ESMO Asia 2015：帕布昔利布(palbociclib)+氟维司群治疗亚洲HR+/HER2-晚期乳腺癌女性疗效佳（PALOMA3试验亚洲结果）

2015-12-19 Mechront 译 MedSci原创

PALOMA3试验中日本和韩国患者的数据表明，内分泌治疗无效的HR+/HER2-晚期乳腺癌女性使用帕布昔利布+氟维司群治疗是有效的。帕布昔利布是化学合成的细胞周期蛋白依赖性激酶CDK4和CDK6的选择性抑制剂。对HR+乳腺癌患者其活性很高，且结合内分泌治疗可其协同作用。PALOMA3试验评估了帕布昔利布+氟维司群治疗HR+/HER2-、进行内分泌治疗时疾病进展的绝经前和绝经后的晚期乳腺癌患者的有效

PALOMA3试验中日本和韩国患者的数据表明，内分泌治疗无效的HR+/HER2-晚期乳腺癌女性使用帕布昔利布(palbociclib)+氟维司群治疗是有效的。而全球的结果，今年6月份发表在新英格兰杂志上（NEJM:palbociclib对激素受体阳性的晚期乳腺癌患者的疗效）。中国的临床试验也正在进行中：招募患者：Palbociclib联合来曲唑治疗亚洲女性绝经后晚期乳腺癌的III期临床研究和招募患者：Palbociclib在患有晚期乳腺癌的中国绝经后女性中的I期临床研究

帕布昔利布(palbociclib)是化学合成的细胞周期蛋白依赖性激酶CDK4和CDK6的选择性抑制剂。对HR+乳腺癌患者其活性很高，且结合内分泌治疗协同作用。

PALOMA3试验评估了帕布昔利布+氟维司群治疗HR+/HER2-、进行内分泌治疗时疾病进展的绝经前和绝经后的晚期乳腺癌患者的有效性和安全性。其中来自亚洲的日本和韩国共105名患者，74名为试验组（帕布昔利布+氟维司群），31名为对照组（安慰剂+氟维司群）。数据显示，对于绝经后患者，试验组展示出了确切的有效性，无进展生存翻了一倍多！不过使用帕布昔利布治疗的患者出现了更多的不良反应，尤其是血液系统不良反应，不过这在临床上很常见，也易于管理。对绝经前女性，数据显示出了试验组疗效的有效性，但介于数量太少，很难得出确切结论。

该研究表明，对于亚洲类似患者，帕布昔利布+氟维司群是可选择的治疗方案。帕布昔利布表现出了其临床有效性和适度毒性，不过亚洲人和非亚洲人毒性表现不同，但根据现有的亚洲人和非亚洲人的差异报道还无法解释毒性不同现象。

在以后还需要大样本长时间随访研究，以支持该药物组合的有效性和安全性。基于PALOMA-2II期试验的结果。美国FDA已经批准帕布昔利布+内分泌治疗方案，现有的研究可以帮助亚洲实现帕布昔利布+氟维司群治疗方案。

原始出处：

1 J. Ro, S.-A. Im, N. Masuda, Y.-H. Im, et al,"Efficacy and safety of palbociclib plus fulvestrant in Asian women with hormone receptor-positive (HR+)/human epidermal growth factor-2 negative (HER2-) metastatic breast cancer (MBC) that progressed on prior endocrine therapy (ET)" ESMO Asia 2015, 19/12/2015 16:30-18:00

Turner NC, Ro J, André F, Loi S, et al; PALOMA3 Study Group.Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer.N Engl J Med. 2015 Jul 16;373(3):209-19.

关于Palbociclib

Palbociclib（正式名PD-0332991）最早进入人们视野的是在2012年圣安东尼奥乳腺癌会议上（SABCS），一经发布就引起行业广泛关注。Palbociclib是一种口服的细胞周期素依赖性激酶4、6的抑制药物，主要通过调节细胞周期发挥作用。Palbociclib主要通过抑制CDK4/6活性来阻止细胞由G1期到S期进而抑制DNA的合成。

来自加州大学洛杉矶分校Jonsson 综合癌症中心的Richard S. Finn医生在此次会议上公布了PALOMA-1研究的中期研究结果：Palbociclib联合来曲唑可将乳腺癌患者的中位无疾病生存期（PFS）提高到26.1个月，而单用来曲唑的PFS只有7.5个月。基于这一中期研究结果，2013年4月FDA授予Palbociclib治疗转移性乳腺癌突破性治疗药物。

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2016-04-13 luwei00

#ASIA#

29 0
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2016-11-05 luwei00

#HER2-#

37 0
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2016-04-04 1de98bedm33(暂无匿称)

马上就用

117 0
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2016-11-10 liuhuangbo

#SMO#

34 0
[GetPortalCommentsPageByObjectIdResponse(id=1780066, encodeId=356e1e80066bb, content=<a href='/topic/show?id=10d62860dd' target=_blank style='color:#2F92EE;'>#ASIA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2860, encryptionId=10d62860dd, topicName=ASIA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, createdName=luwei00, createdTime=Wed Apr 13 23:09:00 CST 2016, time=2016-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982500, encodeId=9d8c1982500ff, content=<a href='/topic/show?id=da628e19d5' target=_blank style='color:#2F92EE;'>#HER2-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8719, encryptionId=da628e19d5, topicName=HER2-)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, createdName=luwei00, createdTime=Sat Nov 05 18:09:00 CST 2016, time=2016-11-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=75477, encodeId=dafce54774f, content=马上就用, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0fac1708265, createdName=1de98bedm33(暂无匿称), createdTime=Mon Apr 04 22:02:00 CST 2016, time=2016-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2024756, encodeId=f4112024e56a0, content=<a href='/topic/show?id=c27516459de' target=_blank style='color:#2F92EE;'>#SMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16459, encryptionId=c27516459de, topicName=SMO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6779163, createdName=liuhuangbo, createdTime=Thu Nov 10 19:09:00 CST 2016, time=2016-11-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=56977, encodeId=3d89569e718, content=收藏, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160113/IMG569619FEB03536446.jpg, createdBy=85f81678980, createdName=Lynee劲飞扬, createdTime=Wed Jan 13 17:34:00 CST 2016, time=2016-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=48226, encodeId=ae9748226e3, content=值得看，好好收藏, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bc301610909, createdName=hixiaoluo, createdTime=Sat Dec 26 16:01:00 CST 2015, time=2015-12-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1280903, encodeId=9ebb128090369, content=<a href='/topic/show?id=50d6e0215a' target=_blank style='color:#2F92EE;'>#ESMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7021, encryptionId=50d6e0215a, topicName=ESMO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7460166, createdName=zhang92560, createdTime=Mon Dec 21 02:09:00 CST 2015, time=2015-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372312, encodeId=60ee13e2312f8, content=<a href='/topic/show?id=48cd1369065' target=_blank style='color:#2F92EE;'>#palbociclib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13690, encryptionId=48cd1369065, topicName=palbociclib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=96d4340, createdName=ysjykql, createdTime=Mon Dec 21 02:09:00 CST 2015, time=2015-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=46806, encodeId=04b34680629, content=赞～, beContent=null, objectType=article, channel=null, level=null, likeNumber=112, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec6488436, createdName=a191008346, createdTime=Sun Dec 20 09:01:00 CST 2015, time=2015-12-20, status=1, ipAttribution=)]
2016-01-13 Lynee劲飞扬

收藏

126 0
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2015-12-26 hixiaoluo

值得看，好好收藏

119 0
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2015-12-21 zhang92560

#ESMO#

34 0
[GetPortalCommentsPageByObjectIdResponse(id=1780066, encodeId=356e1e80066bb, content=<a href='/topic/show?id=10d62860dd' target=_blank style='color:#2F92EE;'>#ASIA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2860, encryptionId=10d62860dd, topicName=ASIA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, createdName=luwei00, createdTime=Wed Apr 13 23:09:00 CST 2016, time=2016-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982500, encodeId=9d8c1982500ff, content=<a href='/topic/show?id=da628e19d5' target=_blank style='color:#2F92EE;'>#HER2-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8719, encryptionId=da628e19d5, topicName=HER2-)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, createdName=luwei00, createdTime=Sat Nov 05 18:09:00 CST 2016, time=2016-11-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=75477, encodeId=dafce54774f, content=马上就用, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0fac1708265, createdName=1de98bedm33(暂无匿称), createdTime=Mon Apr 04 22:02:00 CST 2016, time=2016-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2024756, encodeId=f4112024e56a0, content=<a href='/topic/show?id=c27516459de' target=_blank style='color:#2F92EE;'>#SMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16459, encryptionId=c27516459de, topicName=SMO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6779163, createdName=liuhuangbo, createdTime=Thu Nov 10 19:09:00 CST 2016, time=2016-11-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=56977, encodeId=3d89569e718, content=收藏, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160113/IMG569619FEB03536446.jpg, createdBy=85f81678980, createdName=Lynee劲飞扬, createdTime=Wed Jan 13 17:34:00 CST 2016, time=2016-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=48226, encodeId=ae9748226e3, content=值得看，好好收藏, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bc301610909, createdName=hixiaoluo, createdTime=Sat Dec 26 16:01:00 CST 2015, time=2015-12-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1280903, encodeId=9ebb128090369, content=<a href='/topic/show?id=50d6e0215a' target=_blank style='color:#2F92EE;'>#ESMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7021, encryptionId=50d6e0215a, topicName=ESMO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7460166, createdName=zhang92560, createdTime=Mon Dec 21 02:09:00 CST 2015, time=2015-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372312, encodeId=60ee13e2312f8, content=<a href='/topic/show?id=48cd1369065' target=_blank style='color:#2F92EE;'>#palbociclib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13690, encryptionId=48cd1369065, topicName=palbociclib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=96d4340, createdName=ysjykql, createdTime=Mon Dec 21 02:09:00 CST 2015, time=2015-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=46806, encodeId=04b34680629, content=赞～, beContent=null, objectType=article, channel=null, level=null, likeNumber=112, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec6488436, createdName=a191008346, createdTime=Sun Dec 20 09:01:00 CST 2015, time=2015-12-20, status=1, ipAttribution=)]
2015-12-21 ysjykql

#palbociclib#

26 0
[GetPortalCommentsPageByObjectIdResponse(id=1780066, encodeId=356e1e80066bb, content=<a href='/topic/show?id=10d62860dd' target=_blank style='color:#2F92EE;'>#ASIA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2860, encryptionId=10d62860dd, topicName=ASIA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, createdName=luwei00, createdTime=Wed Apr 13 23:09:00 CST 2016, time=2016-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982500, encodeId=9d8c1982500ff, content=<a href='/topic/show?id=da628e19d5' target=_blank style='color:#2F92EE;'>#HER2-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8719, encryptionId=da628e19d5, topicName=HER2-)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, createdName=luwei00, createdTime=Sat Nov 05 18:09:00 CST 2016, time=2016-11-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=75477, encodeId=dafce54774f, content=马上就用, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0fac1708265, createdName=1de98bedm33(暂无匿称), createdTime=Mon Apr 04 22:02:00 CST 2016, time=2016-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2024756, encodeId=f4112024e56a0, content=<a href='/topic/show?id=c27516459de' target=_blank style='color:#2F92EE;'>#SMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16459, encryptionId=c27516459de, topicName=SMO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6779163, createdName=liuhuangbo, createdTime=Thu Nov 10 19:09:00 CST 2016, time=2016-11-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=56977, encodeId=3d89569e718, content=收藏, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160113/IMG569619FEB03536446.jpg, createdBy=85f81678980, createdName=Lynee劲飞扬, createdTime=Wed Jan 13 17:34:00 CST 2016, time=2016-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=48226, encodeId=ae9748226e3, content=值得看，好好收藏, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bc301610909, createdName=hixiaoluo, createdTime=Sat Dec 26 16:01:00 CST 2015, time=2015-12-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1280903, encodeId=9ebb128090369, content=<a href='/topic/show?id=50d6e0215a' target=_blank style='color:#2F92EE;'>#ESMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7021, encryptionId=50d6e0215a, topicName=ESMO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7460166, createdName=zhang92560, createdTime=Mon Dec 21 02:09:00 CST 2015, time=2015-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372312, encodeId=60ee13e2312f8, content=<a href='/topic/show?id=48cd1369065' target=_blank style='color:#2F92EE;'>#palbociclib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13690, encryptionId=48cd1369065, topicName=palbociclib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=96d4340, createdName=ysjykql, createdTime=Mon Dec 21 02:09:00 CST 2015, time=2015-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=46806, encodeId=04b34680629, content=赞～, beContent=null, objectType=article, channel=null, level=null, likeNumber=112, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec6488436, createdName=a191008346, createdTime=Sun Dec 20 09:01:00 CST 2015, time=2015-12-20, status=1, ipAttribution=)]
2015-12-20 a191008346

赞～

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