The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.
Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia
Open accessAbstract
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 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.).
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Cites
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Obinutuzumab plus Chlorambucil in Patients with CLL and Coexisting Conditions
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Metadata
- Authors
- 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.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-07-17
- Volume
- 371
- Issue
- 3
- Pages
- 213-223
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2108206643
- Cited by
- 1,639
- References
- 21
- FWCI
- 91.53
- Type
- journal article
- Language
- en
- Open access
- bronze
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- The paper
- 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., . . . Hillmen, P. (2014). Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1400376
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
