索拉非尼
医学
肝细胞癌
危险系数
安慰剂
内科学
临床终点
肝硬化
不利影响
肿瘤科
置信区间
外科
临床试验
胃肠病学
病理
替代医学
作者
Masatoshi Kudo,Kazuho Imanaka,Noboru Chida,Kohei Nakachi,Won Young Tak,Tadatoshi Takayama,Jung Hwan Yoon,Takeshi Hori,Hiromitsu Kumada,Norio Hayashi,Shuichi Kaneko,Hirohito Tsubouchi,Dong Jin Suh,Junji Furuse,Takuji Okusaka,Katsuaki Tanaka,Osamu Matsui,Michihiko Wada,Iku Yamaguchi,Toshio Ohya,Gerold Meinhardt,Kiwamu Okita
标识
DOI:10.1016/j.ejca.2011.05.007
摘要
Background In Japan and South Korea, transarterial chemoembolisation (TACE) is an important locoregional treatment for patients with unresectable hepatocellular carcinoma (HCC). Sorafenib, a multikinase inhibitor, has been shown effective and safe in patients with advanced HCC. This phase III trial assessed the efficacy and safety of sorafenib in Japanese and Korean patients with unresectable HCC who responded to TACE. Methods Patients (n = 458) with unresectable HCC, Child-Pugh class A cirrhosis and ⩾25% tumour necrosis/shrinkage 1–3 months after 1 or 2 TACE sessions were randomised 1:1 to sorafenib 400 mg bid or placebo and treated until progression/recurrence or unacceptable toxicity. Primary end-point was time to progression/recurrence (TTP). Secondary end-point was overall survival (OS). Findings Baseline characteristics in the two groups were similar; >50% of patients started sorafenib >9 weeks after TACE. Median TTP in the sorafenib and placebo groups was 5.4 and 3.7 months, respectively (hazard ratio (HR), 0.87; 95% confidence interval (CI), 0.70–1.09; P = 0.252). HR (sorafenib/placebo) for OS was 1.06 (95% CI, 0.69–1.64; P = 0.790). Median daily dose of sorafenib was 386 mg, with 73% of patients having dose reductions and 91% having dose interruptions. Median administration of sorafenib and placebo was 17.1 and 20.1 weeks, respectively. No unexpected adverse events were observed. Interpretation This trial, conducted prior to the reporting of registrational phase III trials, found that sorafenib did not significantly prolong TTP in patients who responded to TACE. This may have been due to delays in starting sorafenib after TACE and/or low daily sorafenib doses.
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