在晚期乳腺癌中早期或延迟使用CDK4/ 6抑制剂
Gabe S Sonke1, Annemiek van Ommen-Nijhof2, Noor Wortelboer3
1Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands. g.sonke@nki.nl.
Nature
|November 28, 2024
概括
在SONIA试验中,没有发现使用循环素依赖性激酶4和6抑制剂 (CDK4/ 6i) 的第一线与二线治疗晚期乳腺癌的显著益处. 这表明第一线CDK4/ 6i可能不适用于所有患者.
科学领域:
- 癌症学
- 临床试验
- 药理学
背景情况:
- 结合内分泌治疗的环素依赖性激酶4和6抑制剂是激素受体阳性,HER2阴性晚期乳腺癌的标准.
- CDK4/ 6i可以作为一线或二线治疗,但直接比较的数据有限.
研究的目的:
- 在先进乳腺癌的第一线与第二线设置中比较CDK4/ 6i的疗效.
- 评估在不同治疗阶段接受CDK4/ 6i的患者的无进展生存期2 (PFS2).
主要方法:
- 在第三期SONIA试验中,有1,050名患有晚期乳腺癌的患者随机接受CDK4/ 6i在一线或二线治疗中.
- 所有患者都接受了一致的内分泌治疗:一种第一线芳酶抑制剂和一种二线富尔韦斯特兰.
- 无进展生存期2 (PFS2) 是主要终点,定义为从随机化到二线治疗后疾病进展的时间.
主要成果:
- 在一线和二线CDK4/ 6i治疗之间没有观察到PFS2的统计学意义上的差异 (中位数为31. 0与26. 8个月;P=0. 10).
- 这两组人与健康相关的生活质量是可比的.
- 与二线使用相比,一线CDK4/ 6i使用导致治疗持续时间更长,但发生3级以上不良事件的发生率更高.
结论:
- 这项研究挑战了所有HR+,HER2-高级乳腺癌患者的第一线CDK4/ 6i的常规需求.
- 顺序使用CDK4/ 6i和内分泌疗法似乎提供了与前期组合疗法相似的结果.
- 根据个体患者的因素和毒性概况,进一步的研究可能会完善治疗序列策略.
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