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阿伐替尼作为慢性髓性白血病二线或二线以上治疗方案治疗患者的疗效和安全性:一项系统评价与荟萃分析

The efficacy and safety of asciminib treatment in patients with chronic myeloid leukemia as a second-line or beyond second-line treatment: a systematic review and meta-analysis.

作者信息

Fan Zixin, Xie Jiayi, Su Pinying, Tai Jingye, Feng Weiyi, Xu Rui, Ouyang Yun

机构信息

Nanshan School, Guangzhou Medical University, Guangzhou, Guangdong, China.

The Third Clinical School, Guangzhou Medical University, Guangzhou, Guangdong, China.

出版信息

Ther Adv Hematol. 2025 Jun 10;16:20406207251342203. doi: 10.1177/20406207251342203. eCollection 2025.

Abstract

BACKGROUND

Patients with chronic myeloid leukemia (CML) are currently experiencing intolerance or lack of efficacy with previous tyrosine kinase inhibitors (TKIs) and benefit from asciminib as a novel TKI.

OBJECTIVES

The purpose of this meta-analysis was to evaluate the efficacy and safety of asciminib as a second-line or beyond second-line treatment for patients with CML.

DESIGN

A systematic review and meta-analysis.

DATA SOURCES AND METHODS

We searched four databases (PubMed, Cochrane, Web of Science, and EMBASE) for relevant literature from the inception of the databases to February 4, 2024. Two authors independently performed data extraction to assess the efficacy of asciminib using metrics such as the rate of major molecular response (MMR) and the safety of asciminib using the rate of adverse event (AE). We also performed a subgroup analysis based on the reason for starting asciminib. Data were analyzed using either a fixed-effects model or a random-effects model to calculate the rate of MMR and the rate of AEs. We also assessed the quality of the studies by selecting appropriate tools according to the type of included studies.

RESULTS

We included 8 studies involving a total of 691 patients. The overall MMR rate for patients with CML treated with asciminib was 46.9% (95% CI: 39.8-54.0, < 0.05). AEs were reported in five studies, with a combined rate of 79.2% (95% CI: 46.6-98.7, < 0.05) for all grades and 39.5% (95% CI: 17.6-61.3, < 0.05) for grade ⩾3 AEs. Thrombocytopenia was the most common AE, with a combined rate of 22.5% (95% CI: 18.8-26.3, < 0.05) for all grades.

CONCLUSION

Asciminib is effective in the treatment of patients with CML, and the most common AE during treatment is thrombocytopenia.

摘要

背景

慢性髓性白血病(CML)患者目前对先前的酪氨酸激酶抑制剂(TKIs)不耐受或疗效不佳,而阿塞西尼布作为一种新型TKI使他们从中获益。

目的

本荟萃分析的目的是评估阿塞西尼布作为CML患者二线或二线以上治疗的疗效和安全性。

设计

系统评价和荟萃分析。

数据来源与方法

我们在四个数据库(PubMed、Cochrane、科学网和EMBASE)中检索从数据库建立至2024年2月4日的相关文献。两位作者独立进行数据提取,使用主要分子反应(MMR)率等指标评估阿塞西尼布的疗效,并使用不良事件(AE)发生率评估阿塞西尼布的安全性。我们还根据开始使用阿塞西尼布的原因进行了亚组分析。使用固定效应模型或随机效应模型分析数据,以计算MMR率和AE发生率。我们还根据纳入研究的类型选择合适的工具评估研究质量。

结果

我们纳入了8项研究,共691例患者。接受阿塞西尼布治疗的CML患者的总体MMR率为46.9%(95%CI:39.8 - 54.0,P < 0.05)。五项研究报告了AE,所有级别的合并发生率为79.2%(95%CI:46.6 - 98.7,P < 0.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7908/12159473/cfb00a13dba5/10.1177_20406207251342203-fig1.jpg

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