Sorafenib in advanced hepatocellular carcinoma
Sorafenib in advanced hepatocellular carcinoma
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DOI：
10.1056/nejmoa0708857
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发表时间：
2008-07-24
影响因子：
158.5
通讯作者：
Bruix, Jordi
中科院分区：
文献类型：
--
作者：
Llovet, Josep M.;Ricci, Sergio;Bruix, Jordi
背景：目前尚无有效的系统疗法治疗晚期肝细胞癌患者。初步研究表明，口服血管内皮生长因子受体、血小板衍生生长因子受体和Raf的多激酶抑制剂索拉非尼可能对肝细胞癌有效。方法在这项多中心、3期、双盲、安慰剂对照试验中，我们随机分配602名未接受系统治疗的晚期肝癌患者接受索拉非尼(每天两次，剂量400 mg)或安慰剂治疗。主要结果是总存活率和症状进展的时间。次要结果包括放射学进展时间和安全性。结果在第二次计划的中期分析中，发生了321例死亡，研究停止。索拉非尼组的中位总生存期为10.7个月，安慰剂组为7.9个月(索拉非尼组的风险比为0.69；95%可信区间为0.55-0.87；P
Background No effective systemic therapy exists for patients with advanced hepatocellular carcinoma. A preliminary study suggested that sorafenib, an oral multikinase inhibitor of the vascular endothelial growth factor receptor, the platelet-derived growth factor receptor, and Raf may be effective in hepatocellular carcinoma.Methods In this multicenter, phase 3, double-blind, placebo-controlled trial, we randomly assigned 602 patients with advanced hepatocellular carcinoma who had not received previous systemic treatment to receive either sorafenib (at a dose of 400 mg twice daily) or placebo. Primary outcomes were overall survival and the time to symptomatic progression. Secondary outcomes included the time to radiologic progression and safety.Results At the second planned interim analysis, 321 deaths had occurred, and the study was stopped. Median overall survival was 10.7 months in the sorafenib group and 7.9 months in the placebo group (hazard ratio in the sorafenib group, 0.69; 95% confidence interval, 0.55 to 0.87; P