Abstract
Based upon prior data suggesting that alpha-interferon possesses chemomodulatory activity, a pilot study was conducted in which patients with advanced colorectal carcinoma were treated with 5-fluorouracil (5-FU), leucovorin (LV) and Roferon-A®. Treatment consisted of LV 20 mg/m2 i.V. push followed by 5-FU, 425 mg/m2 i.V. push daily for 5 days every 4 weeke for 2 cycles, then every 5 weeks; Roferon-A® 9 million units subcutaneously was given three times weekly every week Forty-six eligible patients with bidimensionally measurable disease who had received no prior chemotherapy for advanced disease were treated with this regimen. The most frequent toxicity was leukopenia with 80% of patients experiencing some degree of leukopenia and the most severe toxicity was granulocytopenia with 46% of patients experiencing granulocyte counts <1,000/mm3. Among the 46 eligible patients, the objective response rate was 13% (95%o confidence interal, 5 - 26%). Thirty-five of the 46 patients have died with a median survival of 17 months. This regimen has significant toxicity and insufficient activity against advanced colorectal carcinoma to warrant further trials.
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