JAMA:CAR-T治疗:希望与挑战共存

2017-12-01 肿瘤资讯编辑部 肿瘤资讯

CAR-T细胞治疗是目前非常热门的治疗方法,其在血液肿瘤中的疗效鼓舞人心,在实体肿瘤中也做了一些探索,近期在著名的医学期刊JAMA杂志上,发表了一篇评论性文章,现总结如下:

CAR-T细胞治疗是目前非常热门的治疗方法,其在血液肿瘤中的疗效鼓舞人心,在实体肿瘤中也做了一些探索,近期在著名的医学期刊JAMA杂志上,发表了一篇评论性文章,现总结如下:

今年8月,美国FDA批准了tisagenlecleucel嵌合抗原受体T细胞(CAR-T细胞)治疗用于治疗25岁以上难治性前体B细胞ALL。每年约3100例新发前体B细胞ALL患者,15%-20%患者传统治疗无效或治疗后复发。CAR-T治疗适用于两种及两种以上治疗方案无效的人群。进行CAR-T治疗时,提取患者自身T细胞,体外进行基因修饰,使其能够识别和杀伤表达CD19抗原的白血病细胞,再回输至患者体内。

CAR-T治疗临床试验的项目牵头人,宾夕法尼亚大学血液与骨髓中心白血病专家David Porter教授认为:“tisagenlecleucel治疗的批准具有里程碑式的意义,一定程度上可以使许多年轻复发难治性ALL患者有机会获得新生”。

数月后,CAR-T治疗axicabtagene ciloleucel,用于治疗成人复发难治性弥漫大B细胞淋巴瘤(DLBCL),成为获得FDA批准的第二大基因治疗。axicabtagene ciloleucel的获批使DLBCL的治疗迈上了一个新的台阶。

尽管已经获得了许多成果,部分专家由于担心CAR-T治疗的严重不良反应以及高昂花费,对其持谨慎态度,一定程度上阻碍了CAR-T治疗的广泛应用。

早期研究

将基因工程T细胞用于治疗的设想最早可追溯至20年前,但早期基础研究的成果并未及时转化为临床试验。

随后,研究人员作出了三大努力推动CAR-T治疗领域向前发展。首先,研究人员将第二种可以刺激免疫的基因改变加入工程T细胞中。其次,研究人员发现B细胞特异性抗原CD19可以作为B细胞恶性肿瘤的理想靶点。仅B细胞表达CD19,降低了T细胞靶向作用于体内其他细胞所引起的副作用的发生率。正常B细胞和癌变B细胞都表达CD19,患者会经历正常B细胞缺乏阶段,但这是可控及可耐受的。接着,研究人员发明了CAR-T细胞快速制备技术。

tisagenlecleucel的获批基于一项单臂多中心临床研究。研究入组了88例既往治疗无效的年轻ALL患者,68例接受了tisagenlecleucel治疗。63例可进行疗效评价,治疗3个月时52例(83%)取得了缓解。部分患者可以获得持续缓解甚至可能治愈。考虑到许多患者既往接受过多种方案治疗,这一结果相当引人注目。但有专家认为,意图治疗分析夸大了最终结果。

axicabtagene ciloleucel的获批基于一项多中心ZUMA-1临床研究。101例接受治疗的患者中,52例(51%)取得了完全缓解(CR),21例(21%)取得了部分缓解(PR)。平均随访8.7个月,39%的随访患者仍然处于CR。

Porter教授提到,现有的CAR-T治疗缺乏长期随访数据,目前报道的复发率在20%-50%。他认为,许多患者可以维持缓解状态,对于数年内未显示复发迹象的患者,“认为他们可能已经被治愈。”

短短几年内,CAR-T治疗得到了迅速发展,现有研究数据表明CAR-T治疗相当有效,但仍有许多问题有待解决。

多个国家的医学中心,正在进行包括CD19以及其他靶标在内的CAR-T治疗的临床研究。截至目前已有数百例患者接受CAR-T治疗,主要为血液肿瘤患者。临床试验网站有探索将CAR-T治疗用于包括肝癌、多发性骨髓瘤、神经母细胞瘤、胰腺癌卵巢癌和间皮瘤在内的其它癌症的大量临床试验登记备案,预示着CAR-T治疗正如雨后春笋般迅速发展。

直面挑战

约25%的患者发生危及生命的严重不良反应,如何进行有效的管理是当前最严峻的挑战之一。细胞因子释放综合征(CRS)或细胞因子风暴是一种常见的不良反应。基因工程T细胞活化时,释放炎性分子,称之为细胞因子。细胞因子释放可以引起一系列症状,包括发热、低血压以及肺水肿。这些症状通常较轻,但严重者需进ICU治疗。

axicabtagene ciloleucel ZUMA-1临床研究中,半数以上的患者发生了严重不良反应,包括3级及以上感染(23%)、重度CRS(13%)以及神经毒性作用(31%)。仔细滴定CAR-T细胞数有助于降低CRS发生率。发现用于治疗关节炎的药物托珠单抗,靶向IL-6受体,减少炎症反应,可以逆转CAR-T治疗患者的CRS。CAR-T临床试验中69%的CRS患者在接受1-2个治疗量托珠单抗后,CRS在2周内可以完全消退。FDA批准托珠单抗与tisagenlecleucel联用。

肿瘤负荷高的患者似乎更容易发生重度CRS,尽早治疗可能有助于减少不良反应。另外有些原因不明的不良反应。1例患者在axicabtagene ciloleucel临床试验中死于脑肿胀。部分患者发生了原因不明的可逆性神经毒性反应。分析显示严重神经毒性的患者在血管壁上发生可以削弱血脑屏障的反应,使到达脑部的细胞因子水平升高。

在CAR-T治疗被广泛应用前,有必要减少或去除这些不良反应。需在不降低疗效的同时,提高安全性。CAR-T用于实体瘤治疗可能更具挑战性。“实体瘤具有不同的肿瘤微环境,CAR-T细胞很难到达肿瘤细胞,”Porter教授解释道。

另一项挑战在于如何找到快速生产CAR-T细胞的方法,目前制备CAR-T细胞需要数周。发明一种可以用于治疗所有患者的通用CAR-T细胞可能是一种解决办法。下一代CAR-T有望克服部分挑战。

展望

CAR-T治疗对难治性ALL患者非常有效,但花费高昂。细胞价格只是冰山一角,不包括进ICU或者控制CRS药物的花费。然而,Rosenberg教授指出,比起患者接受一种又一种高昂的治疗来说,有望治愈癌症的CAR-T细胞治疗从根本上有助于降低总花费。

目前CAR-T细胞治疗领域仍处于早期,期待其对癌症治疗产生实质性影响。

点评

CAR-T疗法尽管在血液肿瘤中取得了不错的疗效,但如何维持其长期效果,降低患者的复发率是一个重要的问题。目前CAR-T在实体肿瘤中的结果还不能令人满意,如何提高在实体肿瘤中的疗效,也是科学家们所面临的挑战。

原始出处:Bridget M. Kuehn, MSJ. The Promise and Challenges of CAR-T Gene Therapy. JAMA. November 22, 2017

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    2018-05-09 仁者大医
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    2017-12-01 1ddf0692m34(暂无匿称)

    学习了.涨知识

    0

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    2017-12-01 戒馋,懒,贪

    谢谢分享学习了

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1781199, encodeId=f21f1e81199f1, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4059, encryptionId=8ce8405907, topicName=CAR-)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Wed May 09 17:23:00 CST 2018, time=2018-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265915, encodeId=3c40265915b8, content=学习了.涨知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Fri Dec 01 10:06:24 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265889, encodeId=8a7226588939, content=谢谢分享学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM7GibvIBibibnnnvpajk2stlDF5oichYahI6Bia8uxeTBFoPbdoHWebyXf9eal9FNgUF2lNcrwoZicM3BvQ/0, createdBy=a3742066385, createdName=戒馋,懒,贪, createdTime=Fri Dec 01 08:40:56 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265875, encodeId=8b162658e533, content=谢谢分享.学习了, 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/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Fri Dec 01 08:02:46 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265858, encodeId=5334265858f9, content=谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Pw2csslt7CukWiabqiblnQAXaDEiaxhu025c3P0XshccTrbvGWBjKvnHIxbK3vqa80P7WGIFuicCFet97TicrNKpgB3TdabxP1vMh/0, createdBy=28851960965, createdName=榄枷檬, createdTime=Fri Dec 01 07:21:01 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265852, encodeId=e21726585237, content=学习.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyhb9xDeHojCicsdRdyC3XXdGk2ib9yLypZuHN06WeW4HO8WN0GGrgEfvnTX8gsckof05GHOU5OM4Mvx/0, createdBy=9cee1982656, createdName=执着追梦, createdTime=Fri Dec 01 07:08:47 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265833, encodeId=5e28265833b9, content=好好好好好好好好, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/29/bbc5cc0eed9b8d17623d2fd49dbdf19a.jpg, createdBy=79522135794, createdName=yjs木玉, createdTime=Fri Dec 01 06:08:31 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265829, encodeId=906e26582907, content=阅读.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Fri Dec 01 05:48:41 CST 2017, time=2017-12-01, status=1, ipAttribution=)]
    2017-12-01 明月清辉

    谢谢分享.学习了

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1781199, encodeId=f21f1e81199f1, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4059, encryptionId=8ce8405907, topicName=CAR-)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Wed May 09 17:23:00 CST 2018, time=2018-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265915, encodeId=3c40265915b8, content=学习了.涨知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Fri Dec 01 10:06:24 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265889, encodeId=8a7226588939, content=谢谢分享学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM7GibvIBibibnnnvpajk2stlDF5oichYahI6Bia8uxeTBFoPbdoHWebyXf9eal9FNgUF2lNcrwoZicM3BvQ/0, createdBy=a3742066385, createdName=戒馋,懒,贪, createdTime=Fri Dec 01 08:40:56 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265875, encodeId=8b162658e533, content=谢谢分享.学习了, 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/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Fri Dec 01 08:02:46 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265858, encodeId=5334265858f9, content=谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Pw2csslt7CukWiabqiblnQAXaDEiaxhu025c3P0XshccTrbvGWBjKvnHIxbK3vqa80P7WGIFuicCFet97TicrNKpgB3TdabxP1vMh/0, createdBy=28851960965, createdName=榄枷檬, createdTime=Fri Dec 01 07:21:01 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265852, encodeId=e21726585237, content=学习.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyhb9xDeHojCicsdRdyC3XXdGk2ib9yLypZuHN06WeW4HO8WN0GGrgEfvnTX8gsckof05GHOU5OM4Mvx/0, createdBy=9cee1982656, createdName=执着追梦, createdTime=Fri Dec 01 07:08:47 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265833, encodeId=5e28265833b9, content=好好好好好好好好, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/29/bbc5cc0eed9b8d17623d2fd49dbdf19a.jpg, createdBy=79522135794, createdName=yjs木玉, createdTime=Fri Dec 01 06:08:31 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265829, encodeId=906e26582907, content=阅读.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Fri Dec 01 05:48:41 CST 2017, time=2017-12-01, status=1, ipAttribution=)]
    2017-12-01 榄枷檬

    谢谢分享

    0

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    2017-12-01 执着追梦

    学习.谢谢分享

    0

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    2017-12-01 yjs木玉

    好好好好好好好好

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    2017-12-01 刘煜

    阅读.谢谢分享

    0

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