FOLFOX3 in heavily pretreated patients with metastatic colorectal cancer.

BACKGROUND The combination of oxaliplatin, 5-fluorouracil (5FU) and leucovorin (LV) has shown to be active and safe as first- or second-line chemotherapy for metastatic colorectal cancer (MCC). PATIENTS AND METHODS The outcome of patients with MCC who had progressive disease after at least two lines of palliative chemotherapy and who were subsequently treated with oxaliplatin, 5FU and LV was reviewed. Patients received FOLFOX3 consisting of oxaliplatin (85 mg/m2) on day 1, LV (500 mg/m2) as a two-hour infusion on days 1 and 2, and 5FU (3000 mg/m2) as a 46-hour infusion starting on day 1 in a cycle of two weeks. RESULTS A total of 28 patients were treated with a median number of 9.5 cycles (range 1-24) at a mean dose intensity of 73%. Six patients discontinued treatment due to toxicity, of whom three had sensory neuropathy grade 2. Six patients experienced grade 3 toxicity: nausea (1), vomiting (1), diarrhoea (1), leucopenia (2) and thrombocytopenia (1); grade 4 toxicity was not observed. Twenty-five patients were evaluable for response, of whom four achieved a partial response (response rate 14%, based on intention to treat). The median progression-free survival was 5.8 months and the median overall survival was 8.5 months. CONCLUSION For heavily pretreated patients with MCC, the FOLFOX3 regimen is a fairly safe and effective treatment.