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NEJM：Ivosidenib治疗IDH1突变型AML疗效喜人

2018-06-04 zhangfan MedSci原创

IvosidenibIDH1AML
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研究认为，对于存在异柠檬酸脱氢酶1突变的急性髓细胞样白血病患者，Ivosidenib治疗可有效缓解病情，部分患者可实现持久的病理学缓解

统计发现临床中6-10%的急性髓细胞样白血病(AML)患者存在异柠檬酸脱氢酶1(IDH1)突变，Ivosidenib是一种口服、靶向小分子突变IDH1抑制剂。近日研究人员开展I期临床研究，考察Ivosidenib单药治疗AML的疗效及安全性。

本次研究为剂量递增与扩张研究，参与人群接受安全性及疗效评估，主要终点为复发或难治性AML患者接受500mg每日 ivosidenib治疗后的疗效，随访6个月。

总计179名患者参与研究，Ivosidenib治疗后的3级以上不良事件包括：QT间期延长（7.8%）、IDH分化综合征（3.9%）、贫血（2.2%）、血小板减少或血小板计数减少（3.4%）以及白细胞增多（1.7%）。125人参与疗效评估，完全缓解以及完全缓解伴部分血液学缓解率为30.4%、完全缓解率为21.6%、总响应率为41.6%，上述患者的平均响应时间分别为8.2个月、9.3个月以及6.5个月。35%的患者无需输血，治疗响应患者感染及发热性中性粒细胞减少症的发生率降低。34名完全及部分血液学缓解患者中，7人(21%)数字聚合酶链反应分析无IDH 1突变残留。研究过程中，未发现单基因突变导致的治疗抗性。

研究认为，对于存在异柠檬酸脱氢酶1突变的急性髓细胞样白血病患者，Ivosidenib治疗可有效缓解病情，部分患者可实现持久的病理学缓解。

原始出处：

Courtney D. DiNardo et al. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. June 2， 2018.

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1928027, encodeId=d8c0192802e8a, content=<a href='/topic/show?id=9fba1014332' target=_blank style='color:#2F92EE;'>#Ivosidenib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10143, encryptionId=9fba1014332, topicName=Ivosidenib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=xugumin, createdTime=Sat Jan 12 11:46:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1715483, encodeId=9ea31e1548372, content=<a href='/topic/show?id=4942941e83' target=_blank style='color:#2F92EE;'>#IDH1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9417, encryptionId=4942941e83, topicName=IDH1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=be6531934024, createdName=ms6127405442416114, createdTime=Sat Oct 06 09:46:00 CST 2018, time=2018-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2041374, encodeId=db8c20413e40f, content=<a href='/topic/show?id=baade55002a' target=_blank style='color:#2F92EE;'>#突变型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75500, encryptionId=baade55002a, topicName=突变型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Thu Jun 21 00:46:00 CST 2018, time=2018-06-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379405, encodeId=028513e9405f7, content=<a href='/topic/show?id=86379420cd' target=_blank style='color:#2F92EE;'>#IDH1突变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9420, encryptionId=86379420cd, topicName=IDH1突变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c192448, createdName=diushouji, createdTime=Wed Jun 06 04:46:00 CST 2018, time=2018-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1031790, encodeId=17e81031e901e, 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=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon Jun 04 16:46:00 CST 2018, time=2018-06-04, status=1, ipAttribution=)]
    2019-01-12 xugumin

    #Ivosidenib#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1928027, encodeId=d8c0192802e8a, content=<a href='/topic/show?id=9fba1014332' target=_blank style='color:#2F92EE;'>#Ivosidenib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10143, encryptionId=9fba1014332, topicName=Ivosidenib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=xugumin, createdTime=Sat Jan 12 11:46:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1715483, encodeId=9ea31e1548372, content=<a href='/topic/show?id=4942941e83' target=_blank style='color:#2F92EE;'>#IDH1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9417, encryptionId=4942941e83, topicName=IDH1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=be6531934024, createdName=ms6127405442416114, createdTime=Sat Oct 06 09:46:00 CST 2018, time=2018-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2041374, encodeId=db8c20413e40f, content=<a href='/topic/show?id=baade55002a' target=_blank style='color:#2F92EE;'>#突变型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75500, encryptionId=baade55002a, topicName=突变型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Thu Jun 21 00:46:00 CST 2018, time=2018-06-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379405, encodeId=028513e9405f7, content=<a href='/topic/show?id=86379420cd' target=_blank style='color:#2F92EE;'>#IDH1突变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9420, encryptionId=86379420cd, topicName=IDH1突变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c192448, createdName=diushouji, createdTime=Wed Jun 06 04:46:00 CST 2018, time=2018-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1031790, encodeId=17e81031e901e, 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=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon Jun 04 16:46:00 CST 2018, time=2018-06-04, status=1, ipAttribution=)]
    2018-10-06 ms6127405442416114

    #IDH1#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1928027, encodeId=d8c0192802e8a, content=<a href='/topic/show?id=9fba1014332' target=_blank style='color:#2F92EE;'>#Ivosidenib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10143, encryptionId=9fba1014332, topicName=Ivosidenib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=xugumin, createdTime=Sat Jan 12 11:46:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1715483, encodeId=9ea31e1548372, content=<a href='/topic/show?id=4942941e83' target=_blank style='color:#2F92EE;'>#IDH1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9417, encryptionId=4942941e83, topicName=IDH1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=be6531934024, createdName=ms6127405442416114, createdTime=Sat Oct 06 09:46:00 CST 2018, time=2018-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2041374, encodeId=db8c20413e40f, content=<a href='/topic/show?id=baade55002a' target=_blank style='color:#2F92EE;'>#突变型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75500, encryptionId=baade55002a, topicName=突变型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Thu Jun 21 00:46:00 CST 2018, time=2018-06-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379405, encodeId=028513e9405f7, content=<a href='/topic/show?id=86379420cd' target=_blank style='color:#2F92EE;'>#IDH1突变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9420, encryptionId=86379420cd, topicName=IDH1突变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c192448, createdName=diushouji, createdTime=Wed Jun 06 04:46:00 CST 2018, time=2018-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1031790, encodeId=17e81031e901e, 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=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon Jun 04 16:46:00 CST 2018, time=2018-06-04, status=1, ipAttribution=)]
    2018-06-21 heli0118

    #突变型#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1928027, encodeId=d8c0192802e8a, content=<a href='/topic/show?id=9fba1014332' target=_blank style='color:#2F92EE;'>#Ivosidenib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10143, encryptionId=9fba1014332, topicName=Ivosidenib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=xugumin, createdTime=Sat Jan 12 11:46:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1715483, encodeId=9ea31e1548372, content=<a href='/topic/show?id=4942941e83' target=_blank style='color:#2F92EE;'>#IDH1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9417, encryptionId=4942941e83, topicName=IDH1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=be6531934024, createdName=ms6127405442416114, createdTime=Sat Oct 06 09:46:00 CST 2018, time=2018-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2041374, encodeId=db8c20413e40f, content=<a href='/topic/show?id=baade55002a' target=_blank style='color:#2F92EE;'>#突变型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75500, encryptionId=baade55002a, topicName=突变型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Thu Jun 21 00:46:00 CST 2018, time=2018-06-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379405, encodeId=028513e9405f7, content=<a href='/topic/show?id=86379420cd' target=_blank style='color:#2F92EE;'>#IDH1突变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9420, encryptionId=86379420cd, topicName=IDH1突变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c192448, createdName=diushouji, createdTime=Wed Jun 06 04:46:00 CST 2018, time=2018-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1031790, encodeId=17e81031e901e, 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=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon Jun 04 16:46:00 CST 2018, time=2018-06-04, status=1, ipAttribution=)]
    2018-06-06 diushouji

    #IDH1突变#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1928027, encodeId=d8c0192802e8a, content=<a href='/topic/show?id=9fba1014332' target=_blank style='color:#2F92EE;'>#Ivosidenib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10143, encryptionId=9fba1014332, topicName=Ivosidenib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=xugumin, createdTime=Sat Jan 12 11:46:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1715483, encodeId=9ea31e1548372, content=<a href='/topic/show?id=4942941e83' target=_blank style='color:#2F92EE;'>#IDH1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9417, encryptionId=4942941e83, topicName=IDH1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=be6531934024, createdName=ms6127405442416114, createdTime=Sat Oct 06 09:46:00 CST 2018, time=2018-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2041374, encodeId=db8c20413e40f, content=<a href='/topic/show?id=baade55002a' target=_blank style='color:#2F92EE;'>#突变型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75500, encryptionId=baade55002a, topicName=突变型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Thu Jun 21 00:46:00 CST 2018, time=2018-06-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379405, encodeId=028513e9405f7, content=<a href='/topic/show?id=86379420cd' target=_blank style='color:#2F92EE;'>#IDH1突变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9420, encryptionId=86379420cd, topicName=IDH1突变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c192448, createdName=diushouji, createdTime=Wed Jun 06 04:46:00 CST 2018, time=2018-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1031790, encodeId=17e81031e901e, 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=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon Jun 04 16:46:00 CST 2018, time=2018-06-04, status=1, ipAttribution=)]
    2018-06-04 内科新手

    谢谢梅斯提供这么好的信息，学到很多

    0