Autophagy:氯喹联合放疗和替莫唑胺治疗胶质母细胞瘤:IB期试验

2020-09-01 haibei MedSci原创

研究人员在Autophagy杂志发布了一项临床试验结果,该研究是首次探讨氯喹联合放疗和替莫唑胺对新诊断胶质母细胞瘤患者的安全性、药代动力学和最大耐受剂量。

胶质母细胞瘤(GBM)是最常见的恶性原发性脑肿瘤,在欧洲的发病率估计为4.27/100.000。尽管目前对患者进行了广泛的手术、放疗和替莫唑胺(TMZ)治疗,但预后仍较差,中位总生存期(OS)约为15个月,5年OS为5%-10%。此外,放疗剂量升级、靶向药物和免疫治疗等预期改善预后的尝试都没有改变GBM惨淡的预后。

已有的研究显示,GBM是人类最异质的肿瘤之一,具有主要的瘤间和瘤内变异。分子生物标志物如MGMT(O-6-甲基鸟嘌呤DNA甲基转移酶)启动子甲基化、1p/19q共缺失和IDH1/2(异柠檬酸脱氢酶(NADP(+))1/2)突变可显著预测患者生存率。此外,EGFRvIII(表皮生长因子受体突变III型)的表达与不良预后相关,而这种基因型在50 - 60%的EGFR基因扩增的肿瘤中被观察到。

溶酶体药物氯喹(CQ)是一种4-氨基喹啉,常用于预防和治疗疟疾、类风湿性关节炎、肝阿米巴病、肉芽肿病和红斑狼疮。CQ积聚在溶酶体中,可以提高溶酶体内的pH值,阻止自噬体-溶酶体融合,这对自噬至关重要。

越来越多的临床前证据表明,缺氧细胞依靠自噬生存,用CQ抑制自噬可以增强GBM的放疗和化疗细胞毒性。此外,有证据表明,CQ通过NOTCH1信号介导血管正常化,改善瘤内血管的结构和功能特征,从而降低肿瘤缺氧程度。

已有的临床前数据显示,由于自噬依赖性,表达EGFRvIII的胶质母细胞瘤可能从氯喹中获益最大。

最近,研究人员在Autophagy杂志发布了一项临床试验结果,该研究是首次探讨氯喹联合放疗和替莫唑胺对新诊断胶质母细胞瘤患者的安全性、药代动力学和最大耐受剂量。

该研究是一项单中心、开放标签、剂量测定的I期试验。患者从化放疗疗程前一周开始每日口服氯喹(替莫唑胺75 mg/m2/d),直至放疗(59.4 Gy/33分次)结束。

共有13名患者被纳入研究(n = 6:200 mg,n = 3:300 mg,n = 4:400 mg氯喹)。

该研究共登记了44个不良事件,可能与氯喹有关,包括心电图QTc延长、不可逆的视力模糊和恶心/呕吐,导致停止使用替莫唑胺或推迟辅助治疗周期。

研究表明,氯喹的最大耐受剂量为200mg。中位总生存期为16个月(范围2-32)。EGFRvIII-患者的中位生存期为11.5个月,EGFRvIII+患者为20个月。

因此,联合放疗和替莫唑胺时,新诊断的胶质母细胞瘤患者每日氯喹的最大耐受剂量是200mg。有利的毒性和有希望的总生存期支持进一步的临床研究。

 

 

原始出处:

Inge Compter et al. Chloroquine combined with concurrent radiotherapy and temozolomide for newly diagnosed glioblastoma: a phase IB trial. AUTOPHAGY (2020). DOI: https://doi.org/10.1080/15548627.2020.1816343

 

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    2020-09-16 bioon3
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  6. 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href='/topic/show?id=9fd96409189' target=_blank style='color:#2F92EE;'>#氯喹#</a>中获益最大,这仅仅是1B试验,建议国内专家应该开展这样的研究:对于GBM,使用放疗和<a href='/topic/show?id=6a1c60356fb' target=_blank style='color:#2F92EE;'>#替莫唑胺#</a>之外,增加<a href='/topic/show?id=ee7b800133e' target=_blank style='color:#2F92EE;'>#羟氯喹#</a>(安全性好很多),当然也可以联合paxalisib进行治疗。, beContent=null, objectType=article, channel=null, level=null, likeNumber=305, replyNumber=1, topicName=null, topicId=null, topicList=[TopicDto(id=84064, encryptionId=01858406438, topicName=胶质母细胞瘤), TopicDto(id=64091, encryptionId=9fd96409189, topicName=氯喹), TopicDto(id=60356, encryptionId=6a1c60356fb, topicName=替莫唑胺), TopicDto(id=80013, encryptionId=ee7b800133e, topicName=羟氯喹)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Tue Sep 01 13:16:17 CST 2020, time=2020-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881847, encodeId=8b7788184ea7, content=老药新用, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7ced1734358, createdName=1def5843m65(暂无匿称), createdTime=Tue Sep 01 19:24:36 CST 2020, time=2020-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881828, encodeId=9472881828d5, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/icLAWkJCK7qiaEesKXugHe7j9KdIuA0H6Hqq6Jgz8alianumGnI9JTGiaIPyxIDHm132G8Mt9t8aT9WeoqIicaTmF5w/132, createdBy=553a2149451, createdName=琳紫, createdTime=Tue Sep 01 16:46:01 CST 2020, time=2020-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881802, encodeId=e11c881802e3, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Tue Sep 01 16:00:17 CST 2020, time=2020-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=881796, encodeId=b301881e962f, content=1, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=efb05136804, createdName=14669b93m32暂无昵称, createdTime=Tue Sep 01 15:32:36 CST 2020, time=2020-09-01, status=1, ipAttribution=)]
    2020-09-01 lovetcm

    表达EGFRvIII的#胶质母细胞瘤#可能从#氯喹#中获益最大,这仅仅是1B试验,建议国内专家应该开展这样的研究:对于GBM,使用放疗和#替莫唑胺#之外,增加#羟氯喹#(安全性好很多),当然也可以联合paxalisib进行治疗。

    1

    展开1条回复
  7. 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createdName=huperzia, createdTime=Sat Nov 28 08:58:07 CST 2020, time=2020-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2055388, encodeId=8978205538867, content=<a href='/topic/show?id=9d8b80e07c1' target=_blank style='color:#2F92EE;'>#联合放疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80707, encryptionId=9d8b80e07c1, topicName=联合放疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aa0e14, createdName=lifestar, createdTime=Fri Jan 22 07:58:07 CST 2021, time=2021-01-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2052935, encodeId=b4362052935e1, content=<a href='/topic/show?id=ae848406335' target=_blank style='color:#2F92EE;'>#胶质母细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84063, 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href='/topic/show?id=9fd96409189' target=_blank style='color:#2F92EE;'>#氯喹#</a>中获益最大,这仅仅是1B试验,建议国内专家应该开展这样的研究:对于GBM,使用放疗和<a href='/topic/show?id=6a1c60356fb' target=_blank style='color:#2F92EE;'>#替莫唑胺#</a>之外,增加<a href='/topic/show?id=ee7b800133e' target=_blank style='color:#2F92EE;'>#羟氯喹#</a>(安全性好很多),当然也可以联合paxalisib进行治疗。, beContent=null, objectType=article, channel=null, level=null, likeNumber=305, replyNumber=1, topicName=null, topicId=null, topicList=[TopicDto(id=84064, encryptionId=01858406438, topicName=胶质母细胞瘤), TopicDto(id=64091, encryptionId=9fd96409189, topicName=氯喹), TopicDto(id=60356, encryptionId=6a1c60356fb, topicName=替莫唑胺), TopicDto(id=80013, encryptionId=ee7b800133e, topicName=羟氯喹)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Tue Sep 01 13:16:17 CST 2020, time=2020-09-01, status=1, ipAttribution=), 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    2020-09-01 1def5843m65(暂无匿称)

    老药新用

    0

  8. 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    2020-09-01 琳紫

    学习了

    0

  9. 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    2020-09-01 14818eb4m67暂无昵称

    学习

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