Affiliation:
1. Alexander M.M. Eggermont and Caroline Robert, Institut de Cancérologie Gustave Roussy, Villejuif, France; Stefan Suciu and Gaetan de Schaetzen, European Organisation for Research and Treatment of Cancer Headquarters; François Salès, Institut Jules Bordet, Brussels, Belgium; Alessandro Testori, Istituto Europeo di Oncologia; Mario Santinami, Istituto Nazionale dei Tumori, Milan, Italy; Wim H.J. Kruit, Erasmus University Medical Center, Rotterdam; Cornelis J.A. Punt, Academic Medical Center, Amsterdam, the...
Abstract
PurposeAdjuvant pegylated interferon alfa-2b (PEG-IFN-α-2b) was approved for treatment of resected stage III melanoma in 2011. Here, we present long-term follow-up results of this pivotal trial.Patients and MethodsIn all, 1,256 patients with resected stage III melanoma were randomly assigned to observation (n = 629) or PEG-IFN-α-2b (n = 627) for an intended duration of 5 years. Stratification factors were microscopic (N1) versus macroscopic (N2) nodal involvement, number of positive nodes, ulceration and tumor thickness, sex, and center. Recurrence-free survival (RFS; primary end point), distant metastasis-free survival (DMFS), and overall survival (OS) were analyzed for the intent-to-treat population.ResultsAt 7.6 years median follow-up, 384 recurrences or deaths had occurred with PEG-IFN-α-2b versus 406 in the observation group (hazard ratio [HR], 0.87; 95% CI, 0.76 to 1.00; P = .055); 7-year RFS rate was 39.1% versus 34.6%. There was no difference in OS (P = .57). In stage III-N1 ulcerated melanoma, RFS (HR, 0.72; 99% CI, 0.46 to 1.13; P = .06), DMFS (HR, 0.65; 99% CI, 0.41 to 1.04; P = .02), and OS (HR, 0.59; 99% CI, 0.35 to 0.97; P = .006) were prolonged with PEG-IFN-α-2b. PEG-IFN-α-2b was discontinued for toxicity in 37% of patients.ConclusionAdjuvant PEG-IFN-α-2b for stage III melanoma had a positive impact on RFS, which was marginally significant and slightly diminished versus the benefit seen at prior follow-up (median, 3.8 years). No significant increase in DMFS or OS was noted in the overall population. Patients with ulcerated melanoma and lower disease burden had the greatest benefit.
Publisher
American Society of Clinical Oncology (ASCO)
Cited by
232 articles.
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