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Oncologist:乳腺癌CDK4/6抑制剂治疗的潜在副作用都有啥?

2017-07-22 王强 肿瘤资讯

细胞周期蛋白依赖性激酶抑制剂的出现已大大改变了激素受体阳性转移性乳腺癌的治疗现状。目前已有多种相关药物,FDA也已批准某些药物可联合内分泌治疗。本文即对相关药物潜在治疗副作用及药物相关作用、及其临床处理进行概述。

细胞周期蛋白依赖性激酶抑制剂的出现已大大改变了激素受体阳性转移性乳腺癌的治疗现状。目前已有多种相关药物,FDA也已批准某些药物可联合内分泌治疗。本文即对相关药物潜在治疗副作用及药物相关作用、及其临床处理进行概述。

细胞周期蛋白依赖性激酶(cyclin-dependent kinase,CDK)抑制剂的出现已大大改变了激素受体阳性转移性乳腺癌的治疗现状。随着研究的深入,目前已发展为具有高度选择性、可逆性的CDK抑制剂以提高疗效、并降低副作用。Palbociclib、ribociclib、abemaciclib均为CDK4及CDK6的高度选择性、可逆性抑制剂。美国FDA已批准palbociclib与内分泌治疗联合,用于激素受体阳性转移性乳腺癌的一线及二线治疗;也已批准ribociclib用于一线治疗。Abemaciclib则取得了FDA的突破性药物资格(Breakthrough Therapy designation,BTD)。哈佛大学医学院Spring、Zangardi等人就乳腺癌CDK4/6抑制剂治疗潜在副作用及药物相互作用、及其临床处理等问题撰写了相关文章,介绍了一些实际应用中的考虑并提出了建议,文章于2017年7月在线发表在《The Oncologist》杂志上。

Palbocuclib、ribociclib潜在的药物相互作用

表1.palbocuclib、ribociclib潜在的药物相互作用
CYP:细胞色素P450

CDK4/6抑制剂副作用概述

药物相关研究中,palbociclib加来曲唑时最常见副作用为中性粒细胞减少、白细胞减少、疲倦;palbociclib加氟维司群时最常见的副作用为中性粒细胞减少、白细胞减少、疲倦、恶心。Ribociclib也常见造血系统副作用,常见不同程度的中性粒细胞减少、恶心、感染、疲倦、腹泻等。非造血系统副作用多为1或2级,最常见的3、4级副作用则为中性粒细胞减少、白细胞减少、高血压、谷丙转氨酶升高。Abemaciclib结构上不同于palbociclib及ribociclib,其造血系统副作用似乎少见一些,但疲倦及胃肠道副作用更加显着。Abemaciclib相关研究中最常见的副作用有肌酐升高、腹泻、中性粒细胞减少、疲倦。

Palbocilib及Ribociclib的造血系统副作用与处理

CDK4/6抑制剂所致的中性粒细胞减少不同于细胞毒性药物所致,不管骨髓中中性粒细胞前体的抑制程度如何,均可快速恢复。尽管中性粒细胞减少常见,但粒细胞减少性发热却极少。3级及以上中性粒细胞减少持续时间的中位数约7天。中性粒细胞减少的情况与用药次数有关,一般在下一周期就会减少,这表明并无这方面的蓄积毒性,且如有必要可早期减量。

应用CDK4/6抑制剂的患者均需进行全血细胞计数(complete blood count,CBC)。详见下表。

表2.不同情况下的CBC方案

Palbocilib及Ribociclib的胃肠道副作用与处理

应用palbocilib及ribociclib时可出现恶心、腹泻,但出现3、4级胃肠道副作用的几率较低;二者虽然均有呕吐可能,但无需常规预防性应用止吐药。出现恶心、呕吐可以常规应用止吐药,但应注意ribociclib与止吐药同时应用有导致QT间期延长的风险。无感染症状的情况下,可通过非药物性方法(补液、饮食调节、避免其他刺激性物质)或药物干预(止泻剂)来控制腹泻。较严重的腹泻也可考虑预防性治疗。

其他副作用及一般处理

对于非造血系统的1、2级副作用来说,只要不是持续性、或导致患者其他问题,可以无需停药或调整剂量。经治疗后仍持续存在的3、4级副作用,则可以考虑暂停palbociclib及ribociclin,直至症状缓解、或副作用恢复至1级及以下、或恢复至2级但无危险时。然后以降低一个水平的剂量开始重新应用palbociclib或ribociclin。

Palbociclib的其他副作用大多为1-2级,常见的有疲倦(多为轻度)、脱发;栓塞(如肺栓塞、深静脉血栓)罕有报道,但需要预防。Palbociclib还可导致胚胎毒性,因此建议避孕。

Ribociclib则可有疲倦、转氨酶升高、QTc延长等副作用,且该药导致的QT间期延长与浓度有关。用药前、第14天时、第二周期用药前、有临床迹象时均应进行心电图检查,并避免与可导致QT间期延长的药物合用、注意电解质异常,用药前、第六个周期用药之前、有临床迹象时应检测血清电解质。

Ribociclib肝脏毒性表现为转氨酶升高,因此应在用药前、前两个周期中每两周、每四个周期、有临床迹象时检查肝功能。如有2级及以上的异常则建议更频繁的检查。Ribociclib也可导致胚胎毒性,因此建议避孕。

患者用药期间建议避免手术。应用palbociclib者如需手术,建议术前停药7天、术后最长可等待3周再开始用药,具体取决于伤口愈合及恢复情况。停用palbociclin等待手术期间,应继续内分泌治疗。Ribociclib与手术之间无特殊建议,但本文作者建议与palbociclib相同处理。

表3.Ribociclib出现肝脏毒性时的剂量调整及处理

药物剂量调整

Palbociclib及ribociclib的调整方案见表2,剂量一旦降低,一般不可再次加量。老年人、轻度肝损伤、轻至中度肾损害时无特殊剂量调整建议。

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    2017-12-20 minlingfeng
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    2018-05-24 soongzhihua
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createdName=大爰, createdTime=Mon Jul 24 07:55:49 CST 2017, time=2017-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=225628, encodeId=9112225628a0, content=学习谢谢分享, 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/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Mon Jul 24 06:48:45 CST 2017, time=2017-07-24, status=1, ipAttribution=)]
    2018-01-13 jklm09
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createdName=大爰, createdTime=Mon Jul 24 07:55:49 CST 2017, time=2017-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=225628, encodeId=9112225628a0, content=学习谢谢分享, 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/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Mon Jul 24 06:48:45 CST 2017, time=2017-07-24, status=1, ipAttribution=)]
    2017-08-20 随梦飞扬

    全血细胞计数(completebloodcount,CBC)

    0

  6. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490679, encodeId=859d14906e9d6, content=<a href='/topic/show?id=2765440372' target=_blank style='color:#2F92EE;'>#CDK4/6#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4403, encryptionId=2765440372, topicName=CDK4/6)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c7068807080, createdName=zhangj7111, createdTime=Mon Jul 24 12:15:00 CST 2017, time=2017-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=225676, encodeId=9e852256e6d7, content=学习并分享!!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Mon Jul 24 07:55:49 CST 2017, time=2017-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=225628, encodeId=9112225628a0, content=学习谢谢分享, 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/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Mon Jul 24 06:48:45 CST 2017, time=2017-07-24, status=1, ipAttribution=)]
    2017-07-24 zhouqu_8
  7. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490679, encodeId=859d14906e9d6, content=<a href='/topic/show?id=2765440372' target=_blank style='color:#2F92EE;'>#CDK4/6#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4403, encryptionId=2765440372, topicName=CDK4/6)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c7068807080, createdName=zhangj7111, createdTime=Mon Jul 24 12:15:00 CST 2017, time=2017-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=225676, encodeId=9e852256e6d7, content=学习并分享!!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Mon Jul 24 07:55:49 CST 2017, time=2017-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=225628, encodeId=9112225628a0, content=学习谢谢分享, 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/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Mon Jul 24 06:48:45 CST 2017, time=2017-07-24, status=1, ipAttribution=)]
    2017-07-24 july_977
  8. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490679, encodeId=859d14906e9d6, content=<a href='/topic/show?id=2765440372' target=_blank style='color:#2F92EE;'>#CDK4/6#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4403, encryptionId=2765440372, topicName=CDK4/6)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c7068807080, createdName=zhangj7111, createdTime=Mon Jul 24 12:15:00 CST 2017, time=2017-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=225676, encodeId=9e852256e6d7, content=学习并分享!!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Mon Jul 24 07:55:49 CST 2017, time=2017-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=225628, encodeId=9112225628a0, content=学习谢谢分享, 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/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Mon Jul 24 06:48:45 CST 2017, time=2017-07-24, status=1, ipAttribution=)]
    2017-07-24 zhangj7111
  9. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490679, encodeId=859d14906e9d6, content=<a href='/topic/show?id=2765440372' target=_blank style='color:#2F92EE;'>#CDK4/6#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4403, encryptionId=2765440372, topicName=CDK4/6)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c7068807080, createdName=zhangj7111, createdTime=Mon Jul 24 12:15:00 CST 2017, time=2017-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=225676, encodeId=9e852256e6d7, content=学习并分享!!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Mon Jul 24 07:55:49 CST 2017, time=2017-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=225628, encodeId=9112225628a0, content=学习谢谢分享, 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/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Mon Jul 24 06:48:45 CST 2017, time=2017-07-24, status=1, ipAttribution=)]
    2017-07-24 大爰

    学习并分享!!!

    0

  10. 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createdBy=166330479856, createdName=soongzhihua, createdTime=Thu May 24 23:15:00 CST 2018, time=2018-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1851494, encodeId=3e9c1851494bd, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Sat Jan 13 10:15:00 CST 2018, time=2018-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1824248, encodeId=21ed18242488a, content=<a href='/topic/show?id=56a932e7800' target=_blank style='color:#2F92EE;'>#副作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32778, encryptionId=56a932e7800, topicName=副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Sat Sep 02 16:15:00 CST 2017, time=2017-09-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=235488, encodeId=464523548887, content=全血细胞计数(completebloodcount,CBC), beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/02/7354b3539aae6a0ccb1e0fff04c12084.jpg, createdBy=205b1984786, createdName=随梦飞扬, createdTime=Sun Aug 20 22:45:35 CST 2017, time=2017-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1435497, encodeId=945d143549e01, content=<a href='/topic/show?id=09dc439915' target=_blank style='color:#2F92EE;'>#CDK#</a>, beContent=null, objectType=article, channel=null, 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490679, encodeId=859d14906e9d6, content=<a href='/topic/show?id=2765440372' target=_blank style='color:#2F92EE;'>#CDK4/6#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4403, encryptionId=2765440372, topicName=CDK4/6)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c7068807080, createdName=zhangj7111, createdTime=Mon Jul 24 12:15:00 CST 2017, time=2017-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=225676, encodeId=9e852256e6d7, content=学习并分享!!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Mon Jul 24 07:55:49 CST 2017, time=2017-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=225628, encodeId=9112225628a0, content=学习谢谢分享, 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/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Mon Jul 24 06:48:45 CST 2017, time=2017-07-24, status=1, ipAttribution=)]
    2017-07-24 龙胆草

    学习谢谢分享

    0

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