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Lancet Oncol:CPI-613用于转移性胰腺癌I期临床结果

2017-05-09 zhangfan MedSci原创

CPI-613最大耐受剂量为500 mg/m2,其联合FOLFIRINOX化疗用于转移性胰腺癌的II期临床试验即将开展

目前胰腺癌的治疗结果令人沮丧:5年生存率小于10%,超过50%的患者表现为转移性疾病。近年来胰腺癌代谢重编程是一个新兴治疗靶点。CPI-613是一种新型的在研抗癌药物,选择性的改变肿瘤细胞中线粒体能量代谢,引起线粒体酶活性和氧化还原状态的改变,导致肿瘤细胞凋亡、坏死和自噬。近日研究人员公布了CPI-613联合FOLFIRINOX化疗(奥沙利铂、亚叶酸、氟尿嘧啶、伊立替康)在转移性胰腺癌患者中的安全性。

在这项剂量递增I期试验中,招募的患者为成年新诊断的转移性胰腺癌。患者骨髓、肝肾功能良好。研究使用的治疗药物为CPI-613联合改良的FOLFIRINOX化疗(奥沙利铂65 mg/m2,甲酰四氢叶酸400 mg/m2,伊立替康140 mg/m2,氟尿嘧啶400 mg/m2)。剂量递增试验分为2个阶段:第1阶段为单例病人阶段,初始CPI-613剂量为500 mg/m2每天,若4周内无2级以上的不良事件则剂量加倍;第2阶段为3+3剂量增加试验。研究主要目的是确定CPI-613的最大耐受剂量。

研究于2013-2016年进行,招募20名患者。最大CPI-613耐受剂量为500 mg/m2,在最大耐受剂量给予的治疗周期的中位数为11,在最大耐受剂量下18例患者中位随访时间为378天,2名患者在1000 mg/m2的剂量下表现出限制性毒性。预期的严重不良事件包括:血小板减少,贫血,淋巴细胞减少(2例);高血糖(7例);低钾血症、低蛋白血症、败血症(11例);中性粒细胞减少(20例)。对18例患者给予最大耐受剂量时最常见的3-4级非血液学不良事件高血糖(10例[ 55% ]),低血钾(6例[ 33% ]),外周感觉神经病变(5例[ 28% ]),腹泻(5例[ 28% ]),腹痛(4例[ 22% ])。最常见的3级-4血液学不良反应为中性粒细胞减少(5例[ 28% ]),淋巴细胞减少(5例[ 28% ]),贫血(4例[ 22% ])和血小板减少(3例[ 17% ])。感觉神经病变发生17例(94%)。无因不良事件导致的死亡,但治疗中11例患者死于胰腺癌。8例接受最大耐受剂量患者,11名(61%)表现出客观(完全或部分)治疗应答。

研究认为,CPI-613最大耐受剂量为500 mg/m2,其联合FOLFIRINOX化疗用于转移性胰腺癌的II期临床试验即将开展。

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    2018-03-22 swallow
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    2017-07-29 minlingfeng
  3. 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CST 2017, time=2017-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=195803, encodeId=d5fa195803a2, content=学习了,感谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=60791943465, createdName=1e0f8808m18(暂无匿称), createdTime=Tue May 09 11:27:25 CST 2017, time=2017-05-09, status=1, ipAttribution=)]
    2018-03-11 howi
  4. 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  5. 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  6. 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content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Thu May 11 00:22:00 CST 2017, time=2017-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1390217, encodeId=21b8139021e10, content=<a href='/topic/show?id=8c36934354a' target=_blank style='color:#2F92EE;'>#转移性胰腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93435, encryptionId=8c36934354a, topicName=转移性胰腺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a5002500055, createdName=124986d2m09暂无昵称, createdTime=Thu May 11 00:22:00 CST 2017, time=2017-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=195803, encodeId=d5fa195803a2, content=学习了,感谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=60791943465, createdName=1e0f8808m18(暂无匿称), createdTime=Tue May 09 11:27:25 CST 2017, time=2017-05-09, status=1, ipAttribution=)]
    2017-05-29 laoli

    学习了,谢谢分享!

    0

  7. 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content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Thu May 11 00:22:00 CST 2017, time=2017-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1390217, encodeId=21b8139021e10, content=<a href='/topic/show?id=8c36934354a' target=_blank style='color:#2F92EE;'>#转移性胰腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93435, encryptionId=8c36934354a, topicName=转移性胰腺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a5002500055, createdName=124986d2m09暂无昵称, createdTime=Thu May 11 00:22:00 CST 2017, time=2017-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=195803, encodeId=d5fa195803a2, content=学习了,感谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=60791943465, createdName=1e0f8808m18(暂无匿称), createdTime=Tue May 09 11:27:25 CST 2017, time=2017-05-09, status=1, ipAttribution=)]
    2017-05-11 ylzr123

    感谢小编为我们精心准备了如此精辟的精神大餐,小编辛苦了,点个赞吧!

    0

  8. 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  9. 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  10. 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content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Thu May 11 00:22:00 CST 2017, time=2017-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1390217, encodeId=21b8139021e10, content=<a href='/topic/show?id=8c36934354a' target=_blank style='color:#2F92EE;'>#转移性胰腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93435, encryptionId=8c36934354a, topicName=转移性胰腺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a5002500055, createdName=124986d2m09暂无昵称, createdTime=Thu May 11 00:22:00 CST 2017, time=2017-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=195803, encodeId=d5fa195803a2, content=学习了,感谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=60791943465, createdName=1e0f8808m18(暂无匿称), createdTime=Tue May 09 11:27:25 CST 2017, time=2017-05-09, status=1, ipAttribution=)]
    2017-05-09 1e0f8808m18(暂无匿称)

    学习了,感谢分享。

    0

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