JAMA:ERBB2(HER2)阳性转移性乳腺癌治疗中,曲妥珠单抗生物仿制药的效果与曲妥珠单抗的效果等效吗?

2016-12-02 xing.T MedSci原创

在接受紫杉醇治疗的ERBB2阳性的转移性乳腺癌妇女中,使用曲妥珠单抗生物仿制药与曲妥珠单抗在治疗24周可得到等价的总反应率,但需要进一步的研究以评估其安全性和长期的临床预后。

用抗ERBB2的人源化单克隆抗体-曲妥珠单抗和化疗药物治疗可显著改善ERBB2(HER2)阳性的转移性乳腺癌患者的预后;临床有效的生物仿制药可能有助于这一治疗的普及。近日,权威医学期刊JAMA上发表了一篇研究文章,旨在比较以往没有治疗过的ERBB2阳性的转移性乳腺癌患者用曲妥珠单抗生物仿制药加紫杉类或曲妥珠单抗联合紫杉醇治疗的总体反应率,并评估这些治疗方案的安全性。
 
该研究为在转移性乳腺癌患者中进行的多中心、双盲、随机、平行组设置、3期效性研究。从2012年12月至2015年8月期间,研究人员共纳入了500名患者,按1:1随机分组,分别接受生物仿制药(n=230)或曲妥珠单抗(n=228)联合紫杉醇治疗。先用化疗药物治疗至少24周,其次用单独使用抗体治疗,直到出现不可接受的毒性作用或疾病发生进展。
 
该研究的主要终点事件为24周的总体反应率(ORR)可分为完全或部分反应。等价边界包括ORR比(生物仿制药/曲妥珠单抗)的90%可信区间为0.81到1.24和ORR差异的95%可信区间为-15%至15%。次要终点指标包括肿瘤进展时间、48周无进展生存率和总生存率和不良事件发生率。
 
在500名随机的女性中,意向性治疗人群包括458名女性(平均年龄[SD]为53.6[11.11]岁),安全性人群纳入了493名女性。生物仿制药组的ORR为69.6%(95%可信区间为63.62%-75.51%)和曲妥珠单抗组为64%(95%可信区间为57.81%-70.26%)。ORR比(1.09;90%可信区间为0.974-1.211)和ORR差异(5.53;95%可信区间为-3.08至14.04)均在等价边界范围内。在治疗48周时,生物仿制药组与曲妥珠单抗组在肿瘤进展时间(41.3% vs. 43%;-1.7%;95%可信区间为-11.1%至6.9%)、无进展生存率(44.3% vs. 44.7%;-0.4%;95%可信区间为-9.4%至8.7%)或总生存率(89.1% vs. 85.1%;4%;95%可信区间为-2.1%至10.3%)方面均无统计学差异。在生物仿制药组和曲妥珠单抗组,分别有239名(98.6%)和233名(94.7%)患者发生至少一个不良事件,最常见的不良事件包括中性粒细胞减少(57.5% vs. 53.3%)、周围神经病变(23.1%
vs. 24.8%)和腹泻(20.6% vs. 20.7%)。
 
由此可见,在接受紫杉醇治疗的ERBB2阳性的转移性乳腺癌妇女中,使用曲妥珠单抗生物仿制药与曲妥珠单抗在治疗24周可得到等价的总反应率,但需要进一步的研究以评估其安全性和长期的临床预后。
 
原始出处:
 
Hope S. Rugo, et al. Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)–Positive Metastatic Breast Cancer.A Randomized Clinical Trial. JAMA.December 1, 2016.


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    2020-06-07 lovetcm

    #生物类似物#使用曲妥珠单抗生物仿制药与曲妥珠单抗在治疗24周可得到等价的总反应率,但需要进一步的研究以评估其安全性和长期的临床预后

    0

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  4. 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  6. 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  7. [GetPortalCommentsPageByObjectIdResponse(id=601712, encodeId=6b9b601e1274, content=<a href='/topic/show?id=df1269423df' target=_blank style='color:#2F92EE;'>#生物类似物#</a>使用曲妥珠单抗生物仿制药与曲妥珠单抗在治疗24周可得到等价的总反应率,但需要进一步的研究以评估其安全性和长期的临床预后, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69423, encryptionId=df1269423df, topicName=生物类似物)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sun Jun 07 10:30:54 CST 2020, time=2020-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1662179, encodeId=567d16621e954, content=<a href='/topic/show?id=a9556923d7' target=_blank style='color:#2F92EE;'>#ErbB2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6923, encryptionId=a9556923d7, topicName=ErbB2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=612025370618, createdName=ms7514935887898259, createdTime=Sun Apr 09 13:18:00 CST 2017, time=2017-04-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648096, encodeId=ee471648096ba, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Sun Oct 08 14:18:00 CST 2017, time=2017-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261350, encodeId=372912613504c, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sat Dec 03 22:18:00 CST 2016, time=2016-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386208, encodeId=b46913862084c, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Sat Dec 03 22:18:00 CST 2016, time=2016-12-03, status=1, ipAttribution=), 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createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzfPkmqRTH5rHib5mcib8Wb3QdXjhfOK1UubQL2lictjJFdFJ6Lc3cnnCOSWqxXZ4Kk6y5GdzDoy764R/0, createdBy=156e1644785, createdName=doctorJiangchao, createdTime=Sat Dec 03 10:47:32 CST 2016, time=2016-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=159716, encodeId=5e85159e160a, content=生物仿制药是什么, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/11/19/9bc45f4ae162bd654210831f4e7ea3d0.jpg, createdBy=bbf11609910, createdName=杨帆7792, createdTime=Fri Dec 02 16:22:15 CST 2016, time=2016-12-02, status=1, ipAttribution=)]
  8. [GetPortalCommentsPageByObjectIdResponse(id=601712, encodeId=6b9b601e1274, content=<a href='/topic/show?id=df1269423df' target=_blank style='color:#2F92EE;'>#生物类似物#</a>使用曲妥珠单抗生物仿制药与曲妥珠单抗在治疗24周可得到等价的总反应率,但需要进一步的研究以评估其安全性和长期的临床预后, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69423, encryptionId=df1269423df, topicName=生物类似物)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sun Jun 07 10:30:54 CST 2020, time=2020-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1662179, encodeId=567d16621e954, content=<a href='/topic/show?id=a9556923d7' target=_blank style='color:#2F92EE;'>#ErbB2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6923, encryptionId=a9556923d7, topicName=ErbB2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=612025370618, createdName=ms7514935887898259, createdTime=Sun Apr 09 13:18:00 CST 2017, time=2017-04-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648096, encodeId=ee471648096ba, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Sun Oct 08 14:18:00 CST 2017, time=2017-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261350, encodeId=372912613504c, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sat Dec 03 22:18:00 CST 2016, time=2016-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386208, encodeId=b46913862084c, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Sat Dec 03 22:18:00 CST 2016, time=2016-12-03, status=1, ipAttribution=), 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createdBy=0dfb17256974, createdName=李研东, createdTime=Sat Dec 03 22:18:00 CST 2016, time=2016-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=159960, encodeId=55c31599606f, content=可以借鉴一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20161203/IMG584270550C2E89663.jpg, createdBy=d5381989280, createdName=家乡的竹, createdTime=Sat Dec 03 15:18:08 CST 2016, time=2016-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=159908, encodeId=ebaa15990853, content=继续学习, 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/jW482SpianMayicTRbRZ5RzfPkmqRTH5rHib5mcib8Wb3QdXjhfOK1UubQL2lictjJFdFJ6Lc3cnnCOSWqxXZ4Kk6y5GdzDoy764R/0, createdBy=156e1644785, createdName=doctorJiangchao, createdTime=Sat Dec 03 10:47:32 CST 2016, time=2016-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=159716, encodeId=5e85159e160a, content=生物仿制药是什么, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/11/19/9bc45f4ae162bd654210831f4e7ea3d0.jpg, createdBy=bbf11609910, createdName=杨帆7792, createdTime=Fri Dec 02 16:22:15 CST 2016, time=2016-12-02, status=1, ipAttribution=)]
    2016-12-03 家乡的竹

    可以借鉴一下

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=601712, encodeId=6b9b601e1274, content=<a href='/topic/show?id=df1269423df' target=_blank style='color:#2F92EE;'>#生物类似物#</a>使用曲妥珠单抗生物仿制药与曲妥珠单抗在治疗24周可得到等价的总反应率,但需要进一步的研究以评估其安全性和长期的临床预后, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69423, encryptionId=df1269423df, topicName=生物类似物)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sun Jun 07 10:30:54 CST 2020, time=2020-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1662179, encodeId=567d16621e954, content=<a href='/topic/show?id=a9556923d7' target=_blank style='color:#2F92EE;'>#ErbB2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6923, encryptionId=a9556923d7, topicName=ErbB2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=612025370618, createdName=ms7514935887898259, createdTime=Sun Apr 09 13:18:00 CST 2017, time=2017-04-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648096, encodeId=ee471648096ba, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Sun Oct 08 14:18:00 CST 2017, time=2017-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261350, encodeId=372912613504c, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sat Dec 03 22:18:00 CST 2016, time=2016-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386208, encodeId=b46913862084c, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Sat Dec 03 22:18:00 CST 2016, time=2016-12-03, status=1, ipAttribution=), 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createdBy=0dfb17256974, createdName=李研东, createdTime=Sat Dec 03 22:18:00 CST 2016, time=2016-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=159960, encodeId=55c31599606f, content=可以借鉴一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20161203/IMG584270550C2E89663.jpg, createdBy=d5381989280, createdName=家乡的竹, createdTime=Sat Dec 03 15:18:08 CST 2016, time=2016-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=159908, encodeId=ebaa15990853, content=继续学习, 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/jW482SpianMayicTRbRZ5RzfPkmqRTH5rHib5mcib8Wb3QdXjhfOK1UubQL2lictjJFdFJ6Lc3cnnCOSWqxXZ4Kk6y5GdzDoy764R/0, createdBy=156e1644785, createdName=doctorJiangchao, createdTime=Sat Dec 03 10:47:32 CST 2016, time=2016-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=159716, encodeId=5e85159e160a, content=生物仿制药是什么, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/11/19/9bc45f4ae162bd654210831f4e7ea3d0.jpg, createdBy=bbf11609910, createdName=杨帆7792, createdTime=Fri Dec 02 16:22:15 CST 2016, time=2016-12-02, status=1, ipAttribution=)]
    2016-12-03 doctorJiangchao

    继续学习

    0

  10. 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    2016-12-02 杨帆7792

    生物仿制药是什么

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