SP142 programmed cell death ligand 1 (PD-L1) status predicts response to atezolizumab in triple-negative breast carcinoma (TNBC). Prevalence of VENTANA PD-L1 (SP142) Assay positivity, concordance with the VENTANA PD-L1 (SP263) Assay and Dako PD-L1 IHC 22C3 pharmDx assay, and association with clinicopathologic features were assessed in 447 TNBCs. SP142 PD-L1 intraobserver and interobserver agreement was investigated in a subset of 60 TNBCs, with scores enriched around the 1% cutoff. The effect of a 1-hour training video on pretraining and posttraining scores was ascertained. At a 1% cutoff, 34.2% of tumors were SP142 PD-L1 positive. SP142 PD-L1 positivity was significantly associated with tumor-infiltrating lymphocytes (P <0.01), and node negativity (P=0.02), but not with tumor grade (P=0.35), tumor size (P=0.58), or BRCA mutation (P=0.53). Overall percentage agreement (OPA) for intraobserver and interobserver agreement was 95.0% and 93.7%, respectively, among 5 pathologists trained in TNBC SP142 PD-L1 scoring. In 5 TNBC SP142 PD-L1-naive pathologists, significantly higher OPA to the reference score was achieved after video training (posttraining OPA 85.7%, pretraining OPA 81.5%, P<0.05). PD-L1 status at a 1% cutoff was assessed by SP142 and SP263 in 420 cases, and by SP142 and 22C3 in 423 cases, with OPA of 88.1% and 85.8%, respectively. The VENTANA PD-L1 (SP142) Assay is reproducible for classifying TNBC PD-L1 status by trained observers; however, it is not analytically equivalent to the VENTANA PD-L1 (SP263) Assay and Dako PD-L1 IHC 22C3 pharmDx assay.

中文翻译：

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SP142 PD-L1 评分显示在三阴性乳腺癌中观察者间和观察者内的一致性较高，但与其他 PD-L1 克隆 SP263 和 22C3 的总体一致性百分比较低。


SP142 程序性细胞死亡配体 1 (PD-L1) 状态可预测三阴性乳腺癌 (TNBC) 对 atezolizumab 的反应。在 447 例 TNBC 中评估了 VENTANA PD-L1 (SP142) 检测阳性的患病率、与 VENTANA PD-L1 (SP263) 检测和 Dako PD-L1 IHC 22C3 pharmDx 检测的一致性以及与临床病理特征的关联。在 60 个 TNBC 的子集中研究了 SP142 PD-L1 观察者内和观察者间一致性，得分在 1% 的截止点附近丰富。确定了 1 小时训练视频对训练前和训练后分数的影响。以 1% 为截止值，34.2% 的肿瘤呈 SP142 PD-L1 阳性。 SP142 PD-L1 阳性与肿瘤浸润淋巴细胞 (P <0.01) 和淋巴结阴性 (P=0.02) 显着相关，但与肿瘤分级 (P=0.35)、肿瘤大小 (P=0.58) 或 BRCA 突变无关（P=0.53）。在接受过 TNBC SP142 PD-L1 评分培训的 5 名病理学家中，观察者内和观察者间一致性的总体百分比一致性 (OPA) 分别为 95.0% 和 93.7%。在 5 名未接触过 TNBC SP142 PD-L1 的病理学家中，视频训练后 OPA 显着高于参考分数（训练后 OPA 85.7%，训练前 OPA 81.5%，P<0.05）。在 420 例病例中通过 SP142 和 SP263 评估了 1% 截止点的 PD-L1 状态，在 423 例病例中通过 SP142 和 22C3 进行了评估，OPA 分别为 88.1% 和 85.8%。 VENTANA PD-L1 (SP142) 检测可重复，由训练有素的观察者对 TNBC PD-L1 状态进行分类；然而，它在分析上并不等同于 VENTANA PD-L1 (SP263) 检测和 Dako PD-L1 IHC 22C3 pharmDx 检测。