首页> 外文期刊>Journal of thoracic oncology: official publication of the International Association for the Study of Lung Cancer >A double-blind randomized discontinuation phase-ii study of sorafenib (BAY 43-9006) in previously treated non-small-cell lung cancer patients: Eastern cooperative oncology group study E2501
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A double-blind randomized discontinuation phase-ii study of sorafenib (BAY 43-9006) in previously treated non-small-cell lung cancer patients: Eastern cooperative oncology group study E2501

机译:索拉非尼(BAY 43-9006)在先前治疗的非小细胞肺癌患者中的双盲随机终止ii期研究:东方合作肿瘤小组研究E2501

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Introduction: Sorafenib is a raf kinase and angiogenesis inhibitor with activity in multiple cancers. This phase-II study in heavily pretreated non-small-cell lung cancer (NSCLC) patients (≥ 2 prior therapies) used a randomized discontinuation design. Methods: Patients received 400 mg of sorafenib orally twice daily for two cycles (2 months) (step 1). Responding patients on step 1 continued on sorafenib; progressing patients went off study, and patients with stable disease were randomized to placebo or sorafenib (step 2), with crossover from placebo allowed upon progression. The primary endpoint of this study was the proportion of patients having stable or responding disease 2 months after randomization. Results: There were 299 patients evaluated for step 1; of these, 81 eligible patients were randomized on step 2 and received sorafenib (n = 50) or placebo (n = 31). The 2-month disease control rates after randomization were 54% and 23% for patients initially receiving sorafenib and placebo, respectively, p = 0.005. The hazard ratio for progression on step 2 was 0.51 (95% [confidence interval] CI 0.30, 0.87, p = 0.014) favoring sorafenib. A trend in favor of overall survival with sorafenib was also observed (13.7 versus 9.0 months from time of randomization), hazard ratio 0.67 (95% CI 0.40-1.11), p = 0.117. A dispensing error occurred, which resulted in the unblinding of some patients, but not before completion of the 8-week initial step 2 therapy. Toxicities were manageable and as expected. Conclusions: The results of this randomized discontinuation trial suggest that sorafenib has single-agent activity in a heavily pretreated, enriched patient population with advanced NSCLC. These results support further investigation with sorafenib as a single agent in larger, randomized studies in NSCLC.
机译:简介:索拉非尼是一种raf激酶和血管生成抑制剂,在多种癌症中均具有活性。这项II期研究针对经过高度预处理的非小细胞肺癌(NSCLC)患者(≥2种先前的治疗方法),使用了随机停药设计。方法:患者每天两次口服400 mg索拉非尼,持续两个周期(2个月)(步骤1)。步骤1的患者继续接受索拉非尼治疗;进展中的患者退出研究,病情稳定的患者被随机分配至安慰剂或索拉非尼(步骤2),并在进展时允许与安慰剂交叉使用。这项研究的主要终点是随机化后2个月内疾病稳定或有反应的患者比例。结果:共有299例患者接受了步骤1的评估;在这些患者中,有81位符合条件的患者在第2步中被随机分配并接受了索拉非尼(n = 50)或安慰剂(n = 31)。最初接受索拉非尼和安慰剂的患者,随机分组后的2个月疾病控制率分别为54%和23%,p = 0.005。第二步进展的危险比为0.51(95%[置信区间] CI 0.30,0.87,p = 0.014),有利于索拉非尼。还观察到了索拉非尼有利于总体生存的趋势(随机分组后分别为13.7和9.0个月),风险比为0.67(95%CI 0.40-1.11),p = 0.117。发生分配错误,这导致一些患者失明,但未在完成8周的初始第2步治疗之前出现。毒性是可控的,符合预期。结论:这项随机终止试验的结果表明,索拉非尼在经过大量预处理的,丰富的晚期NSCLC患者人群中具有单药活性。这些结果支持在更大的NSCLC随机研究中索拉非尼作为单药进一步研究。

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