Interferon alpha (IFN alpha) has been demonstrated to possess a significant biological activity for cutaneous malignant melanoma (CMM). Although multiple adjuvant trials utilizing IFNá have been tested, no consensus on the optimal dosing schedule has been reached. From February 1993 to October 1997 we enrolled 86 CMM patients using low doses of IFN alpha-2b (3 MU/d TIW SC for 3 years) in a phase II study. Our present data show a median disease-free survival (DFS) of 30 months (range 2-62), comparable to those obtained in high-dose IFN alpha trials. These findings suggest that positive results may be also obtained using low doses of IFN alpha in adjuvant treatment of CMM patients. in contrast to the high dose, the low dose regimen was well tolerated with an acceptable quality of life of patients.