RANDOMIZED, SURGICAL ADJUVANT CLINICAL-TRIAL OF RECOMBINANT INTERFERON ALFA-2A IN SELECTED PATIENTS WITH MALIGNANT-MELANOMA

Purpose: We conducted a randomized prospective trial in selected patie nts with fully resected high-risk stage I and II malignant melanoma. P atients and methods: Interferon alfa-2a (IFN-alpha 2a) 20 x 10(6) U/m( 2) was administered three times each week for 12 weeks by the intramus cular route, Both the treatment group (n = 131) and the control group (n = 131) were evenly balanced with regard to relevant prognostic disc riminants. Results: The median disease-free survival (DFS) time was 2. 4 years for the IFN-alpha 2a group and 2.0 years for the observation g roup (log-rank P = 0.19), The median survival times were 6.6 years for IFN-alpha 2a and 5.0 years for observation (log-rank P = .40). For st age I patients (n = 102), there was no apparent therapeutic advantage from IFN-alpha 2a therapy. The DFS for stage II patients was a median of 10.8 months in the control group versus 17 months in the treatment group. The overall survival time was 4.1 years for the treatment group versus 2.7 years for the control group, The differences in DFS for st age II patient were significant in a Cox model. These results must be interpreted cautiously because of subset analysis. A severe fly-like t oxicity occurred in 44% of patients, 13% lost at least 10% of their ba seline weight, and 45% experienced a worsening of Eastern Cooperative Oncology Group (ECOG) performance score. Conclusion: Our findings indi cate trends that suggest a possible benefit for selected patients with high-risk malignant melanoma, The results will require further study in a larger patient population for confirmation. (C) 1995 by American Society of Clinical Oncology.