Informační systém MU
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 a T.J. KIPPS. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. New England Journal of Medicine. Waltham: Massachussetts Medical Society, 2015, roč. 373, č. 25, s. 2425-2437. ISSN 0028-4793. doi:10.1056/NEJMoa1509388.
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Základní údaje
Originální název Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia
Autoři BURGER, J.A. (840 Spojené státy), A. TEDESCHI (380 Itálie), P.M. BARR (840 Spojené státy), T. ROBAK (616 Polsko), C. OWEN (124 Kanada), P. GHIA (380 Itálie), O. BAIREY (376 Izrael), P. HILLMEN (826 Velká Británie), N.L. BARTLETT (840 Spojené státy), J. LI (156 Čína), D. SIMPSON (554 Nový Zéland), S. GROSICKI (616 Polsko), S. DEVEREUX (826 Velká Británie), H. MCCARTHY (826 Velká Británie), S. COUTRE (840 Spojené státy), H. QUACH (36 Austrálie), G. GAIDANO (380 Itálie), Z. MASLYAK (804 Ukrajina), D.A. STEVENS (840 Spojené státy), A. JANSSENS (56 Belgie), F. OFFNER (56 Belgie), Jiří MAYER (203 Česká republika, garant, domácí), M. O’DWYER (372 Irsko), A. HELLMANN (616 Polsko), A. SCHUH (826 Velká Británie), T. SIDDIQI (840 Spojené státy), A. POLLIACK (376 Izrael), C.S. TAM (36 Austrálie), D. SURI (840 Spojené státy), M. CHENG (840 Spojené státy), F. CLOW (840 Spojené státy), L. STYLES (840 Spojené státy), D.F. JAMES (840 Spojené státy) a T.J. KIPPS (840 Spojené státy).
Vydání New England Journal of Medicine, Waltham, Massachussetts Medical Society, 2015, 0028-4793.
Další údaje
Originální jazyk angličtina
Typ výsledku Článek v odborném periodiku
Obor 30200 3.2 Clinical medicine
Stát vydavatele Spojené státy
Utajení není předmětem státního či obchodního tajemství
Impakt faktor Impact factor: 59.558
Kód RIV RIV/00216224:14110/15:00085450
Organizační jednotka Lékařská fakulta
Doi http://dx.doi.org/10.1056/NEJMoa1509388
UT WoS 000366461400009
Klíčová slova anglicky PREVIOUSLY UNTREATED PATIENTS; TYROSINE KINASE; PHASE-3 TRIAL; OPEN-LABEL; CHLORAMBUCIL; FLUDARABINE; CLL; CYCLOPHOSPHAMIDE; CANCER; PCI-32765
Štítky EL OK, podil
Příznaky Mezinárodní význam, Recenzováno
Změnil Změnila: Ing. Mgr. Věra Pospíšilíková, učo 9005. Změněno: 13. 1. 2016 13:36.
Anotace
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.
Zobrazeno: 27. 6. 2022 08:56