Adjuvant Combination Treatment for Resected Stage III Melanoma
Posted: Thursday, March 22, 2018
An international team sought to determine whether adjuvant combination therapy with the BRAF inhibitor dabrafenib plus the MEK inhibitor trametinib would improve survival in patients with resected, stage III melanoma with BRAF V600 mutations, as it has been previously shown to do in patients with advanced melanoma with similar mutations. The results of the phase III, double-blind, placebo-controlled trial, published in The New England Journal of Medicine, suggest the combination therapy does indeed improve survival in this group as well.
Lead author Georgina V. Long, MB, BS, PhD, of Melanoma Institute Australia, University of Sydney, and colleagues also noted that in addition to the “significantly lower rate of recurrence” in the treated versus placebo group, the treated patients “had higher rates of overall and distant metastasis–free survival and freedom from relapse, with no reports of new safety signals.”
The trial included 438 and 432 patients, respectively, in the combination-therapy and placebo groups, who were treated for 12 months. The treated group received oral dabrafenib (150 mg twice daily) plus oral trametinib (2 mg once daily).
The estimated 3-year rate of relapse-free survival—the primary study endpoint—was 58% in the combination-therapy group and 39% in the placebo group, at a median follow-up of 2.8 years (P < .001). The 3-year overall survival rate, a secondary study endpoint, was 86% with combination therapy and 77% with placebo. As for toxicity, no new adverse effects were reported.