title: Oxaliplatin in combination with 5-fluorouracil (5-FU) and leucovorin (LV) in patients with metastatic gastric cancer (MGC).
abstract: OBJECTIVE
  Treatment options for advanced or metastatic gastric cancer (A/MGC) are limited and inclusion of novel substances is necessary. Few studies have confirmed the activity and tolerability of the combination of oxaliplatin (OXA) and 5-fluorouracil (5-FU) modulated with leucovorin (LV) administrated to patients with A/MGC. The goal of current study was to evaluate the efficacy and toxicity of Folfox-4 regimen in patients with A/MGC.
  
  
  METHODS
  Fifty-six patients were treated with Folfox-4 regimen. Treatment was continued until disease progression, unacceptable toxicity or until a patient chose to discontinue treatment. Responses to treatment and toxicity were recorded according to the WHO criteria and NCI toxicity criteria.
  
  
  RESULTS
  All patients were assessable for toxicity and response. Patients (71.4% male, 28.6% female) had a median age of 65 years (range, 28-78). All patients had histologically confirmed metastatic (89.3%) or advanced (10.7%) gastric cancer. Response was evaluated every 6 weeks; 1 complete (1.8%) and 23 (41.1%) partial remission were observed (overall response rate 42.9%). Twenty patients (35.7%) showed stable disease and 12 (21.4%) had a progressive disease. Median overall survival, time to progression and follow up were 10 months, 6 months, and 11.5 months, respectively. WHO grade 3 or 4 hematologic toxicities included leucopenia, neutropenia, thrombocytopenia, and anemia. No patient experienced neutropenic fever. Other grade 3/4 toxicities included nausea, vomiting, diarrhea, stomatitis, and anorexia. Three patients (5.3%) experienced grade 3 peripheral neuropathy. No treatment-related deaths were recorded.
  
  
  CONCLUSIONS
  Folfox-4 regimen is active and well tolerated in patients with advanced/metastatic gastric cancer.
authors.affiliation: Department of Oncology, Hospital of Piacenza, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Cavanna
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Artioli
authors.forename: Claudio
authors.initials: C
authors.lastname: Codignola
authors.forename: Antonio
authors.initials: A
authors.lastname: Lazzaro
authors.forename: Anna
authors.initials: A
authors.lastname: Rizzi
authors.forename: Alessandro
authors.initials: A
authors.lastname: Gamboni
authors.forename: Luigina
authors.initials: L
authors.lastname: Rota
authors.forename: Carmelina
authors.initials: C
authors.lastname: Rodinò
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Boni
authors.forename: Aldo
authors.initials: A
authors.lastname: Iop
authors.forename: Alberto
authors.initials: A
authors.lastname: Zaniboni
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil