Adjuvant Interferon in High-Risk Melanoma: The AIM HIGH Study—United Kingdom Coordinating Committee on Cancer Research Randomized Study of Adjuvant Low-Dose Extended-Duration Interferon Alfa-2a in High-Risk Resected Malignant Melanoma

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Abstract
Purpose To evaluate low-dose extended duration interferon alfa-2a as adjuvant therapy in patients with thick (≥ 4 mm) primary cutaneous melanoma and/or locoregional metastases. Patients and Methods In this randomized controlled trial involving 674 patients, the effect of interferon alfa-2a (3 megaunits three times per week for 2 years or until recurrence) on overall survival (OS) and recurrence-free survival (RFS) was compared with that of no further treatment in radically resected stage IIB and stage III cutaneous malignant melanoma. Results The OS and RFS rates at 5 years were 44% (SE, 2.6) and 32% (SE, 2.1), respectively. There was no significant difference in OS or RFS between the interferon-treated and control arms (odds ratio [OR], 0.94; 95% CI, 0.75 to 1.18; P = .6; and OR, 0.91; 95% CI, 0.75 to 1.10; P = .3; respectively). Male sex (P = .003) and regional lymph node involvement (P = .0009), but not age (P = .7), were statistically significant adverse features for OS. Subgroup analysis by disease s...