Background Molecular diagnostic testing is necessary to guide optimal first-line treatment. The number of patients who receive first-line treatment based on biomarker analysis in Japan is unknown. We aimed to determine the proportion of nonsquamous non-small cell lung cancer (NSCLC) patients for whom first-line treatment was selected based on biomarker testing. Methods This retrospective, multicenter, observational study registered patients aged ⩾20 years with locally advanced or metastatic nonsquamous NSCLC who started first-line treatment between August and December 2017 in Japan. Data were collected from medical records between January and May 2018. The primary endpoint was the proportion of patients with confirmed biomarker status for first-line treatment decision. Results Among 202 patients enrolled from 11 centers, 161 (79.7%; 95% confidence interval, 74.2-85.2%) had confirmed biomarker status. The testing rate was highest for epidermal growth factor receptor (EGFR; 97.5%), followed by anaplastic lymphoma kinase (ALK; 88.1%), programmed death ligand-1 (PD-L1; 87.1%), and ROS1 (67.3%). For first-line treatment, 70/75 patients with EGFR-positive tumors were administered an EGFR-TKI; 14/15 patients with ALK-positive tumors received an ALK inhibitor; 2/2 patients with ROS1-positive tumors received a ROS1 inhibitor; and 29/36 driver mutation-negative patients with a PD-L1 tumor proportion score ⩾50% were administered an anti-PD-1 monoclonal antibody. Median times from confirmed diagnosis date to first-line treatment initiation, and from first biomarker test order to last biomarker test result were 19 and 11 days, respectively. Conclusions The proportion of nonsquamous NSCLC patients with confirmed biomarker status for first-line treatment was considered insufficient and in need of improvement.

中文翻译：

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在日本现实世界中对晚期非鳞状非小细胞肺癌患者进行个性化一线治疗的生物标志物测试：一项回顾性、多中心、观察性研究（BRAVE 研究）。

背景 分子诊断测试对于指导最佳一线治疗是必要的。在日本接受基于生物标志物分析的一线治疗的患者人数未知。我们旨在确定根据生物标志物测试选择一线治疗的非鳞状非小细胞肺癌 (NSCLC) 患者的比例。方法 这项回顾性、多中心、观察性研究在日本登记了年龄≥20 岁的局部晚期或转移性非鳞状 NSCLC 患者，他们于 2017 年 8 月至 12 月期间在日本开始一线治疗。数据是从 2018 年 1 月至 2018 年 5 月期间的医疗记录中收集的。主要终点是已确认生物标志物状态的患者在一线治疗决策中的比例。结果 来自 11 个中心的 202 名患者中，161 名（79.7%；95% 置信区间，74.2-85.2%) 已确认生物标志物状态。表皮生长因子受体（EGFR；97.5%）的检测率最高，其次是间变性淋巴瘤激酶（ALK；88.1%）、程序性死亡配体-1（PD-L1；87.1%）和ROS1（67.3%）。对于一线治疗，70/75 的 EGFR 阳性肿瘤患者接受了 EGFR-TKI；14/15 的 ALK 阳性肿瘤患者接受了 ALK 抑制剂；2/2 的 ROS1 阳性肿瘤患者接受了 ROS1 抑制剂；和 29/36 名 PD-L1 肿瘤比例评分≥50% 的驱动突变阴性患者接受了抗 PD-1 单克隆抗体。从确诊日期到一线治疗开始，以及从第一个生物标志物检测订单到最后一个生物标志物检测结果的中位时间分别为 19 天和 11 天。