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

Summary

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 × 10⁶ 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, most likely attributable to rIFN, was the dose – limiting toxicity. The dosage of raIFN-2a could not be further escalated above 12 × 10₆ IU. At this dose level all patients required dose reduction due to fatigue, fever, myalgia and severe reduction of performance status.