Melanoma: patient-reported outcomes stable with dabrafenib-trametinib

  • Schadendorf D & al.
  • Lancet Oncol
  • 27 Mar 2019

  • curated by Brian Richardson, PhD
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Key results

  • 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.

Study design

  • 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.

Limitations

  • Patient-reported data with potential recall and selection bias.

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