A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FLFOX-4) as first-line treatment of advanced gastric cancer patients.

Background: The purpose of this study was to assess the toxicity and clinical activity of biweekly oxaliplatin in combination with infusional 5-fluorouracil and folinic acid administered every 2 weeks (FOLFOX4 regimen) in patients with advanced gastric cancer (AGC). Patients and methods: Sixty-one previously untreated AGC patients were treated with oxaliplatin 85mg/m2 on day 1, folinic acid (FA) 200mg/m2 as a 2-h infusion followed by bolus 5-fluorouracil (5-FU), 400 mg/m2 and a 22-h infusion of 5-FU, 600 mg/m2, repeated for two consecutive days every 2 weeks. Results: All patients were assessable for toxicity and response to treatment. Patient characteristic were: sex (male, 38; female, 23); median age, 64 years (range, 47–75 years); Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, nine patients; 1, 39 patients; 2, 13 patients; metastatic disease, 56 patients; locally advanced disease, five patients. Four (7%) complete responses (CR) and 19 partial responses (PR) were observed (overall response rate, 38%). Stable disease (SD) was observed in 22 (36%) patients, with progressive disease (PD) in the other six (10%) patients. Median time to progression (TTP) and median overall survival (OS) were 7.1 and 11.2 months, respectively. NCI common toxicity criteria grade 3 and 4 hematologic toxic effects were neutropenia, anemia and thrombocytopenia in 36%, 10% and 5% patients, respectively. Grade 3 peripheral neuropathy was recorded in three (5%) patients. No treatment-related deaths were observed. Conclusion: FOLFOX-4 is an active and well tolerated chemotherapy. RR, TTP and OS were comparable with those of other oxaliplatin-based regimens, suggesting a role for this combination in gastric cancer