Conclusions from quality of life studies in patients with resected high-risk melanoma: one part of the full story
Mené dans 25 pays sur 870 patients atteints d'un mélanome de stade III présentant la mutation BRAF V600E ou BRAF V600K et ayant été réséqué, cet essai de phase III évalue l'intérêt, du point de vue de la qualité de vie, d'un traitement adjuvant combinant dabrafénib et tramétinib (durée médiane de suivi : 34 mois)
In The Lancet Oncology, Dirk Schadendorf and colleagues report the health-related quality-of-life outcomes from the COMBI-AD trial using the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) instrument. In the COMBI-AD trial, patients with resected stage III melanoma, with BRAF V600E or BRAF V600K mutations, were randomly assigned to receive adjuvant dabrafenib and trametinib or matching placebos. The authors report no difference in health-related quality of life during the 12 months of treatment, and conclude that the risk–benefit profile of this adjuvant therapy is therefore favourable. There is an implication that the high proportion of patients with pyrexia (273 [63%] of 435 patients) and fatigue (204 [47%]), as well as the 114 [26%] patients who discontinued trial therapy because of adverse events, are not factors associated with the outcome. For an individual patient, the conclusions from this trial are just one part of the full story.
The Lancet Oncology 2019