# Efficacy and safety of gilteritinib combined with chemotherapy in newly diagnosed FLT3-mutated acute myeloid leukemia

## TL;DR

This study evaluates the effectiveness and safety of combining gilteritinib with chemotherapy for newly diagnosed FLT3-mutated acute myeloid leukemia patients.

## Contribution

The novelty lies in the retrospective analysis of gilteritinib combined with chemotherapy in FLT3-mutated AML patients in a single center.

## Key findings

- 93.8% of patients achieved complete remission or CRi after one treatment cycle.
- 12-month overall and relapse-free survival rates were both 73.9%.
- Treatment-related adverse events were generally tolerable.

## Abstract

为评估吉瑞替尼联合化疗治疗初诊FLT3突变阳性急性髓系白血病（AML）的疗效与安全性，我们回顾性收集于江苏省人民医院就诊的16例初诊FLT3突变阳性AML患者的临床资料。患者接受经典“3+7”方案或VA（维奈克拉+阿扎胞苷）方案诱导治疗，并均在检出FLT3-ITD/TKD突变后加用吉瑞替尼。16例患者中，男12例，女4例，中位年龄为52.5（15～76）岁；FLT3-ITD突变15例，FLT3-TKD突变1例。经过1个周期治疗后，完全缓解（CR）/CR伴不完全血细胞恢复（CRi）率达到93.8％（15/16），其中13例患者达到流式细胞术检测的可检测残留病（MRD）阴性。巩固治疗期间所有患者均达到CRMRD−，14例进行二代测序检测并均达FLT3突变阴性。截至2024年5月，中位随访时间为18个月，12个月总生存率和无复发生存率均为73.9％。诱导期间9例（56.2％）患者出现感染性发热，巩固与维持治疗期间3例患者发生3级QTc延长，治疗相关不良反应总体可耐受。