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PLoS One：NHS-IL12 用于恶性黑色素瘤狗的治疗窗口

2015-06-21 范伟译 MedSci原创

NHS-IL12恶性黑色素瘤药效学治疗指数
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背景：白介素(IL)-12是一种促炎细胞因子，介导辅助细胞1型反应和细胞毒T细胞活化，由于其效用可作为抗癌药剂。IL-12的系统性施药往往导致不可接受的毒性，因此，直接输送IL-12到肿瘤部位正在研究中。本研究的目的是协助NHS-IL12的临床发展，免疫细胞因子包括抗体，靶标为肿瘤坏死区域，与IL-12有关。明确本研究试图评估NHS-IL12用于自然产生癌症的狗时的安全性、血清药物动力学、抗肿瘤活

背景：白介素(IL)-12是一种促炎细胞因子，介导辅助细胞1型反应和细胞毒T细胞活化，由于其效用可作为抗癌药剂。IL-12的系统性施药往往导致不可接受的毒性，因此，直接输送IL-12到肿瘤部位正在研究中。本研究的目的是辅助NHS-IL12的临床前研究进展，NHS-IL12是一种免疫细胞因子由抗体组成，靶标为肿瘤坏死区域，与IL-12有关。本研究试图评估NHS-IL12用于自然产生癌症的狗时治疗的安全性、血清药物动力学、抗肿瘤活性、免疫调节。

方法/主要结果：黑色素瘤狗NHS-IL12皮下施药快速剂量递增的研究通过比较肿瘤试验联盟(COTC)进行。11个狗招募参加四个剂量递增组；此后，额外的七条狗接受已定义的容许剂量为0.8毫克/平方米进行治疗。扩大组在这个固定剂量(共10条狗)进一步进行药代学和药效学评价。收集NHS-IL12的水平，血清细胞因子浓度；进行外周血单核细胞鉴定(后处理)，淋巴结免疫资料收集，和肿瘤活检(预处理和后处理)。不良反应包括血小板减少，肝酶病，发烧和血管炎。干扰素(IFN)-γ感应，不良反应和NHS-IL12暴露(最大浓度和浓度-时间曲线下面积)之间的关联是剂量依赖性的。治疗后血清IL - 10的水平和瘤内的CD8 +有增加。根据实体肿瘤(RECIST)标准的反应评估标准，在两只以NHS-IL12 0.8毫克/平方米和1.6毫克/平方米治疗的狗上观察到部分反应。

结论/意义：NHS-IL12对黑色素瘤狗施药的安全性和临床活性得以确认。本研究成功地定义了通过皮下途径系统输送NHS-IL12狭窄的治疗窗口。结果将推动NHS-IL12用于癌症患者首次人体临床试验的设计和实施。

原始出处：
Paoloni M1, Mazcko C1, Selting K2, Lana S3, Barber L4, Phillips J5, Skorupski K6, Vail D7, Wilson H8, Biller B3, Avery A3, Kiupel M9, LeBlanc A1, Bernhardt A10, Brunkhorst B10, Tighe R10, Khanna C1.Defining the Pharmacodynamic Profile and Therapeutic Index of NHS-IL12 Immunocytokine in Dogs with Malignant Melanoma.PLoS One. 2015 Jun 19;10(6):e0129954. doi: 10.1371/journal.pone.0129954

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    2015-08-03 sunylz

    #色素#

    0

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    2015-08-19 124987c6m36暂无昵称

    #NHS-IL12#

    0

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    2016-05-23 119337457

    #Plos one#

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    2015-06-23 小几洁

    #NHS#

    0

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    2015-06-23 cqlidoudou

    #黑色素#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1680297, encodeId=2bdb168029ee7, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86707, encryptionId=9e5c86e0712, topicName=色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=343027846633, createdName=sunylz, createdTime=Mon Aug 03 11:22:00 CST 2015, time=2015-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1984939, encodeId=331f19849393a, content=<a href='/topic/show?id=7db712e84f4' target=_blank style='color:#2F92EE;'>#NHS-IL12#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12784, encryptionId=7db712e84f4, topicName=NHS-IL12)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=85152500072, createdName=124987c6m36暂无昵称, createdTime=Wed Aug 19 06:22:00 CST 2015, time=2015-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1789685, encodeId=d20f1e89685d5, content=<a href='/topic/show?id=6e4814388e2' target=_blank style='color:#2F92EE;'>#Plos one#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14388, encryptionId=6e4814388e2, topicName=Plos one)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fda6311, createdName=119337457, createdTime=Mon May 23 04:22:00 CST 2016, time=2016-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1515242, encodeId=140c151524228, content=<a href='/topic/show?id=402a12e83da' target=_blank style='color:#2F92EE;'>#NHS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12783, encryptionId=402a12e83da, topicName=NHS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=626110750337, createdName=小几洁, createdTime=Tue Jun 23 12:22:00 CST 2015, time=2015-06-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558712, encodeId=ebfb1558e1271, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Tue Jun 23 12:22:00 CST 2015, time=2015-06-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564721, encodeId=d9a11564e21ae, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Tue Jun 23 12:22:00 CST 2015, time=2015-06-23, status=1, ipAttribution=)]
    2015-06-23 cqlidoudou

    #黑色素#

    0