JCO：晚期乳腺癌的患者的治疗--氟维司群+Abemaciclib，有效且安全（MONARCH 2研究）

2017-06-10 MedSci MedSci原创

MONARCH 2临床试验旨在对比 Abemaciclib 联合氟维司群与安慰剂联合氟维司群用于治疗激素受体阳性（HR+）、人体表皮生长因子受体2-阴性（HER2-）的局部晚期或转移性乳腺癌的治疗效果。Abemaciclib是一种选择性细胞周期蛋白依赖性激酶(CDK)4/6抑制剂。MONARCH 2是一个全球性的、双盲的III期临床试验，患者均为激素受体阳性（HR+）、人体表皮生长因子受体2-阴性

MONARCH 2临床试验旨在对比 Abemaciclib 联合氟维司群与安慰剂联合氟维司群用于治疗激素受体阳性（HR+）、人体表皮生长因子受体2-阴性（HER2-）的局部晚期或转移性乳腺癌的治疗效果。Abemaciclib是一种选择性细胞周期蛋白依赖性激酶(CDK)4/6抑制剂。

MONARCH 2是一个全球性的、双盲的III期临床试验，患者均为激素受体阳性（HR+）、人体表皮生长因子受体2-阴性（HER2-）的晚期乳腺癌患者，这些患者已经在接受新辅助疗法或辅助内分泌治疗（ET），且接受辅助ET≤ 12月，或因转移性病变在接受一线ET。患者被随机分配（2:1）接受氟维司群（500mg，频率按药物标签）+Abemaciclib或安慰剂治疗（150mg，每天两次）。主要终点是研究者评估的无进展生存期（PFS），关键次要终点包括总生存率、客观反应率、反应持续时间、临床受益率、生活质量和安全性。

2014年8月-2015年12月间，669例患者被随机分配接受Abemaciclib加氟维司群（n = 446）或安慰剂（n = 223）加氟维司群。与单独接受氟维司群治疗组相比，Abemaciclib加氟维司群显著延长PFS（中位数，16.4 vs 9.3个月；风险比，0.553；95% CI，0.449-0.681；P＜0.001）。在可测量的病变患者中，Abemaciclib加氟维司群的ORR达到48.1%（95% CI，42.6%-53.6%）vs 安慰剂组的21.3%（95% CI，15.1%-27.6%）。在abemaciclib组与安慰剂组最常见的不良反应为腹泻（86.4% vs 24.7%），中性粒细胞减少（46% vs 4%），恶心（45.1% vs 22.9%），疲劳（39.9% vs 26.9%）。

研究人员认为对激素受体阳性（HR+）、人体表皮生长因子受体2-阴性（HER2-）的晚期乳腺癌患者（无论是否进展或正在接受内分泌治疗），在氟维司群治疗中加入Abemaciclib（150mg，每日两次）是有效的，且显著改善PFS和ORR，同时安全性也较高。

原始出处：

Sledge GW Jr1, Toi M,et al.MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy.J Clin Oncol. 2017 Jun 3:JCO2017737585. doi: 10.1200/JCO.2017.73.7585. [Epub ahead of print]

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2018-01-10 lidong40

#JCO#

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2018-01-07 yb6560

#MAC#

98 0
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2017-06-29 医鸣惊人

学习了

0 0
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2017-06-22 jacob9231

学习了谢谢分享

115 0
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2017-06-16 Medsci0421

哎！

113 0
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2017-06-12 fengyi812

#EMA#

63 0
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2017-06-12 ylzr123

好文，值得点赞！认真学习，应用于实践！谢谢分享给广大同好！

107 0
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2017-06-11 天涯183

非常好的文章，学习了，很受益

114 0
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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209240, encodeId=64ba209240c3, content=这个药真的那么有效么？, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Sun Jun 11 07:34:54 CST 2017, time=2017-06-11, status=1, ipAttribution=)]
2017-06-11 方舒

学习

68 0
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createdName=yb6560, createdTime=Sun Jan 07 14:43:00 CST 2018, time=2018-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=216591, encodeId=142421659173, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Thu Jun 29 08:02:59 CST 2017, time=2017-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=213783, encodeId=141e213e83ad, content=学习了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM66WRRAmeqIVSnDN88DpaJfEWzRZxg4yBbiaBmMRwcvViaA2C0sE0Ts3Lic24JSSI4YffujDtpnm0GTHpuiao9TytmNArrcYESnSXY/0, createdBy=7938104912, createdName=jacob9231, createdTime=Thu Jun 22 08:22:28 CST 2017, time=2017-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=211569, encodeId=dc652115699a, content=哎！, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4Ne59unJiaEKVBVsw2H5iaLnmLt108lIrJ6YTqVphNiao7iaUJuuRE3xickhLErmQ99C3vF1zsf7DKXibuAQLOMjy7cgqj/0, createdBy=a8102049538, createdName=Medsci0421, createdTime=Fri Jun 16 14:52:19 CST 2017, time=2017-06-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317303, encodeId=ca9e131e303d1, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Mon Jun 12 14:43:00 CST 2017, time=2017-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209749, encodeId=5a97209e4991, content=好文，值得点赞！认真学习，应用于实践！谢谢分享给广大同好！, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7s7ZCKOmmbBTD6nE7gcd5OZpvyGEzkxBP3S275k5ZJVrsPkotZhBglRHM9rKvcj1OgkssqhcnoPw8zIaMZTF8c/0, createdBy=4c441942088, createdName=ylzr123, createdTime=Mon Jun 12 08:47:05 CST 2017, time=2017-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209365, encodeId=4f772093653e, content=非常好的文章，学习了，很受益, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Sun Jun 11 11:03:30 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209335, encodeId=b96720933580, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5KiblTyxD95ExbzUoCVcRuhPibXboL28wicFMTXUhCA0RWCyQZYC5Na3ap7CxjialMkB50VEJ0XToQQTC/0, createdBy=470c1945776, createdName=方舒, createdTime=Sun Jun 11 09:58:09 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209240, encodeId=64ba209240c3, content=这个药真的那么有效么？, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Sun Jun 11 07:34:54 CST 2017, time=2017-06-11, status=1, ipAttribution=)]
2017-06-11 飛歌

这个药真的那么有效么？

63 0