Real-World Efficacy and Safety of China-Made Flumatinib Mesylate in the Treatment of Chronic Myeloid Leukemia in Chronic Phase
10.19746/j.cnki.issn1009-2137.2024.01.004
- VernacularTitle:真实世界中国产甲磺酸氟马替尼治疗慢性髓性白血病慢性期的疗效与安全性分析
- Author:
Ying-Ying LI
1
;
Chun-Ling WANG
Author Information
1. 徐州医科大学淮安临床学院血液科,江苏淮安 223300
- Keywords:
China-made;
flumatinib;
chronic myeloid leukemia;
clinical efficacy;
real-world
- From:
Journal of Experimental Hematology
2024;32(1):20-26
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safty of China-made flumatinib mesylate in the treatment of chronic myeloid leukemia in chronic phase(CML-CP).Methods:42 CML-CP patients treated with Chinese produced flumatinib(oral,600 mg,1/d)were included in the study,including 14 newly diagnosed patients and 28 patients underwent conversion therapy.The hematological,cytogenetic and molecular response and safety were observed and evaluated after 3,6 and 12 months of treatment.Results:35 patients were treated for more than 3 months,among which 31 patients were treated for more than 6 months and 17 patients were treated for more than 12 months.After 3 months of treatment,33 patients underwent hematological,cytogenetic and molecular examination.Of these,32 patients achieved complete hematological response(CHR),13 patients achieved complete cytogenetic response(CCyR),20 patients showed BCR-ABLIS≤10％and 7 patients reached major molecular response(MMR).After 6 months of treatment,all 30 patients who could evaluate efficacy achieved CHR,of which 17 patients achieved CCyR,18 patients showed BCR-ABLIS ≤ 1％and 16 patients reached MMR.After 12 months of treatment,all 17 patients were evaluated for efficacy,all achieved CHR,10 patients obtained CCyR,7 patients reached MMR.Grade Ⅲ or Ⅳ thrombocytopenia,leukopenia and anemia occurred in 7,2 and 1 patients,respectively.The non-hematological adverse reactions were diarrhea in 6 cases,renal function damage in 4 cases,rash and pruritus in 3 cases,liver function damage in 3 cases,nausea in 1 case,fever in 1 case,bone/joint or muscle pain in 1 case.Conclusion:In the real world,China-made flumatinib mesylate has a positive short-term efficacy and reliable safety in the treatment of CML-CP patients,whether as first-line treatment or second-and third-line conversion therapy.
