According to a subgroup analysis of a phase 3 study, dasatinib produces significantly faster and more durable responses compared with imatinib in patients with chronic phase chronic myeloid leukemia (CML) and a high body mass index (BMI).
Previous studies have reported that patients with a high BMI, defined as over 25 kg/m2, are at an increased risk of not only developing CML but also of experiencing poorer outcomes when treated with first-line tyrosine kinase inhibitors (TKIs) such as imatinib. In the phase 3 DASISION trial, a team of researchers led by Massimo Breccia, MD, of the Department of Translational and Precision Medicine at Sapienza University of Rome, Italy, found that dasatinib, another TKI, demonstrated significant improvements in time to response and major molecular response compared with imatinib in patients with newly diagnosed chronic phase CML. In the results of an analysis of the trial, to be presented at the American Society of Hematology (ASH) Annual Meeting in December, Dr. Breccia and colleagues report that dasatinib is particularly effective in patients with a high BMI.
The trial enrolled 259 patients who were treated with dasatinib, including 109 with a high BMI, and 260 patients who were treated with imatinib, including 107 with a high BMI. Dasatinib produced a significantly faster median time to complete cytogenetic response compared with imatinib in patients with a high BMI (3.1 months vs 6.1 months), as well as a faster median time to major molecular response (9.2 months vs 27.6 months). Additionally, a higher proportion of patients with a high BMI who were treated with dasatinib achieved a major molecular response compared with those who were treated with imatinib (79.8% vs 59.8%). While dasatinib also produced faster and more durable responses compared with imatinib in patients with a normal BMI (defined as 18.5-25 kg/m2), the differences were not statistically significant.
"In this exploratory post hoc analysis, patients with a high BMI treated with dasatinib demonstrated a significantly faster time to response compared with imatinib, with an increased percentage of patients also achieving major molecular response," conclude Dr. Breccia and colleagues. "However, these differences were not apparent in patients with a normal BMI. Although these findings highlight the potential role of BMI in affecting treatment responses to TKIs, additional validation of these findings is necessary to define the overall impact of BMI as a prognostic factor for patients with chronic phase CML."
For More Information
Breccia M, Cortes JE, Shah NP, et al (2019). Association of high body mass index with response outcomes in patients with CML-CP treated with dasatinib versus imatinib in the first line: exploratory post hoc analysis of the phase 3 DASISION trial. 61st American Society of Hematology Annual Meeting & Exposition. Abstract 1531.
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