尼洛替尼与达沙替尼对新发慢性髓性白血病的MR4.5的实现:随机的JALSG CML212研究
Itaru Matsumura1, Shigeki Ohtake2, Yoshiko Atsuta3,4
1Department of Hematology and Rheumatology, Kindai University Faculty of Medicine, Osaka, Japan.
Blood advances
|July 5, 2024
概括
尼洛替尼和达沙替尼在实现新诊断的慢性髓性白血病慢性阶段 (CML-CP) 的深度分子反应方面表现出类似的有效性. 这两种治疗方法在CML-CP患者中提供了可比的无进展和整体生存率.
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:
- 深度分子响应 (DMR) 对于慢性阶段慢性髓性白血病 (CML-CP) 的无治疗缓解 (TFR) 至关重要.
- 尼洛丁尼和达沙替尼是用于CML-CP治疗的铁氨酸激酶抑制剂.
研究的目的:
- 为了比较 de novo CML-CP 患者在 18 个月内尼罗丁尼和达沙替尼之间累计获得的分子响应 4.5 (MR4.5) 的累积成就.
- 为了评估两种治疗手臂之间的无进展生存 (PFS) 和整体生存 (OS).
主要方法:
- 一项前性,随机的第三期研究 (JALSG CML212) 涉及454名新生CML-CP患者.
- 患者被分配给尼洛替尼 (每天两次300毫克) 或达沙替尼 (每天100毫克).
- 每3个月对BCR::ABL1水平进行监测;停止治疗的标准包括失败或不耐受.
主要成果:
- 18个月后MR4.5的累积实现率为尼罗丁尼的32.6%和达沙替尼的30.8% (P = .66),没有显著差异.
- 在两只手臂之间观察到类似的早期分子反应,完整的细胞遗传反应和主要分子反应率.
- 在尼洛丁尼和达沙替尼组之间没有发现PFS (P = .58) 或OS (P = .64) 的显著差异.
结论:
- 尼洛替尼和达沙替尼在实现新发性CML-CP患者的深度分子反应方面表现出相似的疗效.
- 这两种药物在PFS和OS方面都提供了类似的长期结果.
- 这项研究表明,尼洛尼和达沙替尼在初始CML-CP治疗中具有同等的有效性.
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