Objective: To analyze the efficacy and safety of flumatinib in the treatment of patients with chronic myeloid leukemia (CML).
Methods: The clinical data of 56 CML patients treated with flumatinib from January 2020 to December 2021 in the First Affiliated Hospital of Nanchang University were retrospectively analyzed. Patients were divided into three groups: 35 new diagnosed CML patients treated with flumatinib (group A), 10 patients with imatinib/dasatinib intolerance (group B) and 11 patients with imatinib/dasatinib resistance (group C) switched to flumatinib treatment, respectively. The molecular response and adverse effects of flumatinib treatment were evaluated.
Results: In group A, the early molecular response (EMR) at 3 months was 40.0%, and the major molecular response (MMR) at 6 and 12 months was 43.7% and 46.2%, respectively. In group B, the EMR was 50.0% at 3 months, and the MMR was 70.0% and 66.2% at 6 and 12 months, respectively. Among evaluable patients, 6 cases in group B achieved molecular response of 4.5 (MR4.5) at 12 months after switching to flumatinib treatment. In group C, 3 cases who switched from imatinib resistance to flumatinib achieved MR4.5 at 12 months, but 2 cases who switched from dasatinib resistance to flumatinib failed. Subgroup analysis showed significant differences in EUTOS long-term survival (ELTS) scores for patients in the medium-risk/high-risk group compared with those in the low-risk group for 3-month EMR (18.8% vs 57.9%), 6-month MMR (15.4% vs 63.2%) and 12-month MR4.5 (15.4% vs 69.2%) (P =0.036, P =0.012,P =0.015). The most common adverse effect in group A was thrombocytopenia, accounting for 54.5%, and 22.8% (8/35) patients discontinued the drug due to haematological adverse effects. Compared with patients who did not discontinue the drug or whose recovery time from discontinuation due to haematological toxicity was <1 month, patients whose recovery time from discontinuation was ≥1 month had a significantly worse 3-month EMR, 6-month MMR and 12-month MR4.5 (P =0.028, P =0.021, P =0.002).
Conclusions: Flumatinib has better molecular response and tolerance in patients with primary, imatinib/dasatinib-intolerant or resistant CML. Medium-risk/high-risk in ELTS score and time to recovery from discontinuation due to haematological toxicity ≥1 month are important factors influencing achievement of better molecular response in flumatinib treatment.
题目: 氟马替尼治疗慢性粒细胞白血病患者的疗效及安全性分析.
目的: 分析氟马替尼治疗慢性粒细胞白血病（CML）患者的疗效及安全性。.
方法: 回顾性分析南昌大学第一附属医院2020年1月至2021年12月接受氟马替尼治疗的56例CML患者的临床资料，将患者分为3组，氟马替尼治疗初诊CML患者35例（A组），伊马替尼/达沙替尼不耐受（B组）和耐药（C组）转氟马替尼治疗患者分别为10和11例，评价3组患者使用氟马替尼治疗的分子学反应和不良反应。.
结果: A组患者3个月早期分子学反应（EMR）为40.0%，6和12个月主要分子学反应（MMR）分别为43.7%和46.2%。B组患者3个月EMR为50.0%，6和12个月MMR分别为70.0%和66.7%；在可评估患者中，6例转氟马替尼治疗后均达到12个月分子学反应4.5。C组3例伊马替尼耐药转氟马替尼达到12个月分子学反应4.5，但2例达沙替尼耐药转氟马替尼治疗失败。使用EUTOS长期生存（ELTS）评分系统行亚组分析，结果显示，ELTS评分中高危组3个月EMR、6个月MMR和12个月分子学反应4.5分别为18.8%、15.4%和15.4%，较低危组的57.9%、63.2%和69.2%均显著更差（P =0.036，P =0.012，P =0.015）。A组最常见的不良反应为血小板减少，占54.5%，22.8%（8/35）的患者因血液学不良反应而停药；与未停药或因血液学毒性停药恢复时间<1个月的患者比较，停药恢复时间≥1个月的患者3个月EMR、6个月MMR和12个月分子学反应4.5明显更差（P =0.028，P =0.021，P =0.002）。.
结论: 氟马替尼治疗初诊、伊马替尼/达沙替尼不耐受或耐药的CML患者均有较好的分子学反应，且耐受性良好；ELTS评分中高危组和因血液学毒性导致停药恢复时间≥1个月是影响患者使用氟马替尼获得早期和深度分子学反应的重要因素。.
Keywords: chronic meyloid leukemia; efficacy; flumatinib; safety.