Phase II study of combination chemotherapy of 5-fluorouracil, low-dose leucovorin, and oxaliplatin (FLOX regimen) in pretreated advanced gastric cancer

This phase II study describes the efficacy and safety of combination chemotherapy of 5-fluorouracil (5-FU), low-dose leucovorin, and oxaliplatin (FLOX regimen) for pretreated advanced gastric cancer. Patients who had been previously treated with greater than or equal to one regimen were enrolled. Patients received an oxaliplatin 75 mg/m2 on day 1, 5-FU 1000 mg/m2 on days 1–3, and leucovorin 20 mg/m2 on days 1–3, every 3 weeks. The primary end point was overall survival (OS). Among the 52 patients enrolled, 26 patients were treated as second line, and the remaining 26 patients were enrolled as third- or fourth line. A total of 203 cycles of chemotherapy were administered with the median being three cycles (range 1–15) per patient. The median OS was 6.6 months [95% confidence interval (CI) 4.5–8.8] and the median progression-free survival was 2.5 months (95% CI 1.9–3.0). The response rate was 4% (95% CI 0–9%), and the disease control rate was 48% (95% CI 34–62%). The most common toxic effects of grade 3/4 were neutropenia (16%) and vomiting (6%). The FLOX regimen showed modest activity as a salvage treatment in pretreated advanced gastric cancer with a favorable compliance.