Resected Melanoma Benefits from Dabrafenib, Trametinib

HealthDay News — For patients with resected stage III melanoma with BRAF V600E or V600K mutations, adjuvant dabrafenib plus trametinib is associated with a higher rate of relapse-free survival, according to a study published online in the New England Journal of Medicine. The research was published to coincide with the European Society of Medical Oncology Congress, held from September 8-12, 2017, in Madrid.

Georgina V Long, MB, BS, PhD, from the University of Sydney, and colleagues randomized 870 patients with completely resected, stage III melanoma with BRAF V600E or V600K mutations to receive oral dabrafenib plus trametinib (n=438 patients) or 2 matched placebo tablets (n=432 patients) for 12 months.

The researchers found that the estimated 3-year rate of relapse-free survival was 58% in the combination-therapy group and 39% in the placebo group at a median follow-up of 2.8 years (hazard ratio for relapse or death [HR] .47; 95% CI, .39-.58; P <.001). The 3-year overall survival rate was 86% and 77% in the combination-therapy and placebo groups (HR .57; 95% CI, .42-.79; P =.0006).

This did not cross the prespecified interim analysis boundary of P =.000019. The combination-therapy group had higher rates of distant metastasis-free survival and freedom from relapse.

“The adjuvant use of dabrafenib plus trametinib resulted in a significantly lower rate of recurrence than the adjuvant use of placebo,” the authors write.

The study was funded by GlaxoSmithKline and Novartis; Novartis manufactures dabrafenib and trametinib.

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Long GV, Hauschild A, Santinami M. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma [published September 10, 2017]. N Engl J Med. doi: 10.1056/NEJMoa1708539