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已发表论文
氟马替尼治疗慢性期慢性髓性白血病患者的安全性和疗效：一项真实世界队列观察研究
Authors Cheng F, Cui Z, Li Q, Wang L, Li W
Received 9 October 2025
Accepted for publication 11 January 2026
Published 22 January 2026 Volume 2026:16 573070
DOI https://doi.org/10.2147/BLCTT.S573070
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Wilson Gonsalves
Fang Cheng,1,2 Zheng Cui,1,2 Qiang Li,1,2 Liu Wang,1,2 Weiming Li3
1Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People’s Republic of China; 2Hubei Province Clinical Research Center for Precision Medicine for Critical Illness, Wuhan, People’s Republic of China; 3Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People’s Republic of China
Correspondence: Weiming Li, Email lee937@126.com
Background: This study aims to comprehensively evaluate the safety and effectiveness of flumatinib in both first-line and subsequent-line therapies in 244 chronic-phase chronic myeloid leukemia (CML-CP) patients.
Methods: Response criteria were applied according to the European LeukemiaNet. Adverse events (AEs) occurring after flumatinib treatment were documented and graded for severity.
Results: The study encompassed 244 patients with CML-CP, stratified by treatment lines: first-line (1L, N=138), second-line (2L, N=63), and third-line or above (≥ 3L, N=43). First-line flumatinib therapy resulted in a major molecular response achieved by 50.7% at 6 months and 66.7% at 12 months, with a deep molecular response (DMR) achieved by 20.3% at 6 months and 35.5% at 12 months. In subsequent treatment lines, those with baseline MR2 had a DMR rate of 42.9%, compared to 23.3% for those without it. Significant differences in molecular response rates were observed based on treatment line and prior tyrosine kinase inhibitors (TKI) resistance (p< 0.05). However, subgroup analyses showed no significant differences in treatment responses between the warning and resistance groups after flumatinib therapy. Dose reduction strategies, implemented in 19.3% of patients, have proven feasible without compromising efficacy. Eight patients subsequently attempted treatment cessation, with five maintaining treatment-free remission. AEs were predominantly grade 1– 2, with diarrhea (27.0%), fatigue (12.3%), and thrombocytopenia (11.5%) being the most frequent. Grade 3/4 AEs were infrequent, highlighting flumatinib’s manageable safety profile.
Conclusion: Flumatinib displays significant clinical efficacy and a superior safety profile compared to other second-generation TKI, whether administered in first-line or subsequent treatment settings.
Keywords: chronic myeloid leukemia, flumatinib, clinical response, safety, chronic phase
1Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People’s Republic of China; 2Hubei Province Clinical Research Center for Precision Medicine for Critical Illness, Wuhan, People’s Republic of China; 3Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People’s Republic of China
Correspondence: Weiming Li, Email lee937@126.com
Background: This study aims to comprehensively evaluate the safety and effectiveness of flumatinib in both first-line and subsequent-line therapies in 244 chronic-phase chronic myeloid leukemia (CML-CP) patients.
Methods: Response criteria were applied according to the European LeukemiaNet. Adverse events (AEs) occurring after flumatinib treatment were documented and graded for severity.
Results: The study encompassed 244 patients with CML-CP, stratified by treatment lines: first-line (1L, N=138), second-line (2L, N=63), and third-line or above (≥ 3L, N=43). First-line flumatinib therapy resulted in a major molecular response achieved by 50.7% at 6 months and 66.7% at 12 months, with a deep molecular response (DMR) achieved by 20.3% at 6 months and 35.5% at 12 months. In subsequent treatment lines, those with baseline MR2 had a DMR rate of 42.9%, compared to 23.3% for those without it. Significant differences in molecular response rates were observed based on treatment line and prior tyrosine kinase inhibitors (TKI) resistance (p< 0.05). However, subgroup analyses showed no significant differences in treatment responses between the warning and resistance groups after flumatinib therapy. Dose reduction strategies, implemented in 19.3% of patients, have proven feasible without compromising efficacy. Eight patients subsequently attempted treatment cessation, with five maintaining treatment-free remission. AEs were predominantly grade 1– 2, with diarrhea (27.0%), fatigue (12.3%), and thrombocytopenia (11.5%) being the most frequent. Grade 3/4 AEs were infrequent, highlighting flumatinib’s manageable safety profile.
Conclusion: Flumatinib displays significant clinical efficacy and a superior safety profile compared to other second-generation TKI, whether administered in first-line or subsequent treatment settings.
Keywords: chronic myeloid leukemia, flumatinib, clinical response, safety, chronic phase