一项多中心研究中四种程序性死亡受体配体1（PD-L1）免疫组织化学检测方法与22C3基因检测法在食管鳞状细胞癌中的一致性
Concordance between four PD-L1 immunohistochemical assays and 22C3 pharmDx assay in esophageal squamous cell carcinoma in a multicenter study.
作者信息
Xue Liyan, Li Yuan, Jiang Lili, Liu Chao, Cheng Na, Guo Changyuan, Jin Yan, Zhou Ping, Xue Xuemin, Wang Yue, Wang Weiya, Liu Yanhui, Ying Jianming
机构信息
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, China.
Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai, China.
出版信息
J Natl Cancer Cent. 2023 Nov 30;4(2):162-168. doi: 10.1016/j.jncc.2023.11.003. eCollection 2024 Jun.
BACKGROUND
The prediction of response to immunotherapy mostly depends on the programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) status, and the 22C3 pharmDx assay has been approved in esophageal squamous cell carcinoma (ESCC). However, the widespread use of the 22C3 pharmDx assay is limited due to its availability. Thus, alternative PD-L1 assays are needed. We aimed to investigate the analytical and clinical diagnostic performances of four PD-L1 assays and to compare their concordances with the 22C3 pharmDx assay.
METHODS
The PD-L1 22C3 pharmDx assay was performed on the Dako Autostainer Link 48 platform, three testing assays (PD-L1 E1L3N XP antibody [Ab], PD-L1 BP6099 Ab and PD-L1 CST E1L3N Ab) on the Leica BOND-MAX/III platform, and one testing assay (PD-L1 MXR006 Ab) on the Roche VENTANA Benchmark Ultra platform. A total of 218 ESCC cases from four centers were included in this retrospective study. Professionals from each center stained and read the IHC slides independently and determined the combined positive score (CPS) and the tumor proportion score (TPS).
RESULTS
Regarding analytical performance, the four testing assays demonstrated good correlations with the 22C3 pharmDx assay when evaluated by the TPS or CPS (ρ > 0.8 for all four assays). Regarding diagnostic performance (CPS ≥ 10 was used as the cutoff), the four testing assays showed moderate concordances with the 22C3 pharmDx assay (kappa > 0.7 for all four assays). The overall percent agreements between each testing assay and the 22C3 pharmDx assay was at least 87.2 %.
CONCLUSION
This study provides insight into the potential interchangeability of the four PD-L1 assays with the 22C3 pharmDx assay.
背景
免疫治疗反应的预测主要取决于程序性死亡配体1（PD-L1）免疫组化（IHC）状态，22C3药物诊断检测法已在食管鳞状细胞癌（ESCC）中获得批准。然而，由于其可用性，22C3药物诊断检测法的广泛应用受到限制。因此，需要替代的PD-L1检测方法。我们旨在研究四种PD-L1检测方法的分析和临床诊断性能，并比较它们与22C3药物诊断检测法的一致性。
方法
在Dako Autostainer Link 48平台上进行PD-L1 22C3药物诊断检测，在Leica BOND-MAX/III平台上进行三种检测方法（PD-L1 E1L3N XP抗体[Ab]、PD-L1 BP6099 Ab和PD-L1 CST E1L3N Ab），在Roche VENTANA Benchmark Ultra平台上进行一种检测方法（PD-L1 MXR006 Ab）。本回顾性研究共纳入来自四个中心的218例ESCC病例。每个中心的专业人员独立对免疫组化切片进行染色和判读，并确定联合阳性评分（CPS）和肿瘤比例评分（TPS）。
结果
在分析性能方面，当通过TPS或CPS评估时，四种检测方法与22C3药物诊断检测法显示出良好的相关性（所有四种检测方法的ρ>0.8）。在诊断性能方面（以CPS≥10为临界值），四种检测方法与22C3药物诊断检测法显示出中等一致性（所有四种检测方法的kappa>0.7）。每种检测方法与22C3药物诊断检测法之间的总体一致率至少为87.2%。
结论
本研究为四种PD-L1检测方法与22C3药物诊断检测法的潜在互换性提供了见解。
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