Peginterferon Alfa-2b for Metastatic Melanoma after Definitive Surgical Resection

April 2011, Vol 2, No 2 - FDA Approvals, News & Updates

The FDA approved peginterferon alfa-2b (Sylatron; Schering Corporation) for the treatment of patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection, including complete lymphadenectomy.

The recommended dose and schedule for Sylatron is 6 μg/kg/week, subcutaneously for 8 doses, followed by 3 μg/kg/week subcutaneously. The maximum treatment period is 5 years.

The approval was based on a single, 5-year trial, EORTC 18991, an openlabel, multicenter trial with 1256 patients. Patients who had been adequately surgically resected for their primary cutaneous mela noma and affected regional lymph nodes were randomized to peginterferon alfa-2b or to 5-year observation.

The primary end point, relapse-free survival (RFS), was defined as the time to the earliest of local or regional recurrence, distant metastases, or death. Based on 696 RFS events, an improvement in RFS for peginterferon alfa-2b– treated patients was observed. The estimated median RFS was 34.8 months with the active treatment and 25.5 months in the observation arm. After 525 deaths during the study, no difference in OS was seen between the 2 groups.

The most common (>60%) grade 1-4 adverse reactions in the peginterferon alfa-2b group were fatigue, increased alanine transaminase, increased aspartate aminotransferase, pyrexia, headache, anorexia, myalgia, nausea, chills, and injection site reactions.

A total of 33% of patients receiving therapy discontinued treatment because of adverse events. (March 29, 2011)