Liver Unit, Department of Internal Medicine and Human Oncology, Section of Internal Medicine and Clinical Oncology, University of Bari Medical School, Policlinico, Piazza Giulio Cesare 11, 70124 Bari, Italy.
Oncologist. 2012;17(3):359-66. doi: 10.1634/theoncologist.2011-0313. Epub 2012 Feb 14.
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.
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.
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 < .001). Metachronous, multicentric HCC progression occurred less frequently in sorafenib-treated patients (p < .05). Adverse reactions to sorafenib caused withdrawal from the study of 9 (22%) patients.
A conventional TACE procedure followed by sorafenib treatment resulted in a significantly longer TTP in patients with intermediate-stage HCV-related HCC, with no unexpected side effects.
肝细胞癌（HCC）术后或消融治疗后复发是一个主要问题。本前瞻性、单中心、安慰剂对照、随机、双盲临床试验的目的是评估经动脉化疗栓塞（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）感染患者中中期 HCC 进展时间（TTP）的有效性。
2007 年 10 月至 2011 年 1 月，80 例巴塞罗那临床肝癌 B 期 HCV 感染 HCC 患者接受了 TACE 手术。所有患者均为 Child-Pugh 分级 A 级疾病。他们按 1:1 随机接受索拉非尼 400mg 每日 2 次或安慰剂治疗。终点为 TTP 及不良事件和毒性发生率。
80 例患者中 62 例（77%），索拉非尼组 31 例，对照组 31 例完成研究。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 <.001）。索拉非尼治疗组的异时性、多中心 HCC 进展发生率较低（p <.05）。索拉非尼的不良反应导致 9 例（22%）患者退出研究。
常规 TACE 后序贯索拉非尼治疗可显著延长 HCV 相关性中期 HCC 患者的 TTP，且无意外副作用。
