title: Clinical trial to assess the relative efficacy of fluorouracil and leucovorin, fluorouracil and levamisole, and fluorouracil, leucovorin, and levamisole in patients with Dukes' B and C carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project C-04.
abstract: OBJECTIVE
  To compare the efficacy of leucovorin-modulated fluorouracil (FU+LV) with that of fluorouracil and levamisole (FU+LEV) or with the combination of FU+LV and levamisole (FU+LV+LEV).
  
  
  METHODS
  Between July 1989 and December 1990, 2,151 patients with Dukes' B (stage II) and Dukes' C (stage III) carcinoma of the colon were entered onto National Surgical Adjuvant Breast and Bowl Project protocol C-04. Patients were randomly assigned to receive FU+LV (weekly regimen), FU + LEV, or the combination of FU+LV+LEV. The average time on study was 86 months.
  
  
  RESULTS
  A pairwise comparison between patients treated with FU+LV or FU+LEV disclosed a prolongation in disease-free survival (DFS) in favor of the FU+LV group (65% v 60%; P =.04); there was a small prolongation in overall survival that was of borderline significance (74% v 70%; P =.07). There was no difference in the pairwise comparison between patients who received FU+LV or FU+LV+LEV for either DFS (65% v 64%; P =.67) or overall survival (74% v 73%; P =.99). There was no interaction between Dukes' stage and the effect of treatment.
  
  
  CONCLUSIONS
  In patients with Dukes' B and C carcinoma of the colon, treatment with FU+LV seems to confer a small DFS advantage and a borderline prolongation in overall survival when compared with treatment with FU+LEV. The addition of LEV to FU+LV does not provide any additional benefit over and above that achieved with FU+LV. These findings support the use of adjuvant FU+LV as an acceptable therapeutic standard in patients with Dukes' B and C carcinoma of the colon.
authors.affiliation: National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA 15212, USA. nwolmark@pgh.auhs.edu
authors.forename: N
authors.initials: N
authors.lastname: Wolmark
authors.forename: H
authors.initials: H
authors.lastname: Rockette
authors.forename: E
authors.initials: E
authors.lastname: Mamounas
authors.forename: J
authors.initials: J
authors.lastname: Jones
authors.forename: S
authors.initials: S
authors.lastname: Wieand
authors.forename: D L
authors.initials: DL
authors.lastname: Wickerham
authors.forename: H D
authors.initials: HD
authors.lastname: Bear
authors.forename: J N
authors.initials: JN
authors.lastname: Atkins
authors.forename: N V
authors.initials: NV
authors.lastname: Dimitrov
authors.forename: A G
authors.initials: AG
authors.lastname: Glass
authors.forename: E R
authors.initials: ER
authors.lastname: Fisher
authors.forename: B
authors.initials: B
authors.lastname: Fisher
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D007978:Levamisole / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local
chemical_list: D007978:Levamisole; D002955:Leucovorin; D005472:Fluorouracil