Abstract
9007 Background: Ulcerated (Ulc) melanomas have a worse prognosis than non-ulcerated (N-Ulc) melanomas. Ulc and N-Ulc primaries have different stromal characteristics and gene profiles reflecting differences in biology. We analyzed outcome after adjuvant interferon (IFN) therapy in the 2 largest phase III trials (EORTC18952 and 18991) ever conducted in stage IIB-III melanoma patients (pts). Methods: EORTC18952 compared IFNα-2b (10 MIU, sc, qd, 5 days/wk, for 4 wks) followed by either 10MIU,sc, tiw for 12 mts, or 5MIU for 24 mts) with observation in 1,388 stage IIB-III pts (Lancet 2005;366). EORTC18991 evaluated pegylated IFNα-2b (6 μg/Kg, 1×/wk, for 8 wks followed by 3μg/Kg, 1×/wk for up to 5 yrs) versus observation in 1,256 stage III pts (Lancet 2008;372). Using meta-analytical methods, predictive value for Ulc on the value of IFN on relapse-free survival (RFS), distant metastasis-free survival (DMFS), and overall survival (OS) was assessed, overall, and according to stage (IIB, III-N1 or N2=microscopic or macroscopic-nodal disease). Results: Overall, the comparison (PEG-)IFNα-2b versus observation regarding RFS, DMFS, and OS led to a reduction in the hazard ratio (HR) of -16% (SE=5%), -13%(5%), and -8%(5%). Among 2,644 pts randomized, 849 had Ulc primaries, 1,336 N-Ulc primaries, and 459 Ulc unknown. In Ulc group the impact was much greater than in N-Ulc group for RFS (Test For Interaction: p=0.02), DMFS (p<0.001), and OS (p<0.001). The greatest reductions occurred in pts with Ulc and stages IIB/III-N1 In N-Ulc pts reduction was absent. Consistency in the treatment impact was seen in both trials. Conclusions: The post hoc analyses of EORTC1892 and EORTC18991 indicate strongly that pts with an Ulc primary are far more sensitive to IFN than pts with N-Ulc primaries. This hypothesis will now be tested in the EORTC18081 trial, which compares PEG-IFNα-2b versus observation in pts with Ulc primaries ≥ 1mm. [Table: see text] [Table: see text]
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