J Clin Oncol:Venetoclax+达雷木单抗+地塞米松±硼替佐米可有效治疗复发/难治性多发性骨髓瘤!

2021-08-15 Nebula MedSci原创

Venetoclax+达雷木单抗+地塞米松±硼替佐米可有效治疗复发/难治性多发性骨髓瘤

Venetoclax(维奈托克)是一种口服BCL-2抑制剂,对伴t(11;14)易位的复发或难治性多发性骨髓瘤(RRMM)患者具有单药活性。此外,可通过与硼替佐米、地塞米松和达雷木单抗等药物联合使用来增强维奈托克在RRMM中的疗效。

该1期研究(NCT03314181)评估了维奈托克联合达雷木单抗和地塞米松(VenDd)用于t(11;14)易位的RRMM患者,和VenDd+硼替佐米(VenDVd)用于细胞遗传学上未选择的RRMM患者的疗效。主要终点有明确扩展期研究的剂量、安全性和总缓解率。次要终点包括进一步分析安全性、无进展生存期、缓解持续时间、进展前的时间和最小残留病灶阴性。

缓解率和MRD阴性率

共招募了48位患者,VenDd组和VenDVd组各24位患者。VenDd组发生了一例剂量限制性毒性(3级发热性中性粒细胞减少,800 mg VenDd)。最常见不良反应有腹泻(VenDd 和VenDVd:63%和54%)和恶心(50%和50%);VenDd 和VenDVd组分别有88%和71%的患者发生了≥3级的不良反应

各组的PFS和OS

在VenDVd组中,在病情进展的情况下发生了一例急诊死亡(脓毒症);VenDd组和VenDVd组分别中位随访了20.9个月和20.4个月,均未发生其他感染相关死亡。VenDd组的总缓解率为96%(全是非常好或更好的部分缓解[≥VGPR]),VenDVd组的总缓解率为92%(79%≥VGPR)。VenDd组和VenDVd组的18个月无进展生存率分别是90.5%(95%CI 67.0-97.5)和66.7%(95%CI 42.5%-82.5%)。

综上,RRMM患者采用VenDd或VenDVd方案治疗,均可获得较深和较持久的高缓解率。该研究结果支持进一步评估维奈托克联合达雷木单抗治疗RRMM患者(特别是伴有t(11;14)易位)的效果。

原始出处:

Nizar J. Bahlis, et al. Phase I Study of Venetoclax Plus Daratumumab and Dexamethasone, With or Without Bortezomib, in Patients With Relapsed or Refractory Multiple Myeloma With and Without t(11;14). Journal of Clinical Oncology. August 13, 2021. https://ascopubs.org/doi/full/10.1200/JCO.21.00443

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    2022-01-17 jml2009
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    2022-06-18 docwu2019
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    2021-10-14 canlab
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    2021-08-17 freve
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  7. [GetPortalCommentsPageByObjectIdResponse(id=1890285, encodeId=680e1890285db, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Mon Jan 17 02:34:16 CST 2022, time=2022-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866198, encodeId=24a7186619834, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Sat Jun 18 18:34:16 CST 2022, time=2022-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1734412, encodeId=1fb81e34412d1, content=<a href='/topic/show?id=d4f412668a4' target=_blank style='color:#2F92EE;'>#NET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12668, encryptionId=d4f412668a4, topicName=NET)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ea033781210, createdName=canlab, createdTime=Thu Oct 14 13:34:16 CST 2021, time=2021-10-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1499938, encodeId=34d6149993868, 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=27, 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=Tue Aug 17 02:34:16 CST 2021, time=2021-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528783, encodeId=b1d11528e83cb, content=<a href='/topic/show?id=74b798601a1' target=_blank style='color:#2F92EE;'>#难治性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98601, encryptionId=74b798601a1, topicName=难治性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ef11916292, createdName=freve, createdTime=Tue Aug 17 02:34:16 CST 2021, time=2021-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1619615, encodeId=d853161961580, content=<a href='/topic/show?id=8dd46061824' target=_blank style='color:#2F92EE;'>#有效治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60618, encryptionId=8dd46061824, topicName=有效治疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Tue Aug 17 02:34:16 CST 2021, time=2021-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1038402, encodeId=e6bd1038402a3, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Sun Aug 15 14:34:16 CST 2021, time=2021-08-15, status=1, ipAttribution=)]
    2021-08-15 anti-cancer

    谢谢梅斯分享这么多精彩信息

    0

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