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Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma.

Authors
  • Long, Georgina V1
  • Hauschild, Axel1
  • Santinami, Mario1
  • Atkinson, Victoria1
  • Mandalà, Mario1
  • Chiarion-Sileni, Vanna1
  • Larkin, James1
  • Nyakas, Marta1
  • Dutriaux, Caroline1
  • Haydon, Andrew1
  • Robert, Caroline1
  • Mortier, Laurent1
  • Schachter, Jacob1
  • Schadendorf, Dirk1
  • Lesimple, Thierry1
  • Plummer, Ruth1
  • Ji, Ran1
  • Zhang, Pingkuan1
  • Mookerjee, Bijoyesh1
  • Legos, Jeff1
  • And 3 more
  • 1 From the Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals (G.V.L.), and Macquarie University, Melanoma Institute Australia, University of Sydney, and Westmead Hospital (R.K.), Sydney, Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), and Alfred Hospital, Melbourne, VIC (A. Haydon) - all in Australia; University Hospital Schleswig-Holstein, Kiel (A. Hauschild), and University Hospital Essen, Essen, and the German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione Istituto Nazionale Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute, Padua (V.C.-S.) - all in Italy; Rikshospitalet-Radiumhospitalet, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Institute Gustave Roussy, Paris (C.R.), Université de Lille, INSERM Unité 1189, Centre Hospitalier Régional Universitaire de Lille, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Institute for Melanoma, Sheba Medical Center, Tel Hashomer, Israel (J.S.); Royal Marsden NHS Foundation Trust, London (J. Larkin), and Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Novartis Pharmaceuticals, East Hanover, NJ (R.J., P.Z., B.M., J. Legos); University Hospital Zürich Skin Cancer Center, Zurich, Switzerland (R.D.); and the Melanoma Program, Hillman UPMC Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.). , (Australia)
Type
Published Article
Journal
New England Journal of Medicine
Publisher
New England Journal of Medicine
Publication Date
Nov 09, 2017
Volume
377
Issue
19
Pages
1813–1823
Identifiers
DOI: 10.1056/NEJMoa1708539
PMID: 28891408
Source
Medline
License
Unknown

Abstract

Adjuvant use of combination therapy with dabrafenib plus trametinib resulted in a significantly lower risk of recurrence in patients with stage III melanoma with BRAF V600E or V600K mutations than the adjuvant use of placebo and was not associated with new toxic effects. (Funded by GlaxoSmithKline and Novartis; COMBI-AD ClinicalTrials.gov, NCT01682083 ; EudraCT number, 2012-001266-15 .).

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