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NEJM:辅助多西他赛治疗高危的淋巴结阴性乳腺癌

2010-12-29 MedSci原创 MedSci原创

  背景 在有淋巴结阳性乳腺癌的妇女中,作为辅助疗法使用时,多西他赛、多柔比星和环磷酰胺(TAC)方案优于氟尿嘧啶、多柔比星和环磷酰胺(FAC)方案。紫杉烷类在治疗淋巴结阴性疾病中的价值还未被确定。   方法 我们将1060例患有腋淋巴结阴性乳腺癌并至少有一种复发高危因素[按照1998年圣·加仑(St.Gallen)标准]的女患者随机分为两组:一组手术后每3周接受1次TAC治疗,共6个周期;另

  背景 在有淋巴结阳性乳腺癌的妇女中,作为辅助疗法使用时,多西他赛、多柔比星和环磷酰胺(TAC)方案优于氟尿嘧啶、多柔比星和环磷酰胺(FAC)方案。紫杉烷类在治疗淋巴结阴性疾病中的价值还未被确定。

  方法 我们将1060例患有腋淋巴结阴性乳腺癌并至少有一种复发高危因素[按照1998年圣·加仑(St.Gallen)标准]的女患者随机分为两组:一组手术后每3周接受1次TAC治疗,共6个周期;另一组手术后每3周接受1次FAC治疗,共6个周期。主要终点是随访至少5年后的无病生存率。次要终点包括总生存率和毒性。

  结果 在随访中位数为77个月期间,病人无病生存的比例,TAC组中539例病人(87.8%),高于FAC组中的521例病人(81.8%),表明TAC组的复发危险下降了32%[风险比为0.68,95%可信区间(CI)为0.49 ~ 0.93,时序检验P=0.01]。无论激素受体状态、绝经状态或高危因素的数量如何,这种益处都是一致的。两组的生存率(TAC组为95.2%,FAC 组为93.5%)差异没有显著性(风险比为0.76,95%CI为0.45~1.26)。然而,TAC组发生的事件数量少(TAC组为26起,FAC组为 34起)。3级或4级不良事件的发生率在TAC组为28.2%以及在FAC组为17.0%(P<0.001)。当为病人提供粒细胞集落刺激因子进行一级预防时,与TAC相关的毒性减低。

  结论 在有高危、淋巴结阴性乳腺癌的妇女中,与辅助FAC相比,辅助TAC提高了她们的无病生存率。

  (N Engl J Med 2010; 363:2200-10. December 2, 2010)

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    2017-08-03 laoli

    学习了,谢谢分享!

    0

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    2010-12-31 sodoo

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