Selumetinib plus dacarbazine versus placebo plus dacarbazine as first-line treatment for BRAF-mutant metastatic melanoma: a phase 2 double-blind randomised study.

Journal article

BACKGROUND: Patients with metastatic melanoma, 50% of whose tumours harbour a BRAF mutation, have a poor prognosis. Selumetinib, a MEK1/2 inhibitor, has shown antitumour activity in patients with BRAF-mutant melanoma and in preclinical models when combined with chemotherapy. This study was designed to look for a signal of improved efficacy by comparing the combination of selumetinib and dacarbazine with dacarbazine alone. METHODS: This double-blind, randomised, placebo-controlled phase 2 stud...

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Authors: Robert, C; Dummer, R; Gutzmer, R; Lorigan, P; Kim, K

• Publication status: Published
• Journal: Lancet. Oncology
• Volume: 14
• Issue: 8
• Pages: 733-740
• Publication date: 2013-07-01
• DOI: 10.1016/s1470-2045(13)70237-7
• EISSN: 1474-5488
• ISSN: 1470-2045
• Language: English
• Keywords: Antineoplastic Agents, Alkylating; Melanoma; Europe; Antineoplastic Combined Chemotherapy Protocols; Skin Neoplasms; Brazil; Proportional Hazards Models; Humans; Neoplasms, Unknown Primary; Genetic Predisposition to Disease; Kaplan-Meier Estimate; Double-Blind Method; Drug Administration Schedule; Male; Disease-Free Survival; Female; Phenotype; Time Factors; Treatment Outcome; Benzimidazoles; Dacarbazine; United States; Logistic Models; Middle Aged; DNA Mutational Analysis; Proto-Oncogene Proteins B-raf; Aged; Adult; Mutation; Protein Kinase Inhibitors