Comparison of Four PD-L1 Immunohistochemical Assays in Lung Cancer
Comparison of Four PD-L1 Immunohistochemical Assays in Lung Cancer
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DOI：
10.1016/j.jtho.2017.11.112
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发表时间：
2018-03-01
影响因子：
20.4
通讯作者：
Fox, Stephen B.
中科院分区：
文献类型：
--
作者：
Hendry, Shona;Byrne, David J.;Fox, Stephen B.
简介：四种不同的程序性死亡配体1免疫组织化学检测已被批准或正在开发中，作为肺癌中不同免疫抑制剂的伴随或补充诊断。我们试图确定这些检测方法在技术上是否等效，以及一种抗体是否可用于替代染色平台。方法：在Dako Link 48平台上对从368例切除的肺癌构建的组织微阵列的连续切片进行22 C3和28-8染色（Dako，Carpinteria，Ca）以及在Ventana Benchmark Ultra平台（Ventana Medical Systems，Tucson，AZ）上的SP142和SP263。结果：在四种测定法之间观察到平均肿瘤细胞和免疫细胞染色的差异（p < 0.001）。22 C3和28-8之间的差异无统计学显著性。肿瘤细胞评分的一致性良好（组内相关系数[ICC] = 0.674），特别是当排除SP142作为离群值时（ICC = 0.755）。22 C3和28-8之间的一致性最高（ICC = 0.812）。免疫细胞染色的一致性较差（ICC = 0.212）。当根据临床相关临界值进行二分时，成对比较显示出较差至中度一致性（kappa = 0.196-0.578），阳性一致性百分比范围为15.1%至90.0%。22 C3抗体在Dako Link 48平台和替代Ventana Benchmark Ultra平台上进行了重复检测（ICC = 0.921，kappa = 0.897）。结论：当按照预期进行和评分时，四种程序性死亡配体1免疫组织化学检测之间的一致性表明，除28-8和22 C3外，它们在临床实践中不能互换使用。已成功制定了一项在替代平台上使用22 C3的协议，这可能有助于克服执行方面的一些障碍。(C)2017年国际肺癌研究协会。爱思唯尔公司出版All rights reserved.
Introduction: Four different programmed death ligand 1 immunohistochemical assays are approved or in development as companion or complementary diagnostics to different immunotherapeutic agents in lung carcinoma. We sought to determine whether these assays are technically equivalent and whether one antibody can be used on an alternate staining platform.Methods: Serial sections of tissue microarrays constructed from 368 cases of resected lung cancer were stained for 22C3 and 28-8 on the Dako Link 48 platform(Dako, Carpinteria, Ca) and for SP142 and SP263 on the Ventana Benchmark Ultra platform(Ventana Medical Systems, Tucson, AZ) strictly as per product insert. A protocol was developed to use the 22C3 antibody on the Ventana Benchmark Ultra platform.Results: Differences in mean tumor cell and immune cell staining were observed between the four assays (p < 0.001). Differences between 22C3 and 28-8 were not statistically significant. Concordance of tumor cell scores was good (intraclass correlation coefficient [ICC] = 0.674), particularly when SP142 was excluded as an outlier (ICC = 0.755). The highest concordance was seen between 22C3 and 28-8 (ICC = 0.812). Concordance was poor for immune cell staining (ICC = 0.212). When dichotomized according to clinically relevant cutoffs, pairwise comparisons showed poor to moderate concordance (kappa = 0.196-0.578), with positive percent agreement ranging from 15.1% to 90.0%. The 22C3 antibody performed comparably on the Dako Link 48 platform and the alternate Ventana Benchmark Ultra platform (ICC = 0.921, kappa = 0.897).Conclusions: Concordance between the four programmed death ligand 1 immunohistochemical assays when performed and scored as intended show that apart from 28-8 and 22C3, they cannot be used interchangeably in clinical practice. A protocol was successfully developed to use 22C3 on an alternate platform, which may help to overcome some barriers to implementation. (C) 2017 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.