Sorafenib in advanced clear-cell renal-cell carcinoma
Sorafenib in advanced clear-cell renal-cell carcinoma
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DOI：
10.1056/nejmoa060655
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发表时间：
2007-01-11
影响因子：
158.5
通讯作者：
Bukowski, Ronald M.
中科院分区：
文献类型：
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作者：
Escudier, Bernard;Eisen, Tim;Bukowski, Ronald M.
背景：我们进行了一项3期，随机，双盲，安慰剂对照试验索拉非尼，肿瘤细胞增殖和血管生成的多激酶抑制剂，在晚期透明细胞肾细胞cancer.METHODS患者：从2003年11月至2005年3月，我们随机分配903例肾细胞癌患者，这是抵抗标准治疗接受口服索拉非尼（剂量为400毫克，每天两次）或安慰剂连续治疗; 451例患者接受索拉非尼和452例接受安慰剂。主要终点是总生存期。2005年1月，一项计划的无进展生存期分析显示索拉非尼优于安慰剂，具有统计学显著性。结果：在2005年1月的截止日期，索拉非尼组的中位无进展生存期为5.5个月，安慰剂组为2.8个月（索拉非尼组疾病进展的风险比为0.44; 95%可信区间[CI]为0.35 - 0.55; P
BACKGROUND:We conducted a phase 3, randomized, double-blind, placebo-controlled trial of sorafenib, a multikinase inhibitor of tumor-cell proliferation and angiogenesis, in patients with advanced clear-cell renal-cell carcinoma.METHODS:From November 2003 to March 2005, we randomly assigned 903 patients with renal-cell carcinoma that was resistant to standard therapy to receive either continuous treatment with oral sorafenib (at a dose of 400 mg twice daily) or placebo; 451 patients received sorafenib and 452 received placebo. The primary end point was overall survival. A single planned analysis of progression-free survival in January 2005 showed a statistically significant benefit of sorafenib over placebo. Consequently, crossover was permitted from placebo to sorafenib, beginning in May 2005.RESULTS:At the January 2005 cutoff, the median progression-free survival was 5.5 months in the sorafenib group and 2.8 months in the placebo group (hazard ratio for disease progression in the sorafenib group, 0.44; 95% confidence interval [CI], 0.35 to 0.55; P