随机 III 期临床试验：厄洛替尼对比多西他赛在一线铂类双联化疗失败的晚期鳞状非小细胞肺癌患者中的应用，根据 VeriStrat 良好与 VeriStrat 不良进行分层。欧洲胸部肿瘤平台（ETOP） EMPHASIS-lung 试验。
Randomized Phase III Trial of Erlotinib versus Docetaxel in Patients with Advanced Squamous Cell Non-Small Cell Lung Cancer Failing First-Line Platinum-Based Doublet Chemotherapy Stratified by VeriStrat Good versus VeriStrat Poor. The European Thoracic Oncology Platform (ETOP) EMPHASIS-lung Trial.
机构信息
University Hospital of Lausanne (CHUV), Lausanne, Switzerland.
University Hospital Zürich, Clinic of Oncology, Zürich, Switzerland.
出版信息
J Thorac Oncol. 2017 Apr;12(4):752-762. doi: 10.1016/j.jtho.2016.12.017. Epub 2016 Dec 23.
INTRODUCTION
Docetaxel and erlotinib are registered second-line treatments for wild-type EGFR NSCLC. Previous studies suggested a predictive value of the VeriStrat test in second-line therapy of NSCLC, classifying patients as either VeriStrat good or VeriStrat poor. EMPHASIS-lung aimed at exploring this predictive effect in patients with squamous cell NSCLC. The trial closed prematurely because of low accrual and results from other trials. Our analysis includes an exploratory combined analysis with results from the PROSE trial.
METHODS
EMPHASIS-lung was a randomized phase III multicenter trial exploring the differential effect of second-line erlotinib versus docetaxel on progression-free survival (PFS) in VeriStrat good versus VeriStrat poor patients with squamous cell NSCLC.
RESULTS
A total of 80 patients were randomized, with 72.5% categorized as VeriStrat good. Patient characteristics were balanced between VeriStrat status and treatment groups. The median PFS times with docetaxel and erlotinib treatment in the VeriStrat good cohort were 4.1 and 1.6 months, respectively, versus 1.9 and 2.1 months, respectively, in the VeriStrat poor cohort. The median overall survival (OS) times with docetaxel and erlotinib treatment in the VeriStrat good cohort were 7.8 and 8.4 months, respectively, and 4.4 and 5.2 months, respectively, in the VeriStrat poor cohort. An additional exploratory analysis was performed; in it, 47 patients from the squamous cell subgroup of PROSE were included in a combined analysis, contributing with 45 PFS and 41 OS events.
CONCLUSIONS
The final analysis of EMPHASIS-lung did not show a differential effect on PFS for erlotinib versus docetaxel stratified by VeriStrat status. Similarly, in the combined analysis, no significant treatment by VeriStrat status interaction was observed (interaction p = 0.24 for PFS and 0.45 for OS, stratified by study).
简介
多西他赛和厄洛替尼是野生型 EGFR NSCLC 的二线注册治疗药物。先前的研究表明，VeriStrat 检测在 NSCLC 的二线治疗中具有预测价值，将患者分为 VeriStrat 良好或 VeriStrat 不良。EMPHASIS-lung 旨在探索鳞状细胞 NSCLC 患者的这种预测效果。由于入组人数低和其他试验的结果，该试验提前终止。我们的分析包括与 PROSE 试验结果的探索性联合分析。
方法
EMPHASIS-lung 是一项随机 III 期多中心试验，旨在探索在 VeriStrat 良好的鳞状细胞 NSCLC 患者中，二线厄洛替尼与多西他赛治疗对无进展生存期（PFS）的差异影响，根据 VeriStrat 状态和治疗组进行分层。
结果
共随机分配了 80 名患者，其中 72.5%归类为 VeriStrat 良好。患者特征在 VeriStrat 状态和治疗组之间平衡。在 VeriStrat 良好组中，多西他赛和厄洛替尼治疗的中位 PFS 时间分别为 4.1 和 1.6 个月，而在 VeriStrat 不良组中分别为 1.9 和 2.1 个月。在 VeriStrat 良好组中，多西他赛和厄洛替尼治疗的中位总生存期（OS）时间分别为 7.8 和 8.4 个月，而在 VeriStrat 不良组中分别为 4.4 和 5.2 个月。进行了额外的探索性分析；在其中，将 PROSE 鳞状细胞亚组的 47 名患者纳入联合分析，贡献了 45 个 PFS 和 41 个 OS 事件。
结论
EMPHASIS-lung 的最终分析显示，根据 VeriStrat 状态分层，厄洛替尼与多西他赛对 PFS 的影响无差异。同样，在联合分析中，未观察到治疗与 VeriStrat 状态之间的显著相互作用（根据研究，PFS 的交互 p=0.24，OS 的交互 p=0.45）。
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