一项由研究者发起的澳大利亚范围内多中心回顾性观察研究旨在调查非小细胞肺癌 (NSCLC) 中程序性死亡配体 1 (PD-L1) 表达的现实流行率。澳大利亚多个进行 PD-L1 免疫组织化学 (IHC) 的中心受邀参加。 2018 年 1 月 1 日至 2020 年 1 月 1 日期间，对年龄≥18 岁且符合审查资格的人员进行 PD-L1 IHC 测试，并在每个中心鉴定出经组织学证实的任何阶段的 NSCLC，然后进行数据提取和去识别化，之后哪些数据被提交到中央站点进行整理和分析。在来自 6690 项符合条件的 PD-L1 IHC 测试的总数据中，这些测试来自组织学 (75%) 或细胞学 (24%) 证实的任何阶段的 NSCLC，研究对象是中位年龄为 70 岁的人，其中 43% 是女性。大多数 (81%) 的测试是使用 PD-L1 IHC SP263 抗体与 Ventana BenchMark Ultra 平台进行的，19% 的测试是使用 Dako PD-L1 IHC 22C3 pharmDx 检测进行的。报告的 PD-L1 肿瘤比例评分 (TPS) 在 30% 的所有测试中≥50%，其中 62% 和 38% 的 PD-L1 评分≥1% 和 <1%。检查了临床病理特征的相对患病率，PD-L1 评分分为 <50% 和 ≥50%，或 <1% 和 ≥1%。女性得分 ≥1% 的情况略高于男性（分别为 64% 和 61%，p=0.013）。然而，PD-L1 评分≥50% 的性别或年龄组（<70 岁或≥70 岁）之间没有差异。与较低分期 (I/II) 患者的标本相比，较高分期 (III/IV) 患者的样本评分 ≥1% 或 ≥50% 的情况稍多 (p≤0.002)。当 PD-L1 TPS ≥ 1% 时，原发性和转移性样本的比例没有差异，但 TPS ≥ 50% 的转移性样本多于原发性样本（转移性与原发性；34% vs 27%，p<0.001）。细胞学和活检标本的 TPS 得分≥1% 的比例相同，63%，而细胞学样本 TPS ≥50% 的情况略高于活检样本（分别为 34% 和 30%，p=0.004）。据报道，切除标本（测试样本的 16%）TPS 评分≥50% 或 ≥1% 的频率低于活检或细胞学样本（p<0.001）。使用的 PD-L1 IHC 检测中 TPS ≥1% 的测试比例没有差异，但与 SP263 相比，22C3 评分 TPS ≥50% 的测试比例略高（分别为 34% 和 29%） p<0.001）。这些澳大利亚真实世界数据与之前发布的一些全球真实世界数据相当，但也存在一些差异。版权所有 © 2023 作者。由 Elsevier B.V. 出版。保留所有权利。

An investigator-initiated, Australia-wide multi-centre retrospective observational study was undertaken to investigate the real-world prevalence of programmed death ligand-1 (PD-L1) expression in non-small cell lung carcinoma (NSCLC). Multiple centres around Australia performing PD-L1 immunohistochemistry (IHC) were invited to participate. Histologically confirmed NSCLC of any stage with a PD-L1 IHC test performed for persons aged ≥18 years between 1 January 2018 and 1 January 2020, and eligible for review, were identified at each centre, followed by data extraction and de-identification, after which data were submitted to a central site for collation and analysis. In total data from 6690 eligible PD-L1 IHC tests from histologically (75%) or cytologically (24%) confirmed NSCLC of any stage were reviewed from persons with a median age of 70 years, 43% of which were female. The majority (81%) of tests were performed using the PD-L1 IHC SP263 antibody with the Ventana BenchMark Ultra platform and 19% were performed using Dako PD-L1 IHC 22C3 pharmDx assay. Reported PD-L1 tumour proportion score (TPS) was ≥50% for 30% of all tests, with 62% and 38% scoring PD-L1 ≥1% and <1%, respectively. Relative prevalence of clinicopathological features with PD-L1 scores dichotomised to <50% and ≥50%, or to <1% and ≥1%, were examined. Females scored ≥1% slightly more often than males (64% vs 61%, respectively, p=0.013). However, there was no difference between sexes or age groups (<70 or ≥70 years) where PD-L1 scored ≥50%. Specimens from patients with higher stage (III/IV) scored ≥1% or ≥50% marginally more often compared to specimens from patients with lower stage (I/II) (p≤0.002). Proportions of primary and metastatic specimens did not differ where PD-L1 TPS was ≥1%, however more metastatic samples scored TPS ≥50% than primary samples (metastatic vs primary; 34% vs 27%, p<0.001). Cytology and biopsy specimens were equally reported, at 63% of specimens, to score TPS ≥1%, whereas cytology samples scored TPS ≥50% slightly more often than biopsy samples (34% vs 30%, respectively, p=0.004). Resection specimens (16% of samples tested) were reported to score TPS ≥50% or ≥1% less often than either biopsy or cytology samples (p<0.001). There was no difference in the proportion of tests with TPS ≥1% between PD-L1 IHC assays used, however the proportion of tests scored at TPS ≥50% was marginally higher for 22C3 compared to SP263 (34% vs 29%, respectively, p<0.001). These real-world Australian data are comparable to some previously published global real-world data, with some differences noted.Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.