[关键词]
[摘要]
目的 针对表皮生长因子受体(EGFR)敏感突变型晚期非小细胞肺癌(NSCLC)患者在接受靶向治疗耐药后出现广泛疾病进展且耐药机制未明的情况,开展后续治疗方案的临床综合评价,旨在为医疗机构药品目录遴选及个体化治疗决策提供客观、量化的循证依据。方法 系统检索信迪利单抗联合贝伐珠单抗及化疗、依沃西单抗联合化疗、埃万妥单抗联合化疗以及芦康沙妥珠单抗单药治疗4种方案的相关证据。依据《中国医疗机构药品评价与遴选快速指南(第三版)》,从有效性、安全性、药学特性、经济性及其他属性5个维度对上述治疗方案进行量化评分与综合评价。结果 4种治疗方案的综合评分为67.7~75.8分,由高到低依次为:芦康沙妥珠单抗单药(75.8分)、依沃西单抗联合化疗(74.2分)、信迪利单抗联合贝伐珠单抗及化疗(72.4分)、埃万妥单抗联合化疗(67.7分)。其中,芦康沙妥珠单抗单药治疗在有效性、经济性得分最高;依沃西单抗联合化疗在安全性和药学特性维度表现最优;芦康沙妥珠单抗单药治疗、信迪利单抗联合贝伐珠单抗及化疗在其他属性维度得分并列最高。结论 4种针对晚期NSCLC继发EGFR-酪氨酸激酶抑制剂(TKIs)耐药后的治疗方案均具备良好的临床价值,其中芦康沙妥珠单抗单药治疗综合评分最高,可优先考虑纳入医疗机构药品遴选与目录优化范畴,受限于间接比较与主观赋权的评价模式,研究未覆盖未上市药物及合并症亚组,结论不宜盲目外推。
[Key word]
[Abstract]
Objective To perform a comprehensive clinical evaluation of subsequent treatment regimens for patients with EGFRmutant advanced non-small cell lung cancer who experience extensive disease progression following resistance to targeted therapy, with undefined resistance mechanisms, aiming to provide objective and quantitative evidence-based support for hospital formulary selection and individualized therapeutic decision-making. Methods Relevant evidence was systematically collected for four regimens: sintilimab plus bevacizumab and chemotherapy, ivonescimab plus chemotherapy, amivantamab plus chemotherapy, and sacituzumab tirumotecan monotherapy. Based on the Chinese Rapid Guideline for Drug Evaluation and Selection in Medical Institutions (Third Edition), these regimens were quantitatively scored and comprehensively assessed across five domains: efficacy, safety, pharmaceutical characteristics, economy, and other attributes. Results The overall comprehensive scores ranged from 67.7 to 75.8. In descending order: sacituzumab tirumotecan (75.8), ivonescimab plus chemotherapy (74.2), sintilimab plus bevacizumab and chemotherapy (72.4), and amivantamab plus chemotherapy (67.7). Sacituzumab tirumotecan achieved the highest scores in efficacy and economy; ivonescimab plus chemotherapy performed best in safety and pharmaceutical characteristics; Sacituzumab tirumotecan and sintilimab plus bevacizumab and chemotherapy are tied for the highest score in other attributesand. Conclusion All four treatment strategies for advanced NSCLC following resistance to EGFR tyrosine kinase inhibitors (TKIs) demonstrate favorable clinical value. Among them, sacituzumab tirumotecan attained the highest comprehensive score and may be prioritized for inclusion in institutional drug selection and formulary optimization. However, constrained by indirect comparison and subjective weighting in the evaluation framework, this analysis excludes investigational unapproved agents and subgroup analyses based on patient comorbidities; accordingly, cautious extrapolation of the findings is warranted.
[中图分类号]
R965;R979.1
[基金项目]
福建省自然科学基金项目(2023J011276)