Gemcitabine and protracted 5-fluorouracil infusion as third-line chemotherapy in refractory colorectal cancer patients.

Background: There is no standard treatment for patients with advanced colorectal cancer (CRC) progressing after irinotecan and oxaliplatin treatment and having good performance status (PS). Patients and Methods: We investigated gemcitabine 1,000 mg/m(2) days 1, 8 and 15 q28d combined with protracted 5-fluorouracil continuous infusion at 200 mg/m(2)/day, in 37 consecutive patients progressing after oxaliplatin-irinotecan-containing chemotherapies. Results: Partial response (PR) was achieved in 4 (10.8%) and disease stabilization (SD) in 19 (51.4%) cases (PR+SD: 62.2%). Median time to progression and survival were 4.2 and 8.9 months, respectively. Grade III toxicities were thrombocytopenia, neutropenia (in 3 patients) and mucositis (in 2 patients). Clinical benefit was observed in 18 patients (48.6% of the entire population: 64.3% of those patients with PS>0 at study entry). Conclusion: The combination of gemcitabine and 5-fluorouracil continuous infusion was found to be an active and manageable palliative regimen for heavily pre-treated patients with metastatic CRC