After a median follow up of 44 months in the dabrafenib and trametinib group, and a median follow up of 42 months in the placebo group, the median RFS was not reached in the dabrafenib and trametinib group (95% CI, 46.9 months to NR) compared to a median RFS of 16.6 months (95% CI, 12.7 to 22.1 months) in the placebo group (HR=0.49; 95% CI, 0.40 to 0.59). 3- and 4-year RFS rates were 59% (95% CI, 55 to 64%) and 54% (95% CI, 49 to 59%) in the dabrafenib and trametinib group compared to 40% (95% CI, 35 to 45%) and 38% (95% CI, 34 to 44%) in the placebo group.r
RFS favoured dabrafenib and trametinib across all pre-specified subgroups. In particular, RFS favoured dabrafenib and trametinib in patients with each of stage IIIA, stage IIIB and stage IIIC melanoma (per AJCC, 7th edition) and regardless of baseline nodal metastatic burden or ulceration status. Post hoc analysis of RFS showed similar efficacy with dabrafenib and trametinib across all AJCC 8th edition disease stage subgroups compared with AJCC 7th edition.
Kaplan-Meier curves of relapse-free survival in the intention to treat populationr
©J Clin Oncol 2018
Overall survival data is yet to fully mature. However, after a median follow up of 2.8 years, median OS was not reached in ether group. The estimated 3-year OS was calculated at 86% for the dabrafenib and trametinib group and 77% for the placebo group (HR=0.57; 95% CI, 0.42 to 0.79, p=0.0006). This did not meet the pre-specified significance threshold.r
Kaplan-Meier curves of overall-survival in the intention to treat populationr
©N Engl J Med 2017
The use of dabrafenib plus trametinib did not affect patient-reported health-related quality of life outcomes during or after adjuvant treatment.r