基于注册表的随机二期研究恩扎胺与阿比拉:评估老年患有转移性割抵抗性前列腺癌 (REAL-Pro) 的老年患者的认知功能
A Anton1,2,3, C Steer4,5, M Arasaratnam6
1Eastern Health, Melbourne, Australia.
概括
患有转移性割抵抗性前列腺癌 (mCRPC) 的老年男性开始服用雄激素受体通路抑制剂 (ARPIs),需要对认知,抑郁和跌倒风险进行个性化评估. 这些因素影响治疗失败,强调需要仔细评估患者.
科学领域:
- 在瘤学瘤学.
- 老年病的医生 老年病的医生
- 药理学 药理学是指药理学的学科.
背景情况:
- 雄激素受体通路抑制剂 (ARPI) 是老年患者转移性割抵抗性前列腺癌 (mCRPC) 的标准治疗方法.
- 对mCRPC的治疗选择经常考虑不良事件 (AE) 概况,因为缺乏直接比较的III期试验.
- 之前没有任何随机的III期试验在这个患者群体中比较了ARPI.
研究的目的:
- 在老年男性 (≥75岁) 中比较阿比拉和胺的疗效和安全性与mCRPC.
- 评估基线认知功能,抑郁症和跌倒风险对治疗结果的影响.
- 在ARPI治疗期间评估认知,情绪和跌倒风险评估的变化.
主要方法:
- 一项基于注册的前性随机试验,涉及76名75岁以上的男性,患有mCRPC.
- 患者被随机分配给接受阿比拉或恩扎胺,根据先前的多塞塔克塞尔使用分层.
- 评估包括在基线和12周的祝福定向-记忆-度 (BOMC),老年抑郁量表 (GDS) 和跌倒风险问卷 (FRQ).
主要成果:
- 在治疗组之间没有观察到治疗失败的时间 (TTF),整体存活率 (OS) 或前列腺特异性抗原反应的显著差异.
- 较高的基线GDS和FRQ得分与较短的TTF相关.
- 虽然在统计学上并不显著,但趋势表明认知和情绪得分的潜在差异有利于12周的恩扎胺.
结论:
- 对认知,抑郁和跌倒风险的个性化评估对于开始为mCRPC治疗ARPI的老年患者至关重要.
- 基线抑郁和跌倒风险是治疗失败的重要预测因素.
- 需要进一步的研究,以充分阐明ARPI在这个人群中的比较有效性和安全性.
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