Patient-reported outcomes in patients with resected, high-risk melanoma with BRAFV600E or BRAFV600K mutations treated with adjuvant dabrafenib plus trametinib (COMBI-AD): A randomised, placebo-controlled, phase 3 trial
The Lancet Oncology Apr 02, 2019
Schadendorf D, et al. - Researchers describe the patient-reported outcomes from COMBI-AD (a randomised, double-blind, placebo-controlled, phase 3 study), in which adjuvant dabrafenib plus trametinib or placebo was administered to treat patients with resected, stage III melanoma with BRAF V600E or BRAF V600K mutations and significantly improved relapse-free survival at 3 years was revealed in the primary analysis in patients who received dabrafenib plus trametinib. The two groups were compared for health-related quality of life by using a mixed-model repeated-measures analysis. Groups showed similar VAS and utility scores, with no difference from baseline scores, when followed-up for long-term (range 15–48 months). According to findings, there was no impact of dabrafenib plus trametinib on patient-reported outcome scores during or after adjuvant treatment. In this setting, it could be beneficial to prevent or delay relapse with adjuvant therapy.
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