title: Multicenter randomized trial of adjuvant fluorouracil and folinic acid compared with surgery alone after resection of colorectal liver metastases: FFCD ACHBTH AURC 9002 trial.
abstract: OBJECTIVE
  Complete resection of liver metastases of colorectal origin is the only potentially curative treatment. In order to decrease recurrences, the use of adjuvant systemic chemotherapy after liver resection is controversial because no randomized study demonstrated its benefit.
  
  
  METHODS
  In a multicenter trial, we randomly assigned 173 patients with completely resected (R0) hepatic metastases from colorectal cancer to surgery alone and observation (87 patients) or to surgery followed by 6 months of systemic adjuvant chemotherapy with a fluorouracil and folinic acid monthly regimen (86 patients). The main outcome criterion was disease-free survival. Secondary outcome measures were overall survival and treatment-related toxicity.
  
  
  RESULTS
  The intention-to-treat analysis was based on 171 patients, after a median follow-up of 87 months (SE = 5.8). The 5-year disease-free survival rate, after adjustment for major prognostic factors, was 33.5% for patients in the chemotherapy group and 26.7% for patients in the control group (Cox multivariate analysis: odds ratio for recurrence or death = 0.66; 95% CI, 0.46 to 0.96; P = .028). With regard to secondary outcome measures, a trend towards increased overall survival was observed but did not reach statistical significance (5-year overall survival: chemotherapy group, 51.1% v control group, 41.1%; odds ratio for death, 0.73; 95% CI, 0.48 to 1.10; P = .13).
  
  
  CONCLUSIONS
  Despite a suboptimal regimen, which was the standard at the beginning of the study, adjuvant intravenous systemic chemotherapy provided a significant disease-free survival benefit for patients with resected liver metastases from colorectal cancer.
authors.affiliation: Chirurgie Digestive, CHU Purpan, place du Dr. Baylac, 31059 Toulouse, France. portier.g@chu-toulouse.fr
authors.forename: Guillaume
authors.initials: G
authors.lastname: Portier
authors.forename: Dominique
authors.initials: D
authors.lastname: Elias
authors.forename: Olivier
authors.initials: O
authors.lastname: Bouche
authors.forename: Philippe
authors.initials: P
authors.lastname: Rougier
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Bosset
authors.forename: Jean
authors.initials: J
authors.lastname: Saric
authors.forename: Jacques
authors.initials: J
authors.lastname: Belghiti
authors.forename: Pascal
authors.initials: P
authors.lastname: Piedbois
authors.forename: Rosine
authors.initials: R
authors.lastname: Guimbaud
authors.forename: Bernard
authors.initials: B
authors.lastname: Nordlinger
authors.forename: Roland
authors.initials: R
authors.lastname: Bugat
authors.forename: Franck
authors.initials: F
authors.lastname: Lazorthes
authors.forename: Laurent
authors.initials: L
authors.lastname: Bedenne
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000473:pathology*; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005602:France; D006498:Hepatectomy; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D016019:Survival Analysis; D013557:Switzerland; D016896:Treatment Outcome
chemical_list: D002955:Leucovorin; D005472:Fluorouracil