Adjuvant therapy with recombinant alpha-interferon in nonmetastatic melanoma

To assess the efficacy of adjuvant therapy with recombinant alpha-interferon in non-metastatic melanoma 60 patients were included in this study after excision of the primary neoplasia: they were randomly divided in two groups of 30 each. Patients in the first group were treated for one year with 3,000,000 UI of recombinant alpha-interferon on alternate days, while patients in the control group were not submitted to any medical therapy. The follow-up for each patient lasted until the occurrence of a metastatic event and for no longer than two years from the inclusion in the study. Monthly blood analysis, two-monthly clinical examination and six-monthly TU plus ultrasound tomography were performed. Side and adverse effects included transient high blood transaminase in 3 patients, transient leucopenia in 2 patients and psoriasic eruption in 2 patients and psoriasic eruption in 2 patients. Loco-regional and in situ relapses were more frequent in nontreated patients, while lymphonodal and/or organ metastases were equally distributed in both groups. Metastatic events in the treated group occurred mainly during the first months of therapy or long after its suspension, while in the control group they were distributed during the first 15 months of follow-up. These results confirm the efficacy of adjuvant therapy with alpha-interferon in non-metastatic melanoma in preventing loco-regional relapses and in lenghtening disease-free interval. Further trials are warranted, in order to find the most effective therapeutic protocol for long term adjuvant treatment.