A Phase II Study of Oxaliplatin with ELF Regimen in Patients with Advanced Gastric Cancer

4206 Background: ELF (Etoposide, Leucovorin, 5-FU) regimen is widely used in gastric cancer. Oxaliplatin (Eloxatin) is a third generation platinum compound with activity against gastric cancer. A phase II study was conducted to evaluate the efficacy and safety of the combination of Oxaliplatin and ELF regimen in the treatment of patients with advanced gastric cancer. Methods: Patients received Oxaliplatin 100mg/ m2 2hr on day 1, calcium folinate 200mg/m2 1/2 hr on day 1–3, 5-FU 500mg/ m2 2 hr on day 1–3 and etoposide 100mg/ m2 3 hr on day1–3. Cycles were repeated every 21 days. Efficacy and safety were evaluated every 3 cycles and responses were re-confirmed 4 weeks later. Forty-five patients were entered in the study: 46% male / 54% female, median age 44 years (range 28 – 72 yrs), 38 adenocarcinoma and 7 signet ring cell carcinoma, 64% newly diagnosed disease and 36% previously treated. Results: A total of 172 cycles were given, 39 patients were analyzed for response. There were 7 complete responses and 13 partial responses (response rate 51%), 11 stable disease (28%) and 8 progressive disease (21%). The median time to progression was 5.8 months and median overall survival was 8.2 months. All patients were analyzed for toxicity. The most common hematologic toxicity were anemia in 24.4% of patients (7/45 Gr1, 4/45 Gr2), leucopenia in 53.3% (16/45 Gr1, 4/45 Gr2, 4/45 Gr3) and thrombocytopenia in 22.2% ( 6/45 Gr1, 3/45 Gr2, 1/45 Gr3). No Gr4 anemia, leucopenia and thrombocytopenia were observed. The most common non-hematologic toxicity was nausea/vomiting: 48.9% of patients (15/45 Gr1, 4/45 Gr2, 3/45 Gr3). Peripheral neuropathy was noted in 44.4% of patients (12/45 Gr1, 5/45 Gr2, 3/45 Gr3; NCI scale). Grade 3 & 4 alopecia was noted in 13 cases (29%). Conclusions: This Oxaliplatin / ELF regimen shows good efficacy and an acceptable safety profile in advanced gastric cancer patients and may proved to be a suitable alternative regimen in this indication. No significant financial relationships to disclose.