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.
题目: 真实世界中氟马替尼与伊马替尼一线治疗初诊慢性髓性白血病慢性期的疗效和安全性比较.
目的: 比较真实世界中氟马替尼（FM）与伊马替尼（IM）一线治疗初诊慢性髓性白血病慢性期（CML-CP）患者的临床疗效和安全性。.
方法: 回顾性分析2019年12月至2022年12月本中心新诊断的84例CML-CP患者，其中32例一线治疗使用FM，52例使用IM，比较两组患者的分子学反应、疾病进展、生存情况以及不良事件的发生情况。.
结果: 治疗3个月时，FM组早期分子学反应（EMR）、MR2.0和MR3.0发生率分别为96.7%、70.0%和20.0%，IM组分别为77.1%、29.2%和0，FM组患者的分子学缓解情况明显优于IM组，比较差异有统计学意义（均P < 0.05）。治疗6、9及12个月时，FM组的主要分子学反应（MMR）发生率分别为68.2%、85.7%和90.0%，IM组分别为22.9%、34.0%和51.1%，FM组的MMR发生率均高于IM组，比较差异有统计学意义（均P < 0.01）。FM组获得MMR的中位时间为6(6-9)个月，显著短于IM组的18(12-22)个月（P < 0.001）。FM组的3年无进展生存率和3年无事件生存率分别为100%和68.8%，IM组分别为98.1%和55.8%，组间差异均无统计学意义（ P >0.05）。FM组3-4级血液学不良事件发生率为21.9%，略低于IM组的25.0%，但差异无统计学意义（P >0.05）。.
结论: 在真实临床实践中，FM治疗的初诊CML-CP患者较IM能更早达到MMR，且安全性良好，从而有可能使患者获得更好的远期生存并实现无治疗缓解。.
Keywords: chronic myeloid leukemia; flumatinib; imatinib; efficacy; safety.