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Selumetinib in Combination With Dacarbazine in Patients With Metastatic Uveal Melanoma: A Phase III, Multicenter, Randomized Trial (SUMIT)

2018; Lippincott Williams & Wilkins; Volume: 36; Issue: 12 Linguagem: Inglês

10.1200/jco.2017.74.1090

1527-7755

Richard D. Carvajal, Sophie Piperno‐Neumann, Ellen Kapiteijn, Paul B. Chapman, Stephen Jay Frank, Anthony M. Joshua, Josep M. Piulats, Pascal Wolter, Véronique Cocquyt, Bartosz Chmielowski, T.R. Jeffry Evans, Lauris Gastaud, Gerald P. Linette, Carola Berking, Jacob Schachter, Manuel Rodrigues, Alexander N. Shoushtari, Delyth Clemett, Dana Ghiorghiu, G Mariani, Shirley Spratt, Susan Lovick, Peter Barker, Elaine Kilgour, Zhongwu Lai, Gary K. Schwartz, Paul Nathan,

Corneal Surgery and Treatments

Purpose Uveal melanoma is the most common primary intraocular malignancy in adults with no effective systemic treatment option in the metastatic setting. Selumetinib (AZD6244, ARRY-142886) is an oral, potent, and selective MEK1/2 inhibitor with a short half-life, which demonstrated single-agent activity in patients with metastatic uveal melanoma in a randomized phase II trial. Methods The Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) study was a phase III, double-blind trial ( ClinicalTrial.gov identifier: NCT01974752) in which patients with metastatic uveal melanoma and no prior systemic therapy were randomly assigned (3:1) to selumetinib (75 mg twice daily) plus dacarbazine (1,000 mg/m