NEJM:维奈妥拉联合阿扎胞苷治疗老年急性髓系白血病

2020-08-13 MedSci原创 MedSci原创

维奈妥拉联合阿扎胞苷可有效延长75岁及以上老年急性髓系白血病患者生存期

老年急性髓系白血病(AML)患者多数预后不良,即使患者接受了去甲基化剂治疗也难以达到满意的临床效果。在先前的1b期研究中,维奈妥拉(Venetoclax)联合阿扎胞苷对老年AML患者具有很好的疗效。
 
近日,研究人员招募先前未经治疗的AML患者开展III期研究,患者年龄在75岁或以上,在阿扎胞苷标准治疗基础上(皮下或静脉注射,剂量为每平方米体表面积75mg,每28天为1个周期,在每周期的第1-7天给药),随机接受维奈妥拉(400mg)或安慰剂,每天一次。研究的主要终点是总生存期。
 
431例患者参与研究,平均年龄76岁,其中维奈妥拉组286例,安慰剂组145例。在20.5个月的中位随访中,维奈妥拉组的总生存期为14.7个月,对照组为9.6个月(死亡危险比为0.661)。维奈妥拉组的完全缓解发生率高于对照组(36.7% vs 17.9%),复合缓解率(完全缓解或完全缓解伴不完全血液学恢复)高于对照组(66.4% vs 28.3%)。
总生存期差异
维奈妥拉组主要不良事件(包括恶心)发生率为44%,对照组中为35%,3级或更高级别血小板减少症发生率分别为45%和38%,中性粒细胞减少症发生率分别为42%和28%,发热性中性粒细胞减少症发生率分别为42%和19%。85%维奈妥拉组患者发生感染,对照组为67%,83%的维奈妥拉组患者出现严重不良事件,安慰剂组为73%。
 
研究认为,维奈妥拉联合阿扎胞苷可有效延长75岁及以上老年急性髓系白血病患者生存期。
 
原始出处:
 
Courtney D. DiNardo et al. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med, August 13, 2020.

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attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8f435296195, createdName=ms3000000449926787, createdTime=Fri Aug 14 21:45:03 CST 2020, time=2020-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=808646, encodeId=0383808646fe, content=<a href='/topic/show?id=eb2152482d7' target=_blank style='color:#2F92EE;'>#急性髓系白血病#</a><a href='/topic/show?id=11fe2435ff' target=_blank style='color:#2F92EE;'>#AML#</a>维奈妥拉组的总生存期为14.7个月,对照组为9.6个月(死亡危险比为0.661), 这个数据是喜人的!这是针对<a href='/topic/show?id=98701028358a' target=_blank style='color:#2F92EE;'>#高龄老人#</a>的研究,对于年青人,效果会不会更好?另外,接下来应该探索维奈妥拉与其它药物的联合方案了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=169, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52482, encryptionId=eb2152482d7, topicName=急性髓系白血病), TopicDto(id=2435, encryptionId=11fe2435ff, topicName=AML), TopicDto(id=102835, encryptionId=98701028358a, topicName=高龄老人)], attachment=null, 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    2020-10-10 njumedgxl

    学习了

    0

  5. 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    2020-08-14 ms3000000449926787

    哇撒,好结果

    0

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attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8f435296195, createdName=ms3000000449926787, createdTime=Fri Aug 14 21:45:03 CST 2020, time=2020-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=808646, encodeId=0383808646fe, content=<a href='/topic/show?id=eb2152482d7' target=_blank style='color:#2F92EE;'>#急性髓系白血病#</a><a href='/topic/show?id=11fe2435ff' target=_blank style='color:#2F92EE;'>#AML#</a>维奈妥拉组的总生存期为14.7个月,对照组为9.6个月(死亡危险比为0.661), 这个数据是喜人的!这是针对<a href='/topic/show?id=98701028358a' target=_blank style='color:#2F92EE;'>#高龄老人#</a>的研究,对于年青人,效果会不会更好?另外,接下来应该探索维奈妥拉与其它药物的联合方案了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=169, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52482, encryptionId=eb2152482d7, topicName=急性髓系白血病), TopicDto(id=2435, encryptionId=11fe2435ff, topicName=AML), TopicDto(id=102835, encryptionId=98701028358a, topicName=高龄老人)], attachment=null, 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    2020-08-13 lovetcm

    #急性髓系白血病##AML#维奈妥拉组的总生存期为14.7个月,对照组为9.6个月(死亡危险比为0.661), 这个数据是喜人的!这是针对#高龄老人#的研究,对于年青人,效果会不会更好?另外,接下来应该探索维奈妥拉与其它药物的联合方案了!

    0

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attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8f435296195, createdName=ms3000000449926787, createdTime=Fri Aug 14 21:45:03 CST 2020, time=2020-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=808646, encodeId=0383808646fe, content=<a href='/topic/show?id=eb2152482d7' target=_blank style='color:#2F92EE;'>#急性髓系白血病#</a><a href='/topic/show?id=11fe2435ff' target=_blank style='color:#2F92EE;'>#AML#</a>维奈妥拉组的总生存期为14.7个月,对照组为9.6个月(死亡危险比为0.661), 这个数据是喜人的!这是针对<a href='/topic/show?id=98701028358a' target=_blank style='color:#2F92EE;'>#高龄老人#</a>的研究,对于年青人,效果会不会更好?另外,接下来应该探索维奈妥拉与其它药物的联合方案了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=169, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52482, encryptionId=eb2152482d7, topicName=急性髓系白血病), TopicDto(id=2435, encryptionId=11fe2435ff, topicName=AML), TopicDto(id=102835, encryptionId=98701028358a, topicName=高龄老人)], attachment=null, 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    2020-08-13 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

  8. 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    2020-08-13 神盾医疗局局长Jack

    研究认为,维奈妥拉联合阿扎胞苷可有效延长75岁及以上老年急性髓系白血病患者生存期

    0

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