Cancer:ZD4054不延长特定前列腺癌患者的总生存期

2012-07-18 朱金 医学论坛网

     《癌症》(Cancer)杂志近期发表的一项研究表明,10 mg/天的Zibotentan(ZD4054)不能显著延长去势难治性骨转移前列腺癌患者的总生存期(OS)。   内皮素1和内皮素A(ETA)受体已经被证明参与了前列腺癌骨转移进展。这项研究的目的是确定ETA受体拮抗Zibotentan是否能延长无疼痛或有轻度疼痛症状的去势难治性前列腺癌伴骨转移患者的OS。   患者

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  《癌症》(Cancer)杂志近期发表的一项研究表明,10 mg/天的Zibotentan(ZD4054)不能显著延长去势难治性骨转移前列腺癌患者的总生存期(OS)。

  内皮素1和内皮素A(ETA)受体已经被证明参与了前列腺癌骨转移进展。这项研究的目的是确定ETA受体拮抗Zibotentan是否能延长无疼痛或有轻度疼痛症状的去势难治性前列腺癌伴骨转移患者的OS。

  患者被按照1:1的比例随机分配到Zibotentan 10 mg/天或安慰剂组,同时接受前列腺癌标准治疗。主要终点是OS。次要终点包括距疼痛进展时间、化疗的使用、新的骨转移和安全性。疗效终点使用log-rank检验来分析。

  结果显示,共有594例患者被随机分组(zibotentan组299例,安慰剂组295例)。Zibotentan治疗组与安慰剂组的中位OS分别为24.5和22.5个月,但差异未达到统计学意义。研究未发现任何次级疗效终点存在组间统计学差异。周围水肿(44%)和头痛(31%)是Zibotentan组中最常报告的不良事件。Zibotentan组心力衰竭事件的发生率高于安慰剂组,不过这些事件是可控且可逆的。

  相关链接:Joel B. Nelson MD1,†,*, Karim Fizazi MD, PhD2, Kurt Miller MD, PhD3, Celestia Higano MD4, Judd W. Moul MD5, Hideyuki Akaza MD6, Thomas Morris MD7, Stuart McIntosh MD7, Kristine Pemberton MSc7, Martin Gleave MD8 .Phase 3, randomized, placebo-controlled study of zibotentan (ZD4054) in patients with castration-resistant prostate cancer metastatic to bone.Cancer 2012.

 



    

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