Department of Pathology, Duke University Medical Center, Durham, North Carolina.
Department of Medicine, Duke University Medical Center, Durham, North Carolina.
J Am Soc Cytopathol. 2020 Nov-Dec;9(6):485-493. doi: 10.1016/j.jasc.2020.04.003. Epub 2020 Apr 6.
Immune checkpoint pathway markers induce immune tolerance to non-small cell lung cancer (NSCLC). Therapeutic antibodies targeting the programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) pathway have demonstrated efficacy in tumors expressing relatively high PD-L1 levels. Minimally invasive endobronchial ultrasound-guided fine needle aspiration allows patients with inoperable tumors or comorbidities to attain a confirmatory diagnosis. The aims of the present study were to determine whether PD-L1 testing is equivalent to cytology and biopsy or resection specimens at different tumor proportion score cutoffs and for different NSCLC subtypes.
Data were retrospectively collected for patients with paired NSCLC cytology and surgical resection specimens from May 4, 2007 to May 4, 2017. The Food and Drug Administration-approved Dako PD-L1 immunohistochemistry 22C3 pharmDx kit was used to measure PD-L1 on paired cytology cell block and biopsy or resection specimens, and the PD-L1 tumor proportion scores were recorded. Statistical analysis of categorical and continuous variables was performed using SAS, version 9.4.
A total of 53 paired cytology and resection samples (27 adenocarcinoma, 25 squamous cell carcinoma, and 1 unclassified) were analyzed. Supposing the resection specimen to reflect the true PD-L1 expression, the sensitivity, specificity, positive predictive value, negative predictive value, and overall agreement for the cytology method was 73.3%, 65.2%, 73.3%, 65.2%, and 69.8%, respectively. For high PD-L1 expression (≥50%), the cytology method demonstrated an overall agreement of 79.2%. The overall agreement between methods was 81.5% and 76% for cases of adenocarcinoma and squamous cell carcinoma, respectively.
NSCLC cytology samples from endobronchial ultrasound-guided fine needle aspiration are suitable for PD-L1 testing, especially using a high PD-L1 expression cutoff of ≥50% and for adenocarcinoma.
免疫检查点通路标志物诱导非小细胞肺癌(NSCLC)的免疫耐受。针对程序性细胞死亡 1(PD-1)/程序性细胞死亡配体 1(PD-L1)途径的治疗性抗体在表达相对较高 PD-L1 水平的肿瘤中显示出疗效。微创性支气管内超声引导下细针抽吸允许患有无法手术的肿瘤或合并症的患者获得明确的诊断。本研究的目的是确定 PD-L1 检测是否与细胞学和活检或切除术标本等效,以及不同的 NSCLC 亚型的不同肿瘤比例评分截断值。
回顾性收集了 2007 年 5 月 4 日至 2017 年 5 月 4 日期间配对的 NSCLC 细胞学和手术切除标本的患者数据。使用美国食品和药物管理局批准的 Dako PD-L1 免疫组化 22C3 pharmDx 试剂盒测量配对的细胞学细胞块和活检或切除术标本上的 PD-L1,并记录 PD-L1 肿瘤比例评分。使用 SAS 版本 9.4 对分类和连续变量进行统计分析。
共分析了 53 对细胞学和切除样本(27 例腺癌、25 例鳞状细胞癌和 1 例未分类)。假设切除标本反映了真实的 PD-L1 表达,细胞学方法的敏感性、特异性、阳性预测值、阴性预测值和总体一致性分别为 73.3%、65.2%、73.3%、65.2%和 69.8%。对于高 PD-L1 表达(≥50%),细胞学方法的总体一致性为 79.2%。腺癌和鳞状细胞癌的方法之间的总体一致性分别为 81.5%和 76%。
支气管内超声引导下细针抽吸的 NSCLC 细胞学样本适合 PD-L1 检测,尤其是使用高 PD-L1 表达截断值≥50%和腺癌。