酵素胺和生化复发性前列腺癌中的生活质量
Stephen J Freedland1,2, Martin Gleave3, Ugo De Giorgi4
1Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles.
NEJM evidence
|February 6, 2024
概括
在患有高风险复发性前列腺癌的患者中,恩扎胺组合和单独治疗维持了高健康相关的生活质量,显示出与单独使用勒罗化德的结果相似.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 之前的EMBARK试验表明,恩扎胺加上普罗化或恩扎胺单疗改善了高风险生化复发前列腺癌中无转移的存活率.
- 这项试验的健康相关生活质量 (HRQoL) 数据尚未报告.
研究的目的:
- 报告EMBARK试验中患者报告的结果 (PROs).
- 评估患者接受恩扎拉胺组合治疗,恩扎拉胺单疗或单独使用普罗化德的临床意义上的疼痛和HRQoL恶化的时间.
主要方法:
- 患有高风险的生化复发前列腺癌的患者随机分配到恩扎胺加普罗利德,单独普罗利德或恩扎胺单疗法.
- 在基线和每12周收集PRO,使用验证的措施评估疼痛和HRQoL.
- 首次和确定的临床意义上的恶化 (TTFD/TTCD) 的时间是主要终点.
主要成果:
- 所有治疗组在基线报告高HRQoL.
- 最严重疼痛的中位数TTFD为19.35个月 (单独使用leuprolide),13.93个月 (组合治疗) 和16.59个月 (单一治疗).
- 癌症治疗功能评估的中位数TTCD前列腺总得分为36.53个月 (单独使用leuprolide),38.77个月 (组合治疗) 和30.55个月 (单一治疗).
结论:
- 在患有高风险生化复发前列腺癌的患者中,恩扎胺组合和单疗法保持了高HRQoL.
- PROs支持基于酶胺的治疗方法的瘤益处,同时保持患者的生活质量.
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