POSTSURGICAL ADJUVANT THERAPY FOR MELANOMA - EVALUATION OF A 3-YEAR RANDOMIZED TRIAL WITH RECOMBINANT INTERFERON-ALPHA AFTER 3 AND 5 YEARS OF FOLLOW-UP

BACKGROUND, Early surgical intervention is still the most successful t herapy for patients with melanoma. The results obtained with medical t herapies are still quite disappointing, with better results observed i n soft tissue and lymph node metastasis. There currently is no standar dized adjuvant therapy for primary melanoma. On the basis of the activ ity demonstrated in vitro against melanoma cell lines and the results obtained in many clinical trials in patients with advanced melanoma, t he authors chose to study the use of recombinant interferon-alpha (IFN -alpha) as adjuvant therapy for patients with Stage I and Stage II mel anoma. METHODS, A randomized multicenter trial based on the use of rec ombinant IFN-alpha-2b for 3 years at the dose of 3 MU given intramuscu larly 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 ef ficacy of this treatment was evaluated calculating the incidence of re currence after 3 and 5 years. RESULTS, Results were collected at the e nd of the treatment period and after 5 years of follow-up for a smalle r number of patients. Statistical evaluation showed a significant diff erence between treated patients and untreated controls with regard to progression of the disease. In particular, IfN-alpha appears to be mor e effective in patients with worse prognosis lesions. CONCLUSIONS. IFN -alpha appears to be effective as adjuvant therapy for high risk melan oma 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 int ervention only. (C) 1997 American Cancer Society.