title: Postoperative adjuvant chemotherapy after curative resection of hepatocellular carcinoma: a randomized controlled trial.
abstract: OBJECTIVE
  To study the effect of adjuvant chemotherapy after curative hepatic resection in patients with hepatocellular carcinoma.
  
  
  METHODS
  A randomized controlled trial.
  
  
  METHODS
  A tertiary referral center.
  
  
  METHODS
  During a 54-month period, 142 patients with hepatocellular carcinoma underwent hepatic resection at 1 institution. Sixty-six patients who survived the operation and had no demonstrable evidence of residual disease on ultrasonographic examination and hepatic angiographic testing at 1 month after surgery agreed to participate in the study. The median follow-up time was 28.3 months.
  
  
  METHODS
  Thirty patients received a combination of intravenous epirubicin hydrochloride (8 doses of 40 mg/m2 each at 6-week intervals) and transarterial chemotherapy using an emulsion of iodized oil and cisplatin (3 courses with a maximum dose of 20 mL each at 2-month intervals). Thirty-six patients had no adjuvant treatment.
  
  
  METHODS
  Recurrence rate and disease-free survival.
  
  
  RESULTS
  A total of 138 courses of intravenous epirubicin was given to the 30 patients. Sixty-one courses of transarterial chemotherapy were given to only 29 of the 30 patients assigned to the treatment group, because the hepatic artery in 1 patient was thrombosed. Six patients (20%) had chemotherapy-related complications with no mortality. Twenty-three of 30 patients in the treatment group and 17 of 36 patients in the control group had recurrences (P=.01). Patients who received adjuvant chemotherapy had a higher incidence of extrahepatic metastases (11 patients vs 5 patients; P=.03). The respective disease-free survival rates at 1, 2, and 3 years were 50%,36%, and 18% for the treatment group and 69%, 53%, and 48% for the control group (P=.04).
  
  
  CONCLUSIONS
  In a group of patients who underwent curative resection of hepatocellular carcinoma, postoperative adjuvant chemotherapy using the present regimen was associated with more frequent extrahepatic recurrences and a worse outcome.
authors.affiliation: Department of Surgery, The University of Hong Kong, Queen Mary Hospital, People's Republic of China.
authors.forename: E C
authors.initials: EC
authors.lastname: Lai
authors.forename: C M
authors.initials: CM
authors.lastname: Lo
authors.forename: S T
authors.initials: ST
authors.lastname: Fan
authors.forename: C L
authors.initials: CL
authors.lastname: Liu
authors.forename: J
authors.initials: J
authors.lastname: Wong
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007459:Iodized Oil / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007459:Iodized Oil; D002945:Cisplatin