Miniatura

Fitxers

CortesJE.pdf (984.48 KB)

Tipus de document

Article

Versió

Versió publicada

Data de publicació

2016-07-10

Tots els drets reservats

Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/126831

Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients Trial

Títol de la revista

Autors

Director/Tutor

ISSN de la revista

Títol del volum

Recurs relacionat

https://doi.org/10.1200/JCO.2015.64.8899

Resum

Purpose: We report the 5-year analysis from the phase III Dasatinib Versus Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients (DASISION) trial, evaluating long-term efficacy and safety outcomes of patients with chronic myeloid leukemia (CML) in chronic phase (CP) treated with dasatinib or imatinib. Patients and Methods: Patients with newly diagnosed CML-CP were randomly assigned to receive dasatinib 100 mg once daily (n = 259) or imatinib 400 mg once daily (n = 260). Results: At the time of study closure, 61% and 63% of dasatinib- and imatinib-treated patients remained on initial therapy, respectively. Cumulative rates of major molecular response and molecular responses with a 4.0- or 4.5-log reduction in BCR-ABL1 transcripts from baseline by 5 years remained statistically significantly higher for dasatinib compared with imatinib. Rates for progression-free and overall survival at 5 years remained high and similar across treatment arms. In patients who achieved BCR-ABL1 <= 10% at 3 months (dasatinib, 84%; imatinib, 64%), improvements in progression-free and overall survival and lower rates of transformation to accelerated/blast phase were reported compared with patients with BCR-ABL1 greater than 10% at 3 months. Transformation to accelerated/blast phase occurred in 5% and 7% of patients in the dasatinib and imatinib arms, respectively. Fifteen dasatinib-treated and 19 imatinib-treated patients had BCR-ABL1 mutations identified at discontinuation. There were no new or unexpected adverse events identified in either treatment arm, and pleural effusion was the only drug-related, nonhematologic adverse event reported more frequently with dasatinib (28% v 0.8% with imatinib). First occurrences of pleural effusion were reported with dasatinib, with the highest incidence in year 1. Arterial ischemic events were uncommon in both treatment arms. Conclusion: These final results from the DASISION trial continue to support dasatinib 100 mg once daily as a safe and effective first-line therapy for the long-term treatment of CML-CP.

Matèries

Leucèmia, Malalties cròniques

Matèries (anglès)

Leukemia, Chronic diseases

Citació

Col·leccions

Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

CORTES, Jorge e., SAGLIO, Giuseppe, KANTARJIAN, Hagop m., BACCARANI, Michele, MAYER, Jiří, BOQUÉ GENOVARD, Concepción, SHAH, Neil p., CHUAH, Charles, CASANOVA, Luis, BRADLEY-GARELIK, Brigid, MANOS, George, HOCHHAUS, Andreas. Final 5-Year Study Results of DASISION: The Dasatinib
Versus Imatinib Study in Treatment-Naïve Chronic Myeloid
Leukemia Patients Trial. _Journal of Clinical Oncology_. 2016. Vol. 34, núm. 20, pàgs. 2333-2340. [consulta: 24 de gener de 2026]. [Disponible a: https://hdl.handle.net/2445/126831]

Exportar metadades

JSON - METS

Compartir registre