Postsurgical adjuvant therapy for melanoma. Evaluation of a 3-year randomized trial with recombinant interferon-alpha after 3 and 5 years of follow-up

Abstract

Background: Early surgical intervention is still the most successful therapy for patients with melanoma. The results obtained with medical therapies are still quite disappointing, with better results observed in soft tissue and lymph node metastasis. There currently is no standardized adjuvant therapy for primary melanoma. On the basis of the activity demonstrated in vitro against melanoma cell lines and the results obtained in many clinical trials in patients with advanced melanoma, the authors chose to study the use of recombinant interferon-alpha (IFN-alpha) as adjuvant therapy for patients with Stage I and Stage II melanoma.

Methods: A randomized multicenter trial based on the use of recombinant IFN-alpha-2b for 3 years at the dose of 3 MU given intramuscularly 3 times a week for a period of 6 months with a 1-month interval between cycles was conducted in Stage I and Stage II melanoma patients (using the American Joint Committee on Cancer classification). The efficacy of this treatment was evaluated calculating the incidence of recurrence after 3 and 5 years.

Results: Results were collected at the end of the treatment period and after 5 years of follow-up for a smaller number of patients. Statistical evaluation showed a significant difference between treated patients and untreated controls with regard to progression of the disease. In particular, IFN-alpha appears to be more effective in patients with worse prognosis lesions.

Conclusions: IFN-alpha appears to be effective as adjuvant therapy for high risk melanoma patients and the risk/benefit ratio appears to be very favorable. The authors' next goal is to separate those patients who might benefit from adjuvant therapy from those who are cured after the surgical intervention only.