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Title: Effectiveness of dabrafenib in the treatment of patients with BRAF V600-mutated metastatic melanoma in a Named Patient Program.
Austin Authors: Martin-Algarra, Salvador;Hinshelwood, Rebecca;Mesnage, Soizick;Cebon, Jonathan S ;Ferrucci, Pier Francesco;Aglietta, Massimo;Neyns, Bart;Chiarion-Sileni, Vanna;Lindsay, Colin R;Del Vecchio, Michele;Linardou, Helen;Merelli, Barbara;Tonini, Giuseppe;Atkinson, Victoria;Freivogel, Klaus;Stein, Dara;Dalland, Lindi;Lau, Mike;Legenne, Philippe;Queirolo, Paola;Millward, Michael
Affiliation: Department of Medical Oncology, Clínica Universidad de Navarra, University of Navarra, Pamplona, Spain
School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia
Melanoma Unit, European Institute of Oncology, Milano, Italy
Auckland City Hospital, Auckland, New Zealand
Gallipoli Medical Research Foundation, University of Queensland and Princess Alexandra Hospital, Brisbane, QLD, Australia
Department of Medical Oncology, The Crown Princess Mary Cancer Centre, Westmead Hospital, Westmead, NSW, Australia
Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australia
Beatson West of Scotland Cancer Centre, NHS Greater Glasgow and Clyde, and Institute of Cancer Sciences, University of Glasgow, Glasgow, UK
Department of Medical Oncology, Candiolo Cancer Institute, University of Torino, Torino, Italy
Department of Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium
Melanoma and Esophageal Cancer Unit, Istituto Oncologico Veneto, Istituto Di Ricovero e Cura a Carattere Scientifico, Padova, Italy
Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
First Department of Oncology, Metropolitan Hospital, Athens, Greece
Department of Medical Oncology, ASST Papa Giovanni XXIII, Bergamo
Department of Medical Oncology, Campus Bio-Medico University of Rome, Rome, Italy
UBC, Lörrach, Germany
UBC, Montreal, QC, Canada
Novartis Norge AS, Oslo, Norway
Novartis Pharma AG, Basel, Switzerland
UOC Oncologia Medica, IRCCS San Martino-IST, Genova, Italy
Issue Date: Oct-2019 2019-05-14
Publication information: Melanoma research 2019; 29(5): 527-532
Abstract: Given the approval of dabrafenib in patients with BRAF-mutant metastatic melanoma, a better understanding of treatment patterns and clinical outcomes with dabrafenib in a clinical setting is warranted. We performed a retrospective chart review of patients who received dabrafenib in a compassionate use setting through the Named Patient Program (DESCRIBE I study) during December 2010-August 2013 in Europe, New Zealand and Australia. Of the 331 Named Patient Program patients included, the majority (95.8%) had stage IV disease at dabrafenib initiation and 39.9% had brain metastases (BMs). Dabrafenib was used first line in 67.7% of patients, and median treatment duration was 6.4 months. Dabrafenib was well tolerated. Common grade 2/3 adverse events were hyperkeratosis (7.6%), pyrexia/fever (6.6%), fatigue (5.1%), hand-foot syndrome (5.4%) and nausea (3.6%). Overall response rate was 45.9%, median progression-free survival was 5.2 months (95% confidence interval, 4.2-6.1 months), and median overall survival was 12.4 months (95% confidence interval, 10.2-15.0 months). In patients with known brain metastases (n = 132) versus patients without (n = 199), overall response rate was 42.4% versus 48.2%, progression-free survival was 3.9 months (95% confidence interval, 3.8-5.5 months) versus 5.9 months (95% confidence interval, 4.8-7.8 months) and overall survival was 9.5 months (95% confidence interval, 6.7-12.4 months) versus 15 months (95% confidence interval, 11.1-20.5 months), respectively. Safety and effectiveness of dabrafenib in patients with unresectable advanced BRAF V600-mutant melanoma treated in an Named Patient Program was similar to the clinical trial experience, demonstrating effectiveness of dabrafenib in a nontrial setting.
DOI: 10.1097/CMR.0000000000000608
ORCID: 0000-0002-3898-950X
PubMed URL: 31095039
Type: Journal Article
Appears in Collections:Journal articles

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