title: Efficacy of capecitabine versus 5-fluorouracil in colorectal and gastric cancers: a meta-analysis of individual data from 6171 patients.
abstract: BACKGROUND
  To compare the effects of oral capecitabine-containing chemotherapy regimens with i.v. 5-fluorouracil (5-FU)-containing chemotherapy regimens on overall survival in patients with gastrointestinal cancers.
  
  
  METHODS
  A meta-analysis, based on individual patient data from six randomised non-inferiority trials, was carried out at the request of regulatory authorities to compare the effects of single-agent capecitabine or capecitabine-containing chemotherapy versus matched 5-FU-based regimens in terms of overall survival in patients with stage III colon, metastatic colorectal or advanced gastric cancer.
  
  
  RESULTS
  Data from a total of 6171 patients with stage III colon cancer (n = 1987), metastatic colorectal cancer (n = 3868) or advanced gastric cancer (n = 316) were included. A total of 3097 patients were treated with capecitabine-containing chemotherapy and 3074 patients with 5-FU-containing chemotherapy. The unadjusted hazard ratio for overall survival for capecitabine-containing chemotherapy versus 5-FU-containing chemotherapy was 0.94 (95% confidence interval 0.89-1.00; P = 0.0489).
  
  
  CONCLUSIONS
  Oral capecitabine is at least equivalent to i.v. 5-FU in terms of overall survival in patients with gastrointestinal cancers. Capecitabine and 5-FU can be used interchangeably in these patient populations.
authors.affiliation: Glasgow University, Glasgow, UK. Electronic address: j.cassidy@beatson.gla.ac.uk.
authors.forename: J
authors.initials: J
authors.lastname: Cassidy
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, USA.
authors.forename: L
authors.initials: L
authors.lastname: Saltz
authors.affiliation: University of Leeds, Leeds, UK.
authors.forename: C
authors.initials: C
authors.lastname: Twelves
authors.affiliation: University Hospital Gasthuisberg, Leuven, Belgium.
authors.forename: E
authors.initials: E
authors.lastname: Van Cutsem
authors.affiliation: Centro De Oncologia/Hospital Sirio Libanes, São Paulo, Brazil.
authors.forename: P
authors.initials: P
authors.lastname: Hoff
authors.affiliation: Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Y
authors.initials: Y
authors.lastname: Kang
authors.affiliation: F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: J P
authors.initials: JP
authors.lastname: Saini
authors.affiliation: F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: F
authors.initials: F
authors.lastname: Gilberg
authors.affiliation: The Royal Marsden Hospital, Sutton, UK.
authors.forename: D
authors.initials: D
authors.lastname: Cunningham
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D015999:Multivariate Analysis; D016032:Randomized Controlled Trials as Topic; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil