Real-World Safety and Clinical Response of Flumatinib in the Treatment of Chronic Myeloid Leukemia: A Retrospective Study

Objective: The objective of this retrospective study was to assess the effectiveness and safety of flumatinib in the treatment of chronic phase chronic myeloid leukemia (CML) in real-world settings.

Methods: A total of 61 patients who received flumatinib as first-line therapy were compared with 92 patients who received first-line imatinib therapy. Furthermore, the 58 patients who received flumatinib as post-line therapy were divided into two groups based on the timing of switching to flumatinib: an early conversion group (n=18) and a late conversion group (n=40). The molecular responses and outcomes were assessed at multiple time points (3, 6, 9, and 12 months) during the treatment of flumatinib, along with the observation of adverse reactions.

Results: In comparison to imatinib, the use of flumatinib as a first-line therapy demonstrated statistically significant increases in early molecular response (EMR), major molecular response (MMR), and deep molecular response (DMR) at various milestones (p<0.05). Additionally, the incidence of adverse events was lower in the flumatinib group, as evidenced by higher event-free survival (EFS) rates (83.6% vs. 39.1%, P=0.01) and a lower medication switching rate (90.2% vs. 31.5%, P<0.001). However, there were no significant differences observed in overall survival (OS) and progression-free survival (PFS) rates between the two groups (P>0.05). In the context of post-line therapy, a significant proportion of patients (72.2%) achieved EMR at 3 months, while 71.9% achieved MMR at 12 months when treated with flumatinib. Notably, the early conversion group exhibited higher rates of molecular response and demonstrated superior OS, PFS, and EFS at the 12-month mark compared to the late conversion group (P>0.05). Adverse events (AEs) commonly associated with flumatinib encompassed limb discomfort, gastrointestinal reactions, and elevated transaminase levels, with thrombocytopenia being the most frequently observed hematologic AE.

Conclusion: Flumatinib exhibited notable efficacy and safety as a therapeutic option for patients with chronic phase CML, whether utilized as a first-line or post-line treatment. In comparison to imatinib, initial administration of flumatinib resulted in more profound and expeditious molecular responses. The utilization of flumatinib as a post-line therapeutic approach during the early stage of treatment exhibits a favorable influence on patient prognosis. However, no statistically significant disparity was noted when compared to the group receiving switch therapy during the late stage.