EGFR-TKI类抗肿瘤药物一线治疗非小细胞肺癌临床综合评价  

Clinical Comprehensive Evaluation of EGFR-TKIs for the First-Line Treatment of Non Small Cell Lung Cancer

作　　者：郝星 王心源 羊红玉[1,2] 王临润 饶跃峰[1,2] HAO Xing;WANG Xinyuan;YANG Hongyu;WANG Linrun;RAO Yuefeng(The First Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou,Zhejiang,China 310003;Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research,Hangzhou,Zhejiang,China 310003;The First People's Hospital of Yuhong District,Hangzhou,Zhejiang,China 311113)

机构地区：[1]浙江大学医学院附属第一医院,浙江杭州310003 [2]浙江省药物临床研究与评价技术重点实验室,浙江杭州310003 [3]浙江省杭州市余杭区第一人民医院,浙江杭州311113

出　　处：《中国药业》2025年第6期116-120,共5页China Pharmaceuticals

基　　金：浙江省药学会药品临床综合评价专项[2024ZYYL02]。

摘　　要：目的综合评价6种一线靶向表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)类抗肿瘤药的临床应用价值。方法以吉非替尼、厄洛替尼、埃克替尼、阿法替尼、达可替尼、奥希替尼为研究对象,以《抗肿瘤药物临床综合评价技术指南(2022年版试行)》为准则,通过文献复习、专家调研和专家论证会构建EGFR-TK突变非小细胞肺癌(NSCLC)一线治疗药品临床综合评价指标体系。通过梳理系统文献综述、网状荟萃分析和其他相关数据资料,重点围绕安全性、有效性、经济性、创新性、适宜性、可及性6个维度进行定性及定量数据/证据整合分析。结果建立了包含6个一级指标(维度)、12个一级指标、4个三级指标的综合评价指标体系。奥希替尼在各维度的综合表现最优,但其可负担性较差;埃克替尼虽然在安全性上表现最优,但其有效性和经济性上最差;吉非替尼在创新性、经济性和可及性上表现均较佳,但其在安全性和有效性上均排在后3位。厄洛替尼在几个维度排名居中,但总生存获益较差。阿法替尼和达可替尼在各维度的表现均排名靠后,如阿法替尼可负担性最差,而达可替尼安全性上表现最差。结论6种药品在各维度指标上各有优缺,建议在临床合理用药和作为药品目录准入决策时应根据各医疗单位及临床实际需求进行综合判断。Objective To comprehensively evaluat the value of epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKIs)as first-line treatment for cancer.Methods The study focuses on gefitinib,erlotinib,icotinib,afatinib,dacomitinib,and osimertinib as the research subjects,guided by the Technical Guidelines for Clinical Comprehensive Evaluation of Antitumor Drugs(Trial Version 2022).Constructing a comprehensive clinical evaluation index system for first-line treatment drugs for EGFR-TK mutant non-small cell lung cancer(NSCLC)through literature review,expert research,and expert argumentation.By reviewing systematic literature reviews,network meta-analyses,and other relevant data,we focus on qualitative analysis around six dimensions:safety,effectiveness,economy,innovation,suitability,and accessibility,and quantitative data/evidence integration analysis.Results A comprehensive evaluation index system has been established,which includes 6 primary indicators(dimensions),12 secondary indicators,and 4 tertiary indicators.Osimertinib demonstrated the best overall performance across all dimensions,except for relatively poor affordability.Icotinib showed the best performance in terms of safety,yet its effectiveness and affordability were the weakest.Gefitinib had a favorable performance in innovativeness,affordability,and accessibility,but ranked among the bottom three in safety and efficacy.Erlotinib was in the middle range on several dimensions,with a poor overall survival benefit.Afatinib and dacomitinib ranked low in all dimensions;specifically,afatinib was the worst in terms of affordability,and dacomitinib was the worst in safety.Conclusion The six EGFR-TKIs included in this comprehensive evaluation for the first-line treatment of NSCLC patients have their respective advantages and disadvantages in various dimensional indicators.It is recommended that comprehensive considerations be made based on actual needs when making decisions regarding rational use and drug catalogue access.

关 键 词：抗肿瘤药 临床综合评价 表皮生长因子受体酪氨酸激酶抑制剂 非小细胞肺癌 

分 类 号：R969.3[医药卫生—药理学]