October 2005, Vol. 12. No. 4

Author: David H. Lawson, MD

Abstract

Background: High-dose interferon (IFN) is the approved agent for adjuvant treatment of melanoma in the United States. This approval is for high-risk, predominantly stage III patients with cutaneous primaries. There are still decisions to be made in the care of these patients. Also, there are questions about whether the IFN data can be extrapolated to patients with other stages of melanoma and whether adjuvant treatment should be offered to these individuals. Clearly there is room for improvement in this area.
Methods: The literature on this topic and ongoing national trials in the United States were reviewed.
Results: The data are insufficient to recommend other agents in the adjuvant treatment of melanoma outside a clinical trial. Extrapolation of the IFN data to patient populations other than those studied is problematic at best. National trials are available for most patient populations.
Conclusions: The adjuvant treatment of choice for melanoma patients is participation in a clinical trial.

Introduction

The availability of only one agent approved by the US Food and Drug Administration (FDA) for the adjuvant therapy of melanoma would seem to simplify treatment decisions in this area, but in fact there are still choices to be made. This article reviews the evidence in support of some of these options, including interferon (IFN) alpha-2b, other commercially available agents, and current clinical trials. It is written primarily from the perspective of trials nationally available in the United States, which are predominantly cooperative group trials. Local phase II trials are beyond the scope of this manuscript, as is a discussion of the proper place of these trials in the adjuvant setting. Also included is a discussion of how these options might be used in treatment planning for three different groups of patients based on risk of recurrence.