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非小细胞肺癌PD-L1表达临床检测中国专家共识（2023版）
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
作者及单位信息
·
DOI： 10.3760/cma.j.cn112151-20230922-00203
Chinese expert consensus on clinical testing standards of PD-L1 expression for non-small cell lung cancer (2023 version)
Lung Cancer Study Group and Molecular Pathology Collaboration Group of Tumor Pathology Committee of Chinese Anti-Cancer Association
Lung Cancer Professional Committee of Chinese Anti-Cancer Association
Expert Committee on Non-Small Cell Lung Cancer of Chinese Society of Clinical Oncology
Ying Jianming
Ying Jianming
Lu Shun
Zhou Caicun
Authors Info & Affiliations
Lung Cancer Study Group and Molecular Pathology Collaboration Group of Tumor Pathology Committee of Chinese Anti-Cancer Association
Lung Cancer Professional Committee of Chinese Anti-Cancer Association
Expert Committee on Non-Small Cell Lung Cancer of Chinese Society of Clinical Oncology
Ying Jianming
Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education), Department of Pathology, Peking University Cancer Hospital and Institute, Beijiing 100142, China], Email: ; Ying Jianming (Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Ying Jianming
Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Lu Shun
Department of Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200030, China
Zhou Caicun
Department of Medical Oncology, Shanghai Pulmonary Hospital, Cancer Institute, School of Medicine, Tongji University, Shanghai 200433, China
·
DOI： 10.3760/cma.j.cn112151-20230922-00203
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摘要

近年来，随着针对程序性死亡受体1（programmed death 1，PD-1）及程序性死亡配体1（programmed death ligand 1，PD-L1）的免疫检查点抑制剂在中国获批的非小细胞肺癌适应证逐步增多，尤其是辅助免疫治疗及新辅助免疫治疗在临床实践中的不断应用，PD-L1免疫组织化学检测适用人群也随之有所变化。另外，国产PD-L1检测试剂也获批作为伴随诊断。因此，本共识在整合2020版国内PD-L1检测共识基础上，纳入近3年有关临床诊治进展内容，为适应并满足临床应用现状和需求，通过共识会议最终形成8条更新意见，旨在更好地指导非小细胞肺癌PD-1/PD-L1免疫检查点抑制剂临床应用中对PD-L1免疫组织化学表达检测的规范使用。随着后续更多研究与临床实践经验和数据的进一步积累，将会陆续进行相关内容的更新和完善。

引用本文

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(02)：121-129.

DOI:10.3760/cma.j.cn112151-20230922-00203

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自2018年首个免疫检查点抑制剂获批治疗非小细胞肺癌（NSCLC）以来，国内陆续有多个程序性死亡受体1（programmed death 1，PD-1）及程序性死亡配体1（programmed death ligand 1，PD-L1）的抗体药物获批用于NSCLC。不同药物及适应证对PD-L1表达提出了不同的检测需求，包括伴随诊断、补充诊断或不需要检测等。同时，对应的PD-L1检测试剂克隆号也有所增加。2020年国内发布的NSCLC PD-L1表达检测共识对此已经进行充分说明或论述 ［ 1 , 2 ］ ，本共识就上版共识之后新上市的临床药物适应证、PD-L1检测适用人群变化及检测试剂方面的进展或研究数据进行梳理。共识编写组基于更新的循证医学证据及新增的中国临床实践需求，形成更新版共识拟解决的问题框架；随后以问题为导向广泛收集近3年国内外发表的高质量文献数据，形成更新点推荐；随后组织多学科专家通过共识会议法，针对更新点进行1轮投票及修改意见收集，根据收集的投票结果及反馈意见，修改及完善后组织第2轮投票；最终形成了本共识8个更新点推荐，推荐等级以证据强度为主，证据级别不足时参考专家投票意见。
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参考文献
[1]
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. DOI: 10.3760/cma.j.cn112152-20200313-00202 .
返回引文位置Google Scholar
百度学术
万方数据
[2]
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. DOI: 10.3779/j.issn.1009-3419.2020.101.43 .
返回引文位置Google Scholar
百度学术
万方数据
[3]
Mok T , Wu YL , Kudaba I ,et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial[J]. Lancet, 2019,393(10183):1819-1830. DOI: 10.1016/S0140-6736(18)32409-7 .
返回引文位置Google Scholar
百度学术
万方数据
[4]
Reck M , Rodríguez-Abreu D , Robinson AG ,et al. Five-year outcomes with Pembrolizumab versus chemotherapy for metastatic non-small-cell lung cancer with PD-L1 tumor proportion score≥50[J]. J Clin Oncol, 2021,39(21):2339-2349. DOI: 10.1200/JCO.21.00174 .
返回引文位置Google Scholar
百度学术
万方数据
[5]
de Castro G Jr, Kudaba I , Wu YL ,et al. Five-year outcomes with Pembrolizumab versus chemotherapy as first-line therapy in patients with non-small-cell lung cancer and programmed death ligand-1 tumor proportion score≥1% in the KEYNOTE-042 study[J]. J Clin Oncol, 2023,41(11):1986-1991. DOI: 10.1200/JCO.21.02885 .
返回引文位置Google Scholar
百度学术
万方数据
[6]
Herbst RS , 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. DOI: 10.1056/NEJMoa1917346 .
返回引文位置Google Scholar
百度学术
万方数据
[7]
Felip E , Altorki N , Zhou C ,et al. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial[J]. Lancet, 2021,398(10308):1344-1357. DOI: 10.1016/S0140-6736(21)02098-5 .
返回引文位置Google Scholar
百度学术
万方数据
[8]
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 III trial[J]. Ann Oncol, 2023,34(10):907-919. DOI: 10.1016/j.annonc.2023.07.001 .
返回引文位置Google Scholar
百度学术
万方数据
[9]
O′Brien M , Paz-Ares L , Marreaud S ,et al. Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB-IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial[J]. Lancet Oncol, 2022,23(10):1274-1286. DOI: 10.1016/S1470-2045(22)00518-6 .
返回引文位置Google Scholar
百度学术
万方数据
[10]
Forde PM , Spicer J , Lu S ,et al. Neoadjuvant Nivolumab plus chemotherapy in resectable lung cancer[J]. N Engl J Med, 2022,386(21):1973-1985. DOI: 10.1056/NEJMoa2202170 .
返回引文位置Google Scholar
百度学术
万方数据
[11]
Liang W , Cai K , Chen C ,et al. Expert consensus on neoadjuvant immunotherapy for non-small cell lung cancer[J]. Transl Lung Cancer Res, 2020,9(6):2696-2715. DOI: 10.21037/tlcr-2020-63 .
返回引文位置Google Scholar
百度学术
万方数据
[12]
Brandone N , Mascaux C , Caselles K ,et al. Validation of the QR1 antibody for the evaluation of PD-L1 expression in non-small cell lung adenocarcinomas[J]. Appl Immunohistochem Mol Morphol, 2020,28(1):23-29. DOI: 10.1097/PAI.0000000000000758 .
返回引文位置Google Scholar
百度学术
万方数据
[13]
Wang Z , Ying J , Xu J ,et al. Safety, antitumor activity, and pharmacokinetics of toripalimab, a programmed cell death 1 inhibitor, in patients with advanced non-small cell lung cancer: a phase 1 trial[J]. JAMA Netw Open, 2020,3(10):e2013770. DOI: 10.1001/jamanetworkopen.2020.13770 .
返回引文位置Google Scholar
百度学术
万方数据
[14]
Keller MD , Neppl C , Irmak Y ,et al. Adverse prognostic value of PD-L1 expression in primary resected pulmonary squamous cell carcinomas and paired mediastinal lymph node metastases[J]. Mod Pathol, 2018,31(1):101-110. DOI: 10.1038/modpathol.2017.111 .
返回引文位置Google Scholar
百度学术
万方数据
[15]
Rimm DL , Han G , Taube JM ,et al. A prospective, multi-institutional, pathologist-based assessment of 4 immunohistochemistry assays for PD-L1 expression in non-small cell lung cancer[J]. JAMA Oncol, 2017,3(8):1051-1058. DOI: 10.1001/jamaoncol.2017.0013 .
返回引文位置Google Scholar
百度学术
万方数据
[16]
Munari E , Zamboni G , Lunardi G ,et al. PD-L1 expression in non-small cell lung cancer: evaluation of the diagnostic accuracy of a laboratory-developed test using clone E1L3N in comparison with 22C3 and SP263 assays[J]. Hum Pathol, 2019,90:54-59. DOI: 10.1016/j.humpath.2019.05.003 .
返回引文位置Google Scholar
百度学术
万方数据
[17]
李梅,陈龙云,李冬梅,等. 非小细胞肺癌肿瘤细胞不同抗体PD-L1免疫组织化学染色一致性分析[J]. 中华病理学杂志, 2020,49(11):1174-1176. DOI: 10.3760/cma.j.cn112151-20200211-00076
返回引文位置Google Scholar
百度学术
万方数据
[18]
Hastings K , Yu HA , Wei W ,et al. EGFR mutation subtypes and response to immune checkpoint blockade treatment in non-small-cell lung cancer[J]. Ann Oncol, 2019,30(8):1311-1320. DOI: 10.1093/annonc/mdz141 .
返回引文位置Google Scholar
百度学术
万方数据
[19]
Best MG , Wesseling P , Wurdinger T . Tumor-educated platelets as a noninvasive biomarker source for cancer detection and progression monitoring[J]. Cancer Res, 2018,78(13):3407-3412. DOI: 10.1158/0008-5472.CAN-18-0887 .
返回引文位置Google Scholar
百度学术
万方数据
[20]
Planchard D , Besse B , Groen H ,et al. Phase 2 study of dabrafenib plus trametinib in patients with BRAF V600E-mutant metastatic NSCLC: updated 5-year survival rates and genomic analysis[J]. J Thorac Oncol, 2022,17(1):103-115. DOI: 10.1016/j.jtho.2021.08.011 .
返回引文位置Google Scholar
百度学术
万方数据
[21]
Cho BC , Abreu DR , Hussein M ,et al. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study[J]. Lancet Oncol, 2022,23(6):781-792. DOI: 10.1016/S1470-2045(22)00226-1 .
返回引文位置Google Scholar
百度学术
万方数据
[22]
Yang X , Jiang L , Jin Y ,et al. PD-L1 expression in Chinese patients with advanced non-small cell lung cancer (NSCLC): a multi-center retrospective observational study[J]. J Cancer, 2021,12(24):7390-7398. DOI: 10.7150/jca.63003 .
返回引文位置Google Scholar
百度学术
万方数据
[23]
Adam J , Le Stang N , Rouquette I ,et al. Multicenter harmonization study for PD-L1 IHC testing in non-small-cell lung cancer[J]. Ann Oncol, 2018,29(4):953-958. DOI: 10.1093/annonc/mdy014 .
返回引文位置Google Scholar
百度学术
万方数据
[24]
Mino-Kenudson M , Le Stang N , Daigneault JB ,et al. The international association for the study of lung cancer global survey on programmed death-ligand 1 testing for NSCLC[J]. J Thorac Oncol, 2021,16(4):686-696. DOI: 10.1016/j.jtho.2020.12.026 .
返回引文位置Google Scholar
百度学术
万方数据
[25]
国家病理质控中心,中华医学会病理学分会,中国临床肿瘤学会肿瘤病理专家委员会. 实体肿瘤PD-L1免疫组织化学检测专家共识(2021版)[J]. 中华病理学杂志, 2021,50(7):710-718. DOI: 10.3760/cma.j.cn112151-20210228-00172 .
返回引文位置Google Scholar
百度学术
万方数据
[26]
Fernandez AI , Gaule P , Rimm DL . Tissue age affects antigenicity and scoring for the 22C3 immunohistochemistry companion diagnostic test[J]. Mod Pathol, 2023,36(7):100159. DOI: 10.1016/j.modpat.2023.100159 .
返回引文位置Google Scholar
百度学术
万方数据
[27]
Haragan A , Liebler DC , Das DM ,et al. Accelerated instability testing reveals quantitative mass spectrometry overcomes specimen storage limitations associated with PD-L1 immunohistochemistry[J]. Lab Invest, 2020,100(6):874-886. DOI: 10.1038/s41374-019-0366-y .
返回引文位置Google Scholar
百度学术
万方数据
[28]
Forest F , Cote G , Laville D ,et al. Impact of delayed fixation and decalcification on PD-L1 expression: a comparison of two clones[J]. Virchows Arch, 2019,475(6):693-699. DOI: 10.1007/s00428-019-02613-w .
返回引文位置Google Scholar
百度学术
万方数据
[29]
Shen X , Wang Y , Jin Y ,et al. PD-L1 expression in non-small cell lung cancer: heterogeneity by pathologic types, tissue sampling and metastasis[J]. J Thorac Dis, 2021,13(7):4360-4370. DOI: 10.21037/jtd-21-388 .
返回引文位置Google Scholar
百度学术
万方数据
[30]
Hwang DM , Albaqer T , Santiago RC ,et al. Prevalence and heterogeneity of PD-L1 expression by 22C3 assay in routine population-based and reflexive clinical testing in lung cancer[J]. J Thorac Oncol, 2021,16(9):1490-1500. DOI: 10.1016/j.jtho.2021.03.028 .
返回引文位置Google Scholar
百度学术
万方数据
[31]
Pan ZK , Ye F , Wu X ,et al. Clinicopathological and prognostic significance of programmed cell death ligand1 (PD-L1) expression in patients with non-small cell lung cancer: a meta-analysis[J]. J Thorac Dis, 2015,7(3):462-470. DOI: 10.3978/j.issn.2072-1439.2015.02.13 .
返回引文位置Google Scholar
百度学术
万方数据
[32]
Igarashi T , Teramoto K , Ishida M ,et al. Scoring of PD-L1 expression intensity on pulmonary adenocarcinomas and the correlations with clinicopathological factors[J]. ESMO Open, 2016,1(4):e000083. DOI: 10.1136/esmoopen-2016-000083 .
返回引文位置Google Scholar
百度学术
万方数据
[33]
Blichárová A , Tancoš V , Benetinová Z ,et al. Programmed death ligand-1 expression and its association with the degree of differentiation and the presence of necrosis in non-small cell lung carcinoma[J]. Pathol Res Pract, 2023,242:154296. DOI: 10.1016/j.prp.2022.154296 .
返回引文位置Google Scholar
百度学术
万方数据
[34]
Liu LU , Xie B , Zhu W ,et al. High expression of PD-L1 mainly occurs in non-small cell lung cancer patients with squamous cell carcinoma or poor differentiation[J]. Oncol Res, 2023,31(3):275-286. DOI: 10.32604/or.2023.028227 .
返回引文位置Google Scholar
百度学术
万方数据
[35]
Wu J , Sun W , Yang X ,et al. Heterogeneity of programmed death-ligand 1 expression and infiltrating lymphocytes in paired resected primary and metastatic non-small cell lung cancer[J]. Mod Pathol, 2022,35(2):218-227. DOI: 10.1038/s41379-021-00903-w .
返回引文位置Google Scholar
百度学术
万方数据
[36]
Ben Dori S , Aizic A , Sabo E ,et al. Spatial heterogeneity of PD-L1 expression and the risk for misclassification of PD-L1 immunohistochemistry in non-small cell lung cancer[J]. Lung Cancer, 2020,147:91-98. DOI: 10.1016/j.lungcan.2020.07.012 .
返回引文位置Google Scholar
百度学术
万方数据
[37]
Sun W , Yang X , Wang H ,et al. Among multiple needle core biopsy samples, the one with the highest tumor proportion score best represents the PD-L1 status of the whole surgical specimen in non-small cell lung cancer[J]. Appl Immunohistochem Mol Morphol, 2022,30(3):190-196. DOI: 10.1097/PAI.0000000000000985 .
返回引文位置Google Scholar
百度学术
万方数据
[38]
Wu J , Liu C , Liu X ,et al. Artificial intelligence-assisted system for precision diagnosis of PD-L1 expression in non-small cell lung cancer[J]. Mod Pathol, 2022,35(3):403-411. DOI: 10.1038/s41379-021-00904-9 .
返回引文位置Google Scholar
百度学术
万方数据
备注信息
A
林冬梅（北京大学肿瘤医院暨北京市肿瘤防治研究所病理科 恶性肿瘤发病机制及转化研究教育部重点实验室，北京 100142），Email： nc.defudabe.umjb3mdnil
B
应建明（国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院 北京协和医学院肿瘤医院病理科，北京 100021），Email： nc.defcaab.smacicgniymj
C
陆舜（上海市胸科医院 上海交通大学医学院附属胸科医院肿瘤科，上海 200030），Email： nc.defudabe.utjsulnuhs
D
周彩存（同济大学医学院肿瘤研究所 同济大学附属上海市肺科医院肿瘤科，上海 200433），Email： mocdef.3ab61rd_uohznuciac
E

执笔人：杨欣（北京大学肿瘤医院暨北京市肿瘤防治研究所病理科 恶性肿瘤发病机制及转化研究教育部重点实验室，北京 100142）；袁培（国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院 北京协和医学院肿瘤医院病理科，北京 100021）

F
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. DOI: 10.3760/cma.j.cn112151-20230922-00203.
G
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