SABC 2015:PD-L1抗体atezolizumab联合白蛋白紫杉醇治疗晚期三阴乳腺癌Ib期临床研究显示良好疗效与安全性(GP28328研究)

2015-12-21 MedSci MedSci原创

GP28328研究:atezolizumab(摘要号P2-11-06)来自纽约大学的Sylvia Adams教授等人在大会壁报上展示了他们的成果[safety and clinical activity of atezolizumab (anti-PDL1) in combination with nab-paclitaxel in patients with metastatic triple-

GP28328研究:atezolizumab(摘要号P2-11-06)

来自纽约大学的Sylvia Adams教授等人在大会壁报上展示了他们的成果[safety and clinical activity of atezolizumab (anti-PDL1) in combination with nab-paclitaxel in patients with metastatic triple-negative breast cancer],公布了PD-L1抑制剂atezolizumab治疗三阴乳腺癌的最新研究结果。GP28328 (NCT01633970)研究是一项atezolizumab联合白蛋白紫杉醇治疗晚期三阴乳腺癌的多中心Ib期临床研究,旨在研究其安全性和疗效。

安全性队列纳入了32例患者,中位年龄55.5岁,中位随访5.2个月(0.6~12.6个月)。结果显示无治疗相关死亡事件,56%的患者观察到3~4级副作用,主要为白细胞减少(41%)、血小板减少(9%)以及贫血(6%)。

疗效队列纳入了24例患者,随访时间均大于3个月,9例患者接受atezolizumab联合白蛋白紫杉醇一线治疗,8例患者接受二线治疗,7例患者接受三线或以上治疗。结果显示,相比接受二线或以上治疗的患者,接受一线治疗的患者可获得更高的有效率。接受一线治疗时,11.1%的患者获得完全缓解(CR),77.8%的患者获得部分缓解(PR),11.1%的患者获得稳定(SD),没有患者出现疾病进展(PD),有效率(ORR)为88.9%,连续两次以上有效率(confirmed ORR)为66.7%。本研究显示了atezolizumab可接受的安全性和耐受性,以及良好的抗肿瘤活性。

同类研究进展:


Atezolizumab联合白蛋白紫杉醇治疗转移性三阴乳腺癌(mTNBC)的Ⅲ期临床研究(摘要号OT1-01-06)

本项研究是由约翰霍普金斯大学医学院的Emens教授牵头的双盲随机对照型多中心Ⅲ期临床试验,旨在评估PD-L1抑制剂atezolizumab联合白蛋白紫杉醇一线治疗mTNBC的安全性和疗效。

入组的患者将1:1随机分配至atezolizumab组和安慰剂组,两组患者均接受白蛋白联合紫杉醇治疗。主要终点是无进展生存期(PFS),次要终点包括总生存、客观缓解率、有效持续时间、安全性/耐受性、药代动力学和生活质量等指标。本研究还将探索与疗效相关的潜在生物学标志物。

本研究预计在全球招募约350例符合入排标准的患者。统计学上将采用分层log-rank检验来比较两组的疗效,并采用分层Cox比例风险模型评估疾病进展或死亡的风险比,两组的中位PFS则用Kaplan-Meier法进行评估。研究结果将受到广泛关注。

(2)Nivolumab联合白蛋白紫杉醇治疗HER2阴性复发转移乳腺癌的I期临床研究(摘要号OT1-01-07)

本项研究是由美国Waterhouse D教授牵头的开放型多中心I期临床试验,旨在评估PD-1抑制剂nivolumab联合白蛋白紫杉醇治疗HER2阴性复发转移乳腺癌的安全性。

本研究的主要终点是剂量限制性毒性,次要终点包括药物副作用导致的剂量调整、治疗延迟、中断和终止、无进展生存期、疾病控制率、总体有效率以及有效持续时间。探索性终点包括肿瘤相关的PD-L1表达、nivolumab治疗相关的免疫激活机制、nivolumab血清浓度水平等。研究结果值得期待。

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    2016-01-07 bioon3
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    2015-12-21 snf701207
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    2015-12-27 wzf990214

    赞一个

    0

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    2015-12-27 wzf990214

    有意思

    0

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    2015-12-22 smartjoy
  8. [GetPortalCommentsPageByObjectIdResponse(id=1940326, encodeId=2d9919403263c, content=<a href='/topic/show?id=c0e7932e64' target=_blank style='color:#2F92EE;'>#Ib期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9327, encryptionId=c0e7932e64, topicName=Ib期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=322359, createdName=bioon3, createdTime=Thu Jan 07 16:53:00 CST 2016, time=2016-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911727, encodeId=b99f1911e2782, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Mon Dec 21 18:53:00 CST 2015, time=2015-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1777050, encodeId=463b1e7705018, content=<a href='/topic/show?id=45ae1e1830' target=_blank style='color:#2F92EE;'>#ABC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1718, encryptionId=45ae1e1830, topicName=ABC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a54039078223, createdName=cmj21wellington, createdTime=Sat Jun 25 19:53:00 CST 2016, time=2016-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1688618, encodeId=1eb316886184a, content=<a href='/topic/show?id=d661e039969' target=_blank style='color:#2F92EE;'>#疗效与安全性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70399, encryptionId=d661e039969, topicName=疗效与安全性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1a6a28606469, createdName=1179102698_36768935, createdTime=Wed Sep 07 00:53:00 CST 2016, time=2016-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49307, encodeId=0e1f4930e0d, content=赞一个, beContent=null, objectType=article, channel=null, level=null, likeNumber=150, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRiaKicWybj5Q5KN7PWibALciaJ4W5bZwTlDSFRibFu87125pCq0IXePrC0mpbiasADRqL4NcjUoyQCT9De/0, createdBy=7c7e1636498, createdName=wzf990214, createdTime=Sun Dec 27 12:20:00 CST 2015, time=2015-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=49306, encodeId=d37e4930683, content=有意思, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRiaKicWybj5Q5KN7PWibALciaJ4W5bZwTlDSFRibFu87125pCq0IXePrC0mpbiasADRqL4NcjUoyQCT9De/0, createdBy=7c7e1636498, createdName=wzf990214, createdTime=Sun Dec 27 12:19:00 CST 2015, time=2015-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1254885, encodeId=d2e9125488579, content=<a href='/topic/show?id=be71139214f' target=_blank style='color:#2F92EE;'>#PD-L1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13921, encryptionId=be71139214f, topicName=PD-L1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e76f39, createdName=smartjoy, createdTime=Tue Dec 22 23:53:00 CST 2015, time=2015-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1304589, encodeId=5b551304589da, content=<a href='/topic/show?id=cd37e1767b5' target=_blank style='color:#2F92EE;'>#白蛋白#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71767, encryptionId=cd37e1767b5, topicName=白蛋白)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25d7319, createdName=珙桐, createdTime=Tue Dec 22 23:53:00 CST 2015, time=2015-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=47166, encodeId=3e9c4e166e6, content=原文呢, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eocJY6moGTnYzC8V8lUl3k679Uxh0PVMjIamhoDYuSYr6D4KDKlbpuNuCKFlJaiaVrmFIrbseIWqUA/132, createdBy=ad571630249, createdName=马里奥8433, createdTime=Tue Dec 22 23:12:00 CST 2015, time=2015-12-22, status=1, ipAttribution=)]
    2015-12-22 珙桐
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    2015-12-22 马里奥8433

    原文呢

    0

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