TUESDAY, Sept. 12, 2017 (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 Sept. 10 in the New England Journal of Medicine. The research was published to coincide with the European Society of Medical Oncology Congress, held from Sept. 8 to 12 in Madrid.
Georgina V. Long, M.B., B.S., Ph.D., 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 (438 patients) or two matched placebo tablets (432 patients) for 12 months.
The researchers found that the estimated three-year rate of relapse-free survival was 58 percent in the combination-therapy group and 39 percent in the placebo group at a median follow-up of 2.8 years (hazard ratio for relapse or death, 0.47; 95 percent confidence interval, 0.39 to 0.58; P < 0.001). The three-year overall survival rate was 86 and 77 percent in the combination-therapy and placebo groups (hazard ratio for death, 0.57; 95 percent confidence interval, 0.42 to 0.79; P = 0.0006); this did not cross the prespecified interim analysis boundary of P = 0.000019. 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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