title: Oxaliplatin combined with continuous infusion of 5-fluorouracil as first-line chemotherapy in patients with metastatic or recurrent gastric adenocarcinoma.
abstract: BACKGROUND
  The aim of this clinical study was to evaluate the efficacy of combination chemotherapy of oxaliplatin, leucovorin and continuous-infusion 5-fluorouracil (5-FU) for advanced gastric cancer.
  
  
  METHODS
  Patients with previously untreated gastric cancer with measurable disease received oxaliplatin (100 mg/m(2), day 1), followed by leucovorin (100 mg/m(2), day 1) and 5-FU (2,400 mg/m(2), days 1-2), which was repeated every 2 weeks. The primary endpoint was overall response rate (ORR) and secondary endpoints were progression-free survival (PFS), overall survival (OS) and toxicity.
  
  
  RESULTS
  Forty-eight patients were enrolled, and 45 were evaluable for response. A total of 320 cycles of chemotherapy were administered (median 6 cycles per patient). One complete response (2.1%) and 19 partial responses (39.6%) were noted, resulting in an ORR of 41.7% (95% confidence interval, CI: 27.7-55.6%) by intent-to-treat analysis. With a median follow-up duration of 22 months, the median PFS was 5.3 (95% CI: 2.8-7.8) months and the median OS was 13.6 (95% CI: 9.3-17.9) months. There was 1 treatment-related death, and the most common grade 3/4 toxicity was neutropenia (36.1%). Three patients discontinued treatment because of serum creatinine elevation.
  
  
  CONCLUSIONS
  This study reaffirms the efficacy of oxaliplatin in advanced gastric cancer, but its dose of 100 mg/m(2) remains to be reconsidered in Korean patients.
authors.affiliation: Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Jae Yun
authors.initials: JY
authors.lastname: Lim
authors.forename: Jae Yong
authors.initials: JY
authors.lastname: Cho
authors.forename: Kyung Jin
authors.initials: KJ
authors.lastname: Oh
authors.forename: Seung Ho
authors.initials: SH
authors.lastname: Choi
authors.forename: Sang In
authors.initials: SI
authors.lastname: Lee
authors.forename: Hei-Cheul
authors.initials: HC
authors.lastname: Jeung
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005472:Fluorouracil