title: Transarterial chemoembolization plus sorafenib: a sequential therapeutic scheme for HCV-related intermediate-stage hepatocellular carcinoma: a randomized clinical trial.
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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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. d.sansonno@dimo.uniba.it
authors.forename: Domenico
authors.initials: D
authors.lastname: Sansonno
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Lauletta
authors.forename: Sabino
authors.initials: S
authors.lastname: Russi
authors.forename: Vincenza
authors.initials: V
authors.lastname: Conteduca
authors.forename: Loredana
authors.initials: L
authors.lastname: Sansonno
authors.forename: Franco
authors.initials: F
authors.lastname: Dammacco
mesh_terms: D000368:Aged; D001557:Benzenesulfonates / Q000008:administration & dosage* / Q000009:adverse effects; D006528:Carcinoma, Hepatocellular / Q000150:complications / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D016174:Hepacivirus / Q000472:pathogenicity; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008103:Liver Cirrhosis / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D008113:Liver Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D008297:Male; D009367:Neoplasm Staging; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011446:Prospective Studies; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D000077157:Sorafenib
chemical_list: D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib