title: Randomised controlled trial of lipiodol transarterial chemoembolisation with or without amiodarone for unresectable hepatocellular carcinoma.
abstract: BACKGROUND
  There is no consensus about the most effective method for transarterial chemoembolisation of hepatocellular carcinoma.
  
  
  OBJECTIVE
  The aim of this phase II trial was to compare the efficacy and toxicity of lipiodol transarterial chemoembolisation with amiodarone in association with pirarubicin or doxorubicin versus lipiodol transarterial chemoembolisation with anthracycline alone in a control group.
  
  
  METHODS
  Patients with unresectable hepatocellular carcinoma and Child-Pugh A/B7 were considered eligible for the trial. transarterial chemoembolisation was repeated every 6 weeks for a maximum of 4 sessions.
  
  
  RESULTS
  Thirteen patients were randomised in the amiodarone group, and 14 were randomised in the control group. The two groups were comparable with respect to their baseline characteristics. The objective response rate according to the EASL criteria was 62% (95% CI 35-88) in the amiodarone group and 50% (95% CI 24-76) in the control group. At 1 and 2 years, survival rates were 77% (95% CI 44-92) and 52% (95% CI 22-75) in the amiodarone group, and 57% (95% CI 28-78) and 40% (95% CI 15-65) in the control group, respectively. There was no difference between the two groups in terms of toxicity.
  
  
  CONCLUSIONS
  The results of this study suggest that lipiodol transarterial chemoembolisation with anthracycline and amiodarone was safe but did not increase survival compared with lipiodol transarterial chemoembolisation with anthracycline alone in patients with hepatocellular carcinoma.
authors.affiliation: Department of Pharmacy, CHU (University Hospital), Dijon, France. mathieu.boulin@chu-dijon.fr
authors.forename: Mathieu
authors.initials: M
authors.lastname: Boulin
authors.forename: Anne
authors.initials: A
authors.lastname: Ciboulet
authors.forename: Boris
authors.initials: B
authors.lastname: Guiu
authors.forename: Emilie
authors.initials: E
authors.lastname: Maillard
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.forename: Anne
authors.initials: A
authors.lastname: Minello
authors.forename: Alice
authors.initials: A
authors.lastname: Gagnaire
authors.forename: Côme
authors.initials: C
authors.lastname: Lepage
authors.forename: Denis
authors.initials: D
authors.lastname: Krause
authors.forename: Patrick
authors.initials: P
authors.lastname: Hillon
authors.forename: Laurent
authors.initials: L
authors.lastname: Bedenne
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Cercueil
authors.forename: Bruno
authors.initials: B
authors.lastname: Chauffert
authors.forename: Jean Louis
authors.initials: JL
authors.lastname: Jouve
mesh_terms: D000328:Adult; D000368:Aged; D000638:Amiodarone / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000628:therapy*; D016461:Chemoembolization, Therapeutic; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D004998:Ethiodized Oil / Q000008:administration & dosage; D005079:Excipients / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D005079:Excipients; D004998:Ethiodized Oil; D004317:Doxorubicin; C027260:pirarubicin; D000638:Amiodarone