优先考虑:Triptorelin或高风险前列腺癌的积极监测在高风险前列腺癌的第四阶段研究
Vsevolod Matveev1, Xin Gao2, Evgeny Kopyltsov3
1N. N. Blokhin Russian Cancer Research Center, Moscow, Russia.
Asia-Pacific journal of clinical oncology
|July 3, 2024
概括
在前列腺癌的激进前列腺切除术后,triptorelin显示出更长的生化无复发存活的趋势,但这种差异在统计学上并不显著. 在没有淋巴结转移的患者中,治疗耐受性良好,安全性可接受.
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
- 药理学 药理学是指药理学的学科.
背景情况:
- 激进前列腺切除术 (RP) 是前列腺癌的主要治疗方法.
- 辅助雄激素剥夺疗法 (ADT),如triptorelin,用于当癌症已经扩散到淋巴结时.
- 在RP后阴性淋巴结患者中,ADT的益处尚未得到充分证实.
研究的目的:
- 为了评估triptorelin作为后激进前列腺切除术的辅助疗法的疗效和安全性.
- 评估三瑞林对高风险前列腺癌患者没有淋巴结转移的生化无复发生存期 (BRFS) 的影响.
主要方法:
- 一项前性,随机的,受控的第四期研究 (PRIORITI,NCT01753297),涉及中国和俄罗斯的226名患者.
- 患有高风险前列腺腺癌和阴性淋巴结的患者被随机分配给接受triptorelin (11.25毫克在基线,3个月和6个月) 或主动监测.
- 主要终点是BRFS,由前列腺特异性抗原 (PSA) 水平定义,最低随访时间为36个月.
主要成果:
- 在这两组中,均未达到BRFS的中位数.
- 与监测 (30.0个月) 相比,在三列林 (39.1个月) 治疗中,BRFS的第25百分位是较长的,尽管在统计学上不显著 (p=0.10).
- 到9个月,triptorelin在93.9%的患者中实现了化学割,并且耐受性很好.
结论:
- 在RP后,triptorelin显示了与积极监测相比,在RP后阴性淋巴结患者中改善BRFS的趋势.
- 观察到的BRFS差异没有达到统计学意义.
- 特里普托雷林具有可接受的安全性,这表明潜在的益处需要进一步调查.
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