RANDOMIZED TRIAL OF VITAMIN-A VERSUS OBSERVATION AS ADJUVANT THERAPY IN HIGH-RISK PRIMARY MALIGNANT-MELANOMA - A SOUTHWEST-ONCOLOGY-GROUP STUDY

Purpose: A national cooperative group trial was conducted in patients with early-stage cutaneous malignant melanoma to determine if oral vit amin A can increase disease-free survival or survival. Patients and Me thods: Two hundred forty-eight patients with completely resected melan oma of Breslow's thickness greater than 0.75 mm and clinically negativ e lymph nodes were randomized to oral vitamin A (100,000 IU/d) for 18 months or to observation. patients were stratified by Breslow's thickn ess of primary lesion (0.76 to 1.50 mm, 1.51 to 3.00 mm, or > 3.00 mm) , sex, and type of therapy (excision, excision plus node dissection, e xcision plus perfusion, or excision plus both). The median duration of follow-up observation of living patients ii greater than 8 years. The relative risk (RR) in disease-free survival and overall survival in t he treatment compared with the observation group was calculated using Cox proportional hazards models. Results: Overall, there was no differ ence in disease-free survival or overall survival between the two grou ps. Examination of treatment by stratification interactions and subset analysis did not show any treatment-effect differences based on sex o r type of therapy. There was also no difference between groups in dise ase-free survival based on Breslow's thickness of the primary lesion. Overall, 12% of patients who received vitamin A experienced grade 3 or 4 toxicities. Conclusion: Based on the lack of overall survival benef it, further evaluation of vitamin A as adjuvant therapy for melanoma d oes not appear warranted.