Transarterial Chemoembolization Plus Sorafenib: A Sequential Therapeutic Scheme for HCV-Related Intermediate-Stage Hepatocellular Carcinoma: A Randomized Clinical Trial
Transarterial Chemoembolization Plus Sorafenib: A Sequential Therapeutic Scheme for HCV-Related Intermediate-Stage Hepatocellular Carcinoma: A Randomized Clinical Trial
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DOI：
10.1634/theoncologist.2011-0313
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发表时间：
2012-03-01
期刊：
影响因子：
5.8
通讯作者：
Dammacco, Franco
中科院分区：
文献类型：
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作者：
Sansonno, Domenico;Lauletta, Gianfranco;Dammacco, Franco
背景肝细胞癌（HCC）的复发是手术或消融治疗后的主要问题。这项前瞻性、单中心、安慰剂对照、随机、双盲临床研究的目的是评估经动脉化疗栓塞术（TACE）联合索拉非尼作为序贯治疗方案在延迟慢性丙型肝炎病毒（HCV）感染患者中期肝癌进展时间（TTP）方面的有效性。2007年10月至2011年1月期间，80例患有巴塞罗那诊所肝癌B期HCC的HCV感染患者接受了TACE手术。所有患者均患有Child-Pugh A级疾病。他们以1：1的比例随机接受索拉非尼400 mg每日两次或安慰剂治疗。终点为TTP、不良事件发生率和毒性。80例患者中有62例（77%）完成了研究，索拉非尼组31例，对照组31例。索拉非尼组的中位TTP为9.2个月，安慰剂组为4.9个月（风险比，2.5; 95%置信区间，1.66-7.56; p
Background. Recurrence of hepatocellular carcinoma (HCC) is a major problem after surgical or ablative treatments. The aim of this prospective, single-center, placebo-controlled, randomized, double-blind clinical study was to evaluate the effectiveness of transarterial chemoembolization (TACE) combined with sorafenib as a sequential treatment regimen in delaying time to progression (TTP) of intermediate-stage HCC in patients with chronic hepatitis C virus (HCV) infection.Material and Methods. Between October, 2007 and January, 2011, 80 HCV-infected patients with Barcelona Clinic Liver Cancer stage B HCC underwent the TACE procedure. All had Child-Pugh class A disease. They were randomized 1: 1 to receive sorafenib at a dose of 400 mg twice daily or placebo. Endpoints were the TTP and the rates of adverse events and toxicity.Results. Sixty-two of 80 patients (77%), 31 in the sorafenib group and 31 in the control group, completed the study. The median TTP was 9.2 months in the sorafenib group and 4.9 months in the placebo group (hazard ratio, 2.5; 95% confidence interval, 1.66-7.56; p