替雷利珠单抗联合化疗一线治疗局部晚期或转移性肺鳞癌的真实世界研究  

A real-world study of tislelizumab combined with chemotherapy as first-line treatment for locally advanced or metastatic squamous non-small-cell lung cancer

作　　者：乔晓娟[1] 常丽娟 都兰 高萌 邢舴[1] 呼群[1] QIAO Xiaojuan;CHANG Lijuan;DU Lan;GAO Meng;XING Ze;HU Qun(Department of Medical Oncology of the Affiliated Hospital of Inner Mongolia Medical University,Hohhot 010050,China)

机构地区：[1]内蒙古医科大学附属医院肿瘤内科,内蒙古呼和浩特010050

出　　处：《南京医科大学学报（自然科学版）》2024年第11期1565-1572,共8页Journal of Nanjing Medical University(Natural Sciences)

基　　金：内蒙古自治区高等学校青年科技英才(NJYT22011);内蒙古自治区自然科学基金(2021MS08153);内蒙古自治区高等学校科学研究项目(NJZY21596);内蒙古医科大学科技百万工程联合项目[YKD2020KJBW(LH)039];内蒙古自治区卫生健康科技计划项目(202201295)。

摘　　要：目的:评估替雷利珠单抗联合化疗一线治疗局部晚期/转移性肺鳞癌的疗效及安全性。方法:收集2021年1月—2023年12月内蒙古医科大学附属医院就诊的肺鳞癌患者109例,其中替雷利珠单抗联合化疗组66例,化疗组43例,比较两组患者的客观缓解率(objective response rate,ORR)、无进展生存期(progression free survival,PFS)、总生存期(overall survival,OS)和治疗相关不良事件(treatment-related adverse event,TRAE)的发生率。结果:中位随访时间20.2个月,替雷利珠单抗联合化疗组的ORR明显高于化疗组(75.8%vs.51.2%)、中位PFS明显延长(17.3个月vs.9.3个月),替雷利珠单抗联合化疗组中位OS未达到,但死亡风险较化疗组(19.3个月)显著降低(HR=0.38,95%CI:0.19~0.68,P=0.002)。两组任意级别和3级及以上TRAE发生率相似,替雷利珠单抗联合化疗组免疫相关不良事件(immune-related adverse events,irAE)发生率为28.8%,其中3级及以上irAE仅1例(1.5%)发生免疫相关性肺炎。结论:一线替雷利珠单抗联合化疗显著提高局部晚期/转移性肺鳞癌的疗效,且总体不良反应程度可控。Objective:To evaluate the efficacy and safety of tislelizumab combined with chemotherapy as first-line treatment for locally advanced or metastatic squamous non-small-cell lung cancer in the real-world.Methods:A total of 109 patients with lung squamous cell carcinoma were included in the Affiliated Hospital of Inner Mongolia Medical University from January 2021 to December 2023,of whom 66 patients in the tislelizumab combined with chemotherapy group and 43 patients in the chemotherapy group.The objective response rate(ORR),progression-free surviva(l PFS),overall surviva(l OS)and the incidence of treatment-related adverse events(TRAEs)of the two groups were evaluated.Results:At a median follow-up of 20.2 months,the ORR of the tislelizumab combined with chemotherapy group was significantly higher than that of the chemotherapy group(75.8%vs.51.2%).The median PFS prolonged significantly in the tislelizumab combined with chemotherapy group compared to the chemotherapy group(17.3 months vs.9.3 months).OS data were not reached in the tislelizumab combined with chemotherapy group,which was significantly longer than the chemotherapy group(19.3 months,HR=0.38,95%CI:0.19-0.68,P=0.002).The incidence of overall TRAEs and TRAEs above grade 3 in the two groups was similar.The incidence of immune-related adverse events(irAEs)in the tislelizumab combined chemotherapy group was 28.8%,including one case(1.5%)of grade 3 and above immune-associated pneumonia.Conclusion:Tislelizumab combined with chemotherapy as first-line treatment significantly improves the efficacy and manageable safety/tolerability profile in patients with locally advanced or metastatic lung squamous cell carcinoma.

关 键 词：替雷利珠单抗 局部晚期/转移性肺鳞癌 一线治疗 临床疗效 安全性 

分 类 号：R734.2[医药卫生—肿瘤]