达克替尼治疗EGFR突变晚期非小细胞肺癌的快速卫生技术评估#br#

摘要/Abstract

摘要： 目的：评价达克替尼治疗EGFR突变晚期非小细胞肺癌的有效性、安全性和经济性，为临床治疗用药选择提供循证依据。方法：采用快速卫生技术评估（RHTA）方法。计算机检索PubMed、Embase、the Cochrane Library、中国知网、万方、中国生物医药数据库等中英文数据库。由2位评价者根据纳入与排除标准独立筛选文献、提取资料，并进行定性分析和快速卫生技术评估。结果：筛选共纳入16篇文献，其中8篇Meta分析和8篇经济学研究。结果显示，在治疗EGFR突变的晚期NSCLC患者时，与吉非替尼、厄洛替尼、埃克替尼、阿法替尼及标准化疗组相比时，达克替尼组的总生存期（OS）和无进展生存期（PFS）均有更明显的获益，相比于化疗也显示具有更高的客观缓解率（ORR）。与第一代EGFR-TKIs相比，达克替尼组能显著改善治疗失败时间（TTF）。在安全性方面相比于化疗和其他EGFR-TKTs类药物，达克替尼引起皮疹、腹泻和口腔炎的可能性均较高。经济性方面结果存在争议，达克替尼在进入我国医保后显示与吉非替尼相比具有成本-效果优势，且其具有经济优势的概率为83.04%。结论：达克替尼治疗EGFR突变的晚期NSCLC具有良好的有效性，在安全性方面没有明显的优势，经济性结果存在争议不予判定。

关键词: 达克替尼, 非小细胞肺癌, 有效性, 安全性, 经济性, 快速卫生技术评估

Abstract: Objective： To evaluate the efficacy， safety and economy of Dacomitinib in the treatment of advanced non-small cell lung cancer with EGFR mutation， and to provide evidence-based evidence for clinical drug selection. Methods： Rapid Health Technology Assessment (RHTA) was used. Chinese and English databases such as PubMed， Embase， the Cochrane Library， CNKI， Wanfang， China Biomedicine Database were searched by computer. Literature was screened independently by two reviewers according to inclusion and exclusion criteria， data were extracted， and qualitative analysis and rapid health technology assessment were conducted. Results： A total of 16 literatures were selected and included， including 8 meta-analyses and 8 economic studies. In the treatment of patients with advanced NSCLC with EGFR mutations， overall survival (OS) and progression-free survival (PFS) were significantly better in the ducatinib group than in the gefitinib， erotinib， ecotinib， afatinib and standard chemotherapy groups. It has also been shown to have a higher objective response rate (ORR) compared to chemotherapy. Compared with first-generation EGFR-TKIs， it was also shown to significantly improve treatment failure time (TTF). In terms of safety， Dacomitinib is more likely to cause rash， diarrhea， and stomatitis than chemotherapy and other EGFR-TKTs. The economic results are controversial， but in China， Dacomitinib showed a cost-effectiveness advantage compared with gefitinib after entering medical insurance， and the probability of economic advantage was 83.04%. Conclusions： Dacomitinib has good efficacy in the treatment of advanced NSCLC with EGFR mutation， but has no obvious advantage in terms of safety， and the economic results are controversial.

Key words: Dacomitinib, Non-small cell lung cancer, Effectiveness, Safety, Economy, Rapid health technology assessment

中图分类号:

R191

马璟婷1, 宋沧桑1, 2, 李兴德1, 2, 毛盼盼2, 张函舒2, 马雪娇2. 达克替尼治疗EGFR突变晚期非小细胞肺癌的快速卫生技术评估#br#[J]. 中国药物评价, 2024, 41(1): 65-70.

MA Jing-ting1, SONG Cang-sang1, 2, LI Xing-de1, 2, MAO Pan-pan2, ZHANG Han-shu2, MA Xue-jiao2. Dacomitinib for the Treatment of EGFR-mutated Advanced Non-small Cell Lung Cancer：A Rapid Health Technology Assessment#br#[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2024, 41(1): 65-70.

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