BURGER, J.A., A. TEDESCHI, P.M. BARR, T. ROBAK, C. OWEN, P. GHIA, O. BAIREY, P. HILLMEN, N.L. BARTLETT, J. LI, D. SIMPSON, S. GROSICKI, S. DEVEREUX, H. MCCARTHY, S. COUTRE, H. QUACH, G. GAIDANO, Z. MASLYAK, D.A. STEVENS, A. JANSSENS, F. OFFNER, Jiří MAYER, M. O’DWYER, A. HELLMANN, A. SCHUH, T. SIDDIQI, A. POLLIACK, C.S. TAM, D. SURI, M. CHENG, F. CLOW, L. STYLES, D.F. JAMES and T.J. KIPPS. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. New England Journal of Medicine. Waltham: Massachussetts Medical Society, 2015, vol. 373, No 25, p. 2425-2437. ISSN 0028-4793. doi:10.1056/NEJMoa1509388.
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Basic information
Original name Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia
Authors BURGER, J.A. (840 United States of America), A. TEDESCHI (380 Italy), P.M. BARR (840 United States of America), T. ROBAK (616 Poland), C. OWEN (124 Canada), P. GHIA (380 Italy), O. BAIREY (376 Israel), P. HILLMEN (826 United Kingdom of Great Britain and Northern Ireland), N.L. BARTLETT (840 United States of America), J. LI (156 China), D. SIMPSON (554 New Zealand), S. GROSICKI (616 Poland), S. DEVEREUX (826 United Kingdom of Great Britain and Northern Ireland), H. MCCARTHY (826 United Kingdom of Great Britain and Northern Ireland), S. COUTRE (840 United States of America), H. QUACH (36 Australia), G. GAIDANO (380 Italy), Z. MASLYAK (804 Ukraine), D.A. STEVENS (840 United States of America), A. JANSSENS (56 Belgium), F. OFFNER (56 Belgium), Jiří MAYER (203 Czech Republic, guarantor, belonging to the institution), M. O’DWYER (372 Ireland), A. HELLMANN (616 Poland), A. SCHUH (826 United Kingdom of Great Britain and Northern Ireland), T. SIDDIQI (840 United States of America), A. POLLIACK (376 Israel), C.S. TAM (36 Australia), D. SURI (840 United States of America), M. CHENG (840 United States of America), F. CLOW (840 United States of America), L. STYLES (840 United States of America), D.F. JAMES (840 United States of America) and T.J. KIPPS (840 United States of America).
Edition New England Journal of Medicine, Waltham, Massachussetts Medical Society, 2015, 0028-4793.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30200 3.2 Clinical medicine
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
Impact factor Impact factor: 59.558
RIV identification code RIV/00216224:14110/15:00085450
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1056/NEJMoa1509388
UT WoS 000366461400009
Keywords in English PREVIOUSLY UNTREATED PATIENTS; TYROSINE KINASE; PHASE-3 TRIAL; OPEN-LABEL; CHLORAMBUCIL; FLUDARABINE; CLL; CYCLOPHOSPHAMIDE; CANCER; PCI-32765
Tags EL OK, podil
Tags International impact, Reviewed
Changed by Changed by: Ing. Mgr. Věra Pospíšilíková, učo 9005. Changed: 13/1/2016 13:36.
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.
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