Stage III melanoma is a type of melanoma that has metastasized to nearby lymph nodes, lymph vessels, and or skin. The combination of dabrafenib and trametinib, two anti-cancer drugs, showed promising outcomes in previous clinical trials. This study aims to efficacy and stability of dabrafenib-dabrafenib combination therapy in patients with resected stage III melanoma with BRAF V600E or V600K mutations.
This randomized, controlled trial included a total of 870 patients who had resected stage III melanoma with BRAF V600E or V600K mutations. The patients were randomly assigned to receive oral dabrafenib plus trametinib (combination group) or two matched placebos for 12 months. The primary outcomes of the study were 5-year relapse-free survival and survival without distant metastasis at the site of relapse.
At 5 years of follow-up, the rate of relapse-free survival was 52% in the combination group, as compared with 36% in the placebo group. The rate of survival without distant metastasis was 65% in the combination group and 54% in the placebo group. No significant difference in terms of the severity of adverse events was found.
The research concluded that dabrafenib-dabrafenib combination therapy was associated with an improved rate of relapse-free survival and survival without distant metastasis in patients with resected stage III melanoma with BRAF V600E or V600K mutations.