吉列替尼治疗FLT3突变的复发或难治性急性髓系白血病的应用研究

Application of gilitinib in treatment of recurrent or refractory acute myeloid leukemia with FLT3 mutation

摘要:

目的 观察吉列替尼治疗Fms样酪氨酸激酶3（FLT3）突变型复发或难治性急性髓系白血病（AML）的效果及安全性。方法 本文为前瞻性研究，选择南阳医学高等专科学校第一附属医院2020年6月至2022年4月期间收治的85例FLT3突变型AML患者为研究对象，经数字表法将其分为常规组（42例）和试验组（43例），常规组实施AMI常规化疗，试验组采用吉列替尼辅助治疗，所有患者治疗后均开展为期1年随访，比较两组患者的近期疗效及远期预后。结果 在不同治疗方案下，试验组治疗1个周期后、2个周期后、3个周期后的β2微球蛋白（β2-MG）分别为（5.25±1.33）mg/L、（3.31±1.27）mg/L、（2.66±0.41）mg/L，均低于常规组［（6.31±2.05）mg/L、（4.49±1.88）mg/L、（3.12±0.72）mg/L］；试验组的治疗总有效率为88.37%（38/43），高于常规组69.05%（29/42），差异有统计学意义（P<0.05）。试验组随访期间的中位无进展生存期（PFS）、中位总生存期（OS）分别为（7.72±2.36）个月、（10.45±2.28）个月，均高于常规组［（6.41±1.25）月、（9.11±2.72）月］；试验组病情复发率及死亡率分别为23.26%（10/43）、16.28%（7/43），均低于常规组［38.10%（16/42）、30.95%（13/42）］，差异有统计学意义（P<0.05）。试验组的毒副反应发生率为46.51%（20/43），略高于常规组42.86%（18/42），差异无统计学意义（P>0.05）。结论 吉列替尼辅助常规化疗能改善FLT3突变型AML患者的近期疗效及远期预后，此联合疗法未明显增强副反应发生风险，具有一定推广价值。

Abstract:

Objective To observe the efficacy and safety of gilitinib in the treatment of recurrent or refractory FLT3 mutant acute myeloid leukemia (AML).Methods This article is a prospective study of 85 patients with FLT3 mutant AML admitted between June 2020 and April 2022. The grouping method was the number table method, and the enrolled patients were divided into the conventional group (42 cases) and the experimental group (43 cases). The conventional group received routine AMI chemotherapy, while the experimental group received adjuvant treatment with gilitinib. All patients underwent a one-year follow-up after treatment to compare the short-term efficacy and long-term prognosis of the two groups of patients.Results Under different treatment regimens, after 1 cycle, 2 cycles, and 3 cycles of treatment, β2-MG levels in the experimental group were 5.25±1.33 mg/L, 3.31±1.27 mg/L, and 2.66±0.41 mg/L, respectively, lower than those in the conventional group (6.31±2.05 mg/L, 4.49±1.88 mg/L, and 3.12±0.72 mg/L). The remission rate of the experimental group after treatment was 88.37% (38/43), which was higher than that of the conventional group (69.05%, 29/42) (P<0.05). During the follow-up period, the PFS and OS of the experimental group were 7.72±2.36 months and 10.45±2.28 months, respectively, which were higher than those of the conventional group (6.41±1.25 months and 9.11±2.72 months). The recurrence rate and mortality rate of the experimental group were 23.26% (10/43) and 16.28% (7/43), respectively, which were lower than those of the conventional group [38.10% (16/42) and 30.95% (13/42)] (P<0.05). The incidence of drug-related side effects in the experimental group was 46.15% (20/43), slightly higher than 42.86% (18/42) in the conventional group (P>0.05).Conclusion Gilitinib combined with conventional chemotherapy can improve the short-term efficacy and long-term prognosis of FLT3 mutant AML patients. This combination therapy does not significantly increase the risk of side effects and has certain promotional value.