PD-L1检测指导中国非小细胞肺癌患者免疫治疗的成本效果分析  

Cost-effectiveness of PD-L1 testing to guide immunotherapy for patients with non-small cell lung cancer in China

作　　者：李媛 郭凌川[2] 袁勇 郑强 金燕 明坚 LI Yuan;GUO Lingchuan;YUAN Yong;ZHENG Qiang;JIN Yan;MING Jian(Department of Pathology,Fudan University Shanghai Cancer Center,Department of Oncology,Shanghai Medical College,Fudan University,Shanghai 200032,China;Department of Pathology,The First Affiliated Hospital of Soochow University,Suzhou 215006,Jiangsu Province,China;Department of Pathology,Shaanxi Provincial Cancer Hospital,Xi'an 710061,Shaanxi Province,China;School of Public Health,Fudan University,Shanghai 200032,China)

机构地区：[1]复旦大学附属肿瘤医院病理科,复旦大学上海医学院肿瘤学系,上海200032 [2]苏州大学附属第一医院病理科,江苏苏州215006 [3]西安交通大学附属陕西省肿瘤医院病理科,陕西西安710061 [4]复旦大学公共卫生学院,上海200032

出　　处：《中国癌症杂志》2025年第2期237-248,共12页China Oncology

摘　　要：背景与目的:根据国家癌症中心最新数据显示,中国肺癌发病率和死亡率均居所有恶性肿瘤首位,且85%为非小细胞肺癌(non-small cell lung cancer,NSCLC)。近年来,以程序性死亡[蛋白]-1(programmed death-1,PD-1)/程序性死亡[蛋白]配体-1(programmed death ligand-1,PD-L1)免疫检查点抑制剂为主的免疫治疗在肺癌的治疗中取得了突破性的进展,为肺癌患者带来了更多的生存获益。本研究旨在评估使用不同PD-L1检测方案指导NSCLC患者免疫治疗的成本和效果,为中国NSCLC患者选择具有成本效果的诊断以及指导免疫单药方案提供科学依据。方法:基于卫生体系视角,构建决策树模型,模拟评估早中期(ⅡA~ⅢB期)、晚期(Ⅳ期)NSCLC患者接受Ventana SP263检测、Dako 22C3即用型及Dako 22C3浓缩液检测的成本,以及获得正确诊断且接受正确治疗的比例(正确诊治率)。通过增量分析比较SP263相对于其他检测方式的经济性。通过单因素敏感性分析和概率敏感性分析检验基础分析结果的稳健性。结果:指导NSCLC早中期患者化疗后辅助阿替利珠单抗治疗时,相比22C3即用型检测方案或22C3浓缩液检测方案,SP263检测方案每正确诊断且接受正确治疗一位患者需要的增量成本为9449元,SP263检测方案具有成本效果。指导NSCLC晚期患者免疫单药治疗时,与22C3即用型或22C3浓缩液检测方案相比,SP263检测方案可以指导多种免疫单药治疗(阿替利珠单抗单药、帕博利珠单抗单药),同时正确诊治率更高,且成本更低。单因素敏感性分析和概率敏感性分析均证实结果的稳健性。结论:中国早中期和晚期NSCLC患者在进行免疫单药治疗时,SP263检测方案是具有成本效果的PD-L1检测方案。Background and purpose:According to the latest data from the National Cancer Center,the incidence rate and mortality of lung cancer in China rank first among all malignant tumors,and 85%are non-small cell lung cancer(NSCLC).In recent years,immunotherapy based on programmed cell death protein-1(PD-1)/programmed death ligand-1(PD-L1)immune checkpoint inhibitors(ICIs)has made breakthrough progress in lung cancer,bringing more survival benefits to lung cancer patients.This study aimed to evaluate the cost-effectiveness of three major PD-L1 testing assays in guiding immunotherapy for patients with NSCLC,and to provide empirical evidence to guide the selection of cost-effective diagnosis and ICIs monotherapy regimens for NSCLC patients in China.Methods:From a healthcare system perspective,a decision-tree model was constructed to simulate the cost and effectiveness(percentage of the patients who were successfully diagnosed and who were correctly prescribed and underwent correct treatment according to China treatment guidelines)of employing Ventana PD-L1 IHC(SP263)assay,PD-L1 IHC 22C3 pharmDx,and Dako 22C3 antibody concentrate in early to mid-stage and advanced NSCLC patients in China,respectively.The costeffectiveness of SP263 assay compared to other testing methods was assessed through the incremental analysis.The robustness of the base case analysis results was validated by using one-way sensitivity analysis and probabilistic sensitivity analysis.Results:When considering atezolizumab monotherapy following chemotherapy for early to mid-stage(ⅡA-ⅢB)NSCLC patients,in comparison to the 22C3 assay or 22C3 antibody concentrate,the SP263 assay incurred an additional cost of 9449 yuan per successfully diagnosed and treated patient.The SP263 assay,which can guide multiple ICIs monotherapies(e.g.,atezolizumab,pembrolizumab)for advanced(Ⅳ)NSCLC patients,was dominant by achieving a higher percentage of successfully diagnosed and treated patients at a lower cost compared to Dako 22C3 assay and Dako 22C3 antibody concentrate.

关 键 词：PD-L1检测 非小细胞肺癌 免疫单药治疗 成本效果分析 

分 类 号：R734.2[医药卫生—肿瘤]