助剂登诺苏马布对乳腺癌的长期结果
Michael Gnant1,2, Sophie Frantal2, Georg Pfeiler3
1Medical University of Vienna, Comprehensive Cancer Center, Vienna.
NEJM evidence
|February 6, 2024
概括
辅助剂denosumab显著改善了接受芳酶抑制剂的绝经后妇女的无疾病生存,无骨转移生存和整体生存. 长期分析证实了这些好处,没有新的毒性.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 骨的新陈代谢 骨的新陈代谢
背景情况:
- 辅助性芳香酶抑制剂 (AIs) 与激素受体阳性乳腺癌患者的骨质疏松和骨折增加有关.
- 之前ABCSG-18试验的研究结果表明,代诺苏马布可以减轻这些不良影响.
- 本报告介绍了ABCSG-18试验的最终长期结果.
研究的目的:
- 为了评估后更年期妇女早期激素受体阳性乳腺癌接受芳酶抑制剂治疗的辅助剂denosumab的长期疗效和安全性.
- 评估德诺苏马布对无疾病存活率 (DFS),无骨转移存活率 (BMFS) 和整体存活率 (OS) 的影响.
主要方法:
- 一项前性,双盲,安慰剂控制的第三期试验 (ABCSG-18) 涉及3425名绝经后患者.
- 患者接受了每6个月一次皮下注射60毫克的登苏马布或安慰剂.
- 主要终点是第一个临床骨折的时间;次要终点包括DFS,BMFS和OS.
主要成果:
- 随访时间中位数为8年.
- 辅助剂德诺苏马布导致9年DFS的绝对好处为3.5个百分点 (79.4%vs75.9%).
- 代诺苏马布还提高了BMFS的2.5个百分点 (88.9% vs. 86.4%) 和OS的1.0个百分点 (90.9% vs. 89.9%).
结论:
- 在ABCSG-18试验的最终长期分析中,辅助剂德诺苏马布在DFS,BMFS和OS中显示了持续的益处.
- 在被研究的剂量中,没有观察到辅助剂denosumab的新毒性.
- 在乳腺癌患者中,丹诺苏马布有效抵消与人工智能治疗相关的骨并发症.
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