What is the role of dasatinib in the treatment of chronic myelogenous leukemia (CML)?

Updated: May 23, 2021
  • Author: Emmanuel C Besa, MD; Chief Editor: Sara J Grethlein, MD, FACP  more...
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Dasatinib has been shown to be more effective in inducing molecular remission than imatinib. In a comparison of dasatinib with imatinib in 519 patients with newly diagnosed chronic-phase CML, the rate of confirmed complete cytogenetic response after a minimum follow-up of 12 months was 77% with dasatinib versus 66% with imatinib. [42]

A study by Cortes et al that compared dasatinib 100 mg daily or 50 mg twice daily for at least 3 months as initial therapy for early chronic-phase CML found no difference in outcome between the 2 dosages. [43] Of the 50 patients in the study, 49 (98%) achieved a complete cytogenetic response and 41 (82%) achieved a major molecular response. The projected event-free survival rate at 24 months was 88%, and all patients were alive after a median follow-up time of 24 months. [43]

In June 2013, the FDA approved a change to the product labeling of dasatinib, updating efficacy and safety information to include 3-year efficacy and safety data for patients with newly diagnosed Philadelphia (Ph) chromosome–positive CML that is in the chronic phase. [44] The new labeling also includes 5-year data for patients with chronic-phase Ph chromosome–positive CML that is imatinib-resistant or imatinib-intolerant.

The 3-year data are from the DASISION (Dasatinib vs Imatinib Study in Treatment-Naïve CML Patients) study, an ongoing open-label randomized phase 3 trial. [45] At 12 months, the confirmed cytogenetic response rate (CCyR) was 77% in patients treated with dasatinib and 66% in those treated with imatinib. At 36 months, a higher percentage of patients in the dasatinib group had confirmed CCyR (83% vs 77%). The rate of major molecular response (MMR) was also higher for dasatinib at both 12 and 36 months.

The 5-year data are from an open-label phase 3 dose-optimization study in which fewer than 5% of dasatinib patients had transformed to accelerated or blast-phase CML by 5 years. [44] The primary endpoint of the study was major cytogenetic response in patients who were resistant to or intolerant of imatinib. This endpoint was achieved by 63% of such patients who were receiving dasatinib at 2 years.

In a study of 670 patients with imatinib-resistant/-intolerant CML in chronic phase, Shah et al found that treatment with dasatinib (in 4 different regimens) improved survival, particularly among those who achieved BCR/ABL transcripts of 10% or less by 3 months. [46]

Estimated 6-year progression-free survival (PFS) rates were 49%, 51%, 40%, and 47% for the 100 mg once daily, 50 mg twice daily, 140 mg once daily, and 70 mg twice daily dosage groups, respectively. [46] Notably, estimated 6-year PFS rates were 68% for BCR/ABL transcripts of 1% or less, 58% for BCR/ABL greater than 1% up to 10%, and 26% for BCR/ABL greater than 10%. Estimated 6-year overall survival rates were 71% for 100 mg once daily, 74% for 50 mg twice daily, 77% for 140 mg once daily, and 70% for 70 mg twice daily.

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