Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/16115
Title: Overall survival and durable responses in patients with BRAF V600–mutant metastatic melanoma receiving dabrafenib combined with trametinib
Austin Authors: Long, Georgina V;Weber, Jeffrey s;Infante, Jeffrey R;Kim, Kevin B;Daud, Adil;Gonzalez, Rene;Sosman, Jeffrey A;Hamid, Omid;Schuchter, Lynn;Cebon, Jonathan S ;Kefford, Richard F;Lawrence, Donald P;Kudchadkar, Ragini;Burris, Howard A;Falchook, Gerald S;Algazi, Alain;Lewis, Karl;Puzanov, Igor;Ibrahim, Nageatte;Sun, Peng;Cunningham, Elizabeth;Kline, Amy S;Del Buono, Heather;McDowell, Diane Opatt;Patel, Kiran;Flaherty, Keith T
Affiliation: Austin Health, Heidelberg, Victoria, Australia
Melanoma Institute Australia, North Sydney, NSW, Australia
The University of Sydney, Sydney, NSW, Australia
Macquarie University, Sydney, NSW, Australia
Westmead Hospital, Westmead, NSW, Australia
Moffitt Cancer Center, Tampa, FL, USA
Sarah Cannon Research Institute, Nashville, TN, USA
California Pacific Medical Center, San Francisco, CA, USA
Tennessee Oncology, Nashville, TN, USA
University of California, San Francisco, CA, USA
The Angeles Clinic and Research Institute, Los Angeles, CA, US
University of Colorado, Boulder, CO, USA
Sarah Cannon Research Institute at HealthONE, Denver, CO, USA
Vanderbilt University Medical Center, Nashville, TN, USA
University of Pennsylvania Abramson Cancer Center, Phildelphia, PA, USA
Merck, USA
GlaxoSmithKline, Philadelphia, PA, USA
Incyte Corporation, Wilmington, DE, USA
Massachusetts General Hospital Cancer Center, Boston, MA, USA
Issue Date: 10-Mar-2016
metadata.dc.date: 2016-01-25
Publication information: Journal of Clinical Oncology 2016; 34(8): 871-878
Abstract: Purpose: To report the overall survival (OS) and clinical characteristics of BRAF inhibitor–naive long-term responders and survivors treated with dabrafenib plus trametinib in a phase I and II study of patients with BRAF V600 mutation–positive metastatic melanoma. Methods: BRAF inhibitor–naive patients treated with dabrafenib 150 mg twice daily plus trametinib 2 mg daily (the 150/2 group) from the non–randomly assigned (part B) and randomly assigned (part C) cohorts of the study were analyzed for progression-free and OS separately. Baseline characteristics and factors on treatment were analyzed for associations with durable responses and OS. Results: For BRAF inhibitor–naive patients in the 150/2 groups (n = 78), the progression-free survival at 1, 2, and 3 years was 44%, 22%, and 18%, respectively, for part B (n = 24) and 41%, 25%, and 21%, respectively, for part C (n = 54). Median OS was 27.4 months in part B and 25 months in part C. OS at 1, 2, and 3 years was 72%, 60%, and 47%, respectively, for part B and 80%, 51%, and 38%, respectively, for part C. Prolonged survival was associated with metastases in fewer than three organ sites and lower baseline lactate dehydrogenase. OS at 3 years was 62% in patients with normal baseline lactate dehydrogenase and 63% in patients with a complete response. Conclusion: Dabrafenib plus trametinib results in a median OS of more than 2 years in BRAF inhibitor–naive patients with BRAF V600 mutation–positive metastatic melanoma, and approximately 20% were progression free at 3 years. Durable responses occurred in patients with good prognostic features at baseline, which may be predictive.
URI: http://ahro.austin.org.au/austinjspui/handle/1/16115
DOI: 10.1200/JCO.2015.62.9345
PubMed URL: https://pubmed.ncbi.nlm.nih.gov/26811525
Type: Journal Article
Subjects: Antineoplastic combined chemotherapy protocols
Melanoma
Proto-oncogene proteins B-raf
Appears in Collections:Journal articles

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