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Title: | Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia |
Author: | Burger, Jan A. Tedeschi, Alessandra Barr, Paul M. Robak, Tadeusz Owen, Carolyn Ghia, Paolo Bairey, Osnat Hillmen, Peter Bartlett, Nancy L. Li, Jianyong Simpson, David Grosicki, Sebastian Devereux, Stephen McCarthy, Helen Coutre, Steven Quach, Hang Gaidano, Gianluca Maslyak, Zvenyslava Stevens, Don A. Janssens, Ann Offner, Fritz Mayer, Jiří O'Dwyer, Michael Hellmann, Andrezj Schuh, Anna Siddiqi, Tanya Polliack, Aaron Tam, Constantine S. Suri, Deepali Cheng, Mei Clow, Fong Styles, Lori James, Danelle F. Kipps, Thomas J. González Barca, Eva RESONATE-2 Investigators |
Keywords: | Medicaments antineoplàstics Leucèmia Pirimidines Cèl·lules B Antineoplastic agents Leukemia Pyrimidines B cells |
Issue Date: | 17-Dec-2015 |
Publisher: | Massachusetts Medical Society |
Abstract: | Background: chronic lymphocytic leukemia (CLL) primarily affects older persons who often have coexisting conditions in addition to disease-related immunosuppression and myelosuppression. We conducted an international, open-label, randomized phase 3 trial to compare two oral agents, ibrutinib and chlorambucil, in previously untreated older patients with CLL or small lymphocytic lymphoma. Methods: we randomly assigned 269 previously untreated patients who were 65 years of age or older and had CLL or small lymphocytic lymphoma to receive ibrutinib or chlorambucil. The primary end point was progression-free survival as assessed by an independent review committee. Results: the median age of the patients was 73 years. During a median follow-up period of 18.4 months, ibrutinib resulted in significantly longer progression-free survival than did chlorambucil (median, not reached vs. 18.9 months), with a risk of progression or death that was 84% lower with ibrutinib than that with chlorambucil (hazard ratio, 0.16; P<0.001). Ibrutinib significantly prolonged overall survival; the estimated survival rate at 24 months was 98% with ibrutinib versus 85% with chlorambucil, with a relative risk of death that was 84% lower in the ibrutinib group than in the chlorambucil group (hazard ratio, 0.16; P=0.001). The overall response rate was higher with ibrutinib than with chlorambucil (86% vs. 35%, P<0.001). The rates of sustained increases from baseline values in the hemoglobin and platelet levels were higher with ibrutinib. Adverse events of any grade that occurred in at least 20% of the patients receiving ibrutinib included diarrhea, fatigue, cough, and nausea; adverse events occurring in at least 20% of those receiving chlorambucil included nausea, fatigue, neutropenia, anemia, and vomiting. In the ibrutinib group, four patients had a grade 3 hemorrhage and one had a grade 4 hemorrhage. A total of 87% of the patients in the ibrutinib group are continuing to take ibrutinib. Conclusions: ibrutinib was superior to chlorambucil in previously untreated patients with CLL or small lymphocytic lymphoma, as assessed by progression-free survival, overall survival, response rate, and improvement in hematologic variables. (Funded by Pharmacyclics and others; RESONATE-2 ClinicalTrials.gov number, NCT01722487.). |
Note: | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1509388 |
It is part of: | New England Journal of Medicine, 2015, vol. 373, num. 25, p. 2425-2437 |
URI: | http://hdl.handle.net/2445/178506 |
Related resource: | https://doi.org/10.1056/NEJMoa1509388 |
ISSN: | 0028-4793 |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) |
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