title: A randomised phase III intergroup trial comparing high-dose infusional 5-fluorouracil with or without folinic acid with standard bolus 5-fluorouracil/folinic acid in the adjuvant treatment of stage III colon cancer: the Pan-European Trial in Adjuvant Colon Cancer 2 study.
abstract: OBJECTIVE
  To investigate whether infusional high-dose 5-flurouracil (HD-FU) provides a significant improvement in recurrence-free survival (RFS) and overall survival (OS) compared with a standard bolus 5-FU regimen (Mayo Clinic) in patients with curatively resectable stage III colon cancer.
  
  
  METHODS
  Patients (n=1601) were randomised to receive either the Mayo Clinic regimen or one of the three HD-FU regimens; LV5FU2, the Arbeitsgemeinschaft Internistische Onkologie (AIO) or the Grupo Espaňol para el Tratamiento Digestivos (TTD), the data from which were combined to provide the HD-FU arm for final analysis.
  
  
  RESULTS
  Patients were evenly balanced for age, TMN, tumor grade and vascular and lymphatic invasion. Median follow-up was approximately 42months, RFS (hazard ratio [HR]=0.997) and OS (HR=0.96) (primary end-point) were not statistically different between the two treatment arms. Infusional HD-FU was generally better tolerated than bolus 5-FU regimen.
  
  
  CONCLUSIONS
  Infusional HD-FU does not improve RFS and OS in curatively resected stage III colon cancer patients compared to the Mayo Clinic regimen, but is less toxic.
authors.affiliation: Department of Oncology and Hematology, Klinikum Oldenburg, European Medical School Oldenburg/Groningen, Carl von Ossietzky University, Oldenburg, Germany. onkologie@klinikum-oldenburg.de
authors.forename: Claus-Henning
authors.initials: CH
authors.lastname: Köhne
authors.forename: Laurent
authors.initials: L
authors.lastname: Bedenne
authors.forename: Alfredo
authors.initials: A
authors.lastname: Carrato
authors.forename: Olivier
authors.initials: O
authors.lastname: Bouché
authors.forename: Ivan
authors.initials: I
authors.lastname: Popov
authors.forename: Losa
authors.initials: L
authors.lastname: Gaspà
authors.forename: Manuel
authors.initials: M
authors.lastname: Valladares
authors.forename: Phillipe
authors.initials: P
authors.lastname: Rougier
authors.forename: Christiane
authors.initials: C
authors.lastname: Gog
authors.forename: Peter
authors.initials: P
authors.lastname: Reichardt
authors.forename: Jacques
authors.initials: J
authors.lastname: Wils
authors.forename: Francesco
authors.initials: F
authors.lastname: Pignatti
authors.forename: Frank
authors.initials: F
authors.lastname: Biertz
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002955:Leucovorin; D005472:Fluorouracil