Efficacy and safety of switching to flumatinib in patients with chronic myeloid leukemia who have not achieved optimal response or are intolerant to TKI treatment

Songfan YANG; Qin WEN; Ying ZHANG; Jinglong LYU; Hua'e SHU; Hongju YAN; Cheng ZHANG; Jin WEI; Xi ZHANG

doi:10.16016/j.2097-0927.202310076

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Efficacy and safety of switching to flumatinib in patients with chronic myeloid leukemia who have not achieved optimal response or are intolerant to TKI treatment

Monographic Reports: Advances in diagnosis and treatment for hematological malignancies | 更新时间：2026-01-09

- Efficacy and safety of switching to flumatinib in patients with chronic myeloid leukemia who have not achieved optimal response or are intolerant to TKI treatment
- Journal of Army Medical University Vol. 46, Issue 4, Pages: 340-346(2024)
- 作者机构：
  
  1.637002 南充，川北医学院附属医院血液科
  2.400037 重庆，陆军军医大学(第三军医大学)第二附属医院血液病医学中心，全军临床重点专科，创伤与化学中毒全国重点实验室，重庆市临床重点专科，血液病与微环境重庆市重点实验室
  3.401336 重庆，重庆医科大学第二附属医院血液科
  4.404100 重庆，重庆大学附属三峡医院血液科
  5.405400 重庆，开州区人民医院血液科
  6.401329 重庆，金凤实验室
- 作者简介：
- 基金信息：
  
  the General Joint Medical Research Project of Chongqing Science and Technology Commission and Chongqing Health Commission(2023MSXM079);the General Project of Technical Innovation and Application Development of Chongqing(cstc2019jscx-msxmX0147)
- DOI：10.16016/j.2097-0927.202310076
  CLC： R181.32;R733.7;R979.12
- Received：20 October 2023，
  
  Revised：2023-12-25，
  
  Published：28 February 2024
- 稿件说明：
移动端阅览
Songfan YANG, Qin WEN, Ying ZHANG, et al. Efficacy and safety of switching to flumatinib in patients with chronic myeloid leukemia who have not achieved optimal response or are intolerant to TKI treatment[J]. Journal of Army Medical University, 2024, 46(4): 340-346.
DOI：

Songfan YANG, Qin WEN, Ying ZHANG, et al. Efficacy and safety of switching to flumatinib in patients with chronic myeloid leukemia who have not achieved optimal response or are intolerant to TKI treatment[J]. Journal of Army Medical University, 2024, 46(4): 340-346. DOI： 10.16016/j.2097-0927.202310076.

摘要

目的

观察TKI未达最佳反应或不耐受的慢性髓系白血病-慢性期(chronic myelogenous leukemia-chronicphase

CML-CP)患者转换氟马替尼治疗的效果及安全性。

方法

从重庆市医院及川北医学院附属医院共5家医院收集2020年2月至2022年8月对一线伊马替尼、达沙替尼、尼洛替尼未达最佳反应或不耐受

转换氟马替尼(600 mg/d)治疗的患者

观察氟马替尼的疗效及安全。统计患者治疗3、6、12个月时最佳反应率及主要分子学反应(major molecular response

MMR)率、累积完全细胞遗传学反应(complete cytogenetic response

CCyR)率、累积MMR率、累积深度分子学反应(deep molecular response

DMR)率、无进展生存(progression-free survival

PFS)、无事件生存(event-free survival

EFS)情况及不良反应情况。

结果

共纳入100例CML-CP患者

中位随访时间为18(3~36)个月

3、6、12个月最佳反应率分别为92.6%(88/95)、94.4%(85/90)和92.9%(79/85)

随访截止至2023年8月20日

累积CCyR、MMR率分别为98.0%(98/100)、81.9%(77/94)

达CCyR和MMR的中位时间均为3个月

累积DMR率为51.0%(51/100)。随访时间内

PFS率为100.0%(100/100)

1年EFS率为85.6%(75/90)。氟马替尼最常见非血液学不良反应为腹泻腹痛(7.0%)

其次为肾功能损害(6.0%)、肌肉骨骼疼痛(2.0%); 血液学不良反应主要有血小板减少(12.0%)、贫血(6.0%)和白细胞减少(2.0%)。

结论

氟马替尼治疗TKI未达最佳反应或不耐受的CML-CP患者有较好的MMR和DMR

耐受性及安全性良好。

Abstract

Objective

To observe the efficacy and safety of flumatinib conversion in chronic myelogenous leukemia-chronicphase (CML-CP) patients with suboptimal TKI response or intolerance.

Methods

Patients who did not have the best response or intolerance to first-line imatinib

dasatinib

and nilotinib and switched to flumatinib (600 mg/d) from February 2020 to August 2022 were collected from 5 hospitals from Chongqing and affiliated hospitals of North Sichuan Medical College.The efficacy and safety of flumatinib were observed.The optimal response rate

major molecular response (MMR)

cumulative complete cytogenetic response (CCyR) rate

cumulative MMR rate

cumulative deep molecular response (DMR)

progression-free survival (PFS)

event-free survival (EFS) and adverse reactions in 3

6 and 12 months after treatment were observed and analyzed.

Results

A total of 100 patients with CML-CP were enrolled

with a median follow-up of 18(3~36) months.The optimal response rate was 92.6%(88/95)

94.4%(85/90) and 92.9%(79/85) respectively

at 3

6 and 12 months after treatment.Till August 20

2023

the cumulative CCyR and MMR rate was 98.0%(98/100) and 81.9%(77/94)

respectively

the median time to reach CCyR and MMR was 3 months

and cumulative DMR rate was 51.0%(51/100).PFS rate was 100.0%(100/100) and 1-year EFS rate was 85.6%(75/90).The most common non-hematologic adverse reactions of flumatinib were diarrhea and abdominal pain (7.0%)

followed by renal dysfunction (6.0%) and musculoskeletal pain (2.0%).The main hematologic adverse reactions were thrombocytopenia (12.0%)

anemia (6.0%) and leukopenia (2.0%).

Conclusion

Flumatinib has better MMR and DMR and is well tolerated in CML-CP patients with TKI resistance or intolerance.

关键词

Keywords

references

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