title: Phase III study of capecitabine plus oxaliplatin compared with continuous-infusion fluorouracil plus oxaliplatin as first-line therapy in metastatic colorectal cancer: final report of the Spanish Cooperative Group for the Treatment of Digestive Tumors Trial.
abstract: OBJECTIVE
  The aim of this phase III trial was to compare the efficacy and safety of capecitabine plus oxaliplatin (XELOX) versus Spanish-based continuous-infusion high-dose fluorouracil (FU) plus oxaliplatin (FUOX) regimens as first-line therapy for metastatic colorectal cancer (MCRC).
  
  
  METHODS
  A total of 348 patients were randomly assigned to receive XELOX (oral capecitabine 1,000 mg/m2 bid for 14 days plus oxaliplatin 130 mg/m2 on day 1 every 3 weeks) or FUOX (continuous-infusion FU 2,250 mg/m2 during 48 hours on days 1, 8, 15, 22, 29, and 36 plus oxaliplatin 85 mg/m2 on days 1, 15, and 29 every 6 weeks).
  
  
  RESULTS
  There were no significant differences in efficacy between XELOX and FUOX arms, which showed, respectively, median time to tumor progression (TTP; 8.9 v 9.5 months; P = .153); median overall survival (18.1 v 20.8 months; P = .145); and confirmed response rate (RR; 37% v 46%; P = .539). The safety profile of the two regimens was similar, although there were lower rates of grade 3/4 diarrhea (14% v 24%) and grade 1/2 stomatitis (28% v 43%), and higher rates of grade 1/2 hyperbilirubinemia (37% v 21%) and grade 1/2 hand-foot syndrome (14% v 5%) with XELOX versus FUOX, respectively.
  
  
  CONCLUSIONS
  This randomized study shows a similar TTP of XELOX compared with FUOX in the first-line treatment of MCRC, although there was a trend for slightly lower RR and survival. XELOX can be considered as an alternative to FUOX.
authors.affiliation: Department of Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid, Spain. ediazrubio.hcsc@salud.madrid.org
authors.forename: Eduardo
authors.initials: E
authors.lastname: Díaz-Rubio
authors.forename: Jose
authors.initials: J
authors.lastname: Tabernero
authors.forename: Auxiliadora
authors.initials: A
authors.lastname: Gómez-España
authors.forename: Bartomeu
authors.initials: B
authors.lastname: Massutí
authors.forename: Javier
authors.initials: J
authors.lastname: Sastre
authors.forename: Manuel
authors.initials: M
authors.lastname: Chaves
authors.forename: Alberto
authors.initials: A
authors.lastname: Abad
authors.forename: Alfredo
authors.initials: A
authors.lastname: Carrato
authors.forename: Bernardo
authors.initials: B
authors.lastname: Queralt
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Reina
authors.forename: Joan
authors.initials: J
authors.lastname: Maurel
authors.forename: Encarnación
authors.initials: E
authors.lastname: González-Flores
authors.forename: Jorge
authors.initials: J
authors.lastname: Aparicio
authors.forename: Fernando
authors.initials: F
authors.lastname: Rivera
authors.forename: Ferrán
authors.initials: F
authors.lastname: Losa
authors.forename: Enrique
authors.initials: E
authors.lastname: Aranda
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage*; D000077150:Oxaliplatin; D013030:Spain; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil