www.nature.com/bjc ARTICLE Clinical Study Apatorsen plus docetaxel versus docetaxel alone in platinum- resistant metastatic urothelial carcinoma (Borealis-2) 1 2 3 3 4 5 6 7 Jonathan E. Rosenberg , Noah M. Hahn , Meredith M. Regan , Lillian Werner , Ajjai Alva , Saby George , Joel Picus , Robert Alter , 8 9 10 11 12 13 14 Arjun Balar , Jean Hoffman-Censits , Petros Grivas , Richard Lauer , Elizabeth A. Guancial , Christopher Hoimes , Guru Sonpavde , 15 16 17 18 18 3 3 Constantine Albany , Mark N. Stein , Tim Breen , Cindy Jacobs , Kirsten Anderson , Joaquim Bellmunt , Aly-Khan A. Lalani , 19 3 Sumanta Pal and Toni K. Choueiri BACKGROUND: A randomised study to assess the addition of apatorsen, an antisense oligonucleotide that inhibits Hsp27 expression, to docetaxel in patients with metastatic urothelial carcinoma (mUC) relapsed after prior platinum-based chemotherapy. METHODS: Multicentre, phase II study with 1:1 randomisation to apatorsen (three loading doses at 600 mg intravenous followed by weekly doses) plus docetaxel (75 mg/m intravenous every 21 days) (A/D) or docetaxel alone. Overall survival (OS) was the primary end point with a P value <0.1 (one-sided) being positive.
British Journal of Cancer – Springer Journals
Published: May 16, 2018
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