- Adjuvant dabrafenib plus trametinib does not affect patient-reported outcomes in patients with BRAF-mutated melanoma, according to the multicenter COMBI-AD phase 3 randomized controlled trial.
Why this matters
- Dabrafenib plus trametinib was approved by the FDA on the basis of improved relapse-free survival.
- Neither dabrafenib/trametinib nor placebo treatment led to clinically meaningful changes in European Quality of Life 5-Dimensions 3-Levels or utility scores compared with baseline.
- Both dabrafenib/trametinib and placebo treatment led to decreased VAS scores (mean change, −6.02 [P=.0032] and −6.84 [P<.0001 respectively and utility scores change at the time of recurrence.>
- More patients receiving dabrafenib/trametinib experienced problems in mobility (15% vs 8%) and usual activities (19% vs 13%) than patients receiving placebo.
- More patients receiving placebo experienced problems in anxiety/depression (27% vs 22%) than patients receiving dabrafenib/trametinib.
- 870 patients with stage III BRAF-mutated melanoma who underwent complete resection were randomly assigned to receive dabrafenib/trametinib (N=438) or placebo (N=432).
- Funding: Novartis.
- Patient-reported data with potential recall and selection bias.