title: Capecitabine in combination with Oxaliplatin (XELOX) as a first-line therapy for advanced gastric cancer.
abstract: OBJECTIVE
  We evaluated efficacy and safety of XELOX in previously untreated patients with AGC.
  
  
  METHODS
  Patients received intravenous oxaliplatin 130 mg/m(2) over 2 h on day 1 plus oral capecitabine 1,000 mg/m(2) twice daily on days 1-14, every 3 weeks (XELOX). Treatment was continued until disease progression, intolerable toxicities or eight cycles reached. All tumour evaluations were reviewed and confirmed centrally. Design was according to Ensign's three-stage method.
  
  
  RESULTS
  Fifty-four patients (37 men) were enrolled; median age 57 years (range 29-70). In total, 311 cycles of XELOX were delivered. Overall response rate was 63% (95% CI, 50-76%), with 3 complete and 31 partial responses. At 13 months' median follow-up, median progression-free and overall survival were 5.8 (95% CI, 4.4-7.2) and 11.9 months (95% CI, 8.8-15.1), respectively. The most common haematological adverse event was anaemia (70% of patients). Grade 3-4 neutropenia was observed in four patients, with neutropenic fever in only one patient. Most common non-haematological toxicities were neuropathy (70%), vomiting (50%), diarrhoea (33%), and hand-foot syndrome (HFS) (39%). Grade 3-4 toxicities were rare. Treatment was delayed or the dose reduced in 30 and 15% of cycles, respectively. There was one treatment-related death associated with grade 4 neutropenic sepsis.
  
  
  CONCLUSIONS
  XELOX was active and well tolerated as a first-line therapy for AGC.
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Korea Institute of Radiological and Medical Sciences, Seoul, 139-706, South Korea.
authors.forename: Yeon Hee
authors.initials: YH
authors.lastname: Park
authors.forename: Jae-Lyun
authors.initials: JL
authors.lastname: Lee
authors.forename: Baek-Yeol
authors.initials: BY
authors.lastname: Ryoo
authors.forename: Min-Hee
authors.initials: MH
authors.lastname: Ryu
authors.forename: Sung Hyun
authors.initials: SH
authors.lastname: Yang
authors.forename: Bong Seog
authors.initials: BS
authors.lastname: Kim
authors.forename: Dong Bok
authors.initials: DB
authors.lastname: Shin
authors.forename: Heung Moon
authors.initials: HM
authors.lastname: Chang
authors.forename: Tae Won
authors.initials: TW
authors.lastname: Kim
authors.forename: Young Jin
authors.initials: YJ
authors.lastname: Yuh
authors.forename: Yoon-Koo
authors.initials: YK
authors.lastname: Kang
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; 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; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy*; D016019:Survival Analysis
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil