A phase II study of oxaliplatin with biweekly, low dose leucovorin and bolus and continuous infusion 5-fluorouracil (modified FOLFOX-4) as first line therapy for patients with advanced or metastatic gastric cancer

14052 Background: To determine the activity and toxicities of low dose leucovorin (LV) plus fluorouracil (5-FU) regimen, combined with oxaliplatin every two weeks (modified FOLFOX-4), as a first-line therapy for patients with advanced or recurrent gastric cancer. Methods: Between January 2003 and March 2005, forty-five patients were enrolled in this study. Patients were treated with oxaliplatin 85 mg/m2 as a 2-hour infusion at day 1 plus LV 20 mg/m2 over 10 minutes, followed by 5-FU a 400 mg/m2 bolus and 22 hour continuous infusion of 600 mg/m2 5-FU at day 1–2. This treatment was repeated in 2 week intervals. Results: There was one patient (2.2%) demonstrated a complete response. Twenty patients (44.4%) showed a partial response. Overall response rate was 46.6%. Ten patients (22.2%) showed a stable disease and fourteen patients (31.1%) progressed during the course of the treatment. The median time to progression and overall survival time were 7.73 months (95% CI: 3.6–11.86 months) and 11.17 months (95% CI: 9.06–13.28 months) from the start of the chemotherapy, respectively. A total of 247 cycles were analyzed for toxicity. Major hematologic toxicities included grade 1–2 anemia (39.7%), neutropenia (30.4%), grade 3–4 neutropnenia (10.9%) and thrombocytopenia (9.3%).There were 12 cycles of neutropenic fever. The most common non-hematological toxicities were grade 2 nausea/vomiting (20%), grade 1–2 neuropathy (13.4%) and grade 3 diarrhea (2.2%). There was no treatment related death. Conclusions: The modified FOLFOX-4 regimen is safe and effective regimen as a first line therapy in advanced or metastatic gastric cancer. No significant financial relationships to disclose.