Objective: To analyze the efficacy and safety of flumatinib, a second-generation tyrosine kinase inhibitor (TKI) independently developed in China, in patients with chronic myelogenous leukemia in chronic phase (CML-CP) who falied first-line and second-line treatment.
Methods: The clinical data of 30 CML-CP patients treated with flumatinib in Lianyungang First People's Hospital from January 2020 to September 2022 were collected retrospectively. Among them, 15 patients who received imatinib first-line treatment but failed treatment were included in the second-line group, and the other 15 patients who failed second-line treatment with nilotinib or dasatinib were included in the third-line group. The hematological and molecular responses of the patients in the two groups at 3, 6 and 12 months of treatment, and the event-free survival (EFS) and adverse reactions of patients at the end of follow-up were statistical analyzed.
Results: At 3, 6, and 12 months of treatment, 10, 11, and 12 patients in the second line group achieved major molecular response (MMR), which was higher than that of 3, 4, and 5 patients in the third line group (P =0.010, P =0.011, P =0.010). At 3 months of treatment, 12 and 13 patients achieved complete hematological response (CHR) and early molecular response (EMR) in the second-line group, which was higher than that of 9 and 13 patients in the third-line group, but the difference between the two groups was not statistically significant (P =0.232, P =1.000); At 6 and 12 months of treatment, 6 and 7 patients in the second-line group achieved MR4.5, which were higher than of 3 and 2 cases in the third-line group, but the difference was not statistically significant (P =0.427, P =0.713). The hematological adverse reactions of patients in the second-line group during treatment the period were mainly grade 1-2 thrombocytopenia and anemia, and no grade 3-4 of adverse reactions occurred. In the third-line group, there were 2 cases of grade 1-2 thrombocytopenia, grade 1-2 anemia and white blood cell 3 cases were reduced each, 1 case of grade 3-4 anemia, 2 cases of grade 3-4 neutropenia. The non-hematological adverse reactions in the second-line group were rash (2 cases), headache (1 case), diarrhea (1 case), fatigue (1 case), limb pain (1 case). There were 1 cases of diarrhea, 1 cases of nausea, and 1 cases of edema in the third-line group. There was no statistical significance in hematological and non-hematological adverse reactions between the two groups of patients (P >0.05). At the end of follow-up, the EFS rate of patients in the second-line group was higher than that in the third-line group (100% vs 93.3%), but the difference was not statistically significant (P =0.317).
Conclusion: The second-generation TKI flumatinib independently developed in China, has good curative effect and safety for CML-CP patients who failed first-line and second-line treatment.
题目: 氟马替尼在一、二线治疗失败的慢性髓系白血病患者中的疗效及安全性分析.
目的: 分析我国自主研发的第二代酪氨酸激酶抑制剂（TKI）氟马替尼对一、二线治疗失败的慢性髓系白血病慢性期（CML-CP）患者的疗效及安全性。.
方法: 回顾性收集2020年1月至2022年9月连云港市第一人民医院采用氟马替尼治疗的30例CML-CP患者的临床资料，其中15例曾接受伊马替尼一线治疗且治疗失败的患者作为二线组，另外15例采用尼洛替尼或达沙替尼二线治疗失败的患者作为三线组；统计分析两组患者治疗3、6和12个月时的血液学、分子学反应，以及至随访终点患者的无事件生存（EFS）和不良反应发生情况。.
结果: 二线组治疗3、6和12个月时获得主要分子学反应（MMR）分别有10、11、12例患者，均高于三线组的 3、4、5例患者（P =0.010，P =0.011，P =0.010）。二线组患者治疗3个月时获完全血液学反应（CHR）、早期分子学反应（EMR）分别有12、13例，高于三线组患者的9、13例，但两组差异无统计学意义（P =0.232，P =1.000）；治疗6和12个月时二线组获得MR4.5的患者分别有6、7例，高于三线组的3、2例，但差异无统计学意义（P =0.427，P =0.713）。二线组患者治疗期间出现的血液学不良反应主要为1-2级血小板减少和贫血，未出现3-4级不良反应；三线组中1-2级血小板减少2例，1-2级贫血及白细胞减少各3例，3-4级贫血1例、中性粒细胞减少2例。二线组非血液学不良反应为皮疹（2例）、头痛（1例）、腹泻（1例）、疲乏（1例）、四肢疼痛（1例），三线组腹泻、恶心、水肿各1例。两组患者在血液学不良反应及非血液学不良反应方面均无统计学意义（P ＞0.05）。截止随访时，二线组患者的EFS 率高于三线组（100% vs 93.3%， P =0.317）。.
结论: 我国自主研发的二代TKI氟马替尼对一、二线治疗失败的CML-CP患者具有良好的疗效及安全性。.
Keywords: flumatinib; second line; third line; chronic myelogenous leukemia.