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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.
Další formáty: BibTeX LaTeX RIS @article{1322352, author = {Burger, J.A. and Tedeschi, A. and Barr, P.M. and Robak, T. and Owen, C. and Ghia, P. and Bairey, O. and Hillmen, P. and Bartlett, N.L. and Li, J. and Simpson, D. and Grosicki, S. and Devereux, S. and McCarthy, H. and Coutre, S. and Quach, H. and Gaidano, G. and Maslyak, Z. and Stevens, D.A. and Janssens, A. and Offner, F. and Mayer, Jiří and O’Dwyer, M. and Hellmann, A. and Schuh, A. and Siddiqi, T. and Polliack, A. and Tam, C.S. and Suri, D. and Cheng, M. and Clow, F. and Styles, L. and James, D.F. and Kipps, T.J.}, article_location = {Waltham}, article_number = {25}, doi = {http://dx.doi.org/10.1056/NEJMoa1509388}, keywords = {PREVIOUSLY UNTREATED PATIENTS; TYROSINE KINASE; PHASE-3 TRIAL; OPEN-LABEL; CHLORAMBUCIL; FLUDARABINE; CLL; CYCLOPHOSPHAMIDE; CANCER; PCI-32765}, language = {eng}, issn = {0028-4793}, journal = {New England Journal of Medicine}, title = {Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia}, volume = {373}, year = {2015} } TY - JOUR ID - 1322352 AU - Burger, J.A. - Tedeschi, A. - Barr, P.M. - Robak, T. - Owen, C. - Ghia, P. - Bairey, O. - Hillmen, P. - Bartlett, N.L. - Li, J. - Simpson, D. - Grosicki, S. - Devereux, S. - McCarthy, H. - Coutre, S. - Quach, H. - Gaidano, G. - Maslyak, Z. - Stevens, D.A. - Janssens, A. - Offner, F. - Mayer, Jiří - O’Dwyer, M. - Hellmann, A. - Schuh, A. - Siddiqi, T. - Polliack, A. - Tam, C.S. - Suri, D. - Cheng, M. - Clow, F. - Styles, L. - James, D.F. - Kipps, T.J. PY - 2015 TI - Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia JF - New England Journal of Medicine VL - 373 IS - 25 SP - 2425-2437 EP - 2425-2437 PB - Massachussetts Medical Society SN - 00284793 KW - PREVIOUSLY UNTREATED PATIENTS KW - TYROSINE KINASE KW - PHASE-3 TRIAL KW - OPEN-LABEL KW - CHLORAMBUCIL KW - FLUDARABINE KW - CLL KW - CYCLOPHOSPHAMIDE KW - CANCER KW - PCI-32765 N2 - 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. ER - 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. \textit{New England Journal of Medicine}. Waltham: Massachussetts Medical Society, 2015, roč.~373, č.~25, s.~2425-2437. ISSN~0028-4793. doi:10.1056/NEJMoa1509388.

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.

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.