氟马替尼与尼罗替尼作为慢性期慢性髓性白血病患者一线治疗的真实世界比较：一项多中心回顾性研究。
Real-world comparison of flumatinib and nilotinib as first-line therapy for patients with chronic phase chronic myeloid leukemia: a multicenter retrospective study.
作者信息
Lei Yutian, Zhao Xiaoli, Qiao Chun, Hong Ming, Qian Sixuan, Li Jianyong, Li Weiming, Zhu Yu
机构信息
Department of Hematology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
出版信息
Ther Adv Med Oncol. 2025 Apr 29;17:17588359251335905. doi: 10.1177/17588359251335905. eCollection 2025.
BACKGROUND
Flumatinib is a novel second-generation tyrosine kinase inhibitor (2G-TKI), which was approved in November 2019 in China. A previous phase III study evaluated the efficacy and safety of flumatinib as a first-line therapy for patients with chronic phase chronic myeloid leukemia (CML-CP). However, randomized trials comparing flumatinib with other 2G-TKIs remain lacking.
OBJECTIVES
To assess the efficacy and safety of flumatinib versus nilotinib as a first-line treatment for CML-CP.
DESIGN
A multicenter retrospective study.
METHODS
We retrospectively analyzed 101 and 64 patients treated with flumatinib and nilotinib during the same period, respectively.
RESULTS
Patients in the flumatinib group were significantly older than patients in the nilotinib group (median age, 44 vs 37 years; = 0.004). The optimal response and treatment failure rates at 24 months were comparable between the two groups. At 12 months, 85.1% and 88.2% of patients in the flumatinib and nilotinib groups, respectively, achieved a major molecular response (MMR; = 0.648). By 24 months, 9.9% and 12.5% of patients suffered treatment failure in the flumatinib and nilotinib groups, respectively ( = 0.602). At 9, 12, and 24 months, the rate of MR (a transcript level ⩽0.01%) achievement was significantly higher in patients treated with nilotinib than in those treated with flumatinib (26.0% vs 53.7%, = 0.007; 40.4% vs 60.8%, = 0.044; and 41.7% vs 80.8%, = 0.042, respectively). In addition, elevated alanine aminotransferase or aspartate aminotransferase (ALT/AST), glucose, and serum lipid; hyperbilirubinemia; rash; and alopecia were more frequent among patients receiving nilotinib, whereas diarrhea was more frequent in those receiving flumatinib.
CONCLUSION
Flumatinib is a suitable alternative as a first-line treatment for patients with CML-CP to achieve a fast MMR with better tolerability.
背景
氟马替尼是一种新型第二代酪氨酸激酶抑制剂（2G-TKI），于2019年11月在中国获批。此前一项III期研究评估了氟马替尼作为慢性期慢性髓性白血病（CML-CP）患者一线治疗的疗效和安全性。然而，仍缺乏比较氟马替尼与其他2G-TKI的随机试验。
目的
评估氟马替尼与尼罗替尼作为CML-CP一线治疗的疗效和安全性。
设计
一项多中心回顾性研究。
方法
我们分别回顾性分析了同期接受氟马替尼和尼罗替尼治疗的101例和64例患者。
结果
氟马替尼组患者的年龄显著大于尼罗替尼组患者（中位年龄，44岁对37岁；P = 0.004）。两组在24个月时的最佳反应率和治疗失败率相当。在12个月时，氟马替尼组和尼罗替尼组分别有85.1%和88.2%的患者达到主要分子反应（MMR；P = 0.648）。到24个月时，氟马替尼组和尼罗替尼组分别有9.9%和12.5%的患者出现治疗失败（P = 0.602）。在9个月、12个月和24个月时，接受尼罗替尼治疗的患者达到MR（a转录水平≤0.01%）的比例显著高于接受氟马替尼治疗的患者（分别为26.0%对53.7%，P = 0.007；40.4%对60.8%，P = 0.044；41.7%对80.8%，P = 0.042）。此外，接受尼罗替尼治疗的患者中丙氨酸氨基转移酶或天冬氨酸氨基转移酶（ALT/AST）升高、血糖和血脂升高、高胆红素血症、皮疹和脱发更为常见，而接受氟马替尼治疗的患者腹泻更为常见。
结论
氟马替尼是CML-CP患者一线治疗的合适替代药物，可快速实现MMR且耐受性更好。
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