Adjuvant interferon has modest activity in melanoma patients at high risk for relapse. Patient selection is important; stage and ulceration of the primary tumour are key prognostic factors. Methods: In this post hoc meta-analysis of European Organisation for Research and Treatment of Cancer (EORTC) trials 18952 (intermediate doses of interferon α-2b [IFN] versus observation in stage IIb-III patients) and 18991 (pegylated [PEG]-IFN versus observation in stage III patients), the predictive value of ulceration on the efficacy of IFN/PEG-IFN with regard to relapse-free survival (RFS), distant metastasis-free survival (DMFS), and overall survival (OS) was assessed in the overall population and in subgroups stratified by stage (IIb and III-N1 [microscopic nodal disease] and III-N2 [macroscopic nodal disease]). Findings: In the overall population, the comparison of IFN/PEG-IFN versus observation for RFS, DMFS and OS yielded estimated hazard ratios (HR) of 0.85 (p = 0.004), 0.89 (p = 0.04) and 0.94 (p = 0.36), respectively. The impact of treatment was greater in the ulceration group (n = 849) compared with the non-ulceration group (n = 1336) for RFS (test for interaction: p = 0.02), DMFS (p < 0.001) and OS (p < 0.001). The greatest risk reductions were observed in patients with ulceration and stage IIb/III-N1, with estimated HR for RFS, DMFS, and OS of 0.69 (p = 0.003), 0.59 (p < 0.0001) and 0.58 (p < 0.0001), respectively. The efficacy of IFN/PEG-IFN was lower in stage III-N2 patients with ulceration and uniformly absent in patients without ulceration. There was consistency between the data of both trials. Interpretation: This meta-analysis of the EORTC 18952 and 18991 trials indicated that both tumour stage and ulceration were predictive factors for the efficacy of adjuvant IFN/PEG-IFN therapy.

Additional Metadata
Keywords Adjuvant Interferon Efficacy, Melanoma, Phase III Trials, Predictive Factors, Stage, Ulceration
Persistent URL,
Journal European Journal of Cancer
Eggermont, A.M.M, Suciu, S, Testori, A, Kruit, W.H.J, Marsden, J, Punt, C.J.A, … Spatz, A. (2012). Ulceration and stage are predictive of interferon efficacy in melanoma: Results of the phase III adjuvant trials EORTC 18952 and EORTC 18991. European Journal of Cancer, 48(2), 218–225. doi:10.1016/j.ejca.2011.09.028