Dasatinib 100 mg once daily is safe and effective as frontline therapy for the long-term treatment of patients with chronic myeloid leukemia in chronic phase (CML-CP), final results from the DASISION trial published in the Journal of Clinical Oncology have shown.1
In the phase 3 DASISION trial, researchers enrolled 519 patients with newly diagnosed CML-CP and randomly assigned them 1:1 to receive dasatinib 100 mg orally once daily or imatinib 400 mg orally once daily. At the time of study closure, 61% of patients remained on dasatinib and 63% remained on imatinib.
Final results showed that 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 in dasatinib-treated patients compared with imatinib-treated patients. Researchers found that 5-year progression-free and overall survival rates remained high but were similar between the 2 treatment arms.
The study demonstrated that in the 84% of dasatinib-treated patients and the 64% of imatinib-treated patients who achieved BCR–ABL ≤ 10% at 3 months, progression-free and overall survival rates were higher and rates of transformation to accelerated/blast phase were lower compared with patients with BCR–ABL > 10% at 3 months.
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A total of 5% and 7% of patients in the dasatinib and imatinib arms, respectively, transformed to accelerated/blast phase, and 15 and 19 patients, respectively, had BCR–ABL mutations detected at the time of treatment discontinuation.
In terms of safety, dasatinib was associated with an increased incidence of pleural effusion, but no new or unexpected adverse events were identified in either group. The highest incidence of pleural effusion occurred during the first year of treatment. Of note, arterial ischemic events were uncommon in both arms.
- Cortes JE, Saglio G, Kantarjian HM, et al. Final 5-year study results of DASISION: the dasatinib versus imatinib study in treatment-naïve chronic myeloid leukemia patients trial [published online ahead of print May 23, 2016]. J Clin Oncol. doi: 10.1200/JCO.2015.64.8899.