Biomarker testing for personalized, first-line therapy in advanced nonsquamous non-small cell lung cancer patients in the real world setting in Japan: a retrospective, multicenter, observational study (the BRAVE study)
Biomarker testing for personalized, first-line therapy in advanced nonsquamous non-small cell lung cancer patients in the real world setting in Japan: a retrospective, multicenter, observational study (the BRAVE study)
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DOI：
10.1177/1758835920904522
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发表时间：
2020-02-01
影响因子：
4.9
通讯作者：
Dosaka-Akita, Hirotoshi
中科院分区：
文献类型：
--
作者：
Shimizu, Junichi;Masago, Katsuhiro;Dosaka-Akita, Hirotoshi
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，根据生物标记物分析接受一线治疗的患者数量尚不清楚。我们的目标是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、观察性研究登记了从2017年8月至12月在日本开始一线治疗的20岁局部晚期或转移性非小细胞肺癌患者。数据是从2018年1月至5月的医疗记录中收集的。结果：在来自11个中心的202名患者中，161人(79.7%；95%可信区间，74.2-85.2%)已确认生物标记物状态。表皮生长因子受体(EGFR)的检测率最高(97.5%)，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例EGFR阳性肿瘤患者接受EGFR-TKI治疗；14/15例ALK阳性肿瘤患者接受ALK抑制剂治疗；2/2 ROS1阳性肿瘤患者接受ROS1抑制剂治疗；29/36例驱动程序突变阴性患者接受PD-L1肿瘤比例评分50%的抗PD-1单抗治疗。从确诊日期到一线治疗开始的中位时间为19天，从第一个生物标记物检测指令到最后一个生物标记物检测结果的中位时间分别为11天。结论：非鳞状细胞肺癌患者中确认生物标记物状态用于一线治疗的比例不足，需要改进。
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.