Toxicity of adjuvant high-dose interferon-alpha-2b in patients with cutaneous melanoma at high risk of recurrence

Interferon-alpha-2b (INF-alpha-2b) has been approved by the FDA as adjuvant treatment for patients with melanoma at high risk of recurrence. INF-alpha -2b is administered at 20 MU/m(2)/day IV, 5 days per week for 4 weeks, and then 10 MU/m2/day SC, three times weekly for 48 weeks. We investigated the toxicity of this protocol in 30 patients between June 1996 and February 199 8. An intensive toxicity evaluation program was developed to monitor side e ffects. During both induction and maintenance phases, 60% of patients requi red a dose delay and/or reduction. Twenty percent were unable to complete t he treatment plan, and 53% tolerated at least 80% of the scheduled dose. Th e frequently reported toxicity during induction included constitutional sym ptoms, myelosuppression, and hepatotoxicity. All were reversible on cessati on of treatment or dose modification. During maintenance, toxicity included thyroid dysfunction, hypertriglyceridemia, retinopathy and a combination o f mood disturbances, memory loss, cognitive slowing and impaired executive function. Administration of high-dose INF-alpha-2b is feasible, with close patient monitoring.