中国全科医学2026，Vol.29Issue(29)：4258-4264,7.DOI:10.12114/j.issn.1007-9572.2025.0201
间变性淋巴瘤激酶抑制剂用于间变性淋巴瘤激酶阳性晚期非小细胞肺癌患者一线治疗的临床综合评价研究
Comprehensive Evaluation of ALK Inhibitors in the First-line Treatment of Patients with ALK-positive Non-small Cell Lung Cancer
摘要
Abstract
Background Currently,six ALK inhibitors(including crizotinib,alectinib,ceritinib,brigatinib,ensartinib,and lorlatinib)have been approved for first-line treatment of ALK-positive advanced non-small cell lung cancer(NSCLC),yet clinical decision-making remains challenging.Objective This study aimed to comprehensively evaluate these six ALK inhibitors across five dimensions(safety,efficacy,pharmaceutical properties,drug economy,and other properties)to provide evidence-based support for clinical drug selection.Methods Data were sourced from drug labels,guidelines by the National Comprehensive Cancer Network(NCCN),Chinese Society of Clinical Oncology(CSCO),and European Society for Medical Oncology(ESMO),network meta-analyses,as well as authoritative platforms including Zhejiang Provincial Two-Designated Healthcare Security Information Database,the National Healthcare Security Administration Information Database,and the National Medical Products Administration Drug Evaluation Center,covering information essential for evaluating drug efficacy,safety,and pricing.Based on the Rapid Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(2nd Edition),a comprehensive evaluation system comprising five dimensions(safety,efficacy,pharmaceutical properties,drug economy,and other properties)was developed using the Delphi method to assess six ALK inhibitors(including crizotinib,alectinib,ceritinib,brigatinib,ensartinib,and lorlatinib).A nine-member expert panel with senior titles and over five years of relevant experience conducted six discussion rounds to finalize evaluation criteria(three rounds to define items and three to assign weights).Final scoring and statistical analysis were performed independently by a two-author team according to the established standards.Results The overall ranking of the six ALK inhibitors was:brigatinib(85.5 points)>alectinib(82.7 points)>lorlatinib(82.2 points)>ensartinib(78.8 points)>ceritinib(77.4 points)>crizotinib(76.5 points).Alectinib scored highest in the core dimensions(safety,efficacy,and pharmaceutical properties)(71.0 points).Generational trend analysis revealed that second-generation inhibitors outperformed third-generation and first-generation drugs(except for ceritinib and ensartinib),while in core dimensions,third-generation inhibitors scored higher than second-generation and first-generation drugs(except for alectinib and ceritinib).Conclusion This study demonstrates that different ALK inhibitors exhibit distinct advantages across the five evaluated dimensions.Brigatinib achieved the highest overall score,while alectinib ranked highest in core dimensions.Second-and third-generation drugs generally performed better,providing valuable evidence for individualized treatment selection based on clinical needs.关键词
ALK抑制剂/非小细胞肺癌/综合评价/临床合理用药/个体化治疗Key words
ALK inhibitors/Non-small cell lung cancer/Comprehensive evaluation/Clinical rational drug use/Individualized treatment分类
医药卫生引用本文复制引用
叶子奇,周昱君,刘浏,张燕芳,洪昀,饶跃峰..间变性淋巴瘤激酶抑制剂用于间变性淋巴瘤激酶阳性晚期非小细胞肺癌患者一线治疗的临床综合评价研究[J].中国全科医学,2026,29(29):4258-4264,7.基金项目
浙江省药学会药品临床综合评价专项科研资助项目(2022ZYYL01) （2022ZYYL01）
国家自然科学基金资助项目(81872213) （81872213）
