Feasibility of Pegylated Interferon in Children and Young Adults With Resected High-Risk Melanoma.

Background. Pegylated interferon alpha-2b (IFN alpha-2b) improves disease-free survival in adults with resected stage III melanoma. We conducted a study to determine the feasibility and safety of incorporating pegylated IFN alpha-2b as adjuvant therapy in the treatment of children and adolescents with high-risk melanoma. Pharmacokinetic studies of IFN alpha-2b and neuropsychological and quality of life (OL) assessments were performed. Patient and Methods. Eligible patients with resected American Joint Committee on Cancer Stage IIC, IIIA, and IIIB cutaneous melanoma received nonpegylated IFN alpha-2b 20 million units/m(2)/day intravenously 5 days per week for 4 weeks (induction) followed by pegylated IFN alpha-2b 1 mu g/kg/dose weekly subcutaneously (SQ) for 48 weeks (maintenance). Results. Twenty-three patients (15 females, median age 10 years) were enrolled. All patients completed induction therapy; five patients did not complete maintenance therapy either because of recurrent disease (n = 2) or toxicity (n = 3). The most common grade 3 and 4 toxicities of pegylated IFN alpha-2b were neutropenia (35%) and elevated liver transaminases (17%). The median nonpegylated IFN alpha-2b AUC(0-infinity) (5,026 pcg.hr/ml) was similar to adults. The median pegylated IFN alpha-2b exposure (48,480 pcg.hr/ml) was greater than the cumulative weekly exposure for nonpegylated IFN alpha-2b administered SQ three times per week (TIW). Validated measures demonstrated an improvement in QOL scores and no decline in psychological functioning over the course of therapy. Conclusions. Pegylated IFN alpha-2b 1 mu g/kg/dose SQ weekly as maintenance therapy in children and adolescents with high-risk melanoma is feasible with tolerable toxicity and appears to yield higher exposures than nonpegylated IFN alpha-2b administered SQ TIW. (C) 2016 Wiley Periodicals, Inc.