Journal article
Safety and efficacy of vemurafenib in BRAFV600E and BRAFV600K mutation-positive melanoma (BRIM-3): Extended follow-up of a phase 3, randomised, open-label study
GA McArthur, PB Chapman, C Robert, J Larkin, JB Haanen, R Dummer, A Ribas, D Hogg, O Hamid, PA Ascierto, C Garbe, A Testori, M Maio, P Lorigan, C Lebbé, T Jouary, D Schadendorf, SJ O'Day, JM Kirkwood, AM Eggermont Show all
Lancet Oncology | Published : 2014
Abstract
Background: In the BRIM-3 trial, vemurafenib was associated with risk reduction versus dacarbazine of both death and progression in patients with advanced BRAFV600 mutation-positive melanoma. We present an extended follow-up analysis of the total population and in the BRAFV600E and BRAFV600K mutation subgroups. Methods: Patients older than 18 years, with treatment-naive metastatic melanoma and whose tumour tissue was positive for BRAFV600 mutations were eligible. Patients also had to have a life expectancy of at least 3 months, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate haematological, hepatic, and renal function. Patients were randomly assigned b..
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Awarded by National Cancer Institute
Funding Acknowledgements
We thank the patients who participated in this study. We also thank the clinical trial team for their support in the execution of the trial, and F Hoffmann-La Roche-Genentech for supporting the trial. Medical writing assistance was provided by David Gibson, PhD, of ApotheCom, San Francisco, CA, USA, and funded by F Hoffmann-La Roche. JL is funded by the National Institute for Health Research Biomedical Research Centre for cancer at Royal Marsden Hospital/Institute of Cancer Research. GAM is a practitioner fellow of National Health and Medical Research Council.