title: Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients.
abstract: OBJECTIVE
  To report the results of a planned safety analysis from a phase III trial comparing capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil/leucovorin (FU/LV) as adjuvant therapy for stage III colon cancer.
  
  
  METHODS
  Patients with stage III colon carcinoma were randomly assigned to receive either XELOX (intravenous oxaliplatin plus oral capecitabine; 3-week cycle for eight cycles) or standard intravenous bolus FU/LV administered as the Mayo Clinic (Mayo; Rochester, MN) or Roswell Park (RP; Buffalo, NY) regimen for a similar length of time. A total of 1,886 patients were randomly assigned.
  
  
  RESULTS
  The safety population comprised 1,864 patients, of whom 938 received XELOX and 926 received FU/LV. Most treatment-related adverse events (AEs) occurred at similar rates in both treatment arms. However, patients receiving XELOX experienced less all-grade diarrhea, alopecia, and more neurosensory toxicity, vomiting, and hand-foot syndrome than those patients receiving FU/LV. Compared with Mayo, XELOX showed fewer grade 3/4 hematologic AE and more grade 3/4 gastrointestinal AE. Compared with RP, XELOX showed less grade 3/4 gastrointestinal AE and more grade 3/4 hematologic AE. As expected grade 3/4 neurosensory toxicity and grade 3 hand-foot syndrome were higher with XELOX. Treatment-related mortality within 28 days from the last study dose was 0.6% in the XELOX group and 0.6% in the FU/LV group.
  
  
  CONCLUSIONS
  XELOX has a manageable tolerability profile in the adjuvant setting. Efficacy data will be available within the next 24 months.
authors.affiliation: Martin Luther University, Halle, Germany. hans-joachim.schmoll@medizin.uni-halle.de
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Schmoll
authors.forename: Thomas
authors.initials: T
authors.lastname: Cartwright
authors.forename: Josep
authors.initials: J
authors.lastname: Tabernero
authors.forename: Marek P
authors.initials: MP
authors.lastname: Nowacki
authors.forename: Arie
authors.initials: A
authors.lastname: Figer
authors.forename: Jean
authors.initials: J
authors.lastname: Maroun
authors.forename: Timothy
authors.initials: T
authors.lastname: Price
authors.forename: Robert
authors.initials: R
authors.lastname: Lim
authors.forename: Eric
authors.initials: E
authors.lastname: Van Cutsem
authors.forename: Young-Suk
authors.initials: YS
authors.lastname: Park
authors.forename: Joseph
authors.initials: J
authors.lastname: McKendrick
authors.forename: Claire
authors.initials: C
authors.lastname: Topham
authors.forename: Gemma
authors.initials: G
authors.lastname: Soler-Gonzalez
authors.forename: Filipo
authors.initials: F
authors.lastname: de Braud
authors.forename: Mark
authors.initials: M
authors.lastname: Hill
authors.forename: Florin
authors.initials: F
authors.lastname: Sirzén
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Haller
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant / Q000379:methods*; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000627:therapeutic use*; D000077150:Oxaliplatin; D012107:Research Design; D012449:Safety; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D002955:Leucovorin; D005472:Fluorouracil