Oxaliplatin with biweekly, low dose leucovorin and bolus and continuous infusion 5-fluorouracil (Modified FOLFOX 4) as first-line therapy for patients with metastatic colorectal cancer.

PURPOSE: 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 metastatic colorectal cancer.
MATERIALS AND METHODS: Between March 2001 and August 2003, fifty-five patients were enrolled in this study. Patients were treated with oxaliplatin 85 mg/m(2) as a 2-hour infusion at days 1 plus LV 20 mg/m(2) over 10 minutes, followed by 5-FU bolusa 400 mg/m(2) bolus and 22 hour continuous infusion of 600 mg/m(2) 5-FU at day 1 approximately 2. This treatment was repeated in 2 week intervals.
RESULTS: The objective response rate was 40% on an intent-to-treatment analysis. Three patients (6%) demonstrated a complete response and nineteen patients (38%) showed a partial response. Sixteen patients (32%) showed a stable disease and eleven patients (22%) progressed during the course of the treatment. The median time to progression and overall survival time were as 6.6 months (95% CI: 4.98 approximately 8.02 months) and the median overall survival time was 17.0 months (95% CI: 9.15 approximately 24.85 months) from the start of the chemotherapy, respectively. A total of 275 cycles were analyzed for toxicity. Major hematologic toxicities included grade 1 approximately 2 anemia (23.5%), neutropenia (25.3%) and thrombocytopenia (10.6%). There were only 2 cycles of neutropenic fever. The most common non-hematologic toxicities were grade 1 approximately 2 nausea/vomiting (10.9%), diarrhea (9.1%) and grade 1 neuropathy (18.0%). There was no treatment related death.
CONCLUSION: The modified folfox 4 regimen is safe and effective regimen as a first-line therapy in advanced colorectal cancer patients.