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A cohort of 35 patients with advanced colorectal cancer, not previously exposed to chemotherapy, were included in a phase II study exploring the combination of interferon-alpha, 9 MU subcutaneously three times weekly, and 5-fluorouracil 750 mg/m2/day during 5 consecutive days in continuous intravenous infusion followed with weekly bolus injection of fluorouracil 750 mg/m2. Of 33 cases evaluable for 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 evaluable for 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.

Original publication

DOI

10.3109/07357909209032749

Type

Journal article

Journal

Cancer investigation

Publication Date

01/1992

Volume

10

Pages

259 - 264

Addresses

Department of Medical Oncology, Hospital Clínico Universitario, Madrid, Spain.

Keywords

Humans, Colorectal Neoplasms, Fluorouracil, Interferon Type I, Recombinant Proteins, Antineoplastic Combined Chemotherapy Protocols, Aged, Middle Aged, Female, Male