[Efficacy and Safety of Flumatinib and Imatinib as First-line Treatments for Newly-diagnosed Chronic Myeloid Leukemia in Chronic Phase: A Real-world Study].

Objective: To compare the efficacy and safety of flumatinib (FM) and imatinib (IM) as first-line treatment in newly-diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP) in real world.

Methods: A total of 84 newly-diagnosed CP-CML patients in our center from December 2019 to December 2022 were retrospectively analyzed. Among them, 32 cases received FM as first-line treatment, and 52 cases received IM. Molecular response (MR), disease progression, survival and incidence of adverse events (AEs) were compared between the two groups.

Results: At 3 months of treatment, the incidences of early molecular response (EMR), MR2.0 and MR3.0 were 96.7%, 70.0% and 20.0% in FM group, respectively, which were significantly higher than 77.1%, 29.2% and 0 in IM group (all P < 0.05). At 6, 9 and 12 months of treatment, the incidences of major molecular response (MMR) in FM group were 68.2%, 85.7% and 90.0%, respectively, which were significantly higher than 22.9%, 34.0% and 51.1% in IM group (all P < 0.01). The median time to achieve MMR in FM group was 6(6-9) months, which was significantly shorter than 18(12-22) months in IM group (P < 0.001). The 3-year progression-free survival rate and 3-year event-free survival rate in FM group were 100% and 68.8%, respectively, while in IM group were 98.1% and 55.8%. There were no significant differences between the two groups ( P >0.05). The incidence of grade 3-4 hematologic AEs in FM group was 21.9%, which was slightly lower than 25.0% in IM group, but the difference was not significant ( P >0.05).

Conclusion: In real clinical practice, FM as first-line treatment achieves MMR earlier than IM, and exhibits good safety profile in newly-diagnosed CML-CP patients, which potentially leads to improved long-term survival and treatment-free remission.