Induction therapy with intravenous interferon-α-2b was no better than observation alone with respect to relapse-free survival and overall survival for the management of patients with intermediate-risk melanoma, a study published in the Journal of Clinical Oncology has shown.1
Interferon-α-2b is approved as adjuvant therapy for patients with high-risk surgically resected stage IIB and III melanoma as an intravenous infusion given for 5 days per week for 4 weeks followed by 3 days per week for 11 months. Investigators hypothesized that the major source of benefit from the interferon regimen may be due to the initial induction therapy administered over 4 weeks.
To evaluate the efficacy of 4 weeks of intravenous induction with high-dose interferon compared with observation in patients with surgically resected intermediate-risk melanoma, investigators enrolled 1150 patients with T2bN0, T3a-bN0, T4a-bN0, or T1-4N1a-2a (microscopic) cutaneous melanoma who had undergone surgical resection.
For the international, open-label, phase 3 trial (ClinicalTrials.gov Identifier: NCT00003641), investigators randomly assigned patients to receive interferon-α-2b for 5 days every week for 4 weeks or observation alone.
At a median follow-up of 7 years, results showed no significant differences in the 5-year relapse-free survival rate (P = .964) or 5-year overall survival rate (P = .558) between the 2 treatment arms.
At 5 years, 70% (95% CI, 66-74) of patients in the interferon arm and 70% (95% CI, 66-74) of those in the observation arm were free of relapse. Similarly, 83% (95% CI, 80-86) of patients who received interferon induction and 83% (95% CI, 79-86) of those who received observation were alive at 5 years.
However, researchers found that significantly fewer patients in the observation arm experienced treatment-related grade 3 or worse adverse events than those in the interferon arm (4.6% vs 57.9%; P < .001). Further, quality of life was poorer for the interferon-treated patients.
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]