BMJ:美国国家综合癌症网治疗指南中的超说明书应用

2018-03-08 zhangfan MedSci原创

研究认为,对于抗肿瘤新药,美国国家综合癌症网的治疗指南往往超越FDA的批准用药范围,但大多数NCCN的超说明书推荐在随后的研究中证明是合理的

近日研究人员对美国国家综合癌症网(NCNN)治疗指南与FDA抗肿瘤药物治疗适应症之间的差异进行了考察。

2011-15年间FDA批准的47个新分子实体参与研究,研究的主要终点是FDA批准的适应症与NCCN治疗指南的差异,特别是NCCN指南中的超说明书应用。

获FDA批准的47个药物的初始治疗领域包括血液或实体瘤,包括69个适应症,而NCCN指南则包含113个适应症,62%的适应症与FDA批准症状相同,而44个适应症(39%)为补充建议。在补充建议中,仅10个建议(23%)依据随机对照试验结果,7个建议(16%)根据III期临床证据。在21个月的随访期间,FDA批准其中的6个补充建议(14%),扩大的药物的适用范围。

研究认为,对于抗肿瘤新药,美国国家综合癌症网的治疗指南往往超越FDA的批准用药范围,但大多数NCCN的超说明书推荐在随后的研究中证明是合理的。

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    2018-08-26 gaoxiaoe
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createdName=w984445tii, createdTime=Mon Aug 27 11:36:00 CST 2018, time=2018-08-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1992950, encodeId=dbc9199295001, content=<a href='/topic/show?id=72d29292681' target=_blank style='color:#2F92EE;'>#超说明书#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92926, encryptionId=72d29292681, topicName=超说明书)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5cb32500112, createdName=1508842480_96220437, createdTime=Tue May 29 01:36:00 CST 2018, time=2018-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=323238, encodeId=c9413232381f, content=学习了.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Sat Jun 09 23:43:58 CST 2018, time=2018-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=322568, encodeId=1d1432256873, content=学习了.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Fri Jun 08 19:16:13 CST 2018, time=2018-06-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=322294, encodeId=36e232229411, content=学习了.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Thu Jun 07 19:17:32 CST 2018, time=2018-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=321735, encodeId=8340321e3526, content=学习了.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Tue Jun 05 22:34:28 CST 2018, time=2018-06-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320348, encodeId=de01320348df, content=学习了学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Thu May 31 21:35:21 CST 2018, time=2018-05-31, status=1, ipAttribution=)]
    2018-06-11 qingfengqishi5

    学习了.学习了

    0

  5. 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encodeId=36e232229411, content=学习了.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Thu Jun 07 19:17:32 CST 2018, time=2018-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=321735, encodeId=8340321e3526, content=学习了.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Tue Jun 05 22:34:28 CST 2018, time=2018-06-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320348, encodeId=de01320348df, content=学习了学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Thu May 31 21:35:21 CST 2018, time=2018-05-31, status=1, ipAttribution=)]
    2018-06-10 qingfengqishi5

    学习了.学习了

    0

  6. 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2018, time=2018-06-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320348, encodeId=de01320348df, content=学习了学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Thu May 31 21:35:21 CST 2018, time=2018-05-31, status=1, ipAttribution=)]
    2018-06-09 qingfengqishi5

    学习了.学习了

    0

  7. 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replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Sat Jun 09 23:43:58 CST 2018, time=2018-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=322568, encodeId=1d1432256873, content=学习了.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Fri Jun 08 19:16:13 CST 2018, time=2018-06-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=322294, encodeId=36e232229411, content=学习了.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Thu Jun 07 19:17:32 CST 2018, time=2018-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=321735, encodeId=8340321e3526, content=学习了.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Tue Jun 05 22:34:28 CST 2018, time=2018-06-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320348, encodeId=de01320348df, content=学习了学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Thu May 31 21:35:21 CST 2018, time=2018-05-31, status=1, ipAttribution=)]
    2018-06-08 qingfengqishi5

    学习了.学习了

    0

  8. 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2018, time=2018-06-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320348, encodeId=de01320348df, content=学习了学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Thu May 31 21:35:21 CST 2018, time=2018-05-31, status=1, ipAttribution=)]
    2018-06-07 qingfengqishi5

    学习了.学习了

    0

  9. 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2018, time=2018-06-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320348, encodeId=de01320348df, content=学习了学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Thu May 31 21:35:21 CST 2018, time=2018-05-31, status=1, ipAttribution=)]
    2018-06-05 qingfengqishi5

    学习了.学习了

    0

  10. 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encodeId=36e232229411, content=学习了.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Thu Jun 07 19:17:32 CST 2018, time=2018-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=321735, encodeId=8340321e3526, content=学习了.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Tue Jun 05 22:34:28 CST 2018, time=2018-06-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320348, encodeId=de01320348df, content=学习了学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzTetibytbqFDmFITWHyBWbxU7S9MYibgPSqvu0sYteH0N6zXqbU0Kf3Mbdb7yWM1Kud3zPgYBibE2SZ/0, createdBy=da7696924, createdName=qingfengqishi5, createdTime=Thu May 31 21:35:21 CST 2018, time=2018-05-31, status=1, ipAttribution=)]
    2018-05-31 qingfengqishi5

    学习了学习了

    0