Intermittent high-dose intravenous interferon alpha 2b (IFNa2b) for adjuvant treatment of stage III malignant melanoma: An interim analysis of a randomized phase III study (NCT00226408)

8505 Background: Adjuvant high-dose interferon (HDI) treatment of patients (pts) with malignant melanoma (MM) usually consists of 4 weeks initial intravenous (iv) infusion of 20 MU/m² IFNa2b followed by 11 months of 10 MU/m² subcutaneously (sc). It is still unclear, whether both components are necessary for the efficacy of HDI in high-risk MM pts. The adjuvant phase III DeCOG MM-ADJ-5 trial evaluates efficacy, safety, tolerability and quality of life (QoL) of an intermittent (pulsed) high-dose iv IFNa2b regimen as compared to standard HDI. Methods: Patients with stage III (AJCC 2002) resected intransit or lymph node metastasis from cutaneous malignant melanoma were randomly assigned to receive either standard HDI regimen (Arm A), or 3 courses of IFNa2b 20 MU/m² iv on 5 days a week for 4 weeks repeated every 4 months (Arm B). Distant metastasis free survival (DMFS) was the primary endpoint for efficacy analysis. The EORTC QLQ C30 questionnaire was used before and during the study in a standardized way (wee...