通过多模式治疗策略加速前列腺癌的药物开发:MetaCURE第二阶段随机临床试验
Deaglan McHugh1, Matthew Dallos2, Min Yuen Teo2
1Memorial Sloan Kettering Cancer Center, New York, United States.
概括
多模式治疗 (MMT) 是前列腺癌的可行和安全方法,提供快速的疗效见解. 这一战略有助于确定局部化和转移性疾病的有效治疗方法,指导未来的药物开发.
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:
- 前列腺癌药物开发需要对新疗法的有效评估.
- 中间终点可以加快治疗疗效的评估.
研究的目的:
- 为评估前列腺癌治疗建立一个多式疗法 (MMT) 框架.
- 利用中间疗效终点来快速评估治疗策略.
主要方法:
- 在MetaCURE试验中,随机选择了具有高风险局部或低体积转移性前列腺癌的患者.
- 治疗包括阿帕胺,阿比拉酸盐加上普得尼松和安德روج因剥夺疗法,以及转移队列的放射治疗.
- 主要终点:病理完整反应 (pCR) 或最小残留疾病 (MRD);二级终点:无法检测的前列腺特异抗原 (PSA) 与的恢复.
主要成果:
- 在12% (A队列) 和15% (B队列) 的患者中实现了pCR或MRD.
- 在24个月后,在61% (A队列) 和39% (B队列) 观察到无法检测的PSA与恢复.
结论:
- 对新诊断的前列腺癌来说,MMT是可行的和安全的,提供快速的疗效读数.
- 很大一部分患者在丸激素恢复后实现了不可检测的PSA,这表明治疗有效.
- 结果为适应性试验设计提供信息,用于持续MMT评估和治疗优先级.
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