Toxicity and feasibility of adjuvant high dose interferon alpha-2b in patients with melanoma in clinical oncologic practice

To assess the feasibility and toxicity profile of high-dose interferon alph a-2b (IFN-alpha-2b) in the adjuvant treatment of patients with cutaneous ma lignant melanoma outside the reference ECOG 1684 clinical trial, we conduct ed a prospective follow-up in an identical population of patients (cutaneou s melanoma, T4 and/or N1) treated by intravenous IFN-alpha-2b:20 MIU m(-2), 5 days a week for 4 weeks; and subcutaneous:10 MIU m(-2), 3 times a week f or 11 months. Thirty-six consecutive patients were considered in four diffe rent institutions. The frequency and severity of side-effects related to IF N-alpha, as well as the percentage of the planned dose given to patients, w ere identical to those reported in the initial report by ECOG. Fifty per ce nt and 47% of patients had a grade 3/4 WHO toxicity in the induction and co nsolidation phase respectively. A dose modification was necessary for 47.2% and 55.8% of the patients in the induction and consolidation phase respect ively. The schedule and dose of high-dose IFN-alpha-2b in the adjuvant trea tment of cutaneous malignant melanoma, as reported by ECOG 1684, is feasibl e. The significant toxicity reported in ECOG 1684 was also seen in our pati ents. Nevertheless, this protocol will not be a 'standard' treatment until the publication of the ECOG 1690 trial.