Final 5-year study results of DASISION: The dasatinib versus imatinib study in treatment-Naïve chronic myeloid leukemia patients trial

Jorge E. Cortes, Giuseppe Saglio, Hagop M. Kantarjian, Michele Baccarani, Jiří Mayer, Concepción Boqué, Neil P. Shah, Charles Chuah, Luis Casanova, Brigid Bradley-Garelik, George Manos, Andreas Hochhaus

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2333-2340
Number of pages8
JournalJournal of Clinical Oncology
Volume34
Issue number20
DOIs
StatePublished - Jul 10 2016
Externally publishedYes

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Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic Phase
Blast Crisis
Therapeutics
Disease-Free Survival
Imatinib Mesylate
Dasatinib
Time and Motion Studies
Pleural Effusion
Patient Safety
Survival Rate
Mutation
Incidence

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Final 5-year study results of DASISION : The dasatinib versus imatinib study in treatment-Naïve chronic myeloid leukemia patients trial. / Cortes, Jorge E.; Saglio, Giuseppe; Kantarjian, Hagop M.; Baccarani, Michele; Mayer, Jiří; Boqué, Concepción; Shah, Neil P.; Chuah, Charles; Casanova, Luis; Bradley-Garelik, Brigid; Manos, George; Hochhaus, Andreas.

In: Journal of Clinical Oncology, Vol. 34, No. 20, 10.07.2016, p. 2333-2340.

Research output: Contribution to journalArticle

Cortes, JE, Saglio, G, Kantarjian, HM, Baccarani, M, Mayer, J, Boqué, C, Shah, NP, Chuah, C, Casanova, L, Bradley-Garelik, B, Manos, G & Hochhaus, A 2016, 'Final 5-year study results of DASISION: The dasatinib versus imatinib study in treatment-Naïve chronic myeloid leukemia patients trial', Journal of Clinical Oncology, vol. 34, no. 20, pp. 2333-2340. https://doi.org/10.1200/JCO.2015.64.8899
Cortes, Jorge E. ; Saglio, Giuseppe ; Kantarjian, Hagop M. ; Baccarani, Michele ; Mayer, Jiří ; Boqué, 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. In: Journal of Clinical Oncology. 2016 ; Vol. 34, No. 20. pp. 2333-2340.
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abstract = "Purpose: We report the 5-year analysis from the phase III Dasatinib Versus Imatinib Study in Treatment-Na{\"i}ve 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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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

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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.

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