NEJM:奥拉帕利治疗BRCA突变的转移性乳腺癌患者疗效如何?

2017-06-05 xing.T MedSci原创

HER2阴性的转移性乳腺癌和BRCA突变患者中,奥拉帕尼单药治疗比标准治疗疗效更显著;中位无进展生存期延长了2.8个月,疾病进展或死亡的风险为在奥拉帕尼治疗组要比标准治疗组低42%。

奥拉帕利是一种口服(腺苷二磷酸核糖)多聚合酶抑制剂对转移性乳腺癌以及BRCA突变的患者具有抗肿瘤活性的前景。

最近,顶级医学期刊NEJM上发表了一篇研究文章。研究人员进行了一项随机、开放标签的3期临床试验,研究人员对转移性疾病没有超过前两个化疗方案并且BRCA突变与人类表皮生长因子受体2(HER2)阴性的转移性乳腺癌患者采用奥拉帕利单药治疗与标准治疗进行了比较。这些患者按2:1的比例随机分配,分别接受奥拉帕尼片(300mg,每天两次)或与医师选择的单药化疗的标准治疗(卡培他滨、艾立布林或长春瑞滨,21天为一周期)。该研究的主要终点为无进展生存期,有实施盲法的独立中心审查人员进行评估,并对意向治疗进行分析。

该研究共有302名患者进行了随机分组,205例接受奥拉帕尼治疗,97例接受标准疗法治疗。采用奥拉帕尼治疗组中位无进展生存期显著长于标准治疗组(7个月 vs. 4.2个月;疾病进展或死亡的风危险比为0.58;95%可信区间为0.43-0.80;P<0.001)。奥拉帕尼组治疗反应率为59.9%,标准治疗组为28.8%。3级或更高的不良事件发生率在奥拉帕尼组为36.6%,在标准治疗组为50.5%,由于毒性反应而停止治疗的发生率为分别为4.9%和7.7%。

HER2阴性的转移性乳腺癌和BRCA突变患者中,奥拉帕尼单药治疗比标准治疗疗效更显著;中位无进展生存期延长了2.8个月,疾病进展或死亡的风险为在奥拉帕尼治疗组要比标准治疗组低42%。 

原始出处:

Mark Robson,et al. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation.NEJM.2017. http://www.nejm.org/doi/full/10.1056/NEJMoa1706450

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    2017-06-07 智智灵药
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    2017-06-07 jetleo

    研究人员对转移性疾病没有超过前两个化疗方案?

    0

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    2017-06-06 tanxingdoctor

    学习啦谢谢分享

    0

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    2017-06-05 忠诚向上

    好好的学习一下

    0

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    2017-06-05 榄枷檬

    谢谢分享

    0

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