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胡夕春教授：MONARCH plus研究——Abemaciclib给中国HR+/HER2-晚期乳腺癌患者带来新的希望

2019-10-22 佚名 肿瘤资讯

MONARCHPlusAbemaciclib晚期乳腺癌
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2019年欧洲肿瘤内科学会（ESMO）年会报道了MONARCH plus研究的期中分析结果，证实选择性细胞周期蛋白依赖性激酶4和6（CDK4/6）抑制剂Abemaciclib联合内分泌治疗，无论是联合芳香化酶抑制剂，还是激素受体下调剂氟维司群，均能显着改善HR+/HER2-晚期乳腺癌患者PFS，带来生存获益。

2019年欧洲肿瘤内科学会（ESMO）年会报道了MONARCH plus研究的期中分析结果，证实选择性细胞周期蛋白依赖性激酶4和6（CDK4/6）抑制剂Abemaciclib联合内分泌治疗，无论是联合芳香化酶抑制剂，还是激素受体下调剂氟维司群，均能显着改善HR+/HER2-晚期乳腺癌患者PFS，带来生存获益。

设计独特——MONARCH plus研究证实CDK4&6抑制剂Abemaciclib给HR+/HER2-晚期乳腺癌带来获益

在乳腺癌的诊疗过程中，有一种亚型为激素受体阳性、HER2阴性的Luminal型乳腺癌，也可称之为激素受体阳性乳腺癌。历经数十年的发展，没有药物能够显着提高这类亚型患者的疗效。直到CDK4/6抑制剂的出现，这类疾病真正有了安全、有效的靶向药物。CDK4/6抑制剂包括多种，Abemaciclib就是其中之一。MONARCH plus研究是全球多中心临床试验MONARCH-2和MONARCH-3研究进行结合，在中国进行注册临床试验，其研究对象分为两大队列。队列A是CDK4&6抑制剂Abemaciclib联合AI对比AI单药，队列B是CDK4&6抑制剂Abemaciclib联合氟维司群对比氟维司群单药。因此MONARCH plus研究是在中国注册的桥接试验。不同于其他CDK4/6抑制剂，不仅能够靶向CDK4、CDK6，还能够靶向CDK2和CDK9。临床研究也显示，MONARCH plus研究达到预设的终点，在内分泌治疗的基础上，联合CDK4&6抑制剂Abemaciclib，能够显着提高反应率，延长患者的PFS（队列A显示，Abemaciclib+AI组与安慰剂+AI组的中位PFS分别为未达到和14.73个月，HR 0.499，95%CI 0.346~0.719，双侧检验P = 0.0001；队列B显示，Abemaciclib+氟维司群组与安慰剂+氟维司群组的中位PFS分别为11.47个月和5.59个月，HR 0.376，95%CI 0.240 ~ 0.588，双侧检验P ＜ 0.0001），且安全性分析显示，CDK4&6抑制剂Abemaciclib联合内分泌治疗的毒副反应能够耐受。

安全可耐受——MONARCH plus研究再次验证CDK4&6抑制剂Abemaciclib的安全性

MONARCH plus研究是CDK4&6抑制剂Abemaciclib在中国的注册临床试验。临床非常关心，中国人群是否与欧美人群存在差异，尤其是安全性。在MONARCH plus研究中，安全性分析显示CDK4&6抑制剂Abemaciclib无论是联合AI还是联合氟维司群，主要的不良反应包括中性粒细胞减少、腹泻和白细胞减少，且不良反应多为Ⅰ~Ⅱ度，Ⅲ度不良反应非常少见，临床对症处理即可。全球多中心MONARCH-2和MONARCH-3也显示，患者不良反应可耐受。即无论是中国人群还是欧美人群，都能够在保证安全性的前提下从CDK4&6抑制剂Abemaciclib联合内分泌治疗中获益。

疗效与安全——临床选择治疗方案的“准绳”

CDK4&6抑制剂Abemaciclib不仅能够靶向CDK4、CDK6，还能靶向CDK2、CDK9，因此与其他CDK4/6抑制剂不同，MONARCH plus研究作为CDK4&6抑制剂Abemaciclib在中国的注册研究，可以给更多HR+晚期乳腺癌患者带来生存希望。而未来还会有多种CDK4/6抑制剂上市，临床选择可以从疗效、安全性综合考虑。首先，目前MONARCH-2研究OS分析提示CDK4&6抑制剂Abemaciclib能够显着延长OS，给患者带来生存获益。其次，有的CDK4/6抑制剂会存在一定的心脏毒性，而CDK4&6抑制剂Abemaciclib的安全性分析提示不良反应易于处理。因此临床可以从疗效是否能给患者带来OS获益，安全性患者是否能够耐受等方面进行合理选择。

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    2020-08-31 ms9608593228839890

    #Plus#

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    2020-03-22 yb6560

    #MAC#

    0

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    2019-12-16 luwei00

    #HER2-#

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    2019-10-24 fengyi812

    #EMA#

    0

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    2019-10-24 hanhaisha2013

    #乳腺癌患者#

    0