卡瑞利珠单抗联合化疗一线治疗局部晚期/转移性非小细胞肺癌的快速卫生技术评估  

A rapid health technology assessment of camrelizumab in combination with chemotherapy for the first-line treatment of locally advanced/metastatic non-small cell lung cancer

作　　者：崔艳军 马天 刘一[1,2] 焦玲 柴爱军 樊榕榕[3] 刘彦国[3] 罗兴献 黄琳[2] 张晓红[2] CUI Yanjun;MA Tian;LIU Yi;JIAO Ling;CHAI Aijun;FAN Rongrong;LIU Yanguo;LUO Xingxian;HUANG Lin;ZHANG Xiaohong(Department of Pharmacy,Peking University People's Hospital Shijiazhuang Campus,Shijiazhuang 050000,Hebei,China;Department of Pharmacy,Peking University People's Hospital,Beijing 100044,China;Department of Thoracic Surgery,Peking University People's Hospital,Beijing 100044,China)

机构地区：[1]北京大学人民医院石家庄医院药学部,河北石家庄050000 [2]北京大学人民医院药学部,北京100044 [3]北京大学人民医院胸外科,北京100044

出　　处：《中国临床药理学与治疗学》2024年第7期775-784,共10页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家自然科学基金(72304168);白求恩·求索—药学科研能力建设项目(B-19-H-20200622)。

摘　　要：目的:评价卡瑞利珠单抗(camrelizumab,CAM)联合含铂类化疗(chemotherapy,CT)一线治疗局部晚期/转移性非小细胞肺癌(NSCLC)的有效性、安全性和经济性。方法:系统检索Pubmed、the Cochrane Library、中国知网、万方数据等中英文数据库及相关网站,由两位研究者按照纳入与排除标准对文献进行文献筛选、质量评价、数据提取后,进行快速卫生技术评估(HTA)。结果:共纳入7篇系统评价/Meta分析,17篇经济学评价。有效性方面,对于基因突变阴性的局部晚期/转移性NSCLC患者,与多西他赛化疗相比,CAM+CT可显著延长患者总生存期(OS)、无进展生存期(PFS),提高患者的客观缓解率(ORR);与CT、帕博利珠单抗(pembrolizumab,PEM)相比,CAM+CT可以显著延长患者PFS,提高患者的ORR。亚组分析表明,与CT相比,CAM+CT可以显著延长PD-L1≥1%和PD-L1≥50%患者的PFS。对于基因突变阴性的局部晚期/转移性鳞状NSCLC患者,与CT相比,CAM+CT可以显著延长患者的OS、PFS;与信迪利单抗(sintilimab,SIN)+CT相比,CAM+CT可延长患者的PFS。亚组分析表明,与CT相比,CAM+CT可以显著延长PD-L1<1%患者的OS。安全性方面,对于基因突变阴性的局部晚期/转移性NSCLC患者,与CT、PEM相比,CAM+CT在所有级别不良反应发生方面相当,但3级以上治疗相关不良事件发生率显著增加。对于基因突变阴性的非鳞状晚期NSCLC患者,与CT相比,CAM+CT增加了所有级别不良反应,而3级以上治疗相关不良事件并未增加。经济性方面,对于基因突变阴性的晚期/转移性鳞状NSCLC患者,与CT相比,CAM+CT具有成本效果优势;对于基因突变阴性局部晚期/转移性非鳞状NSCLC患者,与CT、PEM+CT相比,CAM+CT具有成本效果优势;而与SIN+CT相比,CAM+CT不具成本效果优势。结论:CAM+CT一线治疗局部晚期/转移性NSCLC具有较好的有效性和经济性,安全性方面与CT、PEM相当或稍差。AIM:To evaluate the efficacy,safety,and economy of camrelizumab(CAM)combined with platinum-containing chemotherapy(CT)for the first-line treatment of locally advanced/metastatic non-small cell lung cancer(NSCLC).METHODS:Chinese and English databases such as Pubmed,the Cochrane Library,China Knowledge Network,Wanfang Data,and other related websites were systematically searched.After literature screening,quality assessment,and data extraction of the literature according to the inclusion and exclusion criteria,two researchers conducted a rapid health technology assessment(HTA).RESULTS:A total of 7 systematic evaluations/Meta-analyses and 17 economics evaluations were included.In terms of effectiveness,compared to docetaxel chemotherapy,CAM+CT significantly prolonged the overall survival(OS),progression-free survival(PFS),and improved the objective remission rate(ORR)of mutation-negative patients with locally advanced/metastatic NSCLC.Compared with CT and pembrolizumab(PEM),CAM+CT significantly prolonged the PFS,and improved the ORR of mutationnegative patients with locally advanced/metastatic NSCLC.Subgroup analysis showed that CAM+CT significantly prolonged PFS in patients with PD-L1≥1%and PD-L1≥50%compared with CT.Compared with CT,CAM+CT significantly prolonged the OS and PFS of mutation-negative patients with locally advanced/metastatic squamous NSCLC.Compared with sintilimab(SIN),CAM+CT significantly prolonged the PFS of mutation-negative patients with locally advanced/metastatic squamous NSCLC.Subgroup analysis showed that CAM+CT significantly prolonged OS in patients with PD-L1<1%compared with CT.In terms of safety,CAM+CT was comparable in terms of the occurrence of all grades of adverse events,but the incidence of grade 3 or higher treatment-related adverse events was significantly increased compared with CT and PEM for mutation-negative locally advanced/metastatic NSCLC patients.CAM+CT was significantly increased the occurrence of all grades of adverse events compared with CT,but was comparable in terms

关 键 词：卡瑞利珠单抗 非小细胞肺癌 快速卫生技术评估 免疫检查点抑制剂 

分 类 号：R979.1[医药卫生—药品]