An open-label, phase II study of the polo-like kinase-1 (P1k-1) inhibitor, BI 2536, in patients with relapsed small cell lung cancer (SCLC)
An open-label, phase II study of the polo-like kinase-1 (P1k-1) inhibitor, BI 2536, in patients with relapsed small cell lung cancer (SCLC)
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DOI：
10.1016/j.lungcan.2016.12.019
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发表时间：
2017-02-01
期刊：
影响因子：
5.3
通讯作者：
Socinski, Mark A.
中科院分区：
文献类型：
--
作者：
Awad, Mark M.;Chu, Quincy S-C;Socinski, Mark A.
目的：这项II期开放标签研究旨在评估polo样激酶1 （Plk-1）抑制剂BI 2536对敏感复发小细胞肺癌（SCLC）患者的反应率。次要终点包括无进展生存期（PFS）、总生存期（OS）、反应持续时间和安全性。材料和方法：患者采用推荐的II期剂量200mg BI 2536，每21天静脉注射一次。这是一个两阶段的设计，如果在前18名入组患者中至少有2名未见反应，则提前停止规则。结果和结论：23例患者入组研究，21例患者可评估反应。未观察到任何反应，所有23例患者均已进展。中位PFS为1.4个月。治疗一般耐受良好，最常见的不良事件是中性粒细胞减少、疲劳、恶心、呕吐和便秘。BI 2536对敏感性复发的SCLC治疗无效。没有达到将试验扩展到第二阶段的标准，研究因缺乏疗效而终止。2016爱思唯尔爱尔兰有限公司版权所有。
Objectives: This phase II, open-label study was designed to evaluate the response rate to the polo-like kinase 1 (Plk-1) inhibitor BI 2536 in patients with sensitive-relapsed small cell lung cancer (SCLC). Secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response, and safety.Materials and methods: Patients were treated with the recommended phase II dose of 200 mg of BI 2536 intravenously every 21 days. This was a two-stage design with an early stopping rule in place if responses were not seen in at least 2 of the first 18 enrolled patients.Results and conclusion: Twenty-three patients were enrolled in the study and 21 patients were evaluable for response. No responses were observed and all 23 patients have progressed. The median PFS was 1.4 months. Treatment was generally well tolerated and the most frequent adverse events were neutropenia, fatigue, nausea, vomiting, and constipation. BI 2536 is not effective in the treatment of sensitive relapsed SCLC. The criteria for expanding the trial to the second stage were not achieved, and the study was terminated for a lack of efficacy. (C) 2016 Elsevier Ireland Ltd. All rights reserved.