),lungs(14.5%),and heart(13.5%).Comparing the clinical characteristics between the two groups,significant differences were observed in Eastern Cooperative Oncology Group(ECOG)performance status,PD⁃L1 expression,lung cancer pathology type,history of epidermal growth factor receptor tyrosine kinase inhibitor therapy,tobacco and alcohol habits,and previous chronic diseases(all P<0.05).Patients who experience irAEs had a higher disease control rate(95.8%vs.89.6%,P<0.001)and longer median progression⁃free survival(11.1 months vs.9.4 months,log⁃rank P<0.001)compared to those who did not experience irAEs.Conclusion:In the real world,the incidence of irAEs in lung cancer patients treated with ICIs is relative high,with extensive involvement and many influencing factors,but most cases are mild.The incidence of irAEs may be associated with better disease control rates and progression⁃free survival.