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Title: Overall survival and durable responses in patients with BRAF V600–mutant metastatic melanoma receiving dabrafenib combined with trametinib
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
Issue Date: 10-Mar-2016
EDate: 2016-01-25
Citation: 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.
DOI: 10.1200/JCO.2015.62.9345
PubMed URL:
Type: Journal Article
Subjects: Antineoplastic combined chemotherapy protocols
Proto-oncogene proteins B-raf
Appears in Collections:Journal articles

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