JCO:强强联合:多点位立体定向放射治疗(SBRT)+免疫治疗——转移性实体瘤治疗新策略

2018-03-05 慧语 肿瘤资讯

2018年2月13日,《JOURNAL OF CLINICAL ONCOLOGY》杂志上在线发表一项研究,介绍应用多点位立体定向放射(SBRT)与PD-1抑制剂帕姆单抗联合治疗晚期转移性实体瘤的一项I期研究,评价其安全性和临床有效性。

2018年2月13日,《JOURNAL OF CLINICAL ONCOLOGY》杂志上在线发表一项研究,介绍应用多点位立体定向放射(SBRT)与PD-1抑制剂帕姆单抗联合治疗晚期转移性实体瘤的一项I期研究,评价其安全性和临床有效性。

背景

立体定向放射治疗(SBRT)可能会刺激先天性和适应性免疫以增强机体对免疫治疗的反应。多点位SBRT是治疗转移性肿瘤疾病的新兴模式,对于低肿瘤负荷的患者而言,抗PD-1治疗效果会更佳。在此背景下,开展了一项I期研究,以评估帕姆单抗联合多位点SBRT治疗转移性实体瘤患者的安全性和临床有效性。

患者和方法

标准治疗后发生进展的患者对2至4个转移灶进行SBRT治疗,但并非所有的转移灶都需要接受照射,只有大于65mL的转移灶才进行照射。SBRT的剂量根据照射部位不同可进行调整,范围从30~50Gy,如果观察到剂量限制性毒性,在需按事先预定的剂量进行递减。在SBRT完成后7天内开始使用帕姆单抗。对部分患者SBRT前后的活检标本进行量化的基因表达分析。

结果

共有79名患者入组,3名患者未接受任何治疗,3名患者仅接受SBRT治疗。纳入分析的包括接受SBRT治疗并且至少服用一个周期帕姆单抗的患者。大多数患者只针对两个转移灶接受SBRT治疗(69/73,94.5%)。依据RECIST1.1标准,1人达到完全缓解,8人部分缓解,21人疾病稳定,38人疾病进展,图1展示了靶转移灶、照射转移灶以及未照射转移灶肿瘤缓解的瀑布图。中位随访时间为5.5个月(四分位间距,3.3至8.1个月)。6名患者发生限制性剂量毒性,但并没有降低照射剂量。影像随访的68例患者中,总体客观缓解率为13.2%。中位总生存期为9.6个月(95%CI,6.5个月-无法估计),中位无进展生存期为3.1个月(95%CI,2.9至3.4个月)(图2)。对SBRT后肿瘤活检标本的基因分析结果显示,免疫评分和颗粒酶K基因的表达与未照射转移灶的肿瘤缓解程度显着相关(图3)。



图1 肿瘤缓解的瀑布图



图2 经多位点SBRT和帕姆单抗治疗后的总生存及无病生存曲线



图3 未照射病灶的缓解与免疫评分(A)和基因表达(B)的相关性

结论和讨论

多部位SBRT后联合帕姆单抗治疗,整体耐受良好,毒性可接受。此研究也存在一定的局限性,首先入组人群间的异质性很大,其中包括多种原发癌症,并且没有全部进行PD-L1状态筛查。其次,入组患者中多数接受过大量的既往治疗,部分患者在3个月阈值的毒性终点之前死亡。再者,该研究没有比较不同SBRT剂量的效应,并未确定出刺激最佳免疫应答所需的辐射剂量。需要随机对照研究来确定联合使用SBRT和免疫治疗是否会增强疗效,同时有必要进一步研究多点位SBRT和抗PD-1联合治疗临床获益的预测生物标志物。

原始出处:
Jason J. Luke, Jeffrey M. Lemons, Theodore G. Karrison, et al. Safety and Clinical Activity of Pembrolizumab and Multisite Stereotactic Body Radiotherapy in Patients With Advanced Solid Tumors. Journal of Clinical Oncology. Published online before print February 13, 2018

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    2018-05-20 zhouqu_8
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  5. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478416, encodeId=77b014e841650, content=<a href='/topic/show?id=d1a55858e70' target=_blank style='color:#2F92EE;'>#新策略#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58587, encryptionId=d1a55858e70, topicName=新策略)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da0f7431516, createdName=12498568m52暂无昵称, createdTime=Wed Mar 07 12:39:00 CST 2018, time=2018-03-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=293519, encodeId=c9cc293519a7, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Tue Mar 06 08:56:37 CST 2018, time=2018-03-06, status=1, ipAttribution=), 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    2018-03-16 liao1632
  6. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478416, encodeId=77b014e841650, content=<a href='/topic/show?id=d1a55858e70' target=_blank style='color:#2F92EE;'>#新策略#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58587, encryptionId=d1a55858e70, topicName=新策略)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da0f7431516, createdName=12498568m52暂无昵称, createdTime=Wed Mar 07 12:39:00 CST 2018, time=2018-03-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=293519, encodeId=c9cc293519a7, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Tue Mar 06 08:56:37 CST 2018, time=2018-03-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1891491, encodeId=eec218914911b, content=<a href='/topic/show?id=25b0102e2df' target=_blank style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Tue Jan 01 04:39:00 CST 2019, time=2019-01-01, status=1, ipAttribution=)]
    2018-03-10 梦想起航ing

    不错.学习了.谢谢分享

    0

  7. 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encodeId=1bd529483697, content=不错.学习了.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/11/17/cfa76f1048392033b44c71e9bcb628d9.jpg, createdBy=096c2156900, createdName=梦想起航ing, createdTime=Sat Mar 10 10:20:49 CST 2018, time=2018-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386368, encodeId=c3421386368de, 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=26, 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=Wed Mar 07 12:39:00 CST 2018, time=2018-03-07, 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  8. 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  9. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478416, encodeId=77b014e841650, content=<a href='/topic/show?id=d1a55858e70' target=_blank style='color:#2F92EE;'>#新策略#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58587, encryptionId=d1a55858e70, topicName=新策略)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da0f7431516, createdName=12498568m52暂无昵称, createdTime=Wed Mar 07 12:39:00 CST 2018, time=2018-03-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=293519, encodeId=c9cc293519a7, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Tue Mar 06 08:56:37 CST 2018, time=2018-03-06, status=1, ipAttribution=), 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    2018-03-06 yfjms

    学习

    0

  10. 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