دورية أكاديمية

Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia

التفاصيل البيبلوغرافية
العنوان: Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia
المؤلفون: Burger, Ja, Tedeschi, A, Barr, Pm, Robak, T, Owen, C, Ghia, P, Bairey, O, Hillmen, P, Bartlett, Nl, Li, J, Simpson, D, Grosicki, S, Devereux, S, Mccarthy, H, Coutre, S, Quach, H, Gaidano, G, Maslyak, Z, Stevens, Da, Janssens, A, Offner, F, Mayer, J, O'Dwyer, M, Hellmann, A, Schuh, A, Siddiqi, T, Polliack, A, Tam, Cs, Keating, M, Kipps, Tj, Jen, J, Jindra, P, Simkovič, M, Braester, A, Ruchlemer, R, Semenzato, G, Hawkins, T, Atanasio, Cm, Demirkan, F, Kaynar, L, Pylypenko, H, Fox, C, Thirman, M, Campbell, P, Coughlin, P, Harrup, R, Kuss, B, Turner, P, Wu, Kl, Larratt, L, Fineman, R, Marasca, R, Zinzani, Pl, Corbett, G, Abrisqueta, P, Delgado, J, González Barca, E, de Oteyza, Jp, Arsland, O, Kaplan, P, Oliynyk, H, Hamblin, M, Atkins, J, Barrientos, J, Gasic, S, Hou, Jz, Kingsley, E, Shadman, M, Badoux, X, Gill, D, Opat, S, Bron, D, Van Den Neste, E, Jing, H, Zhu, J, Vandenberghe, E, Tadmor, T, Cortelezzi, A, Ganly, P, Weinkove, R, Pluta, A, Pristupa, A, García Marco, Ja, Vural, F, Yağci, M, Kasych, M, Duncombe, A, Fegan, C, Quackenbush, R, Tirumali, N., FOA, Roberto
المساهمون: Burger, Ja, Tedeschi, A, Barr, Pm, Robak, T, Owen, C, Ghia, P, Bairey, O, Hillmen, P, Bartlett, Nl, Li, J, Simpson, D, Grosicki, S, Devereux, S, Mccarthy, H, Coutre, S, Quach, H, Gaidano, G, Maslyak, Z, Stevens, Da, Janssens, A, Offner, F, Mayer, J, O'Dwyer, M, Hellmann, A, Schuh, A, Siddiqi, T, Polliack, A, Tam, C, Keating, M, Kipps, Tj, Jen, J, Jindra, P, Simkovič, M, Braester, A, Ruchlemer, R, Foa, Roberto, Semenzato, G, Hawkins, T, Atanasio, Cm, Demirkan, F, Kaynar, L, Pylypenko, H, Fox, C, Thirman, M, Campbell, P, Coughlin, P, Harrup, R, Kuss, B, Turner, P, Wu, Kl, Larratt, L, Fineman, R, Marasca, R, Zinzani, Pl, Corbett, G, Abrisqueta, P, Delgado, J, González Barca, E, de Oteyza, Jp, Arsland, O, Kaplan, P, Oliynyk, H, Hamblin, M, Atkins, J, Barrientos, J, Gasic, S, Hou, Jz, Kingsley, E, Shadman, M, Badoux, X, Gill, D, Opat, S, Bron, D, Van Den Neste, E, Jing, H, Zhu, J, Vandenberghe, E, Tadmor, T, Cortelezzi, A, Ganly, P, Weinkove, R, Pluta, A, Pristupa, A, García Marco, Ja, Vural, F, Yağci, M, Kasych, M, Duncombe, A, Fegan, C, Quackenbush, R, Tirumali, N.
بيانات النشر: Massachussetts Medical Society
سنة النشر: 2015
المجموعة: Sapienza Università di Roma: CINECA IRIS
مصطلحات موضوعية: Aged, Antineoplastic Agent, Chlorambucil, Diarrhea, Disease-Free Survival, Fatigue, Female, Human, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Neutropenia, Pyrazole, Pyrimidine, Survival Analysi, Medicine (all)
الوصف: 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 ...
نوع الوثيقة: article in journal/newspaper
اللغة: English
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/26639149; info:eu-repo/semantics/altIdentifier/wos/WOS:000366461400009; volume:373; issue:25; firstpage:2425; lastpage:2437; numberofpages:13; journal:NEW ENGLAND JOURNAL OF MEDICINE; http://hdl.handle.net/11573/859626Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-84950133717
DOI: 10.1056/NEJMoa1509388
الإتاحة: https://doi.org/10.1056/NEJMoa1509388Test
http://hdl.handle.net/11573/859626Test
رقم الانضمام: edsbas.1969DD9D
قاعدة البيانات: BASE