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Clin Cancer Res:帕尼单抗联合吉西他滨放化疗用于局部晚期胰腺癌的I期临床研究

2015-06-13 范伟 译 MedSci原创

目的:表皮生长因子受体(EGFR)抑制剂可以改善放射治疗的疗效和吉西他滨的增敏活性。基于单克隆EGFR抗体帕尼单抗和吉西他滨非重叠毒性资料的原理,我们设计了I期临床试验探讨帕尼单抗添加到基于吉西他滨放化疗(CRT)中用于局部晚期胰腺癌患者(LAPC)的最大耐受剂量(MTD)、安全性和活性。病人和方法:对局部晚期胰腺癌患者以及WHO性能状态0 - 1的患者每周给以4个剂量水平(1 - 2.5毫克/公

目的:表皮生长因子受体(EGFR)抑制剂可以改善放射治疗的疗效和吉西他滨的增敏活性。基于单克隆EGFR抗体帕尼单抗和吉西他滨非重叠毒性资料的原理,我们设计了I期临床试验探讨帕尼单抗添加到基于吉西他滨放化疗(CRT)中用于局部晚期胰腺癌患者(LAPC)的最大耐受剂量(MTD)、安全性和活性。

病人和方法:对局部晚期胰腺癌患者以及WHO性能状态0 - 1的患者每周给以4个剂量水平(1 - 2.5毫克/公斤)帕尼单抗,联合每周吉西他滨300 mg / m2和放疗(28片段50.4 gy)6周,其次是每4周里每周吉西他滨1000 mg / m2进行3周,直到疾病进展或有不可接受的毒性。每个组在联合治疗期间进行监测,建立剂量限制毒性(DLT)。在CRT后和吉西他滨单药治疗期间进行肿瘤评估。

结果:招募到了14名患者,评估其毒性,13名有反应。帕尼单抗的MTD 为1.5毫克/公斤。6名中的3名,最大剂量治疗,联合治疗期间经历了3级不良反应,中性粒细胞减少(n = 2;33%),疲劳(n = 1;17%),恶心(n = 1;17%)和呕吐(n = 1;17%)。局部反应在三个病人身上(23%)达到了,每个剂量组一个。三组一起中位无进展生存期(PFS)是8.9个月。

结论:帕尼单抗添加到基于吉西他滨放化疗中用于局部晚期胰腺癌患者的治疗,有可控的毒性和潜在的临床疗效。

帕尼单抗已用于多种肿瘤的临床试验中,如Lancet Oncol:帕唑帕尼加每周紫杉醇用于晚期卵巢癌的II期临床研究

原始出处:

van Zweeden AA, van der Vliet HJ, Wilmink JW, Meijerink MR, et al.Phase I clinical trial to determine the  feasibility and maximum tolerated dose of panitumumab to standard gemcitabinebased chemoradiation in locally advanced  pancreatic cancer.Clin Cancer Res. 2015 Jun 8. pii: clincanres.3364.2014.

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  4. 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topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b2c1627329, createdName=owlhealth, createdTime=Mon Jun 29 18:47:00 CST 2015, time=2015-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=29374, encodeId=d03a293e4cc, content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=167, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ee0d1618732, createdName=huaxipanxing, createdTime=Thu Jun 25 23:40:00 CST 2015, time=2015-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=27737, encodeId=0be52e73714, content=这个研究观察到对局部的晚期胰腺癌,中卫五进站,生辰为8.9个月,其实,它的作用并不是特别的明显。如果他配合的是白蛋白紫杉醇会不会更好一点呢?这个应该值得下一步研究。, beContent=null, objectType=article, channel=null, level=null, likeNumber=184, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Tue Jun 16 08:07:00 CST 2015, time=2015-06-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=27716, encodeId=211b2e71647, content=真希望有这样新的治疗方式, beContent=null, objectType=article, channel=null, level=null, likeNumber=166, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19311619842, createdName=xcjick, createdTime=Mon Jun 15 23:26:00 CST 2015, time=2015-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1287877, encodeId=ddb3128e877ea, content=<a href='/topic/show?id=4d185e31825' target=_blank style='color:#2F92EE;'>#放化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57318, encryptionId=4d185e31825, topicName=放化疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=310e209, createdName=yzh399, createdTime=Mon Jun 15 11:45:00 CST 2015, time=2015-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1389560, encodeId=f01d13895600d, content=<a href='/topic/show?id=82a95988106' target=_blank style='color:#2F92EE;'>#晚期胰腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=99, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59881, encryptionId=82a95988106, topicName=晚期胰腺癌)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/2898B09F0DA89357D0D54A725E611AC7/100, createdBy=fdd32500040, createdName=ms7899726347904398, createdTime=Mon Jun 15 11:45:00 CST 2015, time=2015-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1394236, encodeId=871213942368c, content=<a href='/topic/show?id=f9ba484920f' target=_blank style='color:#2F92EE;'>#帕尼单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48492, encryptionId=f9ba484920f, topicName=帕尼单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1dfd2500156, createdName=12498c24m69暂无昵称, createdTime=Mon Jun 15 11:45:00 CST 2015, time=2015-06-15, status=1, ipAttribution=)]
    2015-06-29 owlhealth

    挺好

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1652729, encodeId=4a621652e29b5, 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=112, 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=Sat Nov 21 20:45:00 CST 2015, time=2015-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1957311, encodeId=9a4c195e31127, content=<a href='/topic/show?id=c87a4e6205d' target=_blank style='color:#2F92EE;'>#局部晚期胰腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47620, encryptionId=c87a4e6205d, topicName=局部晚期胰腺癌)], attachment=null, authenticateStatus=null, 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topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b2c1627329, createdName=owlhealth, createdTime=Mon Jun 29 18:47:00 CST 2015, time=2015-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=29374, encodeId=d03a293e4cc, content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=167, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ee0d1618732, createdName=huaxipanxing, createdTime=Thu Jun 25 23:40:00 CST 2015, time=2015-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=27737, encodeId=0be52e73714, content=这个研究观察到对局部的晚期胰腺癌,中卫五进站,生辰为8.9个月,其实,它的作用并不是特别的明显。如果他配合的是白蛋白紫杉醇会不会更好一点呢?这个应该值得下一步研究。, beContent=null, objectType=article, channel=null, level=null, likeNumber=184, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Tue Jun 16 08:07:00 CST 2015, time=2015-06-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=27716, encodeId=211b2e71647, content=真希望有这样新的治疗方式, beContent=null, objectType=article, channel=null, level=null, likeNumber=166, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19311619842, createdName=xcjick, createdTime=Mon Jun 15 23:26:00 CST 2015, time=2015-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1287877, encodeId=ddb3128e877ea, content=<a href='/topic/show?id=4d185e31825' target=_blank style='color:#2F92EE;'>#放化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57318, encryptionId=4d185e31825, topicName=放化疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=310e209, createdName=yzh399, createdTime=Mon Jun 15 11:45:00 CST 2015, time=2015-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1389560, encodeId=f01d13895600d, content=<a href='/topic/show?id=82a95988106' target=_blank style='color:#2F92EE;'>#晚期胰腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=99, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59881, encryptionId=82a95988106, topicName=晚期胰腺癌)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/2898B09F0DA89357D0D54A725E611AC7/100, createdBy=fdd32500040, createdName=ms7899726347904398, createdTime=Mon Jun 15 11:45:00 CST 2015, time=2015-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1394236, encodeId=871213942368c, content=<a href='/topic/show?id=f9ba484920f' target=_blank style='color:#2F92EE;'>#帕尼单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48492, encryptionId=f9ba484920f, topicName=帕尼单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1dfd2500156, createdName=12498c24m69暂无昵称, createdTime=Mon Jun 15 11:45:00 CST 2015, time=2015-06-15, status=1, ipAttribution=)]
    2015-06-25 huaxipanxing

    看看

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1652729, encodeId=4a621652e29b5, 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=112, 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=Sat Nov 21 20:45:00 CST 2015, time=2015-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1957311, encodeId=9a4c195e31127, content=<a href='/topic/show?id=c87a4e6205d' target=_blank style='color:#2F92EE;'>#局部晚期胰腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47620, encryptionId=c87a4e6205d, topicName=局部晚期胰腺癌)], attachment=null, authenticateStatus=null, 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topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b2c1627329, createdName=owlhealth, createdTime=Mon Jun 29 18:47:00 CST 2015, time=2015-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=29374, encodeId=d03a293e4cc, content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=167, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ee0d1618732, createdName=huaxipanxing, createdTime=Thu Jun 25 23:40:00 CST 2015, time=2015-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=27737, encodeId=0be52e73714, content=这个研究观察到对局部的晚期胰腺癌,中卫五进站,生辰为8.9个月,其实,它的作用并不是特别的明显。如果他配合的是白蛋白紫杉醇会不会更好一点呢?这个应该值得下一步研究。, beContent=null, objectType=article, channel=null, level=null, likeNumber=184, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Tue Jun 16 08:07:00 CST 2015, time=2015-06-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=27716, encodeId=211b2e71647, content=真希望有这样新的治疗方式, beContent=null, objectType=article, channel=null, level=null, likeNumber=166, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19311619842, createdName=xcjick, createdTime=Mon Jun 15 23:26:00 CST 2015, time=2015-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1287877, encodeId=ddb3128e877ea, content=<a href='/topic/show?id=4d185e31825' target=_blank style='color:#2F92EE;'>#放化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57318, encryptionId=4d185e31825, topicName=放化疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=310e209, createdName=yzh399, createdTime=Mon Jun 15 11:45:00 CST 2015, time=2015-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1389560, encodeId=f01d13895600d, content=<a href='/topic/show?id=82a95988106' target=_blank style='color:#2F92EE;'>#晚期胰腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=99, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59881, encryptionId=82a95988106, topicName=晚期胰腺癌)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/2898B09F0DA89357D0D54A725E611AC7/100, createdBy=fdd32500040, createdName=ms7899726347904398, createdTime=Mon Jun 15 11:45:00 CST 2015, time=2015-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1394236, encodeId=871213942368c, content=<a href='/topic/show?id=f9ba484920f' target=_blank style='color:#2F92EE;'>#帕尼单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48492, encryptionId=f9ba484920f, topicName=帕尼单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1dfd2500156, createdName=12498c24m69暂无昵称, createdTime=Mon Jun 15 11:45:00 CST 2015, time=2015-06-15, status=1, ipAttribution=)]
    2015-06-16 lovetcm

    这个研究观察到对局部的晚期胰腺癌,中卫五进站,生辰为8.9个月,其实,它的作用并不是特别的明显。如果他配合的是白蛋白紫杉醇会不会更好一点呢?这个应该值得下一步研究。

    0

  7. 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    2015-06-15 xcjick

    真希望有这样新的治疗方式

    0

  8. 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    2015-06-15 yzh399
  9. 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近日,美国加州大学洛杉矶分校David Geffen医学院肿瘤学研究所的研究人员进行了一项随机、多中心、2期评估试验(SPIRITT研究),比较了伊立替康、氟尿嘧啶和亚叶酸钙(FOLFIRI)方案联合帕尼单抗(panitumumab)或贝伐单抗(bevacizumab)治疗基于奥沙利铂化疗+贝伐单抗治疗而病情进展不可切除的野生型KRAS转移性结直肠癌患者,最新研究成果在线发表于1月7日的Clinc

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