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

To determine the activity and toxicities of a low dose leucovorin ( ldLV) plus fluorouracil ( 5-FU) regimen, combined with oxaliplatin administered fortnightly ( modified FOLFOX-4), as a first-line therapy for patients with advanced gastric cancer. Patients were treated with cycles of oxaliplatin 85 mg/m(2) on day 1 plus LV 20 mg/m(2), followed by 5-FU a 400 mg/m(2) bolus and a 22 hour continuous infusion of 600 mg/m(2) 5-FU on days 1-2 every two week intervals. Forty-five patients were enrolled in this study. Forty-two patients were assessable for response. One of the 42 patients demonstrated complete response, and 20 partial responses, and overall response rate of 50%. The median time to progression and overall survival time were 7.7 months ( 95% CI: 3.6-11.9 months) and 11.2 months ( 95% CI: 9.1-13.3 months), respectively. Major hematologic toxicities included grade 1-2 anemia ( 39.7%), neutropenia ( 30.4%) and grade 3-4 neutropenia ( 10.9%). Twelve cycles were associated with neutropenic fever. The most common non-hematological toxicities were grade 2 nausea/vomiting ( 20%). There was no treatment related death. The modified FOLFOX-4 regimen was found to be a safe and effective first line therapy in advanced gastric cancer.