在全国范围内的非小细胞肺癌患者队列中，PD-L1 阳性存在显著的实验室间差异。
Considerable interlaboratory variation in PD-L1 positivity in a nationwide cohort of non-small cell lung cancer patients.
机构信息
Department of Pathology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.
PALGA Foundation, De Bouw 123, 3991 SZ, Houten, the Netherlands.
出版信息
Lung Cancer. 2021 Sep;159:117-126. doi: 10.1016/j.lungcan.2021.07.012. Epub 2021 Jul 22.
OBJECTIVES
Immunohistochemical expression of programmed death-ligand 1 (PD-L1) is used as a predictive biomarker for prescription of immunotherapy to non-small cell lung cancer (NSCLC) patients. Accurate assessment of PD-L1 expression is therefore crucial. In this study, the extent of interlaboratory variation in PD-L1 positivity in the Netherlands was assessed, using real-world clinical pathology data.
MATERIALS AND METHODS
Data on all NSCLC patients in the Netherlands with a mention of PD-L1 testing in their pathology report from July 2017 to December 2018 were extracted from PALGA, the nationwide network and registry of histo- and cytopathology in the Netherlands. PD-L1 positivity rates were determined for each laboratory that performed PD-L1 testing, with separate analyses for histological and cytological material. Two cutoffs (1% and 50%) were used to determine PD-L1 positivity. Differences between laboratories were assessed using funnel plots with 95% confidence limits around the overall mean.
RESULTS
6,354 patients from 30 laboratories were included in the analysis of histology data. At the 1% cutoff, maximum interlaboratory variation was 39.1% (32.7%-71.8%) and ten laboratories (33.3%) differed significantly from the mean. Using the 50% cutoff, four laboratories (13.3%) differed significantly from the mean and maximum variation was 23.1% (17.2%-40.3%). In the analysis of cytology data, 1,868 patients from 23 laboratories were included. Eight laboratories (34.8%) differed significantly from the mean in the analyses of both cutoffs. Maximum variation was 41.2% (32.2%-73.4%) and 29.2% (14.7%-43.9%) using the 1% and 50% cutoffs, respectively.
CONCLUSION
Considerable interlaboratory variation in PD-L1 positivity was observed. Variation was largest using the 1% cutoff. At the 50% cutoff, analysis of cytology data demonstrated a higher degree of variation than the analysis of histology data.
目的
程序性死亡配体 1（PD-L1）的免疫组化表达被用作预测非小细胞肺癌（NSCLC）患者免疫治疗处方的生物标志物。因此，准确评估 PD-L1 表达至关重要。在这项研究中，使用真实世界的临床病理学数据评估了荷兰实验室间 PD-L1 阳性率的差异程度。
材料和方法
从荷兰全国组织病理学和细胞学网络和注册中心 PALGA 中提取了 2017 年 7 月至 2018 年 12 月所有在病理学报告中提及 PD-L1 检测的荷兰 NSCLC 患者的数据。为每个进行 PD-L1 检测的实验室确定了 PD-L1 阳性率，并分别对组织学和细胞学材料进行了分析。使用 1%和 50%两个截断值来确定 PD-L1 阳性。使用带有 95%置信区间的漏斗图评估实验室间的差异。
结果
在组织学数据分析中，纳入了来自 30 个实验室的 6354 名患者。在 1%的截断值下，最大实验室间差异为 39.1%（32.7%-71.8%），10 个实验室（33.3%）与平均值差异显著。使用 50%的截断值，四个实验室（13.3%）与平均值差异显著，最大差异为 23.1%（17.2%-40.3%）。在细胞学数据分析中，纳入了来自 23 个实验室的 1868 名患者。在两个截断值的分析中，有 8 个实验室（34.8%）与平均值差异显著。使用 1%和 50%的截断值，最大差异分别为 41.2%（32.2%-73.4%）和 29.2%（14.7%-43.9%）。
结论
观察到 PD-L1 阳性率存在相当大的实验室间差异。使用 1%的截断值时，差异最大。在 50%的截断值下，细胞学数据分析显示出比组织学数据分析更高的变异性。
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