Guerini Rocco Elena, Eccher Albino, Girolami Ilaria, Graziano Paolo, Fontanini Gabriella, Vigliar Elena, Troncone Giancarlo, Barberis Massimo, Morbini Patrizia, Martini Maurizio
Division of Pathology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Department of Oncology and Hemato-Oncology, University of Milan, 20141 Milan, Italy.
Diagnostics (Basel). 2022 Feb 13;12(2):477. doi: 10.3390/diagnostics12020477.
The introduction of immunotherapy targeting the programmed death-1 (PD-1)/programmed death-ligand-1 (PD-L1) axis has represented a turning point in the treatment of HNSCC. Harmonization studies comparing the different antibodies and immunohistochemistry platforms available for the evaluation of PD-L1 expression with Combined Positive Score (CPS) in HNSCC are strongly required. Tissue microarrays (TMA) constructed from formalin-fixed, paraffin-embedded (FFPE) tissue blocks of HNSCC tumor were stained with two commercial in-vitro diagnostic (IVD) PD-L1 immunohistochemical assays (22C3 pharmDx on Autostainer Link48 and Omnis platforms, and SP263) and were reviewed by seven trained pathologists to assess CPS. We found a very similar distribution for PD-L1 expression between 22C3 pharmDx assay with both platforms and SP263 assay and a strong significant correlation between the two assays in different platforms ( < 0.0001). The interobserver reliability among pathologists for the continuous scores of CPS with intraclass correlation coefficient (ICC) and the correlation between the two assays were both good. Moreover, the agreement rate between assays was high at all cut-offs, while the kappa values were from substantial to almost perfect. These data suggest the interchangeability of the two antibodies and of the different immunohistochemical platforms in the selection of patients with HNSCC for immunotherapy.
引入针对程序性死亡蛋白1（PD-1）/程序性死亡配体1（PD-L1）轴的免疫疗法代表了头颈部鳞状细胞癌（HNSCC）治疗的一个转折点。强烈需要进行协调研究，比较可用于通过联合阳性评分（CPS）评估HNSCC中PD-L1表达的不同抗体和免疫组织化学平台。用两种商业体外诊断（IVD）PD-L1免疫组织化学检测方法（在Autostainer Link48和Omnis平台上的22C3 pharmDx以及SP263）对由HNSCC肿瘤的福尔马林固定、石蜡包埋（FFPE）组织块构建的组织微阵列（TMA）进行染色，并由七名经过培训的病理学家进行评估以确定CPS。我们发现22C3 pharmDx检测在两个平台上与SP263检测之间的PD-L1表达分布非常相似，并且不同平台上的两种检测之间存在很强的显著相关性（<0.0001）。病理学家之间对于CPS连续评分的观察者间可靠性（组内相关系数[ICC]）以及两种检测之间的相关性都很好。此外，在所有临界值下检测之间的一致率都很高，而kappa值从实质性一致到几乎完美一致。这些数据表明在选择HNSCC患者进行免疫治疗时，这两种抗体以及不同免疫组织化学平台具有互换性。
