title: Adjuvant portal-vein infusion of fluorouracil and heparin in colorectal cancer: a randomised trial. European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group, the Gruppo Interdisciplinare Valutazione Interventi in Oncologia, and the Japanese Foundation for Cancer Research.
abstract: BACKGROUND
  There is conflicting evidence on the efficacy of regional adjuvant chemotherapy, via portal-vein infusion (PVI), after resection of colorectal cancer. We undertook a randomised controlled multicentre trial to investigate the efficacy of PVI (500 mg/m2 fluorouracil plus 5000 IU heparin daily for 7 days).
  
  
  METHODS
  1235 of about 1500 potentially eligible patients were randomly assigned surgery plus PVI or surgery alone (control). The patients were followed up for a median of 63 months, with yearly screening for recurrent disease. The primary endpoint was survival; analyses were by intention to treat.
  
  
  RESULTS
  619 patients in the control group and 616 in the PVI group met eligibility criteria. 164 (26%) control-group patients and 173 (28%) PVI-group patients died. 5-year survival did not differ significantly between the groups (73 vs 72%; 95% Cl for difference -6 to 4). The control and PVI groups were also similar in terms of disease-free survival at 5 years (67 vs 65%) and the number of patients with liver metastases (79 vs 77%).
  
  
  CONCLUSIONS
  PVI of fluorouracil, at a dose of 500 mg/m2 for 7 days, cannot be recommended as the sole adjuvant treatment for high-risk colorectal cancer after complete surgical excision. However, these results cannot eliminate a small benefit when PVI is used at a higher dosage or in combination with mitomycin.
authors.affiliation: Hôpital Ambroise-Paré, Boulogne, France. philippe.rougier@apr.ap-hop-paris.fr
authors.forename: P
authors.initials: P
authors.lastname: Rougier
authors.forename: T
authors.initials: T
authors.lastname: Sahmoud
authors.forename: D
authors.initials: D
authors.lastname: Nitti
authors.forename: D
authors.initials: D
authors.lastname: Curran
authors.forename: R
authors.initials: R
authors.lastname: Doci
authors.forename: B
authors.initials: B
authors.lastname: De Waele
authors.forename: T
authors.initials: T
authors.lastname: Nakajima
authors.forename: H
authors.initials: H
authors.lastname: Rauschecker
authors.forename: R
authors.initials: R
authors.lastname: Labianca
authors.forename: J C
authors.initials: JC
authors.lastname: Pector
authors.forename: S
authors.initials: S
authors.lastname: Marsoni
authors.forename: G
authors.initials: G
authors.lastname: Apolone
authors.forename: P
authors.initials: P
authors.lastname: Lasser
authors.forename: M L
authors.initials: ML
authors.lastname: Couvreur
authors.forename: J
authors.initials: J
authors.lastname: Wils
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000627:therapeutic use; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000401:mortality / Q000473:pathology* / Q000601:surgery*; D018450:Disease Progression; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000627:therapeutic use; D006493:Heparin / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D008113:Liver Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000517:prevention & control* / Q000556:secondary*; D008297:Male; D011169:Portal Vein; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000401:mortality / Q000473:pathology* / Q000601:surgery*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; D006493:Heparin; D005472:Fluorouracil