高风险局部性前列腺癌的早期终点:对三组放射治疗瘤组的探索性分析 第三阶段研究
Felix Feng1, Branko Miladinovic2, Ke Zhang2
1Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.
European urology
|July 1, 2023
概括
早期终点如PSA复发和没有疾病的证据可以加快高风险局部前列腺癌的临床试验. 这些措施有助于识别无法检测到的疾病患者,并可能加速新药的开发.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 前列腺癌研究 研究前列腺癌
背景情况:
- 高风险局部性前列腺癌 (HRLPC) 临床试验中的早期终点对于加速药物开发至关重要.
- 目前的现实实践监测可以为这些早期终点的选择提供信息.
研究的目的:
- 评估前列腺特异性抗原 (PSA) 基于复发的早期终点与无转移生存率 (MFS),总生存率 (OS) 和前列腺癌特异性生存率 (PCSS) 的关联.
- 在HRLPC中确定与长期结果相关的潜在早期终点.
- 确定检测临床上无法检测到的疾病的措施.
主要方法:
- 从放射治疗瘤学小组研究中对HRLPC患者的特异分析 (9202, 9902, 0521).
- 评估无事件生存 (EFS),生物化学失败,一般临床失败和没有疾病证据 (NED),使用相关性,里程碑,卡普兰-梅尔和考克斯比例危险模型.
- 定义的PSA复发 (PSA-R) 基于PSA最低点+2 ng/ml,PSA最低点+2 ng/ml和上升,PSA>5,10,25 ng/ml,或PSA翻倍时间 (PSADT) <6个月.
主要成果:
- 无事件生存期 (EFS) 定义为PSA最低点+2 ng/ml和上升,或PSA>5 ng/ml,与MFS,OS和PCSS相关.
- 在PSADT<6个月或ADT启动时缺少EFS,并在3年内实现NED,与延长的OS,MFS和PCSS有关.
- 危险比率表明了这些终点的显著关联 (例如,HR 0.26 [0.18-0.36]对于NED).
结论:
- 包含PSA最低点+2 ng/ml和上升的EFS,PSA>5 ng/ml,PSADT<6个月±ADT启动,以及NED是HRLPC有希望的早期终点.
- 这些终点需要进一步验证,以加快HRLPC的临床开发.
- 定义了一个新的"没有疾病证据"措施,以帮助识别无法检测到的疾病患者.
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