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Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma

New England Journal of Medicine Oct 12, 2017

Long GV et al. - Combination therapy with dabrafenib plus trametinib improves survival in patients with advanced melanoma and BRAF V600 mutations. In the current study it was shown that adjuvant use of combination therapy with dabrafenib plus trametinib resulted in a significantly lower risk of recurrence in patients with stage III melanoma with BRAF V600E or V600K mutations.

Methods

  • 870 patients with completely resected, stage III melanoma with BRAF V600E or V600K mutations were randomized to receive oral dabrafenib (150 mg twice daily) plus trametinib (2 mg once daily) or 2 matched placebo tablets for 12 months.

Results

  • At a median follow-up of 2.8 years, the estimated 3-year rate of relapse-free survival was 58% in the combination-therapy group and 39% in the placebo group (HR for relapse or death, 0.47).
  • The 3-year overall survival rate was 86% in the combination-therapy group and 77% in the placebo group (HR for death, 0.57).
  • Rates of distant metastasis–free survival and freedom from relapse were also higher in the combination-therapy group than in the placebo group.
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