Blood:达雷木单抗联合CyBorD治疗新确诊的AL淀粉样变

2020-04-06 QQY MedSci原创

Daratumumab皮下注射(DARA SC)-CyBorD在新诊断的AL淀粉样变性患者(不包括Mayo期IIIb患者)中耐受性良好。 DARA SC-CyBorD在这些患者中引起了明显的血液和器官

虽然目前尚还没有针对轻链(AL)淀粉样变的治疗方法被批准,但环磷酰胺、硼替佐米和地塞米松(CyBorD)被认为是新确诊患者的标准治疗方法。基于抗CD38抗体daratumumab(达雷木单抗)在多发性骨髓瘤(MM)中的安全性和有效性,3期ANDROMEDA研究对达雷木单抗-CyBorD与CyBorD治疗新确诊的AL淀粉样变的疗效进行对比评估。

本文报道了28例患者的安全试行结果。

达雷木单抗的给药方式:皮下注射 (DARA SC) ,前两个疗程(28天/疗程),每周一次(QW);第3-6个疗程,每周两次(Q2W);第7个疗程-2年,每周四次(Q4W)。CyBorD的给药方式:每周给药,4周/疗程,连续6个疗程。

受试患者的中位年龄为67.5岁,从确诊到入伍试验的中位时间为59.5天,受累器官中位数为2个;分别有68%和61%的患者的肾脏和心脏受累。接受治疗的中位疗程为16个。

最常见的需紧急治疗的不良反应有腹泻(68%)、疲劳(54%)和外周性水肿(50%),与采用DARA SC治疗的MM和CyBorD的安全性一致。11位患者发生注射相关反应。无5级治疗相关的不良反应;5位患者死亡,3位患者进行了自体干细胞移植。

血液学的总体缓解率为96%,23位(82%)患者获得非常好的部分缓解,15位(54%)患者获得完全缓解;第1个月、3个月和6个月时,分别有20位、22位和17位患者至少获得部分缓解。器官缓解率为64%(中位随访17.6个月)。第3个月、6个月和12个月时,分别有6/16位、7/15位和10/15位患者获得肾缓解,分别有6/16位、6/13位和8/13位患者获得心血管缓解。此外,12个月时,3位累及肝脏的患者中有两位获得肝缓解。

Daratumumab-CyBorD具有良好的耐受性,与静脉给药相比没有新的安全性问题,并显示出较高的血液和器官缓解率。

原始出处:
 

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1216985, encodeId=d3fc12169850f, content=达雷妥尤皮下注射,怎样可以拿到药呢,新确诊的AL淀粉样变患者,体弱,不敢进行二线化疗, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=27a08134224, createdName=ms6000001750321173, createdTime=Thu May 05 09:42:30 CST 2022, time=2022-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405186, encodeId=13f21405186ad, content=<a href='/topic/show?id=cb6e6591850' target=_blank style='color:#2F92EE;'>#淀粉样变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65918, encryptionId=cb6e6591850, topicName=淀粉样变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2ca02527521, createdName=xjy03, createdTime=Wed Apr 08 02:18:53 CST 2020, time=2020-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1499930, encodeId=4720149993087, 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 Apr 08 02:18:53 CST 2020, time=2020-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590572, encodeId=0ff815905e2fa, content=<a href='/topic/show?id=c21b239286' target=_blank style='color:#2F92EE;'>#AL淀粉样变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2392, encryptionId=c21b239286, topicName=AL淀粉样变)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ba917829034, createdName=wjywjy, createdTime=Wed Apr 08 02:18:53 CST 2020, time=2020-04-08, status=1, ipAttribution=)]
    2022-05-05 ms6000001750321173

    达雷妥尤皮下注射,怎样可以拿到药呢,新确诊的AL淀粉样变患者,体弱,不敢进行二线化疗

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1216985, encodeId=d3fc12169850f, content=达雷妥尤皮下注射,怎样可以拿到药呢,新确诊的AL淀粉样变患者,体弱,不敢进行二线化疗, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=27a08134224, createdName=ms6000001750321173, createdTime=Thu May 05 09:42:30 CST 2022, time=2022-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405186, encodeId=13f21405186ad, content=<a href='/topic/show?id=cb6e6591850' target=_blank style='color:#2F92EE;'>#淀粉样变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65918, encryptionId=cb6e6591850, topicName=淀粉样变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2ca02527521, createdName=xjy03, createdTime=Wed Apr 08 02:18:53 CST 2020, time=2020-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1499930, encodeId=4720149993087, 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 Apr 08 02:18:53 CST 2020, time=2020-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590572, encodeId=0ff815905e2fa, content=<a href='/topic/show?id=c21b239286' target=_blank style='color:#2F92EE;'>#AL淀粉样变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2392, encryptionId=c21b239286, topicName=AL淀粉样变)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ba917829034, createdName=wjywjy, createdTime=Wed Apr 08 02:18:53 CST 2020, time=2020-04-08, status=1, ipAttribution=)]
  3. [GetPortalCommentsPageByObjectIdResponse(id=1216985, encodeId=d3fc12169850f, content=达雷妥尤皮下注射,怎样可以拿到药呢,新确诊的AL淀粉样变患者,体弱,不敢进行二线化疗, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=27a08134224, createdName=ms6000001750321173, createdTime=Thu May 05 09:42:30 CST 2022, time=2022-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405186, encodeId=13f21405186ad, content=<a href='/topic/show?id=cb6e6591850' target=_blank style='color:#2F92EE;'>#淀粉样变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65918, encryptionId=cb6e6591850, topicName=淀粉样变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2ca02527521, createdName=xjy03, createdTime=Wed Apr 08 02:18:53 CST 2020, time=2020-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1499930, encodeId=4720149993087, 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 Apr 08 02:18:53 CST 2020, time=2020-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590572, encodeId=0ff815905e2fa, content=<a href='/topic/show?id=c21b239286' target=_blank style='color:#2F92EE;'>#AL淀粉样变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2392, encryptionId=c21b239286, topicName=AL淀粉样变)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ba917829034, createdName=wjywjy, createdTime=Wed Apr 08 02:18:53 CST 2020, time=2020-04-08, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1216985, encodeId=d3fc12169850f, content=达雷妥尤皮下注射,怎样可以拿到药呢,新确诊的AL淀粉样变患者,体弱,不敢进行二线化疗, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=27a08134224, createdName=ms6000001750321173, createdTime=Thu May 05 09:42:30 CST 2022, time=2022-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405186, encodeId=13f21405186ad, content=<a href='/topic/show?id=cb6e6591850' target=_blank style='color:#2F92EE;'>#淀粉样变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65918, encryptionId=cb6e6591850, topicName=淀粉样变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2ca02527521, createdName=xjy03, createdTime=Wed Apr 08 02:18:53 CST 2020, time=2020-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1499930, encodeId=4720149993087, 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 Apr 08 02:18:53 CST 2020, time=2020-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590572, encodeId=0ff815905e2fa, content=<a href='/topic/show?id=c21b239286' target=_blank style='color:#2F92EE;'>#AL淀粉样变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2392, encryptionId=c21b239286, topicName=AL淀粉样变)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ba917829034, createdName=wjywjy, createdTime=Wed Apr 08 02:18:53 CST 2020, time=2020-04-08, status=1, ipAttribution=)]

相关资讯

第17届IMW:GRIFFIN研究揭示daratumumab一线治疗多发性骨髓瘤具有高反应率和反应深度

强生公司近日公布了II期GRIFFIN(MMY2004)研究的最新结果,该研究显示,与硼替佐米、来那度胺和地塞米松(VRd)方案相比,在VRd中添加DARZALEX®(daratumumab)一线治疗多发性骨髓瘤患者能够产生更高的反应率与反应深度。

Lancet:Daratumumab联合标准治疗方案治疗新发多发性骨髓瘤

自体干细胞移植前后的D-VTD疗法提高患者反应深度和无进展生存期,安全性可以接受。CASSIOPEIA是首次表明Daratumumab联合标准治疗对新诊断的多发性骨髓瘤移植患者的临床疗效的研究。

Lancet:Daratumumab联合疗法用于改善多发性骨髓瘤患者总生存期

在新诊断的多发性骨髓瘤患者中,D-VMP延长了不符合干细胞移植条件的患者的总体存活率。随着3年多的随访,Daratumumab联合硼替佐米、美法仑和泼尼松疗法在总生存期方面有显著改善

Blood:Daratumumab单药疗法用于淀粉样变患者的疗效和安全性

中心点:Daratumumab单药治疗在以前治疗的AL患者中引起了深刻和快速的血液反应,具有良好的安全性。非常好的部分缓解或更好的患者采用Daratumumab单药治疗6个月可获得持久的缓解。摘要:Daratumumab(达雷木单抗)是一种靶向CD38的单克隆抗体,CD38是一种在多发性骨髓瘤和轻链淀粉样变患者的浆细胞中普遍表达的抗原。Roussel等研究人员开展了一个前瞻性的多中心的2期试验,研

美国FDA批准daratumumab联合来那度胺和地塞米松治疗初治多发性骨髓瘤

美国FDA已批准强生公司和Genmab公司的daratumumab联合来那度胺和地塞米松一线治疗不具备自体干细胞移植条件的多发性骨髓瘤患者。

DARZALEX(Daratumumab)方案显著增加复发难治多发性骨髓瘤患者的PFS

强生公司近日宣布,CANDOR III期研究的结果显示,与单独使用卡非佐米和地塞米松(Kd)相比,在Kd中添加了DARZALEX®(daratumumab)(DKd)治疗复发难治多发性骨髓瘤患者时,DKd显著延长了患者的无进展生存期(PFS),同时将疾病进展或死亡的风险降低了37%(HR 0.63,95%CI 0.46-0.85,P=0.0014)。