PURPOSE: Low-dose interferon alfa ( @entity3027 ) has been shown to have limited effects in the adjuvant treatment of @entity1 with intermediate- and high-risk primary @entity320 . We hypothesized that a combination regimen with low-dose @entity1199 ( @entity1199 ) may improve survival prospects in these @entity1 . @entity1 AND METHODS: After wide excision of primary @entity320 without clinically detectable lymph node @entity3 (pT3 to 4, cN0, M0), 225 @entity1 from 10 participating centers were randomly assigned to receive either subcutaneous low-dose IFNalpha2b (3 million international units [MU]/m2/d, days 1 to 7, week 1; three times weekly, weeks 3 to 6, repeated all 6 weeks) plus @entity1199 (9 MU/m2/d, days 1 to 4, week 2 of each cycle) for 48 weeks, or observation alone. The primary end point was prolongation of a relapse-free interval. RESULTS: Of the 225 enrolled @entity1 , 223 were found to be eligible. Median follow-up time was 79 months. All evaluated prognostic factors were well balanced between the two arms of the study. Relapses were noticed in 36 of 113 @entity1 treated with IFNalpha2b plus @entity1199 and in 34 of 110 @entity1 with observation alone. Five-year disease-free survival of those who had routine surgery supplemented by IFNalpha2b and @entity1199 treatment was 70.1% (95% confidence interval [CI], 61.3% to 78.9%), compared with 69.9% in those receiving surgery and observation alone (95% CI, 60.7% to 79.1%) in the intention-to-treat analysis. Evaluation of the overall survival did not show any difference between treated and untreated @entity320 @entity1 (P =.93). CONCLUSION: Adjuvant treatment of intermediate- and high-risk @entity320 @entity1 with low-dose IFNalpha2b and @entity1199 is safe and well tolerated by most @entity1 , but it does not improve disease-free or overall survival.

Prospective randomized trial of interferon alfa-2b and XXXX as adjuvant treatment for resected intermediate- and high-risk primary @entity320 without clinically detectable node @entity3 .

@entity1 :: ('9606', 'Species') :: ['patients', 'PATIENTS'] @entity3027 :: ('3439', 'Gene') :: ['IFNalpha'] @entity3 :: ('MESH:D009362', 'Disease') :: ['metastasis'] @entity1199 :: ('3558', 'Gene') :: ['interleukin-2', 'IL-2'] @entity320 :: ('MESH:D008545', 'Disease') :: ['melanoma']
@entity1199 :: (3558,Gene) :: ['interleukin-2']
