Introduction: Nivolumab has demonstrated efficacy against metastatic NSCLC. Four programmed cell death ligand 1 (PD‐L1) immunohistochemistry (IHC) assay systems are available for identification of responders among patients with NSCLC, and these assays show some differing characteristics. Accordingly, in this study, we evaluated the ability of these assays to identify responders to nivolumab therapy. Methods: We retrospectively analyzed patients with previously treated advanced NSCLC, who received nivolumab between January 2016 and September 2016. Specimens were stained using four PD‐L1 IHC assays (28‐8, 22C3, SP142, and SP263). We classified patients as having test results that were strongly positive (tumor proportion score [TPS] ≥50%), weakly positive (TPS 1%–49%), or negative (TPS <1%). Results: A total of 40 patients with NSCLC and their specimens were analyzed. Analytical comparisons demonstrated good concordance of PD‐L1–stained tumor cells among the 28‐8, 22C3, and SP263 assays (weighted &kgr; coefficient 0.64–0.71), whereas the SP142 assay showed lower concordance with other assays (weighted &kgr; coefficient 0.39–0.55). Progression‐free survival in patients showing strongly positive PD‐L1 staining classified by 28‐8, 22C3, and SP263 assays was significantly longer than that in patients with a negative result for PD‐L1 staining. Predictive performance of response to nivolumab, as assessed by receiver operating characteristic analysis, was also equivalent among the 28‐8, 22C3, and SP263 assays (area under the curve 0.75–0.82), whereas the SP142 assay exhibited lower predictive performance (area under the curve 0.68). Conclusions: The 28‐8, 22C3, and SP263 PD‐L1 IHC assays showed equivalent predictive performance, whereas the SP142 assay showed lower predictive performance.

中文翻译：

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四种程序性细胞死亡配体 1 检测系统对既往治疗过的非小细胞肺癌患者 nivolumab 反应的预测性能

简介：纳武单抗已证明对转移性非小细胞肺癌有效。四种程序性细胞死亡配体 1 (PD-L1) 免疫组织化学 (IHC) 检测系统可用于识别 NSCLC 患者中的反应者，这些检测显示出一些不同的特征。因此，在本研究中，我们评估了这些检测确定纳武单抗治疗反应者的能力。方法：我们回顾性分析了 2016 年 1 月至 2016 年 9 月期间接受纳武单抗治疗的既往接受过治疗的晚期 NSCLC 患者。使用四种 PD-L1 IHC 检测（28-8、22C3、SP142 和 SP263）对样本进行染色。我们将测试结果分为强阳性（肿瘤比例评分 [TPS] ≥ 50%）、弱阳性（TPS 1%–49%）或阴性（TPS <1%）的患者。结果：共分析了 40 名 NSCLC 患者及其标本。分析比较表明 PD-L1 染色的肿瘤细胞在 28-8、22C3 和 SP263 检测中具有良好的一致性（加权 &kgr; 系数 0.64-0.71），而 SP142 检测显示与其他检测的一致性较低（加权 &kgr; 系数 0.39 –0.55)。根据 28-8、22C3 和 SP263 检测显示强阳性 PD-L1 染色的患者的无进展生存期显着长于 PD-L1 染色阴性结果的患者。根据受试者操作特征分析评估，纳武单抗反应的预测性能在 28-8、22C3 和 SP263 检测中也相当（曲线下面积 0.75-0.82），而 SP142 检测显示出较低的预测性能（下面积曲线 0.68)。