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Lancet haematol:新型靶向药是否可取代自体造血干细胞移植?

2020-05-02 QQY MedSci原创

高活性的新型药物的出现使一些人开始质疑自体造血干细胞移植(HSCT)和随后的巩固治疗在新诊断的多发性骨髓瘤中的作用。在新型药物的时代,HSCT是否会被逐渐替代呢?

高活性的新型药物的出现使一些人开始质疑自体造血干细胞移植(HSCT)和随后的巩固治疗在新诊断的多发性骨髓瘤中的作用。本研究旨在对比自体HSCT和硼替佐米-美法仑-泼尼松(VMP)强化治疗以及硼替佐米-来那度胺-地塞米松(VRD)强化治疗的疗效。

本研究是一项随机的、开放性的3期临床试验,从172个中心招募既往18-65岁、未治疗过的、有症状的1-3期多发性骨髓瘤患者(EHO表现状态0-2级)。患者共接受两次随机分组,第一次被1:1分至自体HSCT组或VMP组,第二次被1:1分至VRD巩固组或无巩固组。主要终点是每次随机分组后的无进展存活期。

2011年2月25日-2014年4月3日,共招募了1503位患者。1197位进入第一次随机分组,其中702位被分至自体HSCT组,495人被分至VMP组;其次分组中的877位患者参与了第二次分组,其中449位被分至VRD巩固组、428位分至无巩固组。截止2018年11月26日,中位随访60.3个月,与VMP组相比,自体HSCT组患者的中位无进展存活期显著提高(56.7 vs 41.9个月,HR 0.73,p=0.0001)。对于二次分组,在截止日期时,进展或死亡事件的数量低于最终分析中预期的数量,因此,本结果来自第二个预定的中期分析,即进展或死亡事件达到66%时。中位随访42.1个月,与无巩固治疗的患者相比,采用VRD作巩固疗法的患者的中位无进展存活期明显延长(58.9 vs 45.5个月,HR 0.77,p=0.014)。自体HSCT组和VMP组最常见的3级及以上不良反应事件有中性粒细胞减少(79% vs 29%)、血小板减少(83% vs 16%)、胃肠道疾病(12% vs 5%)和感染(30% vs 4%),另分别有239位(34%)和135位(27%)患者至少发生了一次重度不良反应事件。感染是各组最常见的重度不良反应事件(56% vs 37%)。从第一次随机分组后的311例死亡中有38例(12%)与治疗相关:26例(68%)在自体HSCT组,12例(32%)在VMP组,最常见的死因是感染(8例[21%])、心脏事件(6例[16%])和次发恶性肿瘤(20例[53%])。

本研究支持在新诊断的多发性骨髓瘤患者中使用自体HSCT作为强化治疗和巩固治疗,即使在新药物时代也是如此。

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    2021-01-16 changfy
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  3. [GetPortalCommentsPageByObjectIdResponse(id=2008471, encodeId=271f20084e13b, content=<a href='/topic/show?id=1066844469' target=_blank style='color:#2F92EE;'>#HAE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8444, encryptionId=1066844469, topicName=HAE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32d177, createdName=changfy, createdTime=Sat Jan 16 13:08:56 CST 2021, time=2021-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1658932, encodeId=fbe41658932e5, content=<a href='/topic/show?id=c40ce798412' target=_blank style='color:#2F92EE;'>#细胞移植#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77984, encryptionId=c40ce798412, topicName=细胞移植)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ad4724938298, createdName=limedical1982, createdTime=Thu Jul 23 15:08:56 CST 2020, time=2020-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1830618, encodeId=8a3218306188a, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Tue Jun 23 11:08:56 CST 2020, time=2020-06-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1025443, encodeId=f39810254439e, content=干细胞是热点,但是进入临床仍然需要时间和临床疗效验证哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=独孤立克, createdTime=Tue May 05 14:08:56 CST 2020, time=2020-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1271513, encodeId=c3e512e1513ba, content=<a href='/topic/show?id=a0ff950018f' target=_blank style='color:#2F92EE;'>#造血干细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95001, encryptionId=a0ff950018f, topicName=造血干细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e729101, createdName=huanbaofeng, createdTime=Mon May 04 05:08:56 CST 2020, time=2020-05-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317567, encodeId=1c48131e567cb, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Mon May 04 05:08:56 CST 2020, time=2020-05-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1494728, encodeId=7c0c1494e28eb, content=<a href='/topic/show?id=084d9499599' target=_blank style='color:#2F92EE;'>#造血#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94995, encryptionId=084d9499599, topicName=造血)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=caed9138962, createdName=俅侠, createdTime=Mon May 04 05:08:56 CST 2020, time=2020-05-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1535007, encodeId=f51b153500e77, content=<a href='/topic/show?id=f92a8602447' target=_blank style='color:#2F92EE;'>#自体造血干细胞移植#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86024, encryptionId=f92a8602447, topicName=自体造血干细胞移植)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=02d712580056, createdName=dongjia2014, createdTime=Mon May 04 05:08:56 CST 2020, time=2020-05-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1033760, encodeId=619a1033e606f, content=顶刊就是不一样,质量很高,内容精彩!学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=goodbing, createdTime=Sat May 02 17:08:56 CST 2020, time=2020-05-02, status=1, ipAttribution=)]
    2020-06-23 howi
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    2020-05-05 独孤立克

    干细胞是热点,但是进入临床仍然需要时间和临床疗效验证哦

    0

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    2020-05-04 fengyi812
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    2020-05-04 俅侠
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    2020-05-02 goodbing

    顶刊就是不一样,质量很高,内容精彩!学到很多

    0

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