固定的时间与慢性淋巴细胞白血病的持续治疗
Othman Al-Sawaf1, Janina Stumpf1, Can Zhang1
1Department I of Internal Medicine, Center of Integrated Oncology Aachen Bonn Cologne Düsseldorf, University Hospital of Cologne, Cologne, Germany.
The New England journal of medicine
|December 8, 2025
概括
固定持续时间的venetoclax疗法在慢性淋巴细胞白血病 (CLL) 无进展生存方面与连续的易布鲁替尼比无劣. 这项研究将venetoclax-obinutuzumab和venetoclax-ibrutinib与以前未经治疗的CLL患者中的ibrutinib进行了比较.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 目前的慢性淋巴细胞白血病 (CLL) 治疗包括连续使用布鲁顿的氨酸激酶抑制剂 (BTKI) 或基于venetoclax的固定时间治疗方案.
- 这两种主要治疗策略之间缺乏直接比较.
研究的目的:
- 为了比较固定时间的venetoclax-obinutuzumab和venetoclax-ibrutinib的疗效和安全性与以前未经治疗的CLL患者的连续ibrutinib.
- 评估无进展生存率 (PFS) 作为主要终点,最小残留疾病 (MRD) 和总生存率 (OS) 作为次要终点.
主要方法:
- 第三阶段,随机化,由研究人员发起的试验,涉及909名以前未经治疗的CLL患者.
- 患者被分配给固定的持续时间的venetoclax-obinutuzumab,固定的持续时间的venetoclax-ibrutinib或连续的ibrutinib.
- 主要终点:由研究人员评估的PFS;次要终点:MRD,反应,OS,安全性.
主要成果:
- 与ibrutinib (81.0%) 相比,venetoclax-obinutuzumab (81.1%) 和venetoclax-ibrutinib (79.4%) 的三年PFS没有劣势.
- 治疗后无法检测到的MRD在venetoclax-obinutuzumab组 (73.3%) 与venetoclax-ibrutinib (47.2%) 和ibrutinib (0%) 相比显著更高.
- 在所有手臂中,三年后的生存率都很高:91.5% (venetoclax-obinutuzumab),96.0% (venetoclax-ibrutinib) 和95.7% (ibrutinib).
结论:
- 在以前未经治疗的CLL中,基于venetoclax的固定时间治疗表明与连续的ibrutinib相比,非劣质的PFS.
- 这些发现支持固定时间的venetoclax疗法作为有效的替代方案,以持续的BTKI治疗在CLL.
- 在含有venetoclax的疗法中观察到更高的MRD负面率,这表明潜在的更深层次的反应.
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