Abstract
This study (NCT02083354) assessed the efficacy and safety of dabrafenib plus trametinib in East Asian patients with advanced BRAF V600-mutant cutaneous melanoma. Overall, 77 patients of East Asian origin (including 61 from Mainland China) with unresectable or metastatic BRAF V600-mutant cutaneous melanoma were enrolled. Prior treatment was allowed except with BRAF/MEK inhibitors. Patients received dabrafenib 150 mg twice daily and trametinib 2 mg once daily. The primary end-point was objective response rate (ORR) using Response Evaluation Criteria in Solid Tumours 1.1. Secondary end-points were duration of response (DOR), progression-free survival (PFS), overall survival (OS), pharmacokinetics and safety. At data cutoff (February 23, 2018; median follow-up, 8.3 months), treatment was ongoing in 36 patients (47%). The median age was 52 years; 32% of patients had elevated lactate dehydrogenase, and 84% had received prior systemic therapy. ORR was 61% (95% confidence interval: 49.2-72.0), with four patients (5%) achieving complete response. Median DOR and PFS were 11.3 and 7.9 months, respectively. Median OS was not reached. The most common adverse event (AE) of any grade was pyrexia (56%). Grade ≥III AEs occurred in 29 patients (...Continue Reading
References
Dec 18, 2003·Journal of the National Cancer Institute·Janet L MaldonadoBoris C Bastian
Dec 4, 2004·Melanoma Research·John Wen-Cheng ChangChih-Hsun Yang
Jun 6, 2008·PLoS Medicine·Amaya VirosBoris C Bastian
May 28, 2009·JAMA : the Journal of the American Medical Association·Juliana C N ChanFrank B Hu
Feb 24, 2011·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Georgina V LongRichard F Kefford
Jul 27, 2011·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Lu SiJun Guo
Dec 20, 2011·Cancer·John A JakobMichael A Davies
Jan 15, 2014·BMC Cancer·Michaela Angelika IhleSabine Merkelbach-Bruse
Nov 18, 2014·The New England Journal of Medicine·Caroline RobertDirk Schadendorf
Jun 4, 2015·Lancet·Georgina V LongKeith Flaherty
Jun 11, 2016·The Lancet Oncology·David PlanchardBruce E Johnson
Sep 1, 2016·BMC Cancer·Yu WangShuangge Ma
Jun 9, 2017·The Lancet Oncology·Michael A DaviesGeorgina V Long
Sep 12, 2017·The New England Journal of Medicine·Georgina V LongJohn M Kirkwood
Oct 27, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Vivek SubbiahBhumsuk Keam
Sep 13, 2018·CA: a Cancer Journal for Clinicians·Freddie BrayAhmedin Jemal
Jun 6, 2019·The New England Journal of Medicine·Caroline RobertGeorgina V Long