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

李媛; 郭凌川; 袁勇; 郑强; 金燕; 明坚

doi:10.19401/j.cnki.1007-3639.2025.02.011

您当前的位置：

首页 >

文章列表页 >

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

论著 | 更新时间：2025-12-31

- 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
- 中国癌症杂志 2025年35卷第2期页码：237-248
- 作者机构：
  
  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
- 作者简介：
  
  [ "李媛（ORCID: 0000-0001-5651-819X），主任医师，教授，复旦大学附属肿瘤医院病理科副主任。" ]
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2025.02.011
  中图分类号：
- 收稿：2024-08-30，
  
  修回：2024-11-04，
  
  纸质出版：2025-02-28
- 稿件说明：
移动端阅览
李媛, 郭凌川, 袁勇, 等. 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[J]. 中国癌症杂志, 2025,35(2):237-248.

Yuan LI, Lingchuan GUO, Yong YUAN, et al. Cost-effectiveness of PD-L1 testing to guide immunotherapy for patients with non-small cell lung cancer in China[J]. China Oncology, 2025, 35(2): 237-248.
李媛, 郭凌川, 袁勇, 等. 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[J]. 中国癌症杂志, 2025,35(2):237-248. DOI： 10.19401/j.cnki.1007-3639.2025.02.011.

Yuan LI, Lingchuan GUO, Yong YUAN, et al. Cost-effectiveness of PD-L1 testing to guide immunotherapy for patients with non-small cell lung cancer in China[J]. China Oncology, 2025, 35(2): 237-248. DOI： 10.19401/j.cnki.1007-3639.2025.02.011.

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9 449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。

Abstract

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 d

eath 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 cost-effectiveness 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 (Ⅱ A-Ⅲ B) NSCLC patients

in comparison to the 22C3 assay or 22C3 antibody concentrate

the SP263 assay incurred an additional cost of 9 449 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. One-way sensitivity analysis and probabilistic sensitivity analysis both confirmed the robustness of the results.

Conclusion:

The Ventana PD-L1 IHC SP263 assay was cost-effective

compared to Dako PD-L1 IHC 22C3 assay and Dako 22C3 antibody

concentrate for the immunotherapy treatment for both stage Ⅱ A-Ⅲ B and stage Ⅳ NSCLC patients in China.

关键词

Keywords

references

ZHENG R S , CHEN R , HAN B F , et al . Cancer incidence and mortality in China, 2022 [J ] . J Natl Cancer Cent , 2024 , 4 ( 1 ): 47 - 53 .

LIU G B , PEI F , YANG F Q , et al . Role of autophagy and apoptosis in non-small cell lung cancer [J ] . Int J Mol Sci , 2017 , 18 ( 2 ): 367 .

中国抗癌协会肿瘤病理专业委员会肺癌协作组、分子病理协作组, 中国抗癌协会肺癌专业委员会, 中国临床肿瘤学会非小细胞肺癌专业委员会 . 非小细胞肺癌PD-L1表达临床检测中国专家共识(2023版) [J ] . 中华病理学杂志 , 2024 , 53 ( 2 ): 121 - 129 .

The Lung Cancer Collaboration Group and Molecular Pathology Collaboration Group of the Tumor Pathology Professional Committee of the China Anti-Cancer Association, the Lung Cancer Professional Committee of the Chinese Anti Cancer Association, and the Non-Small Cell Lung Cancer Professional Committee of the Chinese Society of Clinical Oncology . Chinese expert consensus on clinical testing standards of PD-L1 expression for non-small cell lung cancer (2023 version) [J ] . Chin J Pathol , 2024 , 53 ( 2 ): 121 - 129 .

中国抗癌协会肿瘤病理专业委员会肺癌学组 , 中国抗癌协会肺癌专业委员会 , PD-L检测共识专家组 . 非小细胞肺癌PD-L1免疫组织化学检测规范中国专家共识 [J ] . 中国肺癌杂志 , 2020 , 23 ( 9 ): 733 - 740 .

Chinese Anti-Cancer Association , Lung Cancer Study Group of Committee of Oncopathology; Chinese Society of Lung Cancer; Expert Group on PD-L1 Testing Consensus . Chinese expert consensus on standards of PD-L1 immunohistochemistry testing for non-small cell lung cancer [J ] . Chin J Lung Cancer , 2020 , 23 ( 9 ): 733 - 740 .

中国抗癌协会肿瘤病理专业委员会 , 中国临床肿瘤学会肿瘤病理专家委员会 , 中国临床肿瘤学会非小细胞肺癌专家委员会 . 中国非小细胞肺癌PD-L1表达检测临床病理专家共识 [J ] . 中华肿瘤杂志 , 2020 , 42 ( 7 ): 513 - 521 .

China Anti-Cancer Association Tumor Pathology Professional Committee , Chinese Society of Clinical Oncology Tumor Pathology Expert Committee , Chinese Society of Clinical Oncology Non-Small Cell Lung Cancer Expert Committee . Expert consensus on PD-L1 expression testing in non-small-cell lung cancer in China [J ] . Chin J Oncol , 2020 , 42 ( 7 ): 513 - 521 .

中国临床肿瘤学会(CSCO) . 非小细胞肺癌诊疗指南2023 [M ] . 北京 : 人民卫生出版社 .

Chinese Society of Clinical Oncology (CSCO) . Diagnosis and treatment guidelines for non-small cell lung cancer 2023 [M ] . Beijing : People's Health Publishing House .

中华医学会肿瘤学分会, 中华医学会杂志社 . 中华医学会肺癌临床诊疗指南(2023版) [J ] . 中华医学杂志 , 2023 , 103 ( 27 ): 2037 - 2074 .

Chinese Medical Association Oncology Branch, Journal of Chinese Medical Association . Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer (2023 edition) [J ] . Natl Med J China , 2023 , 103 ( 27 ): 2037 - 2074 .

NordiQC, PD-L1(lung) assessment run C1-C5(2017-2019) [EB/OL ] . https://www.nordiqc.org/epitope.php?id=107. https://www.nordiqc.org/epitope.php?id=107 https://www.nordiqc.org/epitope.php?id=107

ZHENG Q , HUANG Y , ZENG X , et al . Clinicopathological and molecular characteristics associated with PD-L1 expression in non-small cell lung cancer: a large-scale, multi-center, real-world study in China [J ] . J Cancer Res Clin Oncol , 2021 , 147 ( 5 ): 1547 - 1556 .

FELIP E , ALTORKI N , ZHOU C , et al . Overall survival with adjuvant atezolizumab after chemotherapy in resected stage Ⅱ-ⅢA non-small cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial [J ] . Ann Oncol , 2023 , 34 ( 10 ): 907 - 919 .

HERBST R S , GIACCONE G , DE MARINIS F , et al . Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC [J ] . N Engl J Med , 2020 , 383 ( 14 ): 1328 - 1339 .

RECK M , RODRÍGUEZ-ABREU D , ROBINSON A G , et al . Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer [J ] . N Engl J Med , 2016 , 375 ( 19 ): 1823 - 1833 .

CHEN P , YANG Q , LI Y F , et al . Cost-effectiveness analysis of adjuvant therapy with atezolizumab in Chinese patients with stage ⅠB-ⅢA resectable NSCLC after adjuvant chemotherapy [J ] . Front Oncol , 2022 , 12 : 894656 .

GU X H , ZHANG Q , CHU Y B , et al . Cost-effectiveness of afatinib, gefitinib, erlotinib and pemetrexed-based chemotherapy as first-line treatments for advanced non-small cell lung cancer in China [J ] . Lung Cancer , 2019 , 127 : 84 - 89 . DOI: S0169-5002(18)30668-8 http://doi.org/S0169-5002(18)30668-8

WU B , DONG B J , XU Y J , et al . Economic evaluation of first-line treatments for metastatic renal cell carcinoma: a cost-effectiveness analysis in a health resource-limited setting [J ] . PLoS One , 2012 , 7 ( 3 ): e32530 .

汤雅倩 , 赵明烨 , 唐文熙 . 信迪利单抗对比卡瑞利珠单抗一线治疗晚期非鳞状非小细胞肺癌的经济学评价 [J ] . 卫生经济研究 , 2023 , 40 ( 2 ): 34 - 40 .

TANG Y Q , ZHAO M Y , TANG W X . Pharmacoeconomic evaluation of sintilimab versus camrelizumab in the first-line treatment of patients with non-squamous advanced non-small cell lung cancer in China [J ] . Health Econ Res , 2023 , 40 ( 2 ): 34 - 40 .

石丰豪 , 金敏 , 王子婧 , 等 . 卡瑞利珠单抗对比化疗方案二线治疗晚期或转移性食管鳞状细胞癌的成本效用分析 [J ] . 中国卫生经济 , 2021 , 40 ( 12 ): 73 - 77 .

SHI F H , JIN M , WANG Z J , et al . Cost-utility analysis of camrelizumab versus chemotherapy regimens for second-line treatment of advanced or met-astatic esophageal squamous cell carcinoma [J ] . Chin Health Econ , 2021 , 40 ( 12 ): 73 - 77 .

中华慈善总会泰圣奇慈善援助项目 [EB/OL ] . https://tpap.yao2000.com.cn/flow.html. https://tpap.yao2000.com.cn/flow.html https://tpap.yao2000.com.cn/flow.html

China Charity Federation Tai Shengqi Charity assistance project [EB/OL ] . https://tpap.yao2000.com.cn/flow.html. https://tpap.yao2000.com.cn/flow.html https://tpap.yao2000.com.cn/flow.html

中国初级卫生保健基金会生命之钥-肿瘤免疫治疗患者援助项目 . https://smzy.ilvzhou.com/index.php?m=content & c=index & a=lists & catid=31. https://smzy.ilvzhou.com/index.php?m=content&c=index&a=lists&catid=31 https://smzy.ilvzhou.com/index.php?m=content&c=index&a=lists&catid=31

China Primary Health Care Foundation's key to life-tumor immunotherapy patient assistance project [EB/OL ] . https://smzy.ilvzhou.com/index.php?m=content & c=index & a=lists & catid=31. https://smzy.ilvzhou.com/index.php?m=content&c=index&a=lists&catid=31 https://smzy.ilvzhou.com/index.php?m=content&c=index&a=lists&catid=31

HURWITZ J T , VAFFIS S , GRIZZLE A J , et al . Cost-effectiveness of PD-L1 testing in non-small cell lung cancer (NSCLC) using in vitro diagnostic (IVD) versus laboratory-developed test (LDT) [J ] . Oncol Ther , 2022 , 10 ( 2 ): 391 - 409 .

SHIMABUKURO HO R , MIOTI SEBASTIÃO M , VENEZIAN DE CARVALHO J P , et al . Cost-effectiveness analysis of the SP142 versus 22C3 PD-L1 assays in the treatment of atezolizumab plus nab-paclitaxel for patients with advanced triple negative breast cancer in the Brazilian private healthcare system [J ] . J Med Econ , 2020 , 23 ( 11 ): 1340 - 1344 .

WAN N , ZHANG T T , HUA S H , et al . Cost-effectiveness analysis of pembrolizumab plus chemotherapy with PD-L1 test for the first-line treatment of NSCLC [J ] . Cancer Med , 2020 , 9 ( 5 ): 1683 - 1693 .

HUANG M , LOU Y Y , PELLISSIER J , et al . Cost effectiveness of pembrolizumab vs standard-of-care chemotherapy as first-line treatment for metastatic NSCLC that expresses high levels of PD-L1 in the United States [J ] . PharmacoEconomics , 2017 , 35 ( 8 ): 831 - 844 .

DING D , HU H B , LIAO M T , et al . Cost-effectiveness analysis of atezolizumab plus chemotherapy in the first-line treatment of metastatic non-squamous non-small cell lung cancer [J ] . Adv Ther , 2020 , 37 ( 5 ): 2116 - 2126 . DOI: 10.1007/s12325-020-01292-3 http://doi.org/10.1007/s12325-020-01292-3

郭雪晶 , 曹赫 , 周建娅 , 等 . PD-L1检测方法在非小细胞肺癌的研究进展 [J ] . 中国肺癌杂志 , 2019 , 22 ( 1 ): 40 - 44 .

GUO X J , CAO H , ZHOU J Y , et al . Progress on the study of PD-L1 detection methods in non-small cell lung cancer [J ] . Chin J Lung Cancer , 2019 , 22 ( 1 ): 40 - 44 .

浏览量

2411

下载量

CSCD

文章被引用时，请邮件提醒。

提交

工具集

关联资源

ERα、ERβ在非吸烟非小细胞肺癌患者中的表达与生存期和性别的相关性研究