title: Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial.
abstract: BACKGROUND
  To compare capecitabine/cisplatin with 5-fluorouracil/cisplatin as first-line treatment for advanced gastric cancer (AGC).
  
  
  METHODS
  In this randomised, open-label, phase III study, patients received cisplatin (80 mg/m(2) i.v. day 1) plus oral capecitabine (1000 mg/m(2) b.i.d., days 1-14) (XP) or 5-FU (800 mg/m(2)/day by continuous infusion, days 1-5) (FP) every 3 weeks. The primary end point was to confirm noninferiority of XP versus FP for progression-free survival (PFS).
  
  
  RESULTS
  A total of 316 patients were randomised to XP (n = 160) or FP (n = 156). In the per-protocol population, median PFS for XP (n = 139) versus FP (n = 137) was 5.6 versus 5.0 months. The primary end point was met with an unadjusted hazard ratio (HR) of 0.81 [95% confidence interval (CI) 0.63-1.04, P < 0.001 versus noninferiority margin of 1.25]. Median overall survival was 10.5 versus 9.3 months for XP versus FP (unadjusted HR = 0.85, 95% CI 0.64-1.13, P = 0.008 versus noninferiority margin of 1.25). The most common treatment-related grade 3/4 adverse events in XP versus FP patients were as follows: neutropenia (16% versus 19%), vomiting (7% versus 8%), and stomatitis (2% versus 6%).
  
  
  CONCLUSIONS
  XP showed significant noninferiority for PFS versus FP in the first-line treatment of AGC. XP can be considered an effective alternative to FP.
authors.affiliation: Division of Oncology, Department of Internal Medicine, Asan Medical Center, Songpa-Gu, Seoul, Republic of Korea. ykkang@amc.seoul.kr
authors.forename: Y-K
authors.initials: YK
authors.lastname: Kang
authors.forename: W-K
authors.initials: WK
authors.lastname: Kang
authors.forename: D-B
authors.initials: DB
authors.lastname: Shin
authors.forename: J
authors.initials: J
authors.lastname: Chen
authors.forename: J
authors.initials: J
authors.lastname: Xiong
authors.forename: J
authors.initials: J
authors.lastname: Wang
authors.forename: M
authors.initials: M
authors.lastname: Lichinitser
authors.forename: Z
authors.initials: Z
authors.lastname: Guan
authors.forename: R
authors.initials: R
authors.lastname: Khasanov
authors.forename: L
authors.initials: L
authors.lastname: Zheng
authors.forename: M
authors.initials: M
authors.lastname: Philco-Salas
authors.forename: T
authors.initials: T
authors.lastname: Suarez
authors.forename: J
authors.initials: J
authors.lastname: Santamaria
authors.forename: G
authors.initials: G
authors.lastname: Forster
authors.forename: P I
authors.initials: PI
authors.lastname: McCloud
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000188:drug therapy*; D016019:Survival Analysis
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil