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FDA批准Lenvatinib+依维莫司联合治疗晚期肾癌

2016-05-17 Seven L 译 MedSci原创

FDA基于一项纳入了153名晚期或转移性肾癌患者的多中心研究结果的基础上,扩大了Lenvatinib的使用,批准该药物联合依维莫司治疗既往接受抗血管生成治疗的晚期肾细胞癌患者。该研究中的患者被随机分配到三个治疗方案:18 mg Lenvatinib(Lenvima, Eisai)+5 mg依维莫司(Afinitor, Novartis)、24 mg Lenvatinib或10 mg依维莫司。研究结

FDA基于一项纳入了153名晚期或转移性肾癌患者的多中心研究结果的基础上,扩大了Lenvatinib的使用,批准该药物联合依维莫司治疗既往接受抗血管生成治疗的晚期肾细胞癌患者。

该研究中的患者被随机分配到三个治疗方案:18 mg Lenvatinib(Lenvima, Eisai)+5 mg依维莫司(Afinitor, Novartis)、24 mg Lenvatinib或10 mg依维莫司。

研究结果显示,相比单药治疗,Lenvatinib+依维莫司组(n = 51)有更长的中位数PFS(14.6个月 vs 5.5个月)、更长的中位数OS(25.5个月 vs 15.4个月)和更高的客观反应率(37% vs 6%)。

联合治疗组最常见的不良反应包括腹泻、疲劳、关节痛、肌痛、食欲下降、呕吐、恶心、口腔炎、口腔炎症、高血压、外周水肿、咳嗽、腹痛、呼吸困难、皮疹、体重下降、出血和蛋白尿。

最常见的严重不良反应包括肾功能衰竭(11%)、脱水(10%)、贫血(6%)、血小板减少症(5%)、腹泻(5%)、呕吐(5%)和呼吸困难(5%)。

联合治疗组和单药依维莫司治疗组中分别有89%和54%的患者因为不良反应而减量或停药。

Lenvatinib是一种多靶点受体酪氨酸激酶抑制剂,于2015年获批用于难治性分化型甲状腺癌的治疗。纪念斯隆-凯特林癌症中心临床肿瘤学家Robert Motzer博士说:“Lenvatinib+依维莫司联用是FDA批准的首个也是唯一一个成功治疗晚期肾细胞癌的联合用药方案,可同时抑制酪氨酸激酶和哺乳动物雷帕霉素靶蛋白,而后者是过去几十年里晚期肾癌治疗的主要作用靶标。”

原始出处:

FDA approves Lenvima for advanced renal cell carcinoma.Healio.May 16, 2016


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    2016-05-19 bugit
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    2016-09-30 1e10c84am36(暂无匿称)

    拜读,好文

    0

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    2016-05-31 lsblb

    学习了!有原文吗?

    0

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  5. [GetPortalCommentsPageByObjectIdResponse(id=1839427, encodeId=a0ed183942e60, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Thu May 19 19:48:00 CST 2016, time=2016-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=138154, encodeId=208313815466, content=拜读,好文, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Fri Sep 30 15:20:28 CST 2016, time=2016-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=87748, encodeId=d2638e7486f, content=学习了!有原文吗?, beContent=null, objectType=article, channel=null, level=null, likeNumber=168, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f9f21613855, createdName=lsblb, createdTime=Tue May 31 09:36:00 CST 2016, time=2016-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1313648, encodeId=443c13136483f, content=<a href='/topic/show?id=d4cc80e128f' target=_blank style='color:#2F92EE;'>#联合治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80712, encryptionId=d4cc80e128f, topicName=联合治疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=263b421, createdName=zhaozuguo, createdTime=Thu May 19 04:48:00 CST 2016, time=2016-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1367003, encodeId=6c34136e003d3, content=<a href='/topic/show?id=8232598e33b' target=_blank style='color:#2F92EE;'>#晚期肾癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59873, encryptionId=8232598e33b, topicName=晚期肾癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e251248, createdName=wujh_7312819, createdTime=Thu May 19 04:48:00 CST 2016, time=2016-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464241, encodeId=9c7814642411d, content=<a href='/topic/show?id=90b91081205' target=_blank style='color:#2F92EE;'>#lenvatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10812, encryptionId=90b91081205, topicName=lenvatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0b506628012, createdName=tastas, createdTime=Thu May 19 04:48:00 CST 2016, time=2016-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86145, encodeId=97c18614529, content=试验设计依据是什么,看看原文才知道, beContent=null, objectType=article, channel=null, level=null, likeNumber=144, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Tue May 17 16:48:00 CST 2016, time=2016-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86137, encodeId=055f8613eff, content=Lenvatinib+依维莫司组(n=51)有更长的中位数PFS(14.6个月vs5.5个月)、更长的中位数OS(25.5个月vs15.4个月)和更高的客观反应率(37%vs6%), beContent=null, objectType=article, channel=null, level=null, likeNumber=141, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Tue May 17 16:41:00 CST 2016, time=2016-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86136, encodeId=c46d86136ab, content=数据很好呀, beContent=null, objectType=article, channel=null, level=null, likeNumber=142, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Tue May 17 16:40:00 CST 2016, time=2016-05-17, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1839427, encodeId=a0ed183942e60, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Thu May 19 19:48:00 CST 2016, time=2016-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=138154, encodeId=208313815466, content=拜读,好文, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Fri Sep 30 15:20:28 CST 2016, time=2016-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=87748, encodeId=d2638e7486f, content=学习了!有原文吗?, beContent=null, objectType=article, channel=null, level=null, likeNumber=168, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f9f21613855, createdName=lsblb, createdTime=Tue May 31 09:36:00 CST 2016, time=2016-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1313648, encodeId=443c13136483f, content=<a href='/topic/show?id=d4cc80e128f' target=_blank style='color:#2F92EE;'>#联合治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80712, encryptionId=d4cc80e128f, topicName=联合治疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=263b421, createdName=zhaozuguo, createdTime=Thu May 19 04:48:00 CST 2016, time=2016-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1367003, encodeId=6c34136e003d3, content=<a href='/topic/show?id=8232598e33b' target=_blank style='color:#2F92EE;'>#晚期肾癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59873, encryptionId=8232598e33b, topicName=晚期肾癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e251248, createdName=wujh_7312819, createdTime=Thu May 19 04:48:00 CST 2016, time=2016-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464241, encodeId=9c7814642411d, content=<a href='/topic/show?id=90b91081205' target=_blank style='color:#2F92EE;'>#lenvatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10812, encryptionId=90b91081205, topicName=lenvatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0b506628012, createdName=tastas, createdTime=Thu May 19 04:48:00 CST 2016, time=2016-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86145, encodeId=97c18614529, content=试验设计依据是什么,看看原文才知道, beContent=null, objectType=article, channel=null, level=null, likeNumber=144, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Tue May 17 16:48:00 CST 2016, time=2016-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86137, encodeId=055f8613eff, content=Lenvatinib+依维莫司组(n=51)有更长的中位数PFS(14.6个月vs5.5个月)、更长的中位数OS(25.5个月vs15.4个月)和更高的客观反应率(37%vs6%), beContent=null, objectType=article, channel=null, level=null, likeNumber=141, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Tue May 17 16:41:00 CST 2016, time=2016-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86136, encodeId=c46d86136ab, content=数据很好呀, beContent=null, objectType=article, channel=null, level=null, likeNumber=142, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Tue May 17 16:40:00 CST 2016, time=2016-05-17, status=1, ipAttribution=)]
    2016-05-19 tastas
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    2016-05-17 jetleo

    试验设计依据是什么,看看原文才知道

    0

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    2016-05-17 jetleo

    Lenvatinib+依维莫司组(n=51)有更长的中位数PFS(14.6个月vs5.5个月)、更长的中位数OS(25.5个月vs15.4个月)和更高的客观反应率(37%vs6%)

    0

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    2016-05-17 jetleo

    数据很好呀

    0

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