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NEJM:短期内治疗复发性或难治性多毛细胞白血病,vemurafenib很有效

2015-09-10 MedSci MedSci原创

BRAF V600E是潜在的毛细胞白血病的遗传病变。研究人员评估了口服BRAF抑制剂vemurafenib对多毛细胞白血病患者经过嘌呤类似物治疗后复发或具有嘌呤类似物难治性的疾病患者的安全性和活性。研究人员进行了vemurafenib的两个2阶段,单组,多中心研究(960毫克的剂量,每天两次)—一个在意大利进行,一个在美国进行。该疗法给药中位时间意大利为16周,美国为18周。主要终点是完全缓解率(

BRAF V600E是潜在的毛细胞白血病的遗传病变。研究人员评估了口服BRAF抑制剂vemurafenib对多毛细胞白血病患者经过嘌呤类似物治疗后复发或具有嘌呤类似物难治性的疾病患者的安全性和活性。 


研究人员进行了vemurafenib的两个2阶段,单组,多中心研究(960毫克的剂量,每天两次)—一个在意大利进行,一个在美国进行。该疗法给药中位时间意大利为16周,美国为18周。主要终点是完全缓解率(意大利试验)和总缓解率(美国试验)。意大利试验在2013年4月招募完成(28例),而美国试验仍然是开放的(36例计划中的26例)。

意大利试验平均进行8周后总反应率96%(25/26例可以进行评估),美国试验平均进行12周后总反应率为100%(24/24)。两项试验的完全缓解率分别为35%(9/26例)和42%(10/24例)。在意大利的试验中,经过中位随访23个月后,完全缓解的患者中位无复发生存期为19个月,有部分反应的患者为6个月;中位无治疗生存期分别为25个月和18个月。在美国试验中,在1年时,无进展生存率为73%,总生存率为91%。药物相关的不良事件通常是1级或2级,这些事件最频繁导致的剂量减少为皮疹和关节痛或关节炎。继发性皮肤肿瘤(通过单纯切除治疗)共发生在50例中的7例。磷酸化ERK阳性白血病细胞在骨髓中在治疗结束时频繁持久性表明MEK和ERK的旁路激活是一个阻力机制。

vemurafenib的一个短期口服疗程治疗复发性或难治性多毛细胞白血病非常有效。

原始出处:

Enrico Tiacci, Jae H. Park, Luca De Carolis,et al.Targeting Mutant BRAF in Relapsed or Refractory Hairy-Cell Leukemia,NEJM,2015.9.10

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    2016-03-11 hb2008ye
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    2015-09-12 freve
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    2015-09-10 elisahuang

    挺不错的文章 学习了

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1663178, encodeId=028c16631e824, content=<a href='/topic/show?id=76ed183e2ef' target=_blank style='color:#2F92EE;'>#Vemurafenib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18372, encryptionId=76ed183e2ef, topicName=Vemurafenib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=29c625536559, createdName=ms1292405679162969, createdTime=Thu Nov 12 00:55:00 CST 2015, time=2015-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1909580, encodeId=9618190958008, content=<a href='/topic/show?id=8f1f42518d8' target=_blank style='color:#2F92EE;'>#复发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42518, encryptionId=8f1f42518d8, topicName=复发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Fri Mar 11 19:55:00 CST 2016, time=2016-03-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1925013, encodeId=04091925013e2, content=<a href='/topic/show?id=9a46636996f' target=_blank style='color:#2F92EE;'>#毛细胞白血病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63699, encryptionId=9a46636996f, topicName=毛细胞白血病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6e7948, createdName=李研东, createdTime=Tue Apr 12 20:55:00 CST 2016, time=2016-04-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528297, encodeId=0b5d152829ebc, 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=37, 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=Sat Sep 12 04:55:00 CST 2015, time=2015-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=36680, encodeId=b0bd3668054, content=挺不错的文章 学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=112, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93c31615857, createdName=elisahuang, createdTime=Thu Sep 10 19:56:00 CST 2015, time=2015-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=36681, encodeId=55f03668126, content=挺不错的文章 学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93c31615857, createdName=elisahuang, createdTime=Thu Sep 10 19:56:00 CST 2015, time=2015-09-10, status=1, ipAttribution=)]
    2015-09-10 elisahuang

    挺不错的文章 学习了

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