title: Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07.
abstract: OBJECTIVE
  This phase III clinical trial evaluated the impact on disease-free survival (DFS) of adding oxaliplatin to bolus weekly fluorouracil (FU) combined with leucovorin as surgical adjuvant therapy for stage II and III colon cancer.
  
  
  METHODS
  Patients who had undergone a potentially curative resection were randomly assigned to either FU 500 mg/m2 intravenous (IV) bolus weekly for 6 weeks plus leucovorin 500 mg/m2 IV weekly for 6 weeks during each 8-week cycle for three cycles (FULV), or the same FULV regimen with oxaliplatin 85 mg/m2 IV administered on weeks 1, 3, and 5 of each 8-week cycle for three cycles (FLOX).
  
  
  RESULTS
  A total of 2,407 patients (96.6%) of the 2,492 patients randomly assigned were eligible. Median follow-up for patients still alive is 42.5 months. The hazard ratio (FLOX v FULV) is 0.80 (95% CI, 0.69 to 0.93), a 20% risk reduction in favor of FLOX (P < .004). The 3- and 4-year disease-free survival (DFS) rates were 71.8% and 67.0% for FULV and 76.1% and 73.2% for FLOX, respectively. Grade 3 neurosensory toxicity was noted in 8.2% of patients receiving FLOX and in 0.7% of those receiving FULV (P < .001). Hospitalization for diarrhea associated with bowel wall thickening occurred in 5.5% of the patients receiving FLOX and in 3.0% of the patients receiving FULV (P < .01). A total of 1.2% of patients died as a result of any cause within 60 days of receiving chemotherapy, with no significant difference between regimens.
  
  
  CONCLUSIONS
  The addition of oxaliplatin to weekly FULV significantly improved DFS in patients with stage II and III colon cancer. FLOX can be recommended as an effective option in clinical practice.
authors.affiliation: National Surgical Adjuvant Breast and Bowel Project Operations Office and Biostatistical Center, Pittsburgh, PA, USA.
authors.forename: J Philip
authors.initials: JP
authors.lastname: Kuebler
authors.forename: H Samuel
authors.initials: HS
authors.lastname: Wieand
authors.forename: Michael J
authors.initials: MJ
authors.lastname: O'Connell
authors.forename: Roy E
authors.initials: RE
authors.lastname: Smith
authors.forename: Linda H
authors.initials: LH
authors.lastname: Colangelo
authors.forename: Greg
authors.initials: G
authors.lastname: Yothers
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Petrelli
authors.forename: Michael P
authors.initials: MP
authors.lastname: Findlay
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Seay
authors.forename: James N
authors.initials: JN
authors.lastname: Atkins
authors.forename: John L
authors.initials: JL
authors.lastname: Zapas
authors.forename: J Wendall
authors.initials: JW
authors.lastname: Goodwin
authors.forename: Louis
authors.initials: L
authors.lastname: Fehrenbacher
authors.forename: Ramesh K
authors.initials: RK
authors.lastname: Ramanathan
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Conley
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Flynn
authors.forename: Gamini
authors.initials: G
authors.lastname: Soori
authors.forename: Lauren K
authors.initials: LK
authors.lastname: Colman
authors.forename: Edward A
authors.initials: EA
authors.lastname: Levine
authors.forename: Keith S
authors.initials: KS
authors.lastname: Lanier
authors.forename: Norman
authors.initials: N
authors.lastname: Wolmark
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil