Adjuvant high-dose interferon alfa-2b therapy (HDI) confers no survival benefit in patients with melanoma and a single positive sentinel lymph node, a study published in the Journal of Clinical Oncology has shown.1
For the Sunbelt Melanoma Trial, researchers sought to evaluate the role of HDI or completion lymph node dissection (CLDN) for patients with melanoma staged by SLN biopsy. Researchers enrolled patients 18 to 70 years with primary cutaneous melanoma at least 1.0 mm in Breslow thickness. All participants underwent SLN biopsy.
Patients were then assigned to receive Protocol A or Protocol B depending on their SLN tumor status. In Protocol A, patients with a single tumor-positive lymph node after SLN biopsy underwent CLND and were randomly assigned to HDI or observation.
In Protocol B, patients with tumor-negative SLN underwent molecular staging as detected by reverse transcriptase polymerase chain reaction (RT-PCR). Those positive by PT-PCR were randomly assigned to CLND, or CLND + HDI, or observation.
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Results of intention-to-treat analyses after a median follow-up of 71 months showed that there were no significant differences in disease-free survival (HR, 0.82; P = .45) or overall survival (HR, 1.10; P = .68) between the 2 treatment arms in Protocol A. Similarly, there were no significant differences in overall disease-free survival (P = .069) or overall survival (P = .77) across the 3 groups in Protocol B.
When patients who did not receive the assigned treatment were excluded, researchers continued to find no significant differences in disease-free or overall survival in Protocol A or Protocol B.
- McMasters KM, Egger ME, Edwards MJ, et al. Final results of the Sunbelt Melanoma Trial: a multi-institutional prospective randomized phase III study evaluating the role of adjuvant high-dose interferon alfa-2b and completion lymph node dissection for patients staged by sentinel lymph node biopsy [published online ahead of print February 8, 2016]. J Clin Oncol. doi: 10.1200/JCO.2015.63.3776.