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JCO:伊沙佐米+达雷木单抗+地塞米松用于多发性骨髓瘤体弱患者的疗效和安全性

2021-05-10 Nebula MedSci原创

新确诊多发性骨髓瘤的体弱患者的预后往往较差,主要是因为这类患者常不能耐受治疗的副作用而导致治疗高中断率

新确诊多发性骨髓瘤的体弱患者的预后往往较差,主要是因为这类患者常不能耐受治疗的副作用而导致治疗高中断率

这是一项II期临床试验,专为体弱患者设计的,旨在评估伊沙佐米+达雷木单抗+低剂量地塞米松(Ixa-Dara-dex)用于多发性骨髓瘤体弱患者的疗效和耐受性。

招募了65位符合国际骨髓瘤工作组体弱指数定义的多发性骨髓瘤体弱患者,予以9个诱导疗程(Ixa-Dara-dex),然后再用Ixa-Dara维持治疗至少2年。

存活预后

在诱导治疗过程中,总缓解率达到了78%。中位随访22.9年后,中位无进展生存期(PFS)位13.8个月,12个月总存活率(OS)为78%

仅基于年龄>80岁定义的体弱患者的中位PFS和12个月OS分别为21.6个月和92%,基于其他体弱参数的80岁及以下的患者的中位PFS和12个月OS分别为13.8个月和78%,基于其他体弱参数的>80岁的体弱患者的中位PFS和12个月OS分别为10.1个月和70%。

不良事件

在51%的患者中,诱导化疗需提前终止,其中6%的患者是因为不遵守研究治疗规定,9%的患者是因为死亡(8%的是在2个月内,其中80%的是死于毒副作用)。

生活质量的变化

在诱导治疗期间,患者的生活治疗有所提高,在三个诱导治疗疗程后,已具有显著的临床意义。

总而言之,Ixa-Dara-dex方案给该研究患者人群带来了较高的缓解率,且提高了其生活质量。但是,因毒副作用和早期死亡率导致的治疗中断,明显不利于患者的PFS和OS,仍是体弱患者亟待解决的一个重要问题。

原始出处:

Claudia A. M. Stege, et al. Ixazomib, Daratumumab, and Low-Dose Dexamethasone in Frail Patients With Newly Diagnosed Multiple Myeloma: The Hovon 143 Study. Journal of Clinical Oncology. May 4, 2021. https://doi.org/10.1200/JCO.20.03143

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    2021-12-13 jml2009
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    2021-11-14 lidong40
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createdBy=a1ce9392241, createdName=xuyu, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1526054, encodeId=bafc15260544d, content=<a href='/topic/show?id=3ec02566625' target=_blank style='color:#2F92EE;'>#伊沙佐米#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25666, encryptionId=3ec02566625, topicName=伊沙佐米)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2b311689214, createdName=vividelife, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032908, encodeId=a2511032908ef, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon May 10 20:53:18 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964366, encodeId=163d96436661, content=太棒了,学到了, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210510/68d4869916714ecab29e1a7d24265d42/111e6f0fded24dc3a71fb4fbb00b5bfa.jpg, createdBy=977e5497292, createdName=骨汤, createdTime=Mon May 10 20:35:21 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964357, encodeId=20e196435ea2, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Mon May 10 19:49:26 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
    2021-05-13 smart Ren

    好文章

    0

  5. 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createdBy=b3545492917, createdName=smart Ren, createdTime=Thu May 13 22:46:19 CST 2021, time=2021-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=965270, encodeId=ac599652e071, content=新药,新希望👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=86a75470976, createdName=ms4000000681655625, createdTime=Thu May 13 17:57:23 CST 2021, time=2021-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1499935, encodeId=7758149993564, content=<a href='/topic/show?id=9eb09396903' target=_blank style='color:#2F92EE;'>#达雷木单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93969, encryptionId=9eb09396903, topicName=达雷木单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ce9392241, createdName=xuyu, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1526054, encodeId=bafc15260544d, content=<a href='/topic/show?id=3ec02566625' target=_blank style='color:#2F92EE;'>#伊沙佐米#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25666, encryptionId=3ec02566625, topicName=伊沙佐米)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2b311689214, createdName=vividelife, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032908, encodeId=a2511032908ef, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon May 10 20:53:18 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964366, encodeId=163d96436661, content=太棒了,学到了, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210510/68d4869916714ecab29e1a7d24265d42/111e6f0fded24dc3a71fb4fbb00b5bfa.jpg, createdBy=977e5497292, createdName=骨汤, createdTime=Mon May 10 20:35:21 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964357, encodeId=20e196435ea2, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Mon May 10 19:49:26 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
    2021-05-13 ms4000000681655625

    新药,新希望👍

    0

  6. 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createdBy=b3545492917, createdName=smart Ren, createdTime=Thu May 13 22:46:19 CST 2021, time=2021-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=965270, encodeId=ac599652e071, content=新药,新希望👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=86a75470976, createdName=ms4000000681655625, createdTime=Thu May 13 17:57:23 CST 2021, time=2021-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1499935, encodeId=7758149993564, content=<a href='/topic/show?id=9eb09396903' target=_blank style='color:#2F92EE;'>#达雷木单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93969, encryptionId=9eb09396903, topicName=达雷木单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ce9392241, createdName=xuyu, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1526054, encodeId=bafc15260544d, content=<a href='/topic/show?id=3ec02566625' target=_blank style='color:#2F92EE;'>#伊沙佐米#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25666, encryptionId=3ec02566625, topicName=伊沙佐米)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2b311689214, createdName=vividelife, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032908, encodeId=a2511032908ef, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon May 10 20:53:18 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964366, encodeId=163d96436661, content=太棒了,学到了, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210510/68d4869916714ecab29e1a7d24265d42/111e6f0fded24dc3a71fb4fbb00b5bfa.jpg, createdBy=977e5497292, createdName=骨汤, createdTime=Mon May 10 20:35:21 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964357, encodeId=20e196435ea2, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Mon May 10 19:49:26 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
  7. 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createdBy=a1ce9392241, createdName=xuyu, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1526054, encodeId=bafc15260544d, content=<a href='/topic/show?id=3ec02566625' target=_blank style='color:#2F92EE;'>#伊沙佐米#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25666, encryptionId=3ec02566625, topicName=伊沙佐米)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2b311689214, createdName=vividelife, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032908, encodeId=a2511032908ef, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, 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createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Mon May 10 19:49:26 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
  8. 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createdBy=b3545492917, createdName=smart Ren, createdTime=Thu May 13 22:46:19 CST 2021, time=2021-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=965270, encodeId=ac599652e071, content=新药,新希望👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=86a75470976, createdName=ms4000000681655625, createdTime=Thu May 13 17:57:23 CST 2021, time=2021-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1499935, encodeId=7758149993564, content=<a href='/topic/show?id=9eb09396903' target=_blank style='color:#2F92EE;'>#达雷木单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93969, encryptionId=9eb09396903, topicName=达雷木单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ce9392241, createdName=xuyu, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1526054, encodeId=bafc15260544d, content=<a href='/topic/show?id=3ec02566625' target=_blank style='color:#2F92EE;'>#伊沙佐米#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25666, encryptionId=3ec02566625, topicName=伊沙佐米)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2b311689214, createdName=vividelife, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032908, encodeId=a2511032908ef, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon May 10 20:53:18 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964366, encodeId=163d96436661, content=太棒了,学到了, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210510/68d4869916714ecab29e1a7d24265d42/111e6f0fded24dc3a71fb4fbb00b5bfa.jpg, createdBy=977e5497292, createdName=骨汤, createdTime=Mon May 10 20:35:21 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964357, encodeId=20e196435ea2, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Mon May 10 19:49:26 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
    2021-05-10 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

  9. 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createdBy=a1ce9392241, createdName=xuyu, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1526054, encodeId=bafc15260544d, content=<a href='/topic/show?id=3ec02566625' target=_blank style='color:#2F92EE;'>#伊沙佐米#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25666, encryptionId=3ec02566625, topicName=伊沙佐米)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2b311689214, createdName=vividelife, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032908, encodeId=a2511032908ef, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon May 10 20:53:18 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964366, encodeId=163d96436661, content=太棒了,学到了, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210510/68d4869916714ecab29e1a7d24265d42/111e6f0fded24dc3a71fb4fbb00b5bfa.jpg, createdBy=977e5497292, createdName=骨汤, createdTime=Mon May 10 20:35:21 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964357, encodeId=20e196435ea2, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Mon May 10 19:49:26 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
    2021-05-10 骨汤

    太棒了,学到了

    0

  10. 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createdBy=a1ce9392241, createdName=xuyu, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1526054, encodeId=bafc15260544d, content=<a href='/topic/show?id=3ec02566625' target=_blank style='color:#2F92EE;'>#伊沙佐米#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25666, encryptionId=3ec02566625, topicName=伊沙佐米)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2b311689214, createdName=vividelife, createdTime=Wed May 12 08:53:18 CST 2021, time=2021-05-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032908, encodeId=a2511032908ef, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon May 10 20:53:18 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964366, encodeId=163d96436661, content=太棒了,学到了, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210510/68d4869916714ecab29e1a7d24265d42/111e6f0fded24dc3a71fb4fbb00b5bfa.jpg, createdBy=977e5497292, createdName=骨汤, createdTime=Mon May 10 20:35:21 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=964357, encodeId=20e196435ea2, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Mon May 10 19:49:26 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
    2021-05-10 jyzxjiangqin

    好文章!

    0

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