title: Adjuvant chemotherapy in the treatment of colon cancer: randomized multicenter trial of the Italian National Intergroup of Adjuvant Chemotherapy in Colon Cancer (INTACC).
abstract: BACKGROUND
  To determine whether the addition of leucovorin to the combination 5-fluorouracil plus levamisole prolongs disease-free survival and overall survival in patients with radically resected colon cancer (Dukes' B(2-3) and C).
  
  
  METHODS
  Patients (1703) were accrued between March 1992 and February 1995 in a large-scale clinical trial within five Italian cooperative groups. After stratification for center, patients were randomized as follows: arm A, 5-fluorouracil [450 mg/m(2) intravenous (i.v.) bolus on days 1-5] and levamisole (150 mg orally for 3 days, every 14 days for 6 months) versus arm B, 6-S-leucovorin (100 mg/m(2) i.v. bolus on days 1-5) followed by 5-fluorouracil (370 mg/m(2) i.v. bolus on days 1-5), plus levamisole (as arm A), every 4 weeks for six cycles.
  
  
  RESULTS
  After a median follow-up of 6.4 years no significant difference was seen for either disease-free survival (58% versus 60%, not significant) or 5-year overall survival (68% versus 71%, not significant), respectively. Gastrointestinal toxicity (World Health Organization grade 3/4) was more frequent in arm B (8% versus 18%, not significant).
  
  
  CONCLUSIONS
  In this trial the schedules used showed no statistically significant differences in terms of disease-free survival or overall survival in the treatment of colorectal cancer.
authors.affiliation: Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Parma, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Di Costanzo
authors.forename: A
authors.initials: A
authors.lastname: Sobrero
authors.forename: S
authors.initials: S
authors.lastname: Gasperoni
authors.forename: L
authors.initials: L
authors.lastname: Dogliotti
authors.forename: L
authors.initials: L
authors.lastname: Frassineti
authors.forename: A
authors.initials: A
authors.lastname: Falcone
authors.forename: R
authors.initials: R
authors.lastname: Lionetto
authors.forename: P
authors.initials: P
authors.lastname: Bruzzi
authors.forename: G
authors.initials: G
authors.lastname: Luppi
authors.forename: L
authors.initials: L
authors.lastname: Gallo
authors.forename: P
authors.initials: P
authors.lastname: Conte
authors.forename: A
authors.initials: A
authors.lastname: Comandone
authors.forename: D
authors.initials: D
authors.lastname: Turci
authors.forename: M
authors.initials: M
authors.lastname: Marzola
authors.forename: U
authors.initials: U
authors.lastname: Folco
authors.forename: E
authors.initials: E
authors.lastname: Pfanner
authors.forename: M
authors.initials: M
authors.lastname: Mestriner
authors.forename: C
authors.initials: C
authors.lastname: Boni
authors.forename: C
authors.initials: C
authors.lastname: Galli
authors.forename: M
authors.initials: M
authors.lastname: Tonato
authors.forename: R
authors.initials: R
authors.lastname: Rosso
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use*; D007978:Levamisole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D007978:Levamisole; D002955:Leucovorin; D005472:Fluorouracil