Abstract

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 <. 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. Conclusion. 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. The Oncologist 2012; 17: 359-366

Autore Pugliese

• Lauletta Gianfranco

Tutti gli autori

• SANSONNO D.E.;LAULETTA G.;RUSSI S.

Titolo volume/Rivista

Non Disponibile

Anno di pubblicazione

2012

ISSN

1083-7159

ISBN

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Numero di citazioni Wos

Nessuna citazione

Ultimo Aggiornamento Citazioni

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Numero di citazioni Scopus

106

Ultimo Aggiornamento Citazioni

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Settori ERC

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Codici ASJC

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