信迪利单抗一线治疗晚期非小细胞肺癌的快速卫生技术评估

摘要/Abstract

摘要： 目的：评估信迪利单抗（sintilimab，Sin）一线治疗晚期非小细胞肺癌（non small cell lung cancer，NSCLC）的有效性、安全性及经济性。方法：系统检索中英文数据库和卫生技术评估（HTA）相关的网站及数据库。由2位评价者根据入选与排除标准独立筛选文献、提取资料和评价质量后，对有效性、安全性和经济性进行综合分析。结果：筛选纳入8篇SR/Meta分析和9篇经济学研究。结果显示，对于晚期NSCLC，与单独化疗（Chemotherapy，CT）相比Sin+CT可以显著改善总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）；Sin+CT与Pem（Pembrolizumab，Pem）+CT的OS获益相当，大于Ate（Atezolizumab，Ate）+CT；Sin+CT的PFS延长高于Ate（Atezolizumab，Ate）+CT。对于晚期非鳞状NSCLC，Sin+CT与CT相比，具有延长OS的益处，60个月时OS获益Sin+CT与Pem+CT相当；Sin+CT可以持续改善PFS，且Sin+CT与Pem+CT表现出相当的PFS。对于晚期鳞状NSCLC，与CT相比Sin+CT可显著改善OS、PFS。安全性方面，Sin+CT总体不良事件发生率及3级以上不良事件发生率低于其他组合疗法。经济性方面，从我国卫生体系出发，信迪利单抗可以延长患者的质量调整年，具有较好的成本效果。结论：信迪利单抗一线治疗晚期非小细胞肺癌具有良好的有效性、安全性及经济性。

关键词: font-size:medium, ">信迪利单抗；非小细胞肺癌；快速卫生技术评估；药物经济学

Abstract: Objective： To evaluate the efficacy， safety and economics of sintilimab (Sin) in the first-line treatment of advanced non-small cell lung cancer (NSCLC). Methods： Chinese and English databases and Health Technology assessment (HTA) related websites and databases were searched. According to the inclusion and exclusion criteria， two reviewers independently screened the literature， extracted the data and evaluated thequality， and comprehensively analyzed the effectiveness， safety and economy. Results： 8 SR/meta-analyses and 9 economic studies were selected and included. The results showed that for advanced NSCLC， Sin+CT can significantly prolong overall survival (OS)， progression-free survival (PFS) and objective response rate (ORR) compared with Chemotherapy (CT) alone.Extend for OS， Sin+CT with the Pem (Pembrolizumab， Pem)+CT benefit， greater than Ate (Atezolizumab， Ate)+CT. For PFS， Sin+CT was higher than Ate+CT. For advanced non-squamous NSCLC， Sin+CT has the benefit of prolonged OS compared with CT， and the benefit of OS at 60 months is comparable to that of Pem+CT. Sin+CT can continuously improve PFS， and Sin+CT and Pem+CT show comparable PFS. For advanced squamous NSCLC， Sin+CT can significantly improve OS and PFS compared with CT.In terms of safety，Sin+CT had a lower overall incidence of adverse events and grade III or higher adverse events than other combination therapies. In terms of economy， from the perspective of China′s health system， sintilimab can prolong the quality adjusted year of patients and has good cost-effectiveness. Conclusion： sintilimab is effective， safe and economical in the first-line treatment of advanced non-smallcell lung cancer.

Key words: font-size:medium, ">Sintilimab； Non-small cell lung cancer； Rapid health technology assessment； Pharmacoeconomic

中图分类号:

杨艳青, 陈春梅, 陈伟, 吴瑞, 王学昌, 段莲. 信迪利单抗一线治疗晚期非小细胞肺癌的快速卫生技术评估[J]. 中国药物评价, 2023, 40(5): 409-415.

YANG Yan-qing, CHEN Chun-mei, CHEN Wei, Wu Rui, WANG Xue-chang, DUAN Lian. Rapid Health Technology Evaluation of Sintilimab as First-line Treatment for Advanced Non-small Cell Lung Cancer[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2023, 40(5): 409-415.

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