PD-L1 免疫组织化学在真实临床样本中的可比性研究：Blueprint 阶段 2 项目的结果。
PD-L1 Immunohistochemistry Comparability Study in Real-Life Clinical Samples: Results of Blueprint Phase 2 Project.
机构信息
Department of Pathology, University Health Network/Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
Department of Pathology, Aberdeen Royal Infirmary, Aberdeen University Medical School, Aberdeen, Scotland, United Kingdom.
出版信息
J Thorac Oncol. 2018 Sep;13(9):1302-1311. doi: 10.1016/j.jtho.2018.05.013. Epub 2018 May 22.
OBJECTIVES
The Blueprint (BP) Programmed Death Ligand 1 (PD-L1) Immunohistochemistry Comparability Project is a pivotal academic/professional society and industrial collaboration to assess the feasibility of harmonizing the clinical use of five independently developed commercial PD-L1 immunohistochemistry assays. The goal of BP phase 2 (BP2) was to validate the results obtained in BP phase 1 by using real-world clinical lung cancer samples.
METHODS
BP2 were conducted using 81 lung cancer specimens of various histological and sample types, stained with all five trial-validated PD-L1 assays (22C3, 28-8, SP142, SP263, and 73-10); the slides were evaluated by an international panel of pathologists. BP2 also assessed the reliability of PD-L1 scoring by using digital images, and samples prepared for cytological examination. PD-L1 expression was assessed for percentage (tumor proportional score) of tumor cell (TC) and immune cell areas showing PD-L1 staining, with TCs scored continuously or categorically with the cutoffs used in checkpoint inhibitor trials.
RESULTS
The BP2 results showed highly comparable staining by the 22C3, 28-8 and SP263 assays; less sensitivity with the SP142 assay; and higher sensitivity with the 73-10 assay to detect PD-L1 expression on TCs. Glass slide and digital image scorings were highly concordant (Pearson correlation >0.96). There was very strong reliability among pathologists in TC PD-L1 scoring with all assays (overall intraclass correlation coefficient [ICC] = 0.86-0.93), poor reliability in IC PD-L1 scoring (overall ICC = 0.18-0.19), and good agreement in assessing PD-L1 status on cytological cell block materials (ICC = 0.78-0.85).
CONCLUSION
BP2 consolidates the analytical evidence for interchangeability of the 22C3, 28-8, and SP263 assays and lower sensitivity of the SP142 assay for determining tumor proportion score on TCs and demonstrates greater sensitivity of the 73-10 assay compared with that of the other assays.
目的
Blueprint (BP) 程序性死亡配体 1 (PD-L1) 免疫组织化学可比性项目是一项重要的学术/专业协会和工业合作项目，旨在评估协调五种独立开发的商业 PD-L1 免疫组织化学检测方法临床应用的可行性。BP 阶段 2 (BP2) 的目标是使用各种组织学和样本类型的 81 个肺癌标本验证 BP 阶段 1 获得的结果。
方法
使用所有五种经过试验验证的 PD-L1 检测方法（22C3、28-8、SP142、SP263 和 73-10）对 81 个肺癌标本进行 BP2 检测；国际病理学家小组对切片进行评估。BP2 还评估了使用数字图像和为细胞学检查制备的样本进行 PD-L1 评分的可靠性。PD-L1 表达通过肿瘤细胞 (TC) 和显示 PD-L1 染色的免疫细胞区域的百分比（肿瘤比例评分）进行评估，TC 连续评分或使用免疫检查点抑制剂试验中使用的截定点进行分类评分。
结果
BP2 结果显示 22C3、28-8 和 SP263 检测方法的染色高度可比；SP142 检测方法的敏感性较低；73-10 检测方法对 TC 上 PD-L1 表达的敏感性较高。玻璃载玻片和数字图像评分高度一致（Pearson 相关系数>0.96）。所有检测方法中，病理学家在 TC PD-L1 评分方面具有非常强的可靠性（总体组内相关系数 [ICC]为 0.86-0.93），在 IC PD-L1 评分方面可靠性较差（总体 ICC 为 0.18-0.19），在评估细胞学细胞块材料上的 PD-L1 状态方面具有良好的一致性（ICC 为 0.78-0.85）。
结论
BP2 巩固了 22C3、28-8 和 SP263 检测方法的可互换性的分析证据，以及 SP142 检测方法在确定 TC 肿瘤比例评分方面的敏感性较低，并表明 73-10 检测方法与其他检测方法相比具有更高的敏感性。
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