在患有高风险前列腺癌的患者中,新辅助剂卡巴西塔克塞尔加上阿比拉/乐普罗化德乙酸盐:ACDC-RPII期试验
Neil E Fleshner1, Rashid K Sayyid1, Aaron R Hansen2
1Division of Urologic Oncology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
概括
将cabazitaxel添加到新辅助剂abiraterone acetate和leuprolide acetate中,并没有改善接受激进前列腺切除术的高风险前列腺癌患者的结果. 最小残留疾病率相似,但对cabazitaxel的不良事件更为频繁.
科学领域:
- 在瘤学瘤学.
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 临床试验 临床试验
背景情况:
- 新辅助疗法强化可能会提高接受激进前列腺切除术的高风险局部前列腺癌患者的结果.
- 评估新的治疗组合对于改善前列腺癌管理至关重要.
研究的目的:
- 在急性前列腺切除术前,比较新辅助剂阿比拉酸盐加烯酸与或没有cabazitaxel的病理,瘤和安全结果.
- 评估将cabazitaxel添加到高风险前列腺癌标准新辅助激素治疗的疗效.
主要方法:
- 一个开放的,多中心的II期试验随机选择了70名患有高风险前列腺癌的患者.
- 患者在进行激进前列腺切除术之前接受了新辅助剂阿比拉酸和烯酸,有或没有卡巴西塔塞尔.
- 主要结局是病理完整反应 (pCR) 或最小残留疾病 (MRD);次要结局包括生存和安全.
主要成果:
- 病理完整反应/最小残留疾病率在各组之间相似 (43.2%与45.5%,P=0.85).
- 患有最小残留疾病的患者表现出优异的12个月生化无复发存活率 (96.0%对比62.0%,P=0.03).
- 在cabazitaxel手臂中,3级以上的不良事件更频繁 (42.5%对23.7%).
结论:
- 新辅助剂cabazitaxel的添加并没有改善局部高风险前列腺癌的pCR/MRD.
- 组合治疗没有证明在实现病理反应方面有额外的益处.
- 进一步的研究可能会探索这种患者群体的替代新辅助剂策略.
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