title: A retrospective study of the safety and efficacy of a first-line treatment with modified FOLFOX-4 in unresectable advanced or recurrent gastric cancer patients.
abstract: OBJECTIVE
  Dismal clinical results in patients with unresectable advanced or recurrent gastric cancer highlight the need for effective systemic chemotherapy. An increase in adverse events associated with systemic chemotherapy is shown in elderly patients, but it remains controversial whether they should receive the same chemotherapy used for younger patients. We retrospectively studied 73 patients with unresectable advanced or recurrent gastric cancer, including 48 nonelderly patients (<65 years old) and 25 elderly patients (≥65 years old) who received a combination of oxaliplatin, 5-fluorouracil and leucovorin (modified FOLFOX-4, mFOLFOX-4 regimen).
  
  
  METHODS
  From January 2006 to June 2011, 73 patients with histologically confirmed unresectable advanced or recurrent gastric cancer were enrolled in this study. All patients were treated with an mFOLFOX-4 regimen of 85 mg/m(2) of oxaliplatin and 200 mg/m(2) of leucovorin on the first day, followed by a 24-hour continuous infusion of 1,000 mg/m(2) of 5-fluorouracil in 2 days with a 2-week interval. Treatment continued until disease progression or intolerable adverse events occurred.
  
  
  RESULTS
  Overall response rates show clinical efficacy (41.1%, 30/73 patients), stable cancer (26.0%, 19/73 patients) and progressive cancer (32.9%, 24/73 patients). The response rate was 36.0% in the elderly group and 43.8% in the nonelderly group (p = 0.891). In elderly patients, the overall time to progression was 8.1 months and the median overall survival was 11.9 months. On the other hand, in nonelderly patients, the overall time to progression was 7.9 months (p = 0.483) and the median overall survival was 11.2 months (p = 0.953). The results show no statistical differences in efficacy and adverse events between elderly and nonelderly groups (all p > 0.05).
  
  
  CONCLUSIONS
  The mFOLFOX-4 therapy is an effective and safe first-line treatment for unresectable advanced or recurrent gastric cancer patients. Moreover, mFOLFOX-4 was well tolerated and effective in both nonelderly and elderly patients.
authors.affiliation: Division of Trauma, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan, ROC.
authors.forename: Yung-Sung
authors.initials: YS
authors.lastname: Yeh
authors.forename: Hsiang-Lin
authors.initials: HL
authors.lastname: Tsai
authors.forename: Cheng-Jen
authors.initials: CJ
authors.lastname: Ma
authors.forename: Deng-Chyang
authors.initials: DC
authors.lastname: Wu
authors.forename: Chien-Yu
authors.initials: CY
authors.lastname: Lu
authors.forename: I-Chen
authors.initials: IC
authors.lastname: Wu
authors.forename: Ming-Feng
authors.initials: MF
authors.lastname: Hou
authors.forename: Jaw-Yuan
authors.initials: JY
authors.lastname: Wang
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use; D000077150:Oxaliplatin; D012008:Recurrence; D012189:Retrospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil