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JCO:Pembrolizumab用于难治性或复发性胸腺上皮肿瘤患者:开放性II期试验

2018-06-16 海北 MedSci原创

最近,来自韩国的研究人员对患有TET的患者进行了pembrolizumab的II期研究,以评估其疗效和安全性。

如今,对于胸腺上皮肿瘤(TET)患者而言,如果接受铂类化疗后疾病有所发展,其治疗选择非常有限。最近,来自韩国的研究人员对患有TET的患者进行了pembrolizumab的II期研究,以评估其疗效和安全性。
该项研究招募的患者经过组织学证实为TET患者,接受过至少一种铂类化疗方案后病情有所进展。如果患者在过去的一年内出现需要全身治疗的活跃的自身免疫性疾病,或记录有严重的临床自身免疫性疾病的病史,则排除该患者。患者每3周静脉注射200mg pembrolizumab,直至肿瘤进展或出现不可接受的毒性。研究人员每9周评估一次缓解率,这是主要目标。
在33例患者中,26例患有胸腺癌,7例患有胸腺瘤。在7例胸腺瘤患者中,2例(28.6%; 95%CI,8.2%〜64.1%)有部分缓解,5例(71.6%)病情稳定。在26例胸腺癌中,5例(19.2%; 95%CI,8.5%至37.9%)部分缓解,14例(53.8%)病情稳定。两组患者的中位无进展生存期均为6.1个月。
最常见的不良事件包括呼吸困难(11; 33.3%),胸壁疼痛(10; 30.3%),厌食(7; 21.2%)和疲劳(7; 21.2%)。7例胸腺瘤患者中有5例(71.4%),26例胸腺癌患者中有4例(15.4%)报告3级以上免疫相关不良事件,包括肝炎(4例,12.1%),心肌炎(3例,9.1%),肌无力(一个; 3.0%),亚急性肌阵挛(一个; 3.0%),重症肌无力(两个; 6.1%),甲状腺炎(一个; 3.0%),抗中性粒细胞胞质抗体相关的快速进展性肾小球肾炎(一个; 3.0%)。
因此,结果显示,Pembrolizumab在晚期TET患者中表现出令人鼓舞的抗肿瘤活性。鉴于自身免疫的高发病率,需要进一步的研究来确定哪些人可以从pembrolizumab中获益,而不会发生免疫相关的不良事件。

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  4. [GetPortalCommentsPageByObjectIdResponse(id=1909720, encodeId=32391909e2092, content=<a href='/topic/show?id=8f1f42518d8' target=_blank style='color:#2F92EE;'>#复发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42518, encryptionId=8f1f42518d8, topicName=复发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Sat Mar 02 20:41:00 CST 2019, time=2019-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1947705, encodeId=7f72194e7051b, content=<a href='/topic/show?id=24ef96066d' target=_blank style='color:#2F92EE;'>#II期试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9606, encryptionId=24ef96066d, topicName=II期试验)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKUdkK5dVTue7YQDvwqM1ugOuEpDZEzvXhoGClFiavehcrNAYDuPbks3MkKLPpyAEicgic80KguxwicYQ/132, createdBy=ec952500165, createdName=ms5187542471278033, createdTime=Thu May 30 14:41:00 CST 2019, time=2019-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2081844, encodeId=84aa208184465, content=<a href='/topic/show?id=9b0c2003412' target=_blank style='color:#2F92EE;'>#上皮肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20034, encryptionId=9b0c2003412, topicName=上皮肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4736501, createdName=xiaoyang_ambs, createdTime=Sun May 19 02:41:00 CST 2019, time=2019-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1891522, encodeId=b4ee1891522c8, content=<a href='/topic/show?id=25b0102e2df' target=_blank style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat Aug 11 04:41:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1786983, encodeId=9fbc1e86983cc, content=<a href='/topic/show?id=38601402654' target=_blank style='color:#2F92EE;'>#Pembro#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14026, encryptionId=38601402654, topicName=Pembro)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8994206, createdName=chendoc242, createdTime=Sat Feb 23 07:41:00 CST 2019, time=2019-02-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1663488, encodeId=bdfd1663488f7, content=<a href='/topic/show?id=451a8418304' target=_blank style='color:#2F92EE;'>#胸腺#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84183, encryptionId=451a8418304, topicName=胸腺)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fcbd25619530, createdName=1508842480_96220445, createdTime=Thu Feb 07 19:41:00 CST 2019, time=2019-02-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911997, encodeId=8e9a191199e2f, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sat Jun 23 14:41:00 CST 2018, time=2018-06-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2053102, encodeId=510d2053102c1, content=<a href='/topic/show?id=5b2184184f5' target=_blank style='color:#2F92EE;'>#胸腺上皮肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84184, encryptionId=5b2184184f5, topicName=胸腺上皮肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=263b421, createdName=zhaozuguo, createdTime=Sun Jan 13 23:41:00 CST 2019, time=2019-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1727374, encodeId=ae8e1e27374c3, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Sun Jan 27 18:41:00 CST 2019, time=2019-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=325719, encodeId=90e3325e1919, content=学习学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzR8ylhYfiaoAUx2BsaYHVia1IKhG3Cg8CT84rBrn6iaVRkyAibJxBcLEXabOQ5p19vWgDe34ib5ErxNgx/0, createdBy=8a701629084, createdName=jihuaijun1112, createdTime=Thu Jun 21 02:46:02 CST 2018, time=2018-06-21, status=1, ipAttribution=)]
    2018-08-11 lidong40
  5. 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style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat Aug 11 04:41:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1786983, encodeId=9fbc1e86983cc, content=<a href='/topic/show?id=38601402654' target=_blank style='color:#2F92EE;'>#Pembro#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14026, encryptionId=38601402654, topicName=Pembro)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8994206, createdName=chendoc242, createdTime=Sat Feb 23 07:41:00 CST 2019, time=2019-02-23, status=1, ipAttribution=), 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createdBy=25e7304, createdName=snf701207, createdTime=Sat Jun 23 14:41:00 CST 2018, time=2018-06-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2053102, encodeId=510d2053102c1, content=<a href='/topic/show?id=5b2184184f5' target=_blank style='color:#2F92EE;'>#胸腺上皮肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84184, encryptionId=5b2184184f5, topicName=胸腺上皮肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=263b421, createdName=zhaozuguo, createdTime=Sun Jan 13 23:41:00 CST 2019, time=2019-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1727374, encodeId=ae8e1e27374c3, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Sun Jan 27 18:41:00 CST 2019, time=2019-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=325719, encodeId=90e3325e1919, content=学习学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzR8ylhYfiaoAUx2BsaYHVia1IKhG3Cg8CT84rBrn6iaVRkyAibJxBcLEXabOQ5p19vWgDe34ib5ErxNgx/0, createdBy=8a701629084, createdName=jihuaijun1112, createdTime=Thu Jun 21 02:46:02 CST 2018, time=2018-06-21, status=1, ipAttribution=)]
    2019-02-23 chendoc242
  6. 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style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat Aug 11 04:41:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1786983, encodeId=9fbc1e86983cc, content=<a href='/topic/show?id=38601402654' target=_blank style='color:#2F92EE;'>#Pembro#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14026, encryptionId=38601402654, topicName=Pembro)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8994206, createdName=chendoc242, createdTime=Sat Feb 23 07:41:00 CST 2019, time=2019-02-23, status=1, ipAttribution=), 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topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Sun Jan 27 18:41:00 CST 2019, time=2019-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=325719, encodeId=90e3325e1919, content=学习学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzR8ylhYfiaoAUx2BsaYHVia1IKhG3Cg8CT84rBrn6iaVRkyAibJxBcLEXabOQ5p19vWgDe34ib5ErxNgx/0, createdBy=8a701629084, createdName=jihuaijun1112, createdTime=Thu Jun 21 02:46:02 CST 2018, time=2018-06-21, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1909720, encodeId=32391909e2092, content=<a href='/topic/show?id=8f1f42518d8' target=_blank style='color:#2F92EE;'>#复发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42518, encryptionId=8f1f42518d8, topicName=复发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Sat Mar 02 20:41:00 CST 2019, time=2019-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1947705, encodeId=7f72194e7051b, content=<a href='/topic/show?id=24ef96066d' target=_blank style='color:#2F92EE;'>#II期试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9606, encryptionId=24ef96066d, topicName=II期试验)], attachment=null, authenticateStatus=null, 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style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat Aug 11 04:41:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1786983, encodeId=9fbc1e86983cc, content=<a href='/topic/show?id=38601402654' target=_blank style='color:#2F92EE;'>#Pembro#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14026, encryptionId=38601402654, topicName=Pembro)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8994206, createdName=chendoc242, createdTime=Sat Feb 23 07:41:00 CST 2019, time=2019-02-23, status=1, ipAttribution=), 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createdBy=25e7304, createdName=snf701207, createdTime=Sat Jun 23 14:41:00 CST 2018, time=2018-06-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2053102, encodeId=510d2053102c1, content=<a href='/topic/show?id=5b2184184f5' target=_blank style='color:#2F92EE;'>#胸腺上皮肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84184, encryptionId=5b2184184f5, topicName=胸腺上皮肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=263b421, createdName=zhaozuguo, createdTime=Sun Jan 13 23:41:00 CST 2019, time=2019-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1727374, encodeId=ae8e1e27374c3, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Sun Jan 27 18:41:00 CST 2019, time=2019-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=325719, encodeId=90e3325e1919, content=学习学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzR8ylhYfiaoAUx2BsaYHVia1IKhG3Cg8CT84rBrn6iaVRkyAibJxBcLEXabOQ5p19vWgDe34ib5ErxNgx/0, createdBy=8a701629084, createdName=jihuaijun1112, createdTime=Thu Jun 21 02:46:02 CST 2018, time=2018-06-21, status=1, ipAttribution=)]
    2018-06-23 snf701207
  8. 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  9. 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topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Sun Jan 27 18:41:00 CST 2019, time=2019-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=325719, encodeId=90e3325e1919, content=学习学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzR8ylhYfiaoAUx2BsaYHVia1IKhG3Cg8CT84rBrn6iaVRkyAibJxBcLEXabOQ5p19vWgDe34ib5ErxNgx/0, createdBy=8a701629084, createdName=jihuaijun1112, createdTime=Thu Jun 21 02:46:02 CST 2018, time=2018-06-21, status=1, ipAttribution=)]
    2019-01-27 feather89
  10. 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