作者
Andrew W Roberts, Matthew S Davids, John M Pagel, Brad S Kahl, Soham D Puvvada, John F Gerecitano, Thomas J Kipps, Mary Ann Anderson, Jennifer R Brown, Lori Gressick, Shekman Wong, Martin Dunbar, Ming Zhu, Monali B Desai, Elisa Cerri, Sari Heitner Enschede, Rod A Humerickhouse, William G Wierda, John F Seymour
发表日期
2016/1/28
期刊
New England Journal of Medicine
卷号
374
期号
4
页码范围
311-322
出版商
Massachusetts Medical Society
简介
Background
New treatments have improved outcomes for patients with relapsed chronic lymphocytic leukemia (CLL), but complete remissions remain uncommon. Venetoclax has a distinct mechanism of action; it targets BCL2, a protein central to the survival of CLL cells.
Methods
We conducted a phase 1 dose-escalation study of daily oral venetoclax in patients with relapsed or refractory CLL or small lymphocytic lymphoma (SLL) to assess safety, pharmacokinetic profile, and efficacy. In the dose-escalation phase, 56 patients received active treatment in one of eight dose groups that ranged from 150 to 1200 mg per day. In an expansion cohort, 60 additional patients were treated with a weekly stepwise ramp-up in doses as high as 400 mg per day.
Results
The majority of the study patients had received multiple previous treatments, and 89% had poor prognostic clinical or genetic features. Venetoclax was active at …
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AW Roberts, MS Davids, JM Pagel, BS Kahl… - New England Journal of Medicine, 2016