TY - JOUR
T1 - Final 5-year study results of DASISION
T2 - The dasatinib versus imatinib study in treatment-Naïve chronic myeloid leukemia patients trial
AU - Cortes, Jorge E.
AU - Saglio, Giuseppe
AU - Kantarjian, Hagop M.
AU - Baccarani, Michele
AU - Mayer, Jiří
AU - Boqué, Concepción
AU - Shah, Neil P.
AU - Chuah, Charles
AU - Casanova, Luis
AU - Bradley-Garelik, Brigid
AU - Manos, George
AU - Hochhaus, Andreas
N1 - Publisher Copyright:
© 2016 by American Society of Clinical Oncology.
PY - 2016/7/10
Y1 - 2016/7/10
N2 - Purpose: We report the 5-year analysis from the phase III Dasatinib Versus Imatinib Study in Treatment-Naïve 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 frombaseline by 5 years remained statistically significantly higher for dasatinib comparedwith 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 dasatinibtreated 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 effusionwere 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.
AB - Purpose: We report the 5-year analysis from the phase III Dasatinib Versus Imatinib Study in Treatment-Naïve 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 frombaseline by 5 years remained statistically significantly higher for dasatinib comparedwith 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 dasatinibtreated 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 effusionwere 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.
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U2 - 10.1200/JCO.2015.64.8899
DO - 10.1200/JCO.2015.64.8899
M3 - Article
C2 - 27217448
AN - SCOPUS:84977485123
SN - 0732-183X
VL - 34
SP - 2333
EP - 2340
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 20
ER -