Oxaliplatin, 5-fluorouracil and Leucovorin (FOLFOX-4) Combination Chemotherapy as a Salvage Treatment in Advanced Gastric Cancer

Purpose This study was designed to determine the efficacy and safety of FOLFOX-4 chemotherapy as a salvage treatment for patients with advanced gastric cancer (AGC). Materials and Methods The AGC patients with an ECOG performance status of 0 similar to 1 and progressive disease after prior treatments were registered onto this phase II trial. The patients received oxaliplatin (85 mg/m(2) on day 1), leucovorin (200 mg/m(2) on days 1 and 2) and 5-fluorouracil (400 mg/m(2) as a bolus and 600 mg/m(2) as a 22-hour infusion on days 1 and 2) every 2 weeks. Results For the 42 treated patients, a total of 228 chemotherapy cycles (median: 5, range: 1 similar to 12) were administered. Twenty-nine patients (69%) received FOLFOX-4 chemotherapy as a third(50%) or fourth-line (19%) treatment. On the intent-to-treat analysis, 9 patients (21%) achieved a partial response, which was maintained for 4.6 months. The median progression-free survival and overall survival were 3.0 months and 6.2 months, respectively. The frequently encountered toxicities were neutropenia and gastrointestinal side effects, including anorexia. Although there was one possible treatment-related death, the toxicity profiles were generally predictable and manageable. Conclusion Salvage chemotherapy with FOLFOX-4 is an effective and tolerable regimen for those heavily pretreated AGC patients who have a good performance status.