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Final Results for Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma.
Long, Georgina V; Hauschild, Axel; Santinami, Mario; Kirkwood, John M; Atkinson, Victoria; Mandala, Mario; Merelli, Barbara; Sileni, Vanna Chiarion; Nyakas, Marta; Haydon, Andrew; Dutriaux, Caroline; Robert, Caroline; Mortier, Laurent; Schachter, Jacob; Schadendorf, Dirk; Lesimple, Thierry; Plummer, Ruth; Larkin, James; Tan, Monique; Adnaik, Sachin Bajirao; Burgess, Paul; Jandoo, Tarveen; Dummer, Reinhard.
Afiliación
  • Long GV; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Hauschild A; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Santinami M; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Kirkwood JM; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Atkinson V; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Mandala M; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Merelli B; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Sileni VC; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Nyakas M; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Haydon A; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Dutriaux C; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Robert C; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Mortier L; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Schachter J; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Schadendorf D; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Lesimple T; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Plummer R; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Larkin J; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Tan M; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Adnaik SB; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Burgess P; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Jandoo T; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
  • Dummer R; From the Melanoma Institute Australia, the University of Sydney, Royal North Shore Hospital, and Mater Hospital, Sydney (G.V.L.), Princess Alexandra Hospital, the Gallipoli Medical Research Foundation, and the University of Queensland, Woolloongabba (V.A.), and Alfred Hospital, Melbourne, VIC (A.H.)
N Engl J Med ; 2024 Jun 19.
Article en En | MEDLINE | ID: mdl-38899716
ABSTRACT

BACKGROUND:

The 5-year results of this trial showed that adjuvant therapy with dabrafenib plus trametinib resulted in longer relapse-free survival and distant metastasis-free survival than placebo among patients with BRAF V600-mutated stage III melanoma. Longer-term data were needed, including data regarding overall survival.

METHODS:

We randomly assigned 870 patients with resected stage III melanoma with BRAF V600 mutations to receive 12 months of dabrafenib (150 mg twice daily) plus trametinib (2 mg once daily) or two matched placebos. Here, we report the final results of this trial, including results for overall survival, melanoma-specific survival, relapse-free survival, and distant metastasis-free survival.

RESULTS:

The median duration of follow-up was 8.33 years for dabrafenib plus trametinib and 6.87 years for placebo. Kaplan-Meier estimates for overall survival favored dabrafenib plus trametinib over placebo, although the benefit was not significant (hazard ratio for death, 0.80; 95% confidence interval [CI], 0.62 to 1.01; P = 0.06 by stratified log-rank test). A consistent survival benefit was seen across several prespecified subgroups, including the 792 patients with melanoma with a BRAF V600E mutation (hazard ratio for death, 0.75; 95% CI, 0.58 to 0.96). Relapse-free survival favored dabrafenib plus trametinib over placebo (hazard ratio for relapse or death, 0.52; 95% CI, 0.43 to 0.63), as did distant metastasis-free survival (hazard ratio for distant metastasis or death, 0.56; 95% CI, 0.44 to 0.71). No new safety signals were reported, a finding consistent with previous trial reports.

CONCLUSIONS:

After nearly 10 years of follow-up, adjuvant therapy with dabrafenib plus trametinib was associated with better relapse-free survival and distant metastasis-free survival than placebo among patients with resected stage III melanoma. The analysis of overall survival showed that the risk of death was 20% lower with combination therapy than with placebo, but the benefit was not significant. Among patients with melanoma with a BRAF V600E mutation, the results suggest that the risk of death was 25% lower with combination therapy. (Funded by GlaxoSmithKline and Novartis; COMBI-AD ClinicalTrials.gov number, NCT01682083; EudraCT number, 2012-001266-15.).
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article