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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OA北大核心CSTPCD

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

中文摘要英文摘要

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/meta-static non-small cell lung cancer(NSCLC).METH-ODS:Chinese and English databases such as Pubmed,the Cochrane Library,China Knowledge Network,Wanfang Data,and other related web-sites were systematically searched.After literature screening,quality assessment,and data extraction of the literature according to the inclusion and ex-clusion 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 che-motherapy,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 ad-vanced/metastatic NSCLC.Compared with CT and pembrolizumab(PEM),CAM+CT significantly pro-longed the PFS,and improved the ORR of mutation-negative 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 pro-longed the PFS of mutation-negative patients with locally advanced/metastatic squamous NSCLC.Sub-group analysis showed that CAM+CT significantly prolonged OS in patients with PD-L1<1%com-pared 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/meta-static NSCLC patients.CAM+CT was significantly in-creased the occurrence of all grades of adverse events compared with CT,but was comparable in terms of the occurrence of grade 3 or higher treat-ment-related adverse events.In terms of economy,CAM+CT has a cost-effectiveness advantage over CT for patients with mutation-negative advanced/metastatic squamous NSCLC.CAM+CT has a cost-effectiveness advantage over CT and PEM+CT;and CAM+CT does not have a cost-effectiveness ad-vantage over SIN+CT for patients with mutation-negative locally advanced/metastatic non-squa-mous NSCLC.CONCLUSION:CAM+CT has good ef-ficacy and cost-effectiveness for the first-line treat-ment of locally advanced/metastatic NSCLC,and the safety aspect is compared with CT,PEM or slightly worse.

崔艳军;张晓红;马天;刘一;焦玲;柴爱军;樊榕榕;刘彦国;罗兴献;黄琳

北京大学人民医院石家庄医院药学部,石家庄 050000,河北北京大学人民医院药学部,北京 100044北京大学人民医院石家庄医院药学部,石家庄 050000,河北||北京大学人民医院药学部,北京 100044北京大学人民医院胸外科,北京 100044

药学

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

camrelizumabnon-small cell lung cancerhealth technology assessmentimmune checkpoint inhibitors

《中国临床药理学与治疗学》 2024 (007)

775-784 / 10

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)

10.12092/j.issn.1009-2501.2024.07.007

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