BACKGROUND Programmed cell death ligand-1 (PD-L1) expression on tumor cells (TCs) is associated with improved survival in patients with head and neck squamous cell carcinoma (HNSCC) treated with immunotherapy, although its role as a prognostic factor is controversial. This study investigates whether tumoral expression of PD-L1 is a prognostic marker in patients with recurrent and/or metastatic (R/M) HNSCC treated with standard chemotherapy. METHODS This retrospective, multicenter, noninterventional study assessed PD-L1 expression on archival R/M HNSCC tissue samples using the VENTANA PD-L1 (SP263) Assay. PD-L1 high was defined as PD-L1 staining of ≥ 25% TC, with exploratory scoring at TC ≥ 10% and TC ≥ 50%. The primary objective of this study was to estimate the prognostic value of PD-L1 status in terms of overall survival (OS) in patients with R/M HNSCC. RESULTS 412 patients (median age, 62.0 years; 79.9% male; 88.2% Caucasian) were included from 19 sites in seven countries. 132 patients (32.0%) had TC ≥ 25% PD-L1 expression; 199 patients (48.3%) and 85 patients (20.6%) had TC ≥ 10% and ≥ 50%, respectively. OS did not differ significantly across PD-L1 expression (at TC ≥ 25% cutoff median OS: 8.2 months vs TC < 25%, 10.1 months, P = 0.55) or the ≥ 10% and ≥ 50% cutoffs (at TC ≥ 10%, median OS: 9.6 months vs TC < 10%, 9.4 months, P = 0.32, and at TC ≥ 50%, median OS 7.9 vs TC < 50%, 10.0 months, P = 0.39, respectively). CONCLUSIONS PD-L1 expression, assessed using the VENTANA PD-L1 (SP263) Assay, was not prognostic of OS in patients with R/M HNSCC treated with standard of care chemotherapies. Trial registration ClinicalTrials.gov, NCT02543476. Registered September 4, 2015.

中文翻译：

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SUPREME-HN：一项回顾性生物标志物研究，评估PD-L1表达在头颈部复发和/或转移性鳞状细胞癌患者中的预后价值。

背景技术尽管通过免疫程序治疗的头颈鳞状细胞癌（HNSCC）作为预后因素，但肿瘤细胞（TCs）上的程序性细胞死亡配体-1（PD-L1）表达与存活率提高有关。这项研究调查了PD-L1的肿瘤表达是否为标准化疗治疗的复发和/或转移性（R / M）HNSCC患者的预后标志物。方法采用VENTANA PD-L1（SP263）分析方法对这项回顾性，多中心，非干预性研究评估了档案R / M HNSCC组织样品中PD-L1的表达。PD-L1高被定义为TC≥25％的PD-L1染色，在TC≥10％和TC≥50％时进行探索性评分。这项研究的主要目的是根据R / M HNSCC患者的总生存期（OS）评估PD-L1状态的预后价值。结果来自七个国家19个地区的412例患者（中位年龄为62.0岁；男性为79.9％；白种人为88.2％）。132例（32.0％）的TC≥25％PD-L1表达; TC≥10％和≥50％的患者分别为199例（48.3％）和85例（20.6％）。OS在PD-L1表达之间无显着差异（TC≥25％截止中值OS：8.2个月vs TC <25％，10.1个月，P = 0.55）或≥10％和≥50％截止（TC≥10 ％，中位OS​​：9.6个月vs TC <10％，9.4个月，P = 0.32，在TC≥50％时，中位OS​​ 7.9 vs TC <50％，10.0个月，P = 0.39）。结论使用VENTANA PD-L1（SP263）分析评估了PD-L1表达，经标准护理化学疗法治疗的R / M HNSCC患者不能预后OS。试用注册ClinicalTrials.gov，NCT02543476。2015年9月4日注册。