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dc.date.accessioned2018-07-13T14:35:43Z
dc.date.issued2014-07
dc.identifierhttp://publications.icr.ac.uk/13438/
dc.identifier.citationNEW ENGLAND JOURNAL OF MEDICINE, 2014, 371 (3), pp. 213 - 223
dc.identifier.issn0028-4793
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/2065
dc.description.abstractBackground 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 compared with a median of 8.1 months in the ofatumumab group (hazard ratio for progression or death in the ibrutinib group, 0.22; P<0.001). Ibrutinib also significantly improved overall survival (hazard ratio for death, 0.43; P = 0.005). At 12 months, the overall survival rate was 90% in the ibrutinib group and 81% in the ofatumumab group. The overall response rate was significantly higher in the ibrutinib group than in the ofatumumab group (42.6% vs. 4.1%, P<0.001). An additional 20% of ibrutinib-treated patients had a partial response with lymphocytosis. Similar effects were observed regardless of whether patients had a chromosome 17p13.1 deletion or resistance to purine analogues. The most frequent nonhematologic adverse events were diarrhea, fatigue, pyrexia, and nausea in the ibrutinib group and fatigue, infusion-related reactions, and cough in the ofatumumab group. Conclusions Ibrutinib, as compared with ofatumumab, significantly improved progression-free survival, overall survival, and response rate among patients with previously treated CLL or SLL. (Funded by Pharmacyclics and Janssen; RESONATE ClinicalTrials.gov number, NCT01578707.)
dc.format.extent213 - 223
dc.languageeng
dc.language.isoeng
dc.subjectCHRONIC LYMPHOCYTIC-LEUKEMIA NON-HODGKINS-LYMPHOMAS PHASE-II FLUDARABINE GUIDELINES PCI-32765 RITUXIMAB DIAGNOSIS LENALIDOMIDE THERAPY
dc.titleIbrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia
dc.typeJournal Article
rioxxterms.licenseref.startdate2014-07
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfNEW ENGLAND JOURNAL OF MEDICINE
pubs.issue3
pubs.notesISI Document Delivery No.: AL3BK Times Cited: 1 Cited Reference Count: 29 Byrd, J. C. Brown, J. R. O'Brien, S. Barrientos, J. C. Kay, N. E. Reddy, N. M. Coutre, S. Tam, C. S. Mulligan, S. P. Jaeger, U. Devereux, S. Barr, P. M. Furman, R. R. Kipps, T. J. Cymbalista, F. Pocock, C. Thornton, P. Caligaris-Cappio, F. Robak, T. Delgado, J. Schuster, S. J. Montillo, M. Schuh, A. de Vos, S. Gill, D. Bloor, A. Dearden, C. Moreno, C. Jones, J. J. Chu, A. D. Fardis, M. McGreivy, J. Clow, F. James, D. F. Hillmen, P. Pharmacyclics; Janssen Funded by Pharmacyclics and Janssen; RESONATE ClinicalTrials.gov number, NCT01578707. 1 MASSACHUSETTS MEDICAL SOC WALTHAM NEW ENGL J MED
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR
pubs.volume371
pubs.embargo.termsNot known
dc.contributor.icrauthorDearden, Claireen


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