Laboratory of Clinical and Experimental Pathology, Pasteur Hospital, Hospital University Federation OncoAge, Côte d'Azur University, Nice, France.
Institute for Research on Cancer and Aging in Nice (National Institute of Health and Medical Research Unit 1081 and National Center of Scientific Research Joint Research Unit 7284), Côte d'Azur University, Nice, France.
Cancer Cytopathol. 2018 Apr;126(4):264-274. doi: 10.1002/cncy.21977. Epub 2018 Feb 7.
Pembrolizumab monotherapy is a standard-of-care treatment for the first- and second-line treatment of advanced non-small cell lung cancer with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) values ≥ 50% and ≥ 1%, respectively. PD-L1 testing with the PD-L1 immunohistochemistry (IHC) 22C3 pharmDx companion assay has been validated on tumor tissue with the Dako Autostainer Link 48 (ASL48). 22C3 anti-PD-L1 antibody-based laboratory-developed tests (LDTs) compatible with other autostainers and cytology samples are essential to support pembrolizumab treatment decisions across institutions globally.
ASL48 and BenchMark Ultra LDTs were optimized for the evaluation of cytology samples through comparisons with cell lines with known PD-L1 expression levels (strong, moderate, and negative). The PD-L1 TPS was then evaluated for 70 paired biopsy and cytology samples (bronchial washes, n = 40; pleural effusions, n = 30) with these LDTs. Biopsy and cytology LDT TPS values were also compared with a subset of biopsy samples (n = 37) evaluated with the PD-L1 IHC 22C3 pharmDx assay on the ASL48.
Intraclass correlation coefficients of 0.884 to 0.898 were observed for biopsy samples versus cytology samples with the ASL48 and BenchMark Ultra LDTs. Concordance was high, regardless of the TPS cut point (<1% vs ≥ 1% and <50% vs ≥ 50%), sample type (pleural effusion vs bronchial wash), or tumor histology (adenocarcinoma vs squamous cell carcinoma). Concordance was high for each LDT versus the PD-L1 IHC 22C3 pharmDx assay.
ASL48 and BenchMark Ultra 22C3 antibody concentrate-based LDTs have been validated for PD-L1 testing in cytology samples, and they will support reliable, high-quality PD-L1 testing across regions globally. Cancer Cytopathol 2018;126:264-74. © 2018 American Cancer Society.
帕博利珠单抗单药治疗是晚期非小细胞肺癌的标准治疗方法，适用于程序性死亡配体 1（PD-L1）肿瘤比例评分（TPS）分别为≥50%和≥1%的一线和二线治疗。PD-L1 检测采用 PD-L1 免疫组化（IHC）22C3 pharmDx 伴随检测试剂盒，已在 Dako Autostainer Link 48（ASL48）上对肿瘤组织进行了验证。与其他自动染色机和细胞学样本兼容的基于 22C3 抗 PD-L1 抗体的实验室开发检测（LDT）对于在全球范围内支持 pembrolizumab 治疗决策至关重要。
通过与具有已知 PD-L1 表达水平（强、中、阴性）的细胞系进行比较，对 ASL48 和 BenchMark Ultra LDT 进行了优化，以评估细胞学样本。然后，用这些 LDT 对 70 对活检和细胞学样本（支气管冲洗液，n=40；胸腔积液，n=30）进行了 PD-L1 TPS 评估。还将活检和细胞学 LDT TPS 值与用 ASL48 上的 PD-L1 IHC 22C3 pharmDx 检测试剂盒评估的一部分活检样本（n=37）进行了比较。
ASL48 和 BenchMark Ultra LDT 检测活检样本与细胞学样本的组内相关系数为 0.884 至 0.898。无论 TPS 截断值（<1%与≥1%和<50%与≥50%）、样本类型（胸腔积液与支气管冲洗液）或肿瘤组织学（腺癌与鳞状细胞癌）如何，一致性均很高。每种 LDT 与 PD-L1 IHC 22C3 pharmDx 检测试剂盒的一致性均很高。
ASL48 和 BenchMark Ultra 22C3 抗体浓缩物 LDT 已通过验证，可用于细胞学样本中的 PD-L1 检测，这将支持全球各地区可靠、高质量的 PD-L1 检测。癌症细胞病理学 2018；126：264-74。©2018 美国癌症协会。
