Abstract
We report results of a randomized, phase III study of ofatumumab versus physicians' choice treatment in patients with bulky fludarabine-refractory chronic lymphocytic leukemia and explore extended versus standard-length ofatumumab treatment. Patients (79 ofatumumab, 43 physicians' choice) completed a median 6 (ofatumumab) or 3 (physicians' choice) months' therapy. Ofatumumab-treated patients with stable disease or better were randomized (2:1) to 6 months' extended ofatumumab treatment or observation. Although the study did not meet the primary endpoint of progression-free survival (PFS) by independent review committee (ofatumumab: 5.4 months, physicians' choice: 3.6 months; p = 0.27), median PFS by investigators was significantly longer for ofatumumab versus physicians' choice (7.0 versus 4.5 months; p = 0.003) as was time to next therapy (median 11.5 versus 6.5 months; p = 0.0004). PFS and time to next therapy were significantly longer with ofatumumab extended treatment than observation (p = 0.026 and p = 0.002, respectively; n = 37). The adverse-event profile of long-term ofatumumab administration showed no unexpected findings (Clinicaltrials.gov identifier: NCT01313689).
References
Dec 1, 1982·American Journal of Clinical Oncology·M M OkenP P Carbone
Apr 11, 2003·Leukemia & Lymphoma·M J KeatingH Kantarjian
Mar 2, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Paul MoretonPeter Hillmen
Oct 21, 2006·Cancer·Michael FieglUNKNOWN Austrian Collaborative Study Group on Alemtuzumab in Chronic Lymphocytic Leukemia
Oct 6, 2007·Leukemia & Lymphoma·Constantine S TamWilliam G Wierda
Jan 25, 2008·Blood·Michael HallekUNKNOWN International Workshop on Chronic Lymphocytic Leukemia
Jul 25, 2009·Leukemia·A OsterborgK R Rai
Aug 5, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Wolfgang U KnaufMarco Montillo
Mar 3, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·William G WierdaUNKNOWN Hx-CD20-406 Study Investigators
Jun 21, 2013·The New England Journal of Medicine·John C ByrdSusan O'Brien
Jul 25, 2013·Blood·Yasser M El-SherbinyGraham P Cook
Nov 19, 2013·Leukemia & Lymphoma·Sandra Eketorp SylvanAnders Osterborg
Jan 10, 2014·The New England Journal of Medicine·Valentin GoedeMichael Hallek
Jan 15, 2014·American Journal of Hematology·Robin FoàAnna Guarini
Jan 24, 2014·The New England Journal of Medicine·Richard R FurmanSusan M O'Brien
May 24, 2014·Blood·J Marius MunnekeMette D Hazenberg
May 30, 2014·The New England Journal of Medicine·Jennifer A WoyachJohn C Byrd
Jun 3, 2014·The New England Journal of Medicine·John C ByrdUNKNOWN RESONATE Investigators
Citations
Apr 9, 2013·Hematology/oncology Clinics of North America·Deborah M Stephens, John C Byrd
Nov 7, 2016·Cancer Immunology, Immunotherapy : CII·Maria WinqvistJeanette Lundin
Aug 30, 2017·Future Oncology·Zar Ni Soe, David Allsup
Aug 2, 2017·Annals of Hematology·Lotta HanssonAnders Österborg
Feb 14, 2018·British Journal of Cancer·Marie VialaDiego Tosi
Jan 30, 2020·British Journal of Haematology·Udvardy MiklosAnders Österborg
Jun 6, 2017·Hematology·Yougen WuYang Hong
Oct 7, 2020·The Milbank Quarterly·Maximilian Salcher-KonradCourtney Davis
Oct 24, 2020·Brain Sciences·Despoina FlorouVasso Apostolopoulos