作者
John C Byrd, Jennifer R Brown, Susan O'Brien, Jacqueline C Barrientos, Neil E Kay, Nishitha M Reddy, Steven Coutre, Constantine S Tam, Stephen P Mulligan, Ulrich Jaeger, Steve Devereux, Paul M Barr, Richard R Furman, Thomas J Kipps, Florence Cymbalista, Christopher Pocock, Patrick Thornton, Federico Caligaris-Cappio, Tadeusz Robak, Julio Delgado, Stephen J Schuster, Marco Montillo, Anna Schuh, Sven de Vos, Devinder Gill, Adrian Bloor, Claire Dearden, Carol Moreno, Jeffrey J Jones, Alvina D Chu, Maria Fardis, Jesse McGreivy, Fong Clow, Danelle F James, Peter Hillmen
发表日期
2014/7/17
期刊
New England Journal of Medicine
卷号
371
期号
3
页码范围
213-223
出版商
Massachusetts Medical Society
简介
Background
In patients with chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL), a short duration of response to therapy or adverse cytogenetic abnormalities are associated with a poor outcome. We evaluated the efficacy of ibrutinib, a covalent inhibitor of Bruton's tyrosine kinase, in patients at risk for a poor outcome.
Methods
In this multicenter, open-label, phase 3 study, we randomly assigned 391 patients with relapsed or refractory CLL or SLL to receive daily ibrutinib or the anti-CD20 antibody ofatumumab. The primary end point was the duration of progression-free survival, with the duration of overall survival and the overall response rate as secondary end points.
Results
At a median follow-up of 9.4 months, ibrutinib significantly improved progression-free survival; the median duration was not reached in the ibrutinib group (with a rate of progression-free survival of 88% at 6 months), as …
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JC Byrd, JR Brown, S O'Brien, JC Barrientos, NE Kay… - New England Journal of Medicine, 2014