Dasatinib versus imatinib in newly diagnosed chronic-phase
chronic myeloid leukemia.

J 2010

Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia.

KANTARJIAN, Hagop; Neil P. SHAH; Andreas HOCHHAUS; Jorge CORTES; Sandip SHAH et. al.

Základní údaje

Originální název

Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia.

Autoři

KANTARJIAN, Hagop (840 Spojené státy, garant); Neil P. SHAH (840 Spojené státy); Andreas HOCHHAUS (276 Německo); Jorge CORTES (484 Mexiko); Sandip SHAH (356 Indie); Manuel AYALA (484 Mexiko); Beatriz MOIRAGHI (32 Argentina); Zhixiang SHEN (156 Čína); Jiří MAYER (203 Česká republika, domácí); Ricardo PASQUINI (76 Brazílie); Hirohisa NAKAMAE (392 Japonsko); Francoise HUGUET (250 Francie); Concepcion BOQUÉ (724 Španělsko); Charles CHUAH (702 Singapur); Eric BLEICKARDT (840 Spojené státy); M. Brigid BRADLEY-GARELIK (840 Spojené státy); Chao ZHU (840 Spojené státy); Ted SZATROWSKI (840 Spojené státy); David SHAPIRO (840 Spojené státy) a Michele BACCARANI (380 Itálie)

Vydání

The New England Journal of Medicine, 2010, 0028-4793

Další údaje

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: 53.486

Kód RIV

RIV/00216224:14110/10:00051394

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1056/NEJMoa1002315

UT WoS

000278816300005

Klíčová slova anglicky

CHRONIC MYELOGENOUS LEUKEMIA; KINASE DOMAIN MUTATIONS; DURABLE CYTOGENETIC RESPONSES; PATIENTS RECEIVING IMATINIB; BCR-ABL; INTERFERON-ALPHA; FOLLOW-UP; MOLECULAR RESPONSE; RESISTANCE; SURVIVAL

Příznaky

Mezinárodní význam

Změněno: 17. 1. 2012 14:19, Mgr. Michal Petr

Anotace

V originále

BACKGROUND: Treatment with dasatinib, a highly potent BCR-ABL kinase inhibitor, has resulted in high rates of complete cytogenetic response and progression-free survival among patients with chronic myeloid leukemia (CML) in the chronic phase, after failure of imatinib treatment. We assessed the efficacy and safety of dasatinib, as compared with imatinib, for the first-line treatment of chronic-phase CML. METHODS: In a multinational study, 519 patients with newly diagnosed chronic-phase CML were randomly assigned to receive dasatinib at a dose of 100 mg once daily (259 patients) or imatinib at a dose of 400 mg once daily (260 patients). The primary end point was complete cytogenetic response by 12 months, confirmed on two consecutive assessments at least 28 days apart. Secondary end points, including major molecular response, were tested at a significance level of 0.0001 to adjust for multiple comparisons. RESULTS: After a minimum follow-up of 12 months, the rate of confirmed complete cytogenetic response was higher with dasatinib than with imatinib (77% vs. 66%, P=0.007), as was the rate of complete cytogenetic response observed on at least one assessment (83% vs. 72%, P=0.001). The rate of major molecular response was higher with dasatinib than with imatinib (46% vs. 28%, P<0.0001), and responses were achieved in a shorter time with dasatinib (P<0.0001). Progression to the accelerated or blastic phase of CML occurred in 5 patients who were receiving dasatinib (1.9%) and in 9 patients who were receiving imatinib (3.5%). The safety profiles of the two treatments were similar. CONCLUSIONS: Dasatinib, administered once daily, as compared with imatinib, administered once daily, induced significantly higher and faster rates of complete cytogenetic response and major molecular response. Since achieving complete cytogenetic response within 12 months has been associated with better long-term, progression-free survival, dasatinib may improve the long-term outcomes among patients with newly diagnosed chronic-phase CML.

Citovat

KANTARJIAN, Hagop; Neil P. SHAH; Andreas HOCHHAUS; Jorge CORTES; Sandip SHAH; Manuel AYALA; Beatriz MOIRAGHI; Zhixiang SHEN; Jiří MAYER; Ricardo PASQUINI; Hirohisa NAKAMAE; Francoise HUGUET; Concepcion BOQUÉ; Charles CHUAH; Eric BLEICKARDT; M. Brigid BRADLEY-GARELIK; Chao ZHU; Ted SZATROWSKI; David SHAPIRO a Michele BACCARANI. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. The New England Journal of Medicine. 2010, roč. 362, č. 24, s. 2260-2270. ISSN 0028-4793. Dostupné z: https://dx.doi.org/10.1056/NEJMoa1002315.

@article{888948,
   author = {Kantarjian, Hagop and Shah, Neil P. and Hochhaus, Andreas and Cortes, Jorge and Shah, Sandip and Ayala, Manuel and Moiraghi, Beatriz and Shen, Zhixiang and Mayer, Jiří and Pasquini, Ricardo and Nakamae, Hirohisa and Huguet, Francoise and Boqué, Concepcion and Chuah, Charles and Bleickardt, Eric and BradleyandGarelik, M. Brigid and Zhu, Chao and Szatrowski, Ted and Shapiro, David and Baccarani, Michele},
   article_number = {24},
   doi = {http://dx.doi.org/10.1056/NEJMoa1002315},
   keywords = {CHRONIC MYELOGENOUS LEUKEMIA; KINASE DOMAIN MUTATIONS; DURABLE CYTOGENETIC RESPONSES; PATIENTS RECEIVING IMATINIB; BCR-ABL; INTERFERON-ALPHA; FOLLOW-UP; MOLECULAR RESPONSE; RESISTANCE; SURVIVAL},
   language = {eng},
   issn = {0028-4793},
   journal = {The New England Journal of Medicine},
   title = {Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia.},
   volume = {362},
   year = {2010}
}

TY  - JOUR
ID  - 888948
AU  - Kantarjian, Hagop - Shah, Neil P. - Hochhaus, Andreas - Cortes, Jorge - Shah, Sandip - Ayala, Manuel - Moiraghi, Beatriz - Shen, Zhixiang - Mayer, Jiří - Pasquini, Ricardo - Nakamae, Hirohisa - Huguet, Francoise - Boqué, Concepcion - Chuah, Charles - Bleickardt, Eric - Bradley-Garelik, M. Brigid - Zhu, Chao - Szatrowski, Ted - Shapiro, David - Baccarani, Michele
PY  - 2010
TI  - Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia.
JF  - The New England Journal of Medicine
VL  - 362
IS  - 24
SP  - 2260-2270
EP  - 2260-2270
SN  - 00284793
KW  - CHRONIC MYELOGENOUS LEUKEMIA
KW  - KINASE DOMAIN MUTATIONS
KW  - DURABLE CYTOGENETIC RESPONSES
KW  - PATIENTS RECEIVING IMATINIB
KW  - BCR-ABL
KW  - INTERFERON-ALPHA
KW  - FOLLOW-UP
KW  - MOLECULAR RESPONSE
KW  - RESISTANCE
KW  - SURVIVAL
N2  - BACKGROUND: Treatment with dasatinib, a highly potent BCR-ABL kinase inhibitor, has resulted in high rates of complete cytogenetic response and progression-free survival among patients with chronic myeloid leukemia (CML) in the chronic phase, after failure of imatinib treatment. We assessed the efficacy and safety of dasatinib, as compared with imatinib, for the first-line treatment of chronic-phase CML. METHODS: In a multinational study, 519 patients with newly diagnosed chronic-phase CML were randomly assigned to receive dasatinib at a dose of 100 mg once daily (259 patients) or imatinib at a dose of 400 mg once daily (260 patients). The primary end point was complete cytogenetic response by 12 months, confirmed on two consecutive assessments at least 28 days apart. Secondary end points, including major molecular response, were tested at a significance level of 0.0001 to adjust for multiple comparisons. RESULTS: After a minimum follow-up of 12 months, the rate of confirmed complete cytogenetic response was higher with dasatinib than with imatinib (77% vs. 66%, P=0.007), as was the rate of complete cytogenetic response observed on at least one assessment (83% vs. 72%, P=0.001). The rate of major molecular response was higher with dasatinib than with imatinib (46% vs. 28%, P<0.0001), and responses were achieved in a shorter time with dasatinib (P<0.0001). Progression to the accelerated or blastic phase of CML occurred in 5 patients who were receiving dasatinib (1.9%) and in 9 patients who were receiving imatinib (3.5%). The safety profiles of the two treatments were similar. CONCLUSIONS: Dasatinib, administered once daily, as compared with imatinib, administered once daily, induced significantly higher and faster rates of complete cytogenetic response and major molecular response. Since achieving complete cytogenetic response within 12 months has been associated with better long-term, progression-free survival, dasatinib may improve the long-term outcomes among patients with newly diagnosed chronic-phase CML.
ER  -

KANTARJIAN, Hagop; Neil P. SHAH; Andreas HOCHHAUS; Jorge CORTES; Sandip SHAH; Manuel AYALA; Beatriz MOIRAGHI; Zhixiang SHEN; Jiří MAYER; Ricardo PASQUINI; Hirohisa NAKAMAE; Francoise HUGUET; Concepcion BOQUÉ; Charles CHUAH; Eric BLEICKARDT; M. Brigid BRADLEY-GARELIK; Chao ZHU; Ted SZATROWSKI; David SHAPIRO a Michele BACCARANI. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. \textit{The New England Journal of Medicine}. 2010, roč.~362, č.~24, s.~2260-2270. ISSN~0028-4793. Dostupné z: https://dx.doi.org/10.1056/NEJMoa1002315.

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