E1684 — High-Dose Interferon Alfa-2b Adjuvant Therapy Versus Observation in Resected High-Risk Melanoma

Phase 3 · 1996 · Melanoma

Design

Randomized 1 year of high-dose interferon alfa-2b vs observation after surgery.

Population

Resected high-risk (node-positive or deep primary, T4) cutaneous melanoma.

Primary Endpoint

relapse-free survival (RFS) and overall survival (OS)

Key Result

Median RFS 1.7 vs 1.0 yr and OS 3.8 vs 2.8 yr favoring interferon.

Guideline Impact

Basis for FDA approval of adjuvant high-dose interferon alfa-2b in resected high-risk melanoma