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.”
- 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]