普雷尼松加卡巴西塔克塞尔或米托克桑用于转移性割抵抗性前列腺癌,在多塞塔克塞尔治疗后进展:一个随机的开放标签试验
Johann Sebastian de Bono1, Stephane Oudard, Mustafa Ozguroglu
1Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton, UK. johann.de-bono@icr.ac.uk
Lancet (London, England)
|October 5, 2010
概括
卡巴西塔克塞尔加上普得尼松显著改善了转移性割抵抗性前列腺癌在多塞塔克塞尔后进展的男性的整体存活率. 这种组合疗法在与米托克桑加普雷迪尼松相比,显示出更高的疗效.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学 是一个学科.
- 临床试验 临床试验
背景情况:
- 卡巴西塔克塞尔是一种新型分类物,在耐多塞塔克塞尔癌症中具有抗瘤活性.
- 转移性割抵抗性前列腺癌 (mCRPC) 往往在多塞治疗后进展.
- 评估mCRPC博士后治疗的替代疗法至关重要.
研究的目的:
- 为了比较卡巴西塔克塞尔加普德尼松与米托克桑加普德尼松的疗效和安全性.
- 为了评估基于多塞塔克塞尔的治疗后,mCRPC在男性中进展的治疗结果.
主要方法:
- 一个开放的,随机的第三阶段试验,涉及755名男性,他们接受了docetaxel后的mCRPC.
- 参与者每天服用口服普雷迪尼松,每3周服用静脉注射卡巴西塔克塞尔 (25毫克/米2) 或密托克桑 (12毫克/米2).
- 主要终点是整体存活率;次要终点包括无进展生存率和安全性.
主要成果:
- 卡巴西塔克塞尔的平均整体存活时间为15.1个月,而米托克桑的平均存活时间为12.7个月 (HR 0.70,p<0.0001).
- 随着cabazitaxel的治疗,无进展生存时间的中位数为2.8个月,而随着mitoxantrone的治疗为1.4个月 (HR 0.74,p<0.0001).
- 3级或更高的不良事件包括中性质减退 (82%的cabazitaxel与58%的mitoxantrone相比) 和发烧性中性质减退 (8%与1%相比).
结论:
- 卡巴西塔克塞尔加上普得尼松在mCRPC中显示出显著的临床抗瘤活性.
- 这种疗法改善了dcetaxel治疗后疾病进展的患者的整体存活率.
- 与米托克桑相比,卡巴西塔克塞尔在这种患者群体中提供了更有效的治疗选择.
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