Lancet oncol:Tafasitamab联合来那度胺治疗复发/难治性弥漫性大B细胞淋巴瘤的疗效

2020-06-08 QQY MedSci原创

复发或难治性弥漫性大B细胞淋巴瘤不适合自体干细胞移植的患者预后差,治疗选择少。Tafasitamab (MOR208)是一种Fc强化的人源性抗CD19单克隆抗体,在复发或难治性B细胞恶性肿瘤患者中显示

复发或难治性弥漫性大B细胞淋巴瘤不适合自体干细胞移植的患者预后差,治疗选择少。Tafasitamab (MOR208)是一种Fc强化的人源性抗CD19单克隆抗体,在复发或难治性B细胞恶性肿瘤患者中显示出临床前和单药活性。临床前数据表明,tafasitamab可能与来那度胺有协同作用。本研究旨在评估tafasitamab联合来那度胺对不适合自体干细胞移植的复发或难治性弥漫性大B细胞淋巴瘤患者的抗肿瘤活性和安全性。

本研究是一项多中心的单臂2期试验(L-MIND),于2016年1月18日-2017年11月15日招募了81位年满18岁的组织学确诊的不适合自体干细胞移植或大剂量化疗的复发或难治性弥漫性大B细胞淋巴瘤患者,予以tafasitamab(12 mg/kg,静滴)和来那度胺(25 mg/天,口服)联合治疗12个疗程(28天/疗程),随后予以tafasitamab单药维持治疗直到病程进展。主要终点是客观缓解率。

在招募的81位患者中,有80位至少接受了一剂量的tafasitamab和来那度胺。截止2018年11月30日,中位随访了13.2个月(IQR 7.3-20.4)。48位(48/80,60%)患者获得客观缓解:34位(43%)获得完全缓解,14位(18%)获得部分缓解。最常见的3-4级不良反应是中性粒细胞减少(39/81,48%)、血小板减少(17%)和发热性中性粒细胞减少(12%)。重度不良反应发生于41位(51%)患者。最常见的重度不良反应有肺炎(6%)、发热性中性粒细胞减少(6%)、肺栓塞(4%)、支气管炎(2%)、房颤(2%)和充血性心力衰竭(2%)。

Tafasitamab联合来那度胺用于不适合自体干细胞移植的复发或难治性弥漫性大B细胞淋巴瘤患者的耐受性良好,而且可获得较高比例的完全缓解,或可成为这类患者的新选择。

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    2021-04-04 gracezdd
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    2020-09-25 minlingfeng
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    2021-05-03 zhanglin3079
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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1290170, encodeId=c92112901e021, content=<a href='/topic/show?id=c5795004ece' target=_blank style='color:#2F92EE;'>#弥漫性大B细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50047, encryptionId=c5795004ece, topicName=弥漫性大B细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=346311, createdName=bnjfy, createdTime=Tue Jun 09 15:24:07 CST 2020, time=2020-06-09, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=2057992, encodeId=42a5205e9924f, content=<a href='/topic/show?id=3836e24819' target=_blank style='color:#2F92EE;'>#FAS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7248, encryptionId=3836e24819, topicName=FAS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=872f168, createdName=gracezdd, createdTime=Sun Apr 04 20:24:07 CST 2021, time=2021-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1865841, encodeId=5bbd186584129, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, 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href='/topic/show?id=2f4a1e08342' target=_blank style='color:#2F92EE;'>#tafasitamab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17083, encryptionId=2f4a1e08342, topicName=tafasitamab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fd34186, createdName=wshxjq, createdTime=Fri Oct 23 10:24:07 CST 2020, time=2020-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1273358, encodeId=ca9812e33583b, content=<a href='/topic/show?id=310d383ef5' target=_blank style='color:#2F92EE;'>#B细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3837, encryptionId=310d383ef5, topicName=B细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eba113, createdName=xiaoyeshuang, createdTime=Tue Jun 09 15:24:07 CST 2020, time=2020-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1290170, encodeId=c92112901e021, content=<a href='/topic/show?id=c5795004ece' target=_blank style='color:#2F92EE;'>#弥漫性大B细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50047, encryptionId=c5795004ece, topicName=弥漫性大B细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=346311, createdName=bnjfy, createdTime=Tue Jun 09 15:24:07 CST 2020, time=2020-06-09, status=1, ipAttribution=)]
    2021-02-14 gaoxiaoe
  6. [GetPortalCommentsPageByObjectIdResponse(id=2057992, encodeId=42a5205e9924f, content=<a href='/topic/show?id=3836e24819' target=_blank style='color:#2F92EE;'>#FAS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7248, encryptionId=3836e24819, topicName=FAS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=872f168, createdName=gracezdd, createdTime=Sun Apr 04 20:24:07 CST 2021, time=2021-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1865841, encodeId=5bbd186584129, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1290170, encodeId=c92112901e021, content=<a href='/topic/show?id=c5795004ece' target=_blank style='color:#2F92EE;'>#弥漫性大B细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50047, encryptionId=c5795004ece, topicName=弥漫性大B细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=346311, createdName=bnjfy, createdTime=Tue Jun 09 15:24:07 CST 2020, time=2020-06-09, status=1, ipAttribution=)]
    2021-04-23 howi
  7. 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    2021-01-29 snf701207
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