The Comparison of First-Line Dasatinib Therapy 70 mg/day Versus 100 mg/day in Newly Diagnosed Patients with Chronic Myeloid Leukemia in the Chronic Phase: a Prospective, Randomized, Multicenter 1-year Clinical Study

Abstract This study compared the efficacy and safety of dasatinib 70 mg/day versus the standard 100 mg/day dose in newly diagnosed chronic phase chronic myeloid leukemia (CP-CML) patients from Hubei Province, China. In this prospective, randomized, multicenter trial, 91 patients were assigned to receive dasatinib 70 mg/day ( n = 47) or 100 mg/day ( n = 44). The primary objective was to compare the rates of optimal response, complete cytogenetic response (CCyR), major molecular response (MMR) and molecular response 4.0(MR4.0) at 3, 6, and 12 months. Safety was assessed via adverse event (AE) monitoring. No significant differences were observed in optimal response, CCyR,, MMR or MR4.0 rates between the two groups at any time point (all P > 0.05). By 12 months, CCyR rates were 100% in both groups. The overall incidence of AEs was similar, except for elevated lactate dehydrogenase ( P < 0.05). However, the proportion of patients requiring treatment interruption or dose reduction due to AEs was significantly lower in the 70 mg/day group (4.1% vs. 14.7%, P < 0.05). Dasatinib 70 mg/day demonstrated comparable efficacy to the 100 mg/day dose over 12 months, with a potential trend towards better tolerability, suggesting it is a viable first-line treatment option for CP-CML patients.