Bristol Myers Squibb, Princeton, New Jersey, USA.
Bristol Myers Squibb, Princeton, New Jersey, USA
J Clin Pathol. 2020 Oct;73(10):656-664. doi: 10.1136/jclinpath-2020-206466. Epub 2020 Jun 26.
Programmed death-1/programmed death ligand 1 (PD-1/PD-L1) inhibitor therapy is accompanied by companion or complementary PD-L1 testing in some tumour types. We investigated utilisation of the Dako PD-L1 IHC 28-8 and 22C3 pharmDx assays and the Ventana PD-L1 (SP142) assay and evaluated concordance between the 28-8 and 22C3 assays in a real-world cohort of patients tested at a single US national reference laboratory.
NeoGenomics Laboratories performed PD-L1 testing on tumour samples between October 2015 and March 2018. PD-L1 test results were matched with patient characteristics using unique identifiers. Concordance between the 28-8 and 22C3 assays was evaluated in matched tumour samples. Data were evaluated across multiple tumour types and in subgroups of patients with lung cancer, melanoma, squamous cell carcinoma of the head and neck, and urothelial carcinoma.
62 180 individual PD-L1 tests were conducted on samples from 55 652 patients. PD-L1 test volume increased ~10-fold over the period evaluated. Test failure rates were typically low, and test turnaround time (TAT) ranged between 2 and 4 days. Concordance between the 28-8 and 22C3 assays was strong in the overall population and across tumour type subgroups (Kendall's tau correlations of 0.94 and 0.92-0.98, respectively).
Test failure rates for PD-L1 tests were low and TAT remained reasonable despite marked increases in test volume. Concordance was high between the 28-8 and 22C3 assays across a range of tumour types and biopsy locations. These findings add to the literature showing high concordance between the 28-8 and 22C3 assays.
在某些肿瘤类型中，程序性死亡受体-1/程序性死亡配体 1（PD-1/PD-L1）抑制剂治疗伴随着伴随或互补的 PD-L1 检测。我们研究了在单一美国国家参考实验室检测的真实世界患者队列中，Dako PD-L1 IHC 28-8 和 22C3 pharmDx 检测以及 Ventana PD-L1（SP142）检测的应用，并评估了 28-8 和 22C3 检测之间的一致性。
NeoGenomics Laboratories 于 2015 年 10 月至 2018 年 3 月期间对肿瘤样本进行 PD-L1 检测。使用唯一标识符将 PD-L1 检测结果与患者特征相匹配。在匹配的肿瘤样本中评估 28-8 和 22C3 检测之间的一致性。对多种肿瘤类型和肺癌、黑色素瘤、头颈部鳞状细胞癌和膀胱癌患者亚组的数据进行了评估。
对 55652 名患者的 62180 个单独 PD-L1 检测进行了检测。在评估期间，PD-L1 检测量增加了约 10 倍。测试失败率通常较低，测试周转时间（TAT）在 2 至 4 天之间。在总体人群和肿瘤类型亚组中，28-8 和 22C3 检测之间具有很强的一致性（Kendall's tau 相关性分别为 0.94 和 0.92-0.98）。
尽管 PD-L1 检测量显著增加，但检测失败率仍然较低，TAT 仍然合理。在一系列肿瘤类型和活检部位，28-8 和 22C3 检测之间具有高度一致性。这些发现增加了文献中关于 28-8 和 22C3 检测之间高度一致性的证据。
