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ESMO 2014:帕妥珠单抗方案能显著提高转移性乳腺癌总生存期(CLEOPATRA研究)

2014-10-02 许景红 中国医学论坛报

HER2+转移性乳腺癌被视为乳腺癌中最具侵袭性的疾病形式之一。今年EMSO年会上公布的CLEOPATRA的最新结果(摘要号:350)表明,在HER2阳性转移性乳腺癌患者中,与安慰剂相比,帕妥珠单抗()可显著改善患者总生存(OS)。在夏天公布了安全性结果,提示帕妥珠单抗合并曲妥珠单抗(T)+多西他赛,具有较好的安全性。CLEOPATRA纳入808例HER2+转移性乳腺癌患者,随机接受一线安慰剂(Pl

HER2+转移性乳腺癌被视为乳腺癌中最具侵袭性的疾病形式之一。今年EMSO年会上公布的CLEOPATRA的最新结果(摘要号:350)表明,在HER2阳性转移性乳腺癌患者中,与安慰剂相比,帕妥珠单抗()可显著改善患者总生存(OS)。在夏天公布了安全性结果,提示帕妥珠单抗合并曲妥珠单抗(T)+多西他赛,具有较好的安全性。


CLEOPATRA纳入808例HER2+转移性乳腺癌患者,随机接受一线安慰剂(Pla)+曲妥珠单抗(T)+多西他赛(D)或帕妥珠单抗(Ptz)+T+D治疗。中期分析显示,帕妥珠单抗可显著改善患者OS,但Ptz组未达到中位OS。研究者此次报告了该研究的最终OS,采用的统计方法是利用Kaplan–Meier方法估算两组患者的中位OS,并利用分层Cox比例风险模型估算HR。

结果显示,中位随访时间为50个月,并且Ptz+T+D组的OS显著改善状况持续存在(HR 0.68,P=0.0002)。Pla和Ptz组的中位OS分别为40.8和56.5个月,中位差异为15.7个月。预定亚组的OS获益与既往观察相一致。在总体人群以及在交叉至Ptz组患者中,Ptz+T+D的安全性特征与已知情况相一致,并且长期心脏安全性特征得以维持。

原始出处:

Fleeman N, Bagust A, Beale S, Dwan K, Dickson R, Proudlove C, Dundar Y.Pertuzumab in Combination with Trastuzumab and Docetaxel for the Treatment of HER2-Positive Metastatic or Locally Recurrent Unresectable Breast Cancer. Pharmacoeconomics. 2014 Aug 20.

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    2015-07-01 bsmagic9140
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    2015-07-29 liuhuangbo
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    2014-10-04 zhang92560
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