Blood:Umbralisib用于BTK或PI3Kδ抑制剂不耐受的CLL患者的疗效和耐受性

2020-12-04 MedSci原创 MedSci原创

不耐受是慢性淋巴细胞性白血病(CLL)患者停用激酶抑制剂(Ki)的最常见原因。

不耐受是慢性淋巴细胞性白血病(CLL)患者停用激酶抑制剂(Ki)的最常见原因。

Umbralisib是一种新型的、高选择性PI3Kδ/CK1ε抑制剂,在慢性淋巴细胞白血病患者中具有治疗活性和良好的耐受性。

该项2期试验旨在评估umbralisib用于既往对BTK或PI3K抑制剂治疗不耐受的CLL患者的疗效和耐受性。受试患者每天口服umbralisib 800mg,直到病情进展或出现毒性。主要终点是无进展生存期(PFS)。次要终点包括治疗失败的时间和umbralisib的安全性。通过口腔拭子采集DNA进行CYP3A4、CYP3A5和CYP2D6基因分型。

共招募了51位患者(44位BTKi和7位PI3KδIi不耐受)。中位年龄为70岁(范48~96岁),既往治疗次数中位值为2次(1~7次),24%的患者携带del17p和/或TP53突变,65%为IGHV未突变。

中位无进展生存期(PFS)为23.5个月(95% CI 13.1-未达到)。58%的患者接受umbralisib治疗的时间比既往KI治疗的更长。

最常见的不良反应是皮疹(27%)、关节痛(18%)和心房颤动(16%)。最常见(≥5%)的≥3级不良反应是中性粒细胞减少症(18%)、白细胞增多症(14%)、血小板减少症(12%)、肺炎(12%)和腹泻(8%)。6位患者(12%)因不良反应而停用umbralisib。8位患者(16%)减少了剂量。

Umbralisib可安全有效的治疗BTK和PI3K抑制剂交替耐受的CLL患者,而且可获得持久的缓解,耐受性良好。这是首次证实从BTK或PI3K抑制剂换成umbralisib的前瞻性数据。

原始出处:

Mato Anthony R,Ghosh Nilanjan,Schuster Stephen J et al. Phase 2 Study of the Safety and Efficacy of Umbralisib in Patients with CLL Who Are Intolerant to BTK or PI3Kδ Inhibitor Therapy. Blood, 2020. DOI:10.1182/blood.2020007376

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    2021-06-29 mhm289
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    2021-03-25 jklm09
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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=904890, encodeId=cbf090489093, content=很不错 , beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8baa5441414, createdName=邹大海, createdTime=Fri Dec 04 16:19:06 CST 2020, time=2020-12-04, status=1, ipAttribution=)]
  5. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=904890, encodeId=cbf090489093, content=很不错 , beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8baa5441414, createdName=邹大海, createdTime=Fri Dec 04 16:19:06 CST 2020, time=2020-12-04, status=1, ipAttribution=)]
  6. 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time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1482887, encodeId=271a148288e15, content=<a href='/topic/show?id=657718128fe' target=_blank style='color:#2F92EE;'>#Umbralisib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18128, encryptionId=657718128fe, topicName=Umbralisib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=13e67850736, createdName=ms705947299214030, createdTime=Sun Dec 06 06:54:22 CST 2020, time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1539125, encodeId=47f015391254f, content=<a href='/topic/show?id=6bce3e7106' target=_blank style='color:#2F92EE;'>#BTK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3771, encryptionId=6bce3e7106, topicName=BTK)], attachment=null, 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=904890, encodeId=cbf090489093, content=很不错 , beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8baa5441414, createdName=邹大海, createdTime=Fri Dec 04 16:19:06 CST 2020, time=2020-12-04, status=1, ipAttribution=)]
  7. 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time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1482887, encodeId=271a148288e15, content=<a href='/topic/show?id=657718128fe' target=_blank style='color:#2F92EE;'>#Umbralisib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18128, encryptionId=657718128fe, topicName=Umbralisib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=13e67850736, createdName=ms705947299214030, createdTime=Sun Dec 06 06:54:22 CST 2020, time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1539125, encodeId=47f015391254f, content=<a href='/topic/show?id=6bce3e7106' target=_blank style='color:#2F92EE;'>#BTK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3771, encryptionId=6bce3e7106, topicName=BTK)], attachment=null, 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=904890, encodeId=cbf090489093, content=很不错 , beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8baa5441414, createdName=邹大海, createdTime=Fri Dec 04 16:19:06 CST 2020, time=2020-12-04, status=1, ipAttribution=)]
    2020-12-06 fengting7
  8. [GetPortalCommentsPageByObjectIdResponse(id=2086535, encodeId=abbe20865354c, content=<a href='/topic/show?id=2b1f1424ef3' target=_blank style='color:#2F92EE;'>#PI3Kδ#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14247, encryptionId=2b1f1424ef3, topicName=PI3Kδ)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=af60254, createdName=mhm289, createdTime=Tue Jun 29 15:54:22 CST 2021, time=2021-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1947220, encodeId=4f8f194e22080, content=<a href='/topic/show?id=78af204639e' target=_blank style='color:#2F92EE;'>#不耐受#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20463, encryptionId=78af204639e, topicName=不耐受)], attachment=null, authenticateStatus=null, 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beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14231, encryptionId=ecfa1423117, topicName=PI3K)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/BF4BC9769C2FF12AC93CAA0069C0696C/100, createdBy=7bb22500091, createdName=ms1292405679162969, createdTime=Sun Dec 06 06:54:22 CST 2020, time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1417728, encodeId=e279141e728fe, content=<a href='/topic/show?id=aada80351ae' target=_blank style='color:#2F92EE;'>#耐受性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80351, encryptionId=aada80351ae, topicName=耐受性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=43843300457, createdName=Smile2681, createdTime=Sun Dec 06 06:54:22 CST 2020, time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1482887, encodeId=271a148288e15, content=<a href='/topic/show?id=657718128fe' target=_blank style='color:#2F92EE;'>#Umbralisib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18128, encryptionId=657718128fe, topicName=Umbralisib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=13e67850736, createdName=ms705947299214030, createdTime=Sun Dec 06 06:54:22 CST 2020, time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1539125, encodeId=47f015391254f, content=<a href='/topic/show?id=6bce3e7106' target=_blank style='color:#2F92EE;'>#BTK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3771, encryptionId=6bce3e7106, topicName=BTK)], attachment=null, 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=904890, encodeId=cbf090489093, content=很不错 , beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8baa5441414, createdName=邹大海, createdTime=Fri Dec 04 16:19:06 CST 2020, time=2020-12-04, status=1, ipAttribution=)]
    2020-12-04 挖挖机

    学习了

    0

  9. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14231, encryptionId=ecfa1423117, topicName=PI3K)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/BF4BC9769C2FF12AC93CAA0069C0696C/100, createdBy=7bb22500091, createdName=ms1292405679162969, createdTime=Sun Dec 06 06:54:22 CST 2020, time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1417728, encodeId=e279141e728fe, content=<a href='/topic/show?id=aada80351ae' target=_blank style='color:#2F92EE;'>#耐受性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80351, encryptionId=aada80351ae, topicName=耐受性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=43843300457, createdName=Smile2681, createdTime=Sun Dec 06 06:54:22 CST 2020, time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1482887, encodeId=271a148288e15, content=<a href='/topic/show?id=657718128fe' target=_blank style='color:#2F92EE;'>#Umbralisib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18128, encryptionId=657718128fe, topicName=Umbralisib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=13e67850736, createdName=ms705947299214030, createdTime=Sun Dec 06 06:54:22 CST 2020, time=2020-12-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1539125, encodeId=47f015391254f, content=<a href='/topic/show?id=6bce3e7106' target=_blank style='color:#2F92EE;'>#BTK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3771, encryptionId=6bce3e7106, topicName=BTK)], attachment=null, 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=904890, encodeId=cbf090489093, content=很不错 , beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8baa5441414, createdName=邹大海, createdTime=Fri Dec 04 16:19:06 CST 2020, time=2020-12-04, status=1, ipAttribution=)]
    2020-12-04 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

  10. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=904890, encodeId=cbf090489093, content=很不错 , beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8baa5441414, createdName=邹大海, createdTime=Fri Dec 04 16:19:06 CST 2020, time=2020-12-04, status=1, ipAttribution=)]
    2020-12-04 邹大海

    很不错

    0

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