5-Fluorouracil and Recombinant Alpha Interferon-2a in the Treatment of Advanced Colorectal Carcinoma: a Dose Optimization Study

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Abstract
A dose optimization study was carried out with the aim of identifying the maximally tolerated dose of recombinant alpha interferon-2a (raIFN-2a) in combination with 5-fluorouracil (5FU). 5FU was given at the dose of 750 mg/m2 over a 4-hour infusion on day 1-- > 5 followed by 750 mg/m2 weekly i.v. bolus. Recombinant aIFN-2a was started at 3 .times. 1206 IU subcutaneously three times/week. 12 patients with advanced colorectal carcinoma were included in the study. 10 patients had previously received chemotherapy for advanced disease. Severe fatigue, mostly likely attributable to rIFN, was the dose-limiting toxicity. The dosage of raIFN-2a could not be further escalated above 12 .times. 106 IU. At this dose level all patients required dose reduction due to fatigue, fever, myalgia and severe reduciton of performance status.