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NEJM：Rociletinib药物在EGFR突变的非小细胞肺癌效应评估

2015-04-30 MedSci MedSci原创

Rociletinib非小细胞肺癌
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    编码表皮生长因子受体（EGFR）基因的突变的非小细胞肺癌（NSCLC）对批准EGFR抑制剂敏感，但耐药性的发展，在大多数情况下是由T790M EGFR突变介导的。Rociletinib（CO-1686）是一种活性EGFR抑制剂，应用在EGFR突变的NSCLC的有或无T790M临床前模型中。    在这个1-2阶段研究中，我们给予EGFR突变的非小细胞

编码表皮生长因子受体（EGFR）基因的突变的非小细胞肺癌（NSCLC）对批准EGFR抑制剂敏感，但耐药性的发展，在大多数情况下是由T790M EGFR突变介导的。Rociletinib（CO-1686）是一种活性EGFR抑制剂，应用在EGFR突变的NSCLC的有或无T790M临床前模型中。
 
在这个1-2阶段研究中，我们给予EGFR突变的非小细胞肺癌患者rociletinib，他们在EGFR抑制剂存在情况下前处理过程中有疾病进展。在扩展（阶段2）研究的一部分，T790M阳性患者，接受rociletinib500毫克剂量每天两次，625毫克剂量每天两次，或者750毫克每天两次。主要目标是对安全，副作用情况，药代动力学，和rociletinib的初步的抗肿瘤活性的评估。筛选过程中进行的肿瘤活组织切片检查，以确定T790M。治疗给药连续21天的周期。
 
总共有130名患者参加。第一批57例要登记接受rociletinib的游离碱形式（150毫克，每天一次至900毫克，每天两次）。剩余的患者接受了溴化氢盐（氢溴酸）的形式（500毫克，每天两次至1000mg，每天两次）。最大耐受剂量（最大剂量与剂量率限小于33%的毒性作用有关）没有确定。唯一共同剂量限制性不利事件是高血糖症。疗效分析，包括接受游离碱rociletinib剂量为900毫克，每天两次，或在任何剂量的HBr形式的患者，46例T790M阳性患者被评估率为59％（95％置信区间[Cl]，45至73），以及17例T790M阴性疾病患者，其可被评估率为29％（95％Cl，8到51）。
 
研究表明，Rociletinib在T790M耐药突变的EGFR突变的非小细胞肺癌患者中活跃。
 
原始出处
 
Lecia V. Sequist, M.D., M.P.H., Jean-Charles Soria, M.D., Ph.D., Jonathan W. Goldman, M.D., Heather A. Wakelee, M.D., Shirish M. Gadgeel, M.D., Andrea Varga, M.D., Vassiliki Papadimitrakopoulou, M.D., Benjamin J. Solomon, M.B., B.S., Ph.D., Geoffrey R. Oxnard, M.D., Rafal Dziadziuszko, M.D., Ph.D., Dara L. Aisner, M.D., Ph.D., Robert C. Doebele, M.D., Ph.D.,Rociletinib in EGFR-Mutated Non–Small-Cell Lung Cancer,NEJM,2015.4.30

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    2015-08-02 linlin2312

    #ROC#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1976883, encodeId=4ef219e68839e, content=<a href='/topic/show?id=b9f11560065' target=_blank style='color:#2F92EE;'>#ROC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15600, encryptionId=b9f11560065, topicName=ROC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d590125, createdName=linlin2312, createdTime=Sun Aug 02 15:56:00 CST 2015, time=2015-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2059501, encodeId=2a0d205950115, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Fri Jan 15 22:56:00 CST 2016, time=2016-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534270, encodeId=7c8f15342e096, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Sat May 02 01:56:00 CST 2015, time=2015-05-02, status=1, ipAttribution=)]
    2016-01-15 lingaifan

    #非小细胞#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1976883, encodeId=4ef219e68839e, content=<a href='/topic/show?id=b9f11560065' target=_blank style='color:#2F92EE;'>#ROC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15600, encryptionId=b9f11560065, topicName=ROC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d590125, createdName=linlin2312, createdTime=Sun Aug 02 15:56:00 CST 2015, time=2015-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2059501, encodeId=2a0d205950115, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Fri Jan 15 22:56:00 CST 2016, time=2016-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534270, encodeId=7c8f15342e096, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Sat May 02 01:56:00 CST 2015, time=2015-05-02, status=1, ipAttribution=)]
    2015-05-02 liuyiping

    #GFR#

    0