在内分泌治疗中,富尔韦斯特兰特与阿纳斯托相比-先前没有接受过激素受体阳性晚期乳腺癌的女性:在第三阶段FALCON试验中最终的整体生存率
John F R Robertson1, Zhimin Shao2, Shinzaburo Noguchi3
1Academic of the Unit of Translational Medical Sciences and Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, United Kingdom.
在FALCON试验中,在晚期乳腺癌中,富尔韦斯特兰特和阿纳斯特罗之间整体生存率没有显著差异. 然而,富尔韦斯特兰显示,非内脏疾病患者的生存率有所改善.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 内分泌学 在内分泌学.
背景情况:
- 之前的FALCON试验显示,富尔韦斯坦与阿纳斯托相比,富尔韦斯坦的无进展生存期 (PFS) 得到改善.
- 激素受体阳性/人体表皮生长因子受体2-阴性晚期乳腺癌需要有效的内分泌疗法.
研究的目的:
- 报告随机的第三阶段FALCON试验的最终整体生存 (OS) 分析.
- 为了比较富尔韦斯特兰特和阿纳斯托在绝经后妇女与先前未接受内分泌治疗的晚期乳腺癌的长期疗效.
主要方法:
- 一个随机的III期试验,比较富尔韦斯特兰和阿纳斯托.
- 在初级PFS分析后进行的最终整体生存 (OS) 分析.
- 使用了名义P值的描述性分析.
主要成果:
- 在富尔韦斯特兰特和阿纳斯托之间没有观察到生存寿命的显著差异 (平均生存寿命:44.8个月与42.7个月;HR,0.97;P = .7579).
- 一个趋势表明,非内脏性疾病患者的 fulvestrant 死亡相对风险减少了 15% (中位数 OS: 65.2 与 47.8 个月).
结论:
- 在整个研究人群中,富尔韦斯特兰与阿纳斯托相比没有显示出显著的整体生存益处.
- 研究结果表明,在非内脏疾病患者的子组中,富尔韦斯特兰特具有潜在的长期临床益处,与现有证据一致.
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