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EUR J Cancer:聚乙二醇化脂质体多柔比星联合trebananib或安慰剂治疗卵巢癌的随机双盲III期临床试验

2017-12-31 MedSci MedSci原创

Trebananib作为一种多肽-Fc融合蛋白,能够通过抑制促血管生成素-1/2与受体酪氨酸激酶Tie2的结合来抑制血管的生成。在这个随机双盲,安慰剂对照的III期临床研究中,研究者们证明了trebananib联合聚乙二醇化脂质体多柔比星(PLD)能够改善上皮性卵巢癌复发患者的无进展生存期(PFS)

Trebananib作为一种多肽-Fc融合蛋白,能够通过抑制促血管生成素-1/2与受体酪氨酸激酶Tie2的结合来抑制血管的生成。在这个随机双盲,安慰剂对照的III临床研究中,研究者们证明了trebananib联合聚乙二醇化脂质体多柔比星(PLD)能够改善上皮性卵巢癌复发患者的无进展生存期(PFS)。

对女性复发性卵巢癌患者每41次静脉注射PLD 50 mg / m2),每周静脉注射trebananib 15 mg / kg)或安慰剂。PFS为主要临床终点,次要终点为客观响应率(ORR)和响应时间(DOR)。

结果显示,在223名入组患者中,trebananib组的中位PFS7.6个月(95% CI7.2-9.0),安慰剂组的中位PFS7.2个月(95% CI4.8-8.2)。trebananibORR46%,而安慰剂组为21%。中位DOR得到了显著改善(trebananib组,7.4个月[95CI5.7-7.6];安慰剂组,3.9个月[95CI2.3-6.5])。与trebananib相关的不良反应事件包括局部水肿,腹水和呕吐。

综上所述,trebananib能够显著改善ORRDOR,但对PFS并无明显影响。 

原始出处:

Marth, Christian, et al. "ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer." European journal of cancer 2017 70: 111-121. doi.org/10.1016/j.ejca.

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    2018-07-30 weiz
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  5. [GetPortalCommentsPageByObjectIdResponse(id=2088699, encodeId=72a1208869950, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Tue Sep 11 03:00:00 CST 2018, time=2018-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1652815, encodeId=5743165281544, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, 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encodeId=3327193143254, content=<a href='/topic/show?id=a3d89601f2' target=_blank style='color:#2F92EE;'>#II期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9601, encryptionId=a3d89601f2, topicName=II期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Sun Dec 16 04:00:00 CST 2018, time=2018-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1304349, encodeId=0ba2130434905, content=<a href='/topic/show?id=81724580886' target=_blank style='color:#2F92EE;'>#安慰剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45808, encryptionId=81724580886, topicName=安慰剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4cce318, createdName=wleon8895, createdTime=Tue Jan 02 12:00:00 CST 2018, time=2018-01-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524639, encodeId=6b16152463968, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Tue Jan 02 12:00:00 CST 2018, time=2018-01-02, status=1, ipAttribution=)]
    2018-06-27 juliusluan78
  6. 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  7. 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encodeId=3327193143254, content=<a href='/topic/show?id=a3d89601f2' target=_blank style='color:#2F92EE;'>#II期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9601, encryptionId=a3d89601f2, topicName=II期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Sun Dec 16 04:00:00 CST 2018, time=2018-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1304349, encodeId=0ba2130434905, content=<a href='/topic/show?id=81724580886' target=_blank style='color:#2F92EE;'>#安慰剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45808, encryptionId=81724580886, topicName=安慰剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4cce318, createdName=wleon8895, createdTime=Tue Jan 02 12:00:00 CST 2018, time=2018-01-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524639, encodeId=6b16152463968, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Tue Jan 02 12:00:00 CST 2018, time=2018-01-02, status=1, ipAttribution=)]
    2018-01-14 AspirantSuo
  8. [GetPortalCommentsPageByObjectIdResponse(id=2088699, encodeId=72a1208869950, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Tue Sep 11 03:00:00 CST 2018, time=2018-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1652815, encodeId=5743165281544, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Sun Aug 05 11:00:00 CST 2018, time=2018-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1755197, encodeId=f8dc1e55197c6, content=<a href='/topic/show?id=536f2338e8d' target=_blank style='color:#2F92EE;'>#乙二醇#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23387, encryptionId=536f2338e8d, topicName=乙二醇)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b11f36846752, createdName=weiz, createdTime=Mon Jul 30 14:00:00 CST 2018, time=2018-07-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1987466, encodeId=d898198e46602, content=<a href='/topic/show?id=b5c01e78457' target=_blank style='color:#2F92EE;'>#Trebananib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17784, encryptionId=b5c01e78457, topicName=Trebananib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c66088, createdName=gao_jian4217, createdTime=Wed Nov 07 17:00:00 CST 2018, time=2018-11-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1915986, encodeId=b9241915986e3, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Wed Jun 27 22:00:00 CST 2018, time=2018-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1976446, encodeId=c99819e64461f, content=<a href='/topic/show?id=06fd84425c8' target=_blank style='color:#2F92EE;'>#脂质体#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84425, encryptionId=06fd84425c8, topicName=脂质体)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Fri Jul 27 03:00:00 CST 2018, time=2018-07-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1633438, encodeId=3cf2163343806, content=<a href='/topic/show?id=377824e1c0' target=_blank style='color:#2F92EE;'>#ANA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2471, encryptionId=377824e1c0, topicName=ANA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=434d22047430, createdName=AspirantSuo, createdTime=Sun Jan 14 06:00:00 CST 2018, time=2018-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1931432, 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attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4cce318, createdName=wleon8895, createdTime=Tue Jan 02 12:00:00 CST 2018, time=2018-01-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524639, encodeId=6b16152463968, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Tue Jan 02 12:00:00 CST 2018, time=2018-01-02, status=1, ipAttribution=)]
  9. [GetPortalCommentsPageByObjectIdResponse(id=2088699, encodeId=72a1208869950, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Tue Sep 11 03:00:00 CST 2018, time=2018-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1652815, encodeId=5743165281544, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, 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beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84425, encryptionId=06fd84425c8, topicName=脂质体)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Fri Jul 27 03:00:00 CST 2018, time=2018-07-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1633438, encodeId=3cf2163343806, content=<a href='/topic/show?id=377824e1c0' target=_blank style='color:#2F92EE;'>#ANA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2471, encryptionId=377824e1c0, topicName=ANA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=434d22047430, createdName=AspirantSuo, createdTime=Sun Jan 14 06:00:00 CST 2018, time=2018-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1931432, 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  10. [GetPortalCommentsPageByObjectIdResponse(id=2088699, encodeId=72a1208869950, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Tue Sep 11 03:00:00 CST 2018, time=2018-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1652815, encodeId=5743165281544, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, 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