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NEJM:Axicabtagene Ciloleucel作为大B细胞淋巴瘤二线治疗的效果如何?

2022-02-17 MedSci原创 MedSci原创

与标准治疗相比,Axi-cel治疗显著改善了早期复发或难治性大B细胞淋巴瘤患者无事件生存期和治疗反应,但伴有预期的高毒性水平。

接受一线化学免疫治疗的早期复发或难治性大B细胞淋巴瘤患者预后较差。

近日,顶级医学期刊N Engl J Med上发表了一篇研究文章,研究人员进行了一项国际3期试验。受试者以1:1的比例随机分配接受Axicabtagene ciloleucel(axi-cel,一种自体抗CD19嵌合抗原受体T细胞疗法)或标准护理(研究者选择且方案明确的化学免疫疗法治疗两个或三个周期,然后对有反应的患者进行高剂量化疗和自体干细胞移植化学免疫疗法)。

该研究的主要终点是无事件生存期,该研究的关键次要终点是治疗反应和总生存期。研究人员还评估了这一治疗的安全性。

该研究共有180名患者被随机分配接受axi-cel治疗,179名患者接受标准治疗。无事件生存期的主要终点分析表明,axi-cel治疗优于标准治疗。在中位随访24.9个月时,axi-cel组的中位无事件生存期为8.3个月,标准治疗组为2.0个月,24个月的无事件生存期分别为41%和16%(事件或死亡的风险比为0.40;95%置信区间为0.31至0.51;P<0.001)。axi-cel组中83%的患者和标准治疗组中50%的患者出现缓解(分别有65%和32%的患者完全缓解)。在一项中期分析中,axi-cel组的2年估计总生存率为61%,标准治疗组为52%。91%的接受axi-cel的患者和83%的接受标准治疗的患者发生了3级或更高级别的不良事件。在接受axi-cel的患者中,3级或更高级别的细胞因子释放综合征发生率为6%,3级或更高级别的神经系统事件发生率为21%。没有发生与细胞因子释放综合征或神经系统事件相关的死亡。

由此可见,与标准治疗相比,Axi-cel治疗显著改善了早期复发或难治性大B细胞淋巴瘤患者无事件生存期和治疗反应,但伴有预期的高毒性水平。

原始出处:
 
Frederick L. Locke,et al.Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma.NEJM.2022.https://www.nejm.org/doi/full/10.1056/NEJMoa2116133

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1702707, encodeId=65161e027077e, content=<a href='/topic/show?id=ddc9e795159' target=_blank style='color:#2F92EE;'>#细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77951, encryptionId=ddc9e795159, topicName=细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=201630414353, createdName=marlenexl, createdTime=Sat Mar 12 20:20:40 CST 2022, time=2022-03-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2049407, encodeId=1698204940e0f, content=<a href='/topic/show?id=4363e929ad' target=_blank style='color:#2F92EE;'>#Gene#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7929, encryptionId=4363e929ad, topicName=Gene)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=63a4277, createdName=cy0324, createdTime=Tue Jun 21 22:20:40 CST 2022, time=2022-06-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1962698, encodeId=e9f71962698ad, content=<a href='/topic/show?id=dbe6445416' target=_blank style='color:#2F92EE;'>#CEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4454, encryptionId=dbe6445416, topicName=CEL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Fri Apr 01 02:20:40 CST 2022, time=2022-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1273425, encodeId=e3b012e34259e, content=<a href='/topic/show?id=310d383ef5' target=_blank style='color:#2F92EE;'>#B细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3837, encryptionId=310d383ef5, topicName=B细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eba113, createdName=xiaoyeshuang, createdTime=Fri Feb 18 23:20:40 CST 2022, time=2022-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1543986, encodeId=4206154398672, content=<a href='/topic/show?id=02982402298' target=_blank style='color:#2F92EE;'>#二线治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=24022, encryptionId=02982402298, topicName=二线治疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=520213623738, createdName=ms5768352621950538, createdTime=Fri Feb 18 23:20:40 CST 2022, time=2022-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1194498, encodeId=dd2c119449836, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=92516505448, createdName=ms5000000338578199, createdTime=Thu Feb 17 16:37:32 CST 2022, time=2022-02-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1194343, encodeId=4ee2119434323, content=<a href='/topic/show?id=0d3240e64e' target=_blank style='color:#2F92EE;'>#CAR-T细胞治疗#</a>又出结果,24个月EFS能超过40%,还是相当不错的。中位无事件生存期为8.3个月,意味着大量的人在早期出现复发,如果不复发,则十分稳定,能达24个月,预期有可能随着随访增加,还会延长。也许这个40%能持续36个月,甚至更长!, beContent=null, objectType=article, channel=null, level=null, likeNumber=135, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4076, encryptionId=0d3240e64e, topicName=CAR-T细胞治疗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=医者仁者, createdTime=Thu Feb 17 09:39:08 CST 2022, time=2022-02-17, status=1, ipAttribution=)]
  2. [GetPortalCommentsPageByObjectIdResponse(id=1702707, encodeId=65161e027077e, content=<a href='/topic/show?id=ddc9e795159' target=_blank style='color:#2F92EE;'>#细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77951, encryptionId=ddc9e795159, topicName=细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=201630414353, createdName=marlenexl, createdTime=Sat Mar 12 20:20:40 CST 2022, time=2022-03-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2049407, encodeId=1698204940e0f, content=<a href='/topic/show?id=4363e929ad' target=_blank style='color:#2F92EE;'>#Gene#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7929, encryptionId=4363e929ad, topicName=Gene)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=63a4277, createdName=cy0324, createdTime=Tue Jun 21 22:20:40 CST 2022, time=2022-06-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1962698, encodeId=e9f71962698ad, content=<a href='/topic/show?id=dbe6445416' target=_blank style='color:#2F92EE;'>#CEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4454, encryptionId=dbe6445416, topicName=CEL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Fri Apr 01 02:20:40 CST 2022, time=2022-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1273425, encodeId=e3b012e34259e, content=<a href='/topic/show?id=310d383ef5' target=_blank style='color:#2F92EE;'>#B细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3837, encryptionId=310d383ef5, topicName=B细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eba113, createdName=xiaoyeshuang, createdTime=Fri Feb 18 23:20:40 CST 2022, time=2022-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1543986, encodeId=4206154398672, content=<a href='/topic/show?id=02982402298' target=_blank style='color:#2F92EE;'>#二线治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=24022, encryptionId=02982402298, topicName=二线治疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=520213623738, createdName=ms5768352621950538, createdTime=Fri Feb 18 23:20:40 CST 2022, time=2022-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1194498, encodeId=dd2c119449836, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=92516505448, createdName=ms5000000338578199, createdTime=Thu Feb 17 16:37:32 CST 2022, time=2022-02-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1194343, encodeId=4ee2119434323, content=<a href='/topic/show?id=0d3240e64e' target=_blank style='color:#2F92EE;'>#CAR-T细胞治疗#</a>又出结果,24个月EFS能超过40%,还是相当不错的。中位无事件生存期为8.3个月,意味着大量的人在早期出现复发,如果不复发,则十分稳定,能达24个月,预期有可能随着随访增加,还会延长。也许这个40%能持续36个月,甚至更长!, beContent=null, objectType=article, channel=null, level=null, likeNumber=135, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4076, encryptionId=0d3240e64e, topicName=CAR-T细胞治疗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=医者仁者, createdTime=Thu Feb 17 09:39:08 CST 2022, time=2022-02-17, status=1, ipAttribution=)]
    2022-06-21 cy0324
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    2022-04-01 维他命
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  5. [GetPortalCommentsPageByObjectIdResponse(id=1702707, encodeId=65161e027077e, content=<a href='/topic/show?id=ddc9e795159' target=_blank style='color:#2F92EE;'>#细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77951, encryptionId=ddc9e795159, topicName=细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=201630414353, createdName=marlenexl, createdTime=Sat Mar 12 20:20:40 CST 2022, time=2022-03-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2049407, encodeId=1698204940e0f, content=<a href='/topic/show?id=4363e929ad' target=_blank style='color:#2F92EE;'>#Gene#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7929, encryptionId=4363e929ad, topicName=Gene)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=63a4277, createdName=cy0324, createdTime=Tue Jun 21 22:20:40 CST 2022, time=2022-06-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1962698, encodeId=e9f71962698ad, content=<a href='/topic/show?id=dbe6445416' target=_blank style='color:#2F92EE;'>#CEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4454, encryptionId=dbe6445416, topicName=CEL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Fri Apr 01 02:20:40 CST 2022, time=2022-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1273425, encodeId=e3b012e34259e, content=<a href='/topic/show?id=310d383ef5' target=_blank style='color:#2F92EE;'>#B细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3837, encryptionId=310d383ef5, topicName=B细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eba113, createdName=xiaoyeshuang, createdTime=Fri Feb 18 23:20:40 CST 2022, time=2022-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1543986, encodeId=4206154398672, content=<a href='/topic/show?id=02982402298' target=_blank style='color:#2F92EE;'>#二线治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=24022, encryptionId=02982402298, topicName=二线治疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=520213623738, createdName=ms5768352621950538, createdTime=Fri Feb 18 23:20:40 CST 2022, time=2022-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1194498, encodeId=dd2c119449836, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=92516505448, createdName=ms5000000338578199, createdTime=Thu Feb 17 16:37:32 CST 2022, time=2022-02-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1194343, encodeId=4ee2119434323, content=<a href='/topic/show?id=0d3240e64e' target=_blank style='color:#2F92EE;'>#CAR-T细胞治疗#</a>又出结果,24个月EFS能超过40%,还是相当不错的。中位无事件生存期为8.3个月,意味着大量的人在早期出现复发,如果不复发,则十分稳定,能达24个月,预期有可能随着随访增加,还会延长。也许这个40%能持续36个月,甚至更长!, beContent=null, objectType=article, channel=null, level=null, likeNumber=135, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4076, encryptionId=0d3240e64e, topicName=CAR-T细胞治疗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=医者仁者, createdTime=Thu Feb 17 09:39:08 CST 2022, time=2022-02-17, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1702707, encodeId=65161e027077e, content=<a href='/topic/show?id=ddc9e795159' target=_blank style='color:#2F92EE;'>#细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77951, encryptionId=ddc9e795159, topicName=细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=201630414353, createdName=marlenexl, createdTime=Sat Mar 12 20:20:40 CST 2022, time=2022-03-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2049407, encodeId=1698204940e0f, content=<a href='/topic/show?id=4363e929ad' target=_blank style='color:#2F92EE;'>#Gene#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7929, encryptionId=4363e929ad, topicName=Gene)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=63a4277, createdName=cy0324, createdTime=Tue Jun 21 22:20:40 CST 2022, time=2022-06-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1962698, encodeId=e9f71962698ad, content=<a href='/topic/show?id=dbe6445416' target=_blank style='color:#2F92EE;'>#CEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4454, encryptionId=dbe6445416, topicName=CEL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Fri Apr 01 02:20:40 CST 2022, time=2022-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1273425, encodeId=e3b012e34259e, content=<a href='/topic/show?id=310d383ef5' target=_blank style='color:#2F92EE;'>#B细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3837, encryptionId=310d383ef5, topicName=B细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eba113, createdName=xiaoyeshuang, createdTime=Fri Feb 18 23:20:40 CST 2022, time=2022-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1543986, encodeId=4206154398672, content=<a href='/topic/show?id=02982402298' target=_blank style='color:#2F92EE;'>#二线治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=24022, encryptionId=02982402298, topicName=二线治疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=520213623738, createdName=ms5768352621950538, createdTime=Fri Feb 18 23:20:40 CST 2022, time=2022-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1194498, encodeId=dd2c119449836, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=92516505448, createdName=ms5000000338578199, createdTime=Thu Feb 17 16:37:32 CST 2022, time=2022-02-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1194343, encodeId=4ee2119434323, content=<a href='/topic/show?id=0d3240e64e' target=_blank style='color:#2F92EE;'>#CAR-T细胞治疗#</a>又出结果,24个月EFS能超过40%,还是相当不错的。中位无事件生存期为8.3个月,意味着大量的人在早期出现复发,如果不复发,则十分稳定,能达24个月,预期有可能随着随访增加,还会延长。也许这个40%能持续36个月,甚至更长!, beContent=null, objectType=article, channel=null, level=null, likeNumber=135, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4076, encryptionId=0d3240e64e, topicName=CAR-T细胞治疗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=医者仁者, createdTime=Thu Feb 17 09:39:08 CST 2022, time=2022-02-17, status=1, ipAttribution=)]
    2022-02-17 ms5000000338578199

    学习了

    0

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    2022-02-17 医者仁者

    #CAR-T细胞治疗#又出结果,24个月EFS能超过40%,还是相当不错的。中位无事件生存期为8.3个月,意味着大量的人在早期出现复发,如果不复发,则十分稳定,能达24个月,预期有可能随着随访增加,还会延长。也许这个40%能持续36个月,甚至更长!

    0

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