High-dose interferon-a-2b (IFN) given for 4 weeks intravenously does not improve relapse-free or overall survival over observation among patients with melanoma post-resection, according to a study published in the Journal of Clinical Oncology.1

Patients diagnosed with melanoma with primary legions at least 1.5 mm deep or regional lymph node involvement have 5-year survival rates of 40% to 75%. IFN is approved as a 1-year adjuvant treatment regimen for high-risk patients post-resection. For this phase 3, randomized trial (ClinicalTrials.gov Identifier: NCT00003641), researchers evaluated the efficacy of 4-week, high dose IFN vs observation.

Patients with the following disease states were included: T2bN0, T3a-bN0, T4a-bN0, and T1-4N1a-2a (microscopic). Of 1150 patients enrolled and stratified for lymph node status, disease stage, ulceration status, and Breslow depth, 569 were randomized to observation and 581 to high-dose IFN.

There was no difference in overall survival or relapse-free survival between the 2 groups. The 5-year overall and relapse-free survival rates were 70% and 83%, respectively, in both arms.

Grade 3 or worse adverse events were much more common in the treatment group than observation group (4.6% vs 57.9%). Common grade 3 to 4 adverse events in the IFN arm included neutropenia, fatigue, headache, and aspartate transaminase.

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The authors concluded that 4-week IFN therapy is not superior to observation in this setting. One possible explanation is that IFN “treatment duration may be as important as dose intensity.”

Reference

  1. Agarwala SS, Lee SJ, Yip W, et al. Phase III randomized study of 4 weeks of high-dose interferon-α-2b in stage T2bNO, T3a-bNO, T4a-bNO, and T1-4N1a-2a (microscopic) melanoma: a trial of the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network Cancer Research Group (E1697). J Clin Oncol. 2017 Jan 30. doi: 10.1200/JCO.2016.70.2951 [Epub ahead of print]