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

Real-World Efficacy and Safety of China-Made Flumatinib Mesylate in the Treatment of Chronic Myeloid Leukemia in Chronic Phase

目的:评价国产甲磺酸氟马替尼对慢性髓性白血病慢性期(CML-CP)患者的临床疗效及安全性。方法:42例采用国产氟马替尼治疗的CML-CP患者纳入研究,其中初诊14例、转换治疗28例。氟马替尼口服,600 mg,1/d,观察评估治疗3、6、12个月时的血液学、细胞遗传学和分子学反应及安全性。结果:治疗≥3、≥6、≥12个月的患者分别有35例、31例、17例。治疗满3个月时,可评估疗效的患者33例,其中32例患者获得CHR,13例达到CCyR,20例患者BCR-ABLIS≤10%,7例患者达到MMR。6个月时,可评估疗效的患者30例,全部获得CHR,17例达到CCyR,18例患者BCR-ABLIS≤1%,16例患者达到MMR。12个月时,17例患者均可评估疗效,均获得CHR,10例达到CCyR,7例患者达到MMR。分别有7、2、1例患者出现III-IV级血小板减少、白细胞减少和贫血。非血液学不良反应依次为腹泻6例、肾功能损害4例、皮疹及瘙痒症3例、肝功能损害3例,恶心呕吐、发热及骨关节肌肉痛各1例。结论:在真实世界中,国产甲磺酸氟马替尼无论是作为CML-CP患者的一线治疗还是二、三线转换治疗,近期疗效肯定、安全性可靠。

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 BCRABLIS≤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.