Treatment of Advanced Colorectal Cancer with Recombinant Interferon Alpha and Fluorouracil: Activity in Liver Metastasis

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Abstract
A cohort of 35 patients with advanced colorectal cancer, not previously exposed to chemotherapy, were included in a phase II study exploring the combination ofinterferon-alpha, 9 MU subcutaneously three times weekly, and 5-fluorouracil 750 mg/nf/day during 5 consecutive days in continuous intravenous infusion followed with weekly bolus injection offluorouracil 750mg/m2. Of 33 cases evaluablefor activity; 5 patients achieved partial response and 3 complete response for an overall response rate of 24% (95%; confidence limit 11-42 %). Most of the responses were observed in liver metastases, response rate = 30% (95%; CL 13-53%), with little activity observed in other sites; response rate 3% (95%; CL 8-16%), p =. 0006. The median time to progression and median overall survival were 16+ (range 1+ to 48+) and 21+ weeks (range 1+ to 52+). All patients were evaluablefor analysis of toxicity. Severe mucositis and diarrhea, present in 14 patients were the limiting side effects. Two patients developed progressive renal toxicity and died. Weakness, myalgia, and nonneutropenic fever were observed frequently, one patient developed dementia. This combination is able to induce major responses in patients with advanced colorectal cancer, particularly in liver metastasis. Additional trials evaluating this approach are indicated.