人环素与没有人环素在HER2+乳腺癌的新辅助策略中:现实世界的证据
Inês Soares de Pinho1, Paulo Luz2,3,4, Lucy Alves5
1Medical Oncology Department, Hospital de Santa Maria, CHULN, Lisbon, Portugal.
Clinical drug investigation
|July 21, 2023
概括
在早期HER2阳性乳腺癌 (HER2+ EBC) 治疗中,省去甲环素 (AC) 显示出与含有AC的疗法相似的有效性. 这种降级策略可以减少过度治疗和患者的长期毒性.
科学领域:
- 在瘤学瘤学.
- 乳腺癌研究研究 乳腺癌研究
- 临床药理学 临床药理学
背景情况:
- 对于HER2阳性早期乳腺癌 (HER2+ EBC) 的标准治疗通常包括 antracyclines (AC),尽管降级策略显示了可比的有效性.
- 即使在非高风险的HER2+EBC病例中,也经常使用含有AC的疗法,这引发了对潜在的过度治疗和毒性的担忧.
- 探索新辅助疗法 (NAT) 的降级对于优化治疗结果和患者安全至关重要.
研究的目的:
- 为了比较新辅助剂方案的有效性,在治疗HER2阳性早期乳腺癌 (HER2+ EBC) 中使用和不使用Anthracyclines (AC).
- 评估HER2+EBC患者接受NAT与AC或没有AC的病理完整响应 (pCR) 率.
- 评估AC缺失对长期结果的影响,包括无事件生存 (EFS).
主要方法:
- 这是一项回顾性多中心研究,包括来自葡萄牙,西班牙和智利的371名HER2+EBC患者 (2018年1月至2021年12月).
- 患者接受了新辅助疗法 (NAT),使用双重HER2阻断剂 (特拉斯图祖马布和珀图祖马布),有或没有Anthracyclines (AC).
- 统计分析包括奇平方/费舍尔精确测试,pCR的多变量逻辑回归和无事件生存时间 (EFS) 的卡普兰-梅尔.
主要成果:
- 遗漏的Anthracyclines (AC) 没有妨碍在HER2阳性早期乳腺癌 (HER2+ EBC) (p=0.246) 中实现病理完整反应 (pCR).
- 复发率为6.8%与AC和4.5%与TCHP (docetaxel,碳酸,祖祖马布,祖马布).
- 三年无事件生存率 (EFS) 为AC的92.5%和TCHP的95.4%,有利于AC遗漏的治疗方案 (HR 0.602,p=0.292).
结论:
- 现实世界的证据表明,与HER2阳性早期乳腺癌 (HER2+EBC) 治疗方案的病理完整反应 (pCR) 和无事件生存 (EFS) 具有和没有人环素 (AC).
- 在HER2+EBC治疗中省略甲环素 (AC) 是一种安全有效的降级策略.
- 这些发现表明,有可能减少在HER2+EBC中过度治疗和与 antracyclines (AC) 相关的长期毒性.
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