A Phase II Trial of Oxaliplatin, Folinic Acid, and 5-Fluorouracil (FOLFOX4) as First-Line Chemotherapy in Advanced Colorectal Cancer: A China Single-Center Experience

Abstract

Purpose: To evaluate the efficacy and toxicity of leucovorin (LV) plus 5-fluorouracil (5-FU) combined with oxaliplatin every 2 weeks on previously untreated advanced colorectal cancer patients in Chinese population. Patients and methods: Forty-nine patients were enrolled to receive, entirely as inpatients, 2-weekly cycles of oxaliplatin 85 mg/m² i.v. over 2 hours on Day 1, together with leucovorin 200 mg/m² over 2 hours, 5-FU 400 mg/m², bolus, followed by a 22-hours infusion of 5-FU at 600 mg/m² Days 1–2 (FOLFOX4) every 2 weeks. Treatment was given until progression or unmanageable toxicity. In all, 49 patients received ≥ 1 oxaliplatin dose and a median of 7 treatment cycles (range 1∼ 27 cycles). Results: Of the 45 eligible patients, 1 complete response (CR) and 18 partial responses (PRs) were observed for an overall response rate of 42.2 percent (95 percent confidence interval 26∼ 56 percent). Median progression-free survival was 7.2 months (6.4∼ 8.0) and median overall survival was 14.8 months (13.1∼ 16.5). Six patients (12.2 percent) reported Grade 3∼ 4 neutropenia. Thirty-one patients (62.3 percent) experienced Grade 1∼3 neurotoxicity and only 5 patients (10.2 percent) experienced Grade 3 neurotoxicity. Conclusion: In our experience, FOLFOX4 regimen is active and well tolereated in patients with previously untreated advanced colorectal cancer in Chinese population.

Keywords:

• Colorectal cancer
• 5-fluorouracil infusion
• Leucovorin
• Oxaliplatin