真实世界中局部晚期或转移性非小细胞肺癌程序性死亡配体 1 表达的流行率：全球多中心 EXPRESS 研究。
Real-world prevalence of programmed death ligand 1 expression in locally advanced or metastatic non-small-cell lung cancer: The global, multicenter EXPRESS study.
机构信息
Institute of Pathology, Charité, University Medicine Berlin, Berlin, Germany.
Department of Pathology, Moscow City Oncology Hospital #62, Moscow, Russian Federation.
出版信息
Lung Cancer. 2019 Aug;134:174-179. doi: 10.1016/j.lungcan.2019.06.012. Epub 2019 Jun 12.
OBJECTIVES
Tumor programmed death ligand 1 (PD-L1) expression is associated with improved clinical benefit from immunotherapies targeting the PD-1 pathway. We conducted a global, multicenter, retrospective observational study to determine real-world prevalence of tumor PD-L1 expression in patients with NSCLC.
MATERIALS AND METHODS
Patients ≥18 years with histologically confirmed stage IIIB/IV NSCLC and a tumor tissue block (≤5 years old) obtained before treatment were identified in 45 centers across 18 countries. Tumor samples from eligible patients were selected consecutively, when possible. PD-L1 expression was evaluated at each center using the PD-L1 IHC 22C3 pharmDx kit (Agilent, Santa Clara, CA, USA).
RESULTS
Of 2617 patients who met inclusion criteria, 2368 (90%) had PD-L1 data; 530 (22%) patients had PD-L1 TPS ≥ 50%, 1232 (52%) had PD-L1 TPS ≥ 1%, and 1136 (48%) had PD-L1 TPS < 1%. The most common reason for not having PD-L1 data (n = 249) was insufficient tumor cells (<100) on the slide (n = 170 [6%]). Percentages of patients with PD-L1 TPS ≥ 50% and TPS ≥ 1%, respectively were: 22%/52% in Europe; 22%/53% in Asia Pacific; 21%/47% in the Americas, and 24%/55% in other countries. Prevalence of EGFR mutations (19%) and ALK alterations (3%) was consistent with prior reports from metastatic NSCLC studies. Among 1064 patients negative for both EGFR mutation and ALK alteration, the percentage with PD-L1 TPS ≥ 50% and TPS ≥ 1%, respectively, were 27% and 53%.
CONCLUSIONS
This is the largest real-world study in advanced NSCLC to date evaluating PD-L1 tumor expression using the 22C3 pharmDx kit. Testing failure rate was low with local evaluation of PD-L1 TPS across a large number of centers. Prevalence of PD-L1 TPS ≥ 50% and TPS ≥ 1% among patients with stage IIIB/IV NSCLC was similar across geographic regions and broadly consistent with central testing results from clinical trial screening populations.
目的
肿瘤程序性死亡配体 1（PD-L1）表达与免疫治疗靶向 PD-1 通路的临床获益改善相关。我们进行了一项全球性、多中心、回顾性观察研究，以确定非小细胞肺癌（NSCLC）患者中肿瘤 PD-L1 表达的真实世界流行率。
材料和方法
在 18 个国家的 45 个中心，确定了年龄≥18 岁、组织学证实为 IIIB/IV 期 NSCLC 且在治疗前获得肿瘤组织块（≤5 年）的患者。当可能时，连续选择符合条件的患者的肿瘤样本。使用 PD-L1 IHC 22C3 pharmDx 试剂盒（Agilent，加利福尼亚州圣克拉拉）在每个中心评估 PD-L1 表达。
结果
在符合纳入标准的 2617 名患者中，2368 名（90%）有 PD-L1 数据；530 名（22%）患者的 PD-L1 TPS≥50%，1232 名（52%）患者的 PD-L1 TPS≥1%，1136 名（48%）患者的 PD-L1 TPS<1%。没有 PD-L1 数据的最常见原因（n=249）是载玻片上的肿瘤细胞不足（<100）（n=170 [6%]）。PD-L1 TPS≥50%和 TPS≥1%的患者百分比分别为：欧洲 22%/52%；亚太地区 22%/53%；美洲 21%/47%；其他国家 24%/55%。EGFR 突变（19%）和 ALK 改变（3%）的发生率与转移性 NSCLC 研究中的先前报告一致。在 1064 名 EGFR 突变和 ALK 改变均为阴性的患者中，PD-L1 TPS≥50%和 TPS≥1%的患者百分比分别为 27%和 53%。
结论
这是非小细胞肺癌中迄今为止最大的使用 22C3 pharmDx 试剂盒评估肿瘤 PD-L1 表达的真实世界研究。在大量中心进行局部 PD-L1 TPS 评估后，检测失败率较低。在 IIIB/IV 期 NSCLC 患者中，PD-L1 TPS≥50%和 TPS≥1%的患病率在地理区域之间相似，与临床试验筛选人群的中心检测结果大致一致。
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