美国食品和药物管理局批准摘要:Ribociclib与辅助激素受体中的芳酶抑制剂-阳性,人体表皮生长因子受体2-阴性II期和III期高风险早期乳腺癌治疗设置
Jennifer J Gao1, Tatiana M Prowell1, Haley Gittleman1
1US Food and Drug Administration, Silver Spring, MD.
概括
美国FDA批准了 ribociclib 加上一种芳香酶抑制剂用于高风险的早期乳腺癌. 这种组合在NATALEE试验中显著改善了无侵袭性疾病生存率,证明了有利的益处风险概况.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 激素受体阳性 (HR+),人体表皮生长因子受体2 (HER2) 阴性早期乳腺癌 (EBC) 是一个重大的临床挑战.
- 辅助疗法旨在降低高风险EBC患者复发风险.
- 正在不断研究新的治疗策略,以改善EBC患者的治疗结果.
研究的目的:
- 评估与芳香酶抑制剂 (AI) 结合使用的 ribociclib 的疗效和安全性,用于辅助治疗高风险HR+,HER2阴性II期和III期EBC的成年人.
- 确定这种组合对无侵袭性疾病生存率 (iDFS) 和整体生存率 (OS) 的影响.
主要方法:
- NATALEE试验是一项随机的,开放的,多中心的研究,比较了ribociclib加AI与AI单独的HR+,HER2-阴性II/III阶段EBC患者.
- 患者接受了 ribociclib (400 毫克每天一次,3 周/1 周休息) 长达 36 个月,AI 每个标准护理至少 5 年.
- 主要终点是iDFS,OS作为次要终点. 数据使用治疗意图 (ITT) 人口进行分析.
主要成果:
- 在最终分析中,添加 ribociclib 到 AI 显示出 iDFS 的统计学上显著改善,危险比率 (HR) 为 0.75 (95% CI,0.63 到 0.89).
- 在36个月后,ribociclib加AI组的iDFS为90.7%,AI单独组为87.6%.
- 与AI单独组相比,在ribociclib加AI组中观察到所有级别和≥3级别不良反应的更高率.
结论:
- 辅助性 рибоциклиб与芳香酶抑制剂结合,显示出高风险HR+,HER2-阴性II期和III期EBC的成年人有利的益处风险概况.
- 组合治疗导致了在无侵袭性疾病生存率上具有统计学意义的优势.
- 总体生存数据仍未成熟,需要进一步跟进.
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