(HealthDay)—For patients with stage III melanoma with BRAF V600E or V600K mutations, 12 months of adjuvant dabrafenib plus trametinib results in increased survival without relapse or distant metastasis at five years, according to a study published online Sept. 2 in the New England Journal of Medicine.

Reinhard Dummer, M.D., from the University Hospital Zurich Skin Cancer Center, and colleagues randomly assigned 870 patients who had resected stage III melanoma with BRAF V600E or V600K mutations to receive 12 months of either oral dabrafenib plus trametinib or two matched placebos. The five-year results for relapse-free survival and survival without distant metastasis (with distant metastasis as the site of the first relapse) were reported.

Patients were followed for a minimum of 59 months. The researchers found that at five years, the percentages of patients who were alive without relapse were 52 and 36 percent for dabrafenib plus trametinib and placebo, respectively (hazard ratio for relapse or death, 0.51). The corresponding percentages of patients who were alive without distant metastasis were 65 and 54 percent (hazard ratio for distant metastasis or death, 0.55). During the follow-up period, there were no clinically meaningful differences noted in the incidence or severity of serious adverse events.

"Twelve months of adjuvant therapy with dabrafenib plus trametinib led to durable long-term benefit regarding relapse-free survival in patients with resected stage III melanoma with BRAF V600 mutations," the authors write.

The study was funded by GlaxoSmithKline and Novartis, the manufacturer of dabrafenib and trametinib.

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