比较SB3（曲妥珠单抗生物仿制药）和曲妥珠单抗治疗HER2阳性早期乳腺癌的III期研究：最终安全性，免疫原性和存活

2018-04-29 MedSci MedSci原创

曲妥珠单抗生物仿制药SB3已经被证明在早期或局部晚期人表皮生长因子受体2阳性乳腺癌患者治疗后乳腺病理完全缓解，研究人员拟议的曲妥珠单抗生物仿制药SB3与曲妥珠单抗参考产品（TRZ）之间的等效疗效的研究。在这里，研究人员对比了SB3与TRZ在最终安全性，免疫原性和生存结果等访方面的数据

曲妥珠单抗生物仿制药SB3已经被证明在早期或局部晚期人表皮生长因子受体2阳性乳腺癌患者治疗后乳腺病理完全缓解，研究人员拟议的曲妥珠单抗生物仿制药SB3与曲妥珠单抗参考产品（TRZ）之间的等效疗效的研究。在这里，研究人员对比了SB3与TRZ在最终安全性，免疫原性和生存结果等访方面的数据。

患者随机1：1接受新辅助疗法SB3或TRZ 8个周期同时化疗（4个周期的多西他赛，然后4个周期的5-氟尿嘧啶/表柔比星/环磷酰胺）。然后对患者进行手术，随后进行10个周期的SB3或TRZ。终点包括安全性、免疫原性、无事件存活率（EFS）和辅助期间的总体存活率。

在随机分配的875例患者中，764例（SB3，n = 380；TRZ，n = 384）完成了研究。中位随访时间为SB3组为437天，TRZ组为438天。在整个研究期间，各组间治疗出现不良事件的发生率相当（SB3，97.5％; TRZ，96.1％）。直到研究结束时，两个治疗组的抗药物抗体总发生率较低。

综上所述，该研究的最终安全性，免疫原性和存活结果进一步支持SB3和TRZ之间建立的生物相似性。

原始出处：

X. Pivot et al. A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results. 2018 93: 19-27. doi.org/10.1016/j.ejca.

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2018-10-17 juliusluan78

#III#

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2019-01-12 HinsMax

#III期研究#

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2018-08-09 仁心济世

#曲妥珠#

33 0
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encodeId=8c8f12614031c, 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=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1308508, encodeId=ff5c1308508f8, content=<a href='/topic/show?id=240f8e3234' target=_blank style='color:#2F92EE;'>#HER2阳性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8732, encryptionId=240f8e3234, topicName=HER2阳性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8409354, createdName=闆锋旦, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393800, encodeId=8c00139380040, content=<a href='/topic/show?id=718528982e3' target=_blank style='color:#2F92EE;'>#免疫原性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28982, encryptionId=718528982e3, topicName=免疫原性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/78FA0899509C358B01B975E8EAC1F88A/100, createdBy=7d822500145, createdName=ms5353107019656438, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412910, encodeId=22181412910cf, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, 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style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=)]
2018-05-01 drwjr

#仿制药#

24 0
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encodeId=8c8f12614031c, 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=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1308508, encodeId=ff5c1308508f8, content=<a href='/topic/show?id=240f8e3234' target=_blank style='color:#2F92EE;'>#HER2阳性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8732, encryptionId=240f8e3234, topicName=HER2阳性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8409354, createdName=闆锋旦, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393800, encodeId=8c00139380040, content=<a href='/topic/show?id=718528982e3' target=_blank style='color:#2F92EE;'>#免疫原性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28982, encryptionId=718528982e3, topicName=免疫原性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/78FA0899509C358B01B975E8EAC1F88A/100, createdBy=7d822500145, createdName=ms5353107019656438, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412910, encodeId=22181412910cf, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, 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style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=)]
2018-05-01 闆锋旦

#HER2阳性#

30 0
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encodeId=8c8f12614031c, 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=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1308508, encodeId=ff5c1308508f8, content=<a href='/topic/show?id=240f8e3234' target=_blank style='color:#2F92EE;'>#HER2阳性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8732, encryptionId=240f8e3234, topicName=HER2阳性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8409354, createdName=闆锋旦, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393800, encodeId=8c00139380040, content=<a href='/topic/show?id=718528982e3' target=_blank style='color:#2F92EE;'>#免疫原性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28982, encryptionId=718528982e3, topicName=免疫原性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/78FA0899509C358B01B975E8EAC1F88A/100, createdBy=7d822500145, createdName=ms5353107019656438, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412910, encodeId=22181412910cf, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, 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style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=)]
2018-05-01 ms5353107019656438

#免疫原性#

31 0
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time=2018-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1393800, encodeId=8c00139380040, content=<a href='/topic/show?id=718528982e3' target=_blank style='color:#2F92EE;'>#免疫原性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28982, encryptionId=718528982e3, topicName=免疫原性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/78FA0899509C358B01B975E8EAC1F88A/100, createdBy=7d822500145, createdName=ms5353107019656438, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412910, encodeId=22181412910cf, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, 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style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=)]
2018-05-01 grace5701

#生物仿制药#

23 0
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style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=)]
2018-05-01 李研东

#曲妥珠单抗生物仿制药#

29 0
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style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Tue May 01 14:21:00 CST 2018, time=2018-05-01, status=1, ipAttribution=)]
2018-05-01 智智灵药

#III期#

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比较SB3（曲妥珠单抗生物仿制药）和曲妥珠单抗治疗HER2阳性早期乳腺癌的III期研究：最终安全性，免疫原性和存活

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