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Inter-observer Reliability of Programmed Cell Death Ligand-1 Scoring Using the VENTANA PD-L1 (SP263) Assay in Non-Small Cell Lung Cancer
Journal of Thoracic Oncology ( IF 21.0 ) Pub Date : 2020-04-01 , DOI: 10.1016/j.jtho.2019.11.010
Gareth H Williams 1 , Andrew G Nicholson 2 , David R J Snead 3 , Erik Thunnissen 4 , Sylvie Lantuejoul 5 , Paul Cane 6 , Keith M Kerr 7 , Marco Loddo 1 , Marietta L J Scott 8 , Paul W Scorer 8 , Craig Barker 8
Affiliation  

INTRODUCTION The VENTANA PD-L1 (SP263) Assay is approved for use with anti-programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) therapies in non-small cell lung cancer (NSCLC) and urothelial carcinoma. Here, we investigate inter-observer reliability of the SP263 assay, applied to PD-L1 scoring of tumor cells (TCs) in NSCLC. METHODS Six practicing European pulmonary pathologists independently scored the proportion of TCs expressing PD-L1 (TC score) from 200 archival, commercially sourced, formalin-fixed paraffin-embedded NSCLC resections stained using the SP263 assay. Agreement in scores was analyzed using the intra-class correlation coefficient (ICC) and concordance in patient classification using Fleiss' kappa. RESULTS Results from 172 samples showed strong pair-wise correlations between pathologists (R2 >0.89) for TC scoring with an ICC of 0.96. Overall agreement was >90% for TC ≥1% and >94% for TC ≥25% and ≥50%. Fleiss' kappa showed substantial agreement for TC ≥1% and almost perfect agreement for TC ≥25% and ≥50%. CONCLUSIONS Assessment of TC score in NSCLC was highly reproducible using the SP263 assay, building confidence in the accuracy of this assay in patient selection for anti-PD-1/PD-L1 therapy.

中文翻译:

在非小细胞肺癌中使用 VENTANA PD-L1 (SP263) 检测程序进行细胞死亡配体 1 评分的观察者间可靠性

简介 VENTANA PD-L1 (SP263) 检测被批准与抗程序性细胞死亡-1/程序性细胞死亡配体-1 (PD-1/PD-L1) 疗法一起用于非小细胞肺癌 (NSCLC) 和尿路上皮癌。在这里,我们研究了 SP263 检测的观察者间可靠性,该检测适用于 NSCLC 中肿瘤细胞 (TC) 的 PD-L1 评分。方法 六名执业的欧洲肺部病理学家独立对 200 份使用 SP263 检测染色的商业来源的福尔马林固定石蜡包埋 NSCLC 切除标本中表达 PD-L1 的 TC 比例(TC 评分)进行评分。使用类内相关系数 (ICC) 和使用 Fleiss 的 kappa 进行患者分类的一致性分析分数的一致性。结果 172 个样本的结果显示病理学家之间存在很强的成对相关性(R2 > 0. 89)用于 TC 评分,ICC 为 0.96。TC ≥ 1% 的总体一致性> 90%,TC ≥ 25% 和 ≥ 50% 的总体一致性> 94%。Fleiss 的 kappa 在 TC ≥ 1% 时显示出基本一致,在 TC ≥25% 和 ≥50% 时几乎完全一致。结论 使用 SP263 测定法对 NSCLC 中 TC 评分的评估具有高度可重复性,从而建立了对该测定法在抗 PD-1/PD-L1 治疗的患者选择中的准确性的信心。
更新日期:2020-04-01
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