库尔库明在接受一线或二线多塞塔塞尔治疗的晚期和转移性乳腺癌患者中的作用:一项随机试验
Passildas Jahanmohan Judith1,2,3,4, Bernadach Maureen1, Pouget Mélanie3
1Service d'Oncologie médicale Centre Jean Perrin Clermont-Ferrand France.
Health science reports
|September 17, 2024
概括
将黄素添加到多塞塔克塞尔并没有改善晚期乳腺癌患者的应答率. 该组合是安全的,但不有效的,导致停止研究.
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:
- 研究黄素与多塞塔克塞尔联合治疗晚期和转移性乳腺癌的疗效.
- 专注于接受一线或二线治疗的患者.
研究的目的:
- 为了确定黄素是否增强了多塞的客观反应率 (ORR).
- 评估临床益处,生存和安全结果.
主要方法:
- 这是一项多中心,随机,开放的II期研究.
- 招募了42名患者;临时分析包括37名患者.
- 主要终点:多塞塔克塞尔-库尔库明的ORR与单独的多塞塔克塞尔.
主要成果:
- 在dcetaxel-curcumin组 (55.6%) 和dcetaxel单独组 (73.7%) (p=0.25) 之间ORR没有显著差异.
- 在临床益处,整体存活率或进展时间方面没有观察到差异.
- 在黄素组中,较长的无进展生存期的非显著趋势 (65.5%对41.4%,p=0.14).
结论:
- 将口服黄素添加到多塞塔克塞尔对于在一线或二线治疗中的晚期乳腺癌患者是无效的.
- 这种组合被发现是安全的,但由于徒劳,研究被停止了.
- 需要对更大的队列,不同的黄素制剂和药理动力学分析进行进一步的研究.
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