2018 ESMO:沈琳教授团队专访:突破神经内分泌肿瘤疗效瓶颈,免疫治疗任重而道远

2018-10-29 佚名 肿瘤资讯

近日,2018 ESMO大会在德国慕尼黑隆重召开。在本次ESMO大会上,由北京大学肿瘤医院沈琳教授牵头的JS001治疗晚期神经内分泌肿瘤的IB期研究的结果得以口头报告公布。JS001是我国君实生物自主研发具有全球知识产权的重组人源化PD-1单抗,前期临床研究表明JS001在多个瘤种中均具有一定疗效。特别采访到沈琳教授及其团队的李洁教授和张盼盼博士,共同解读与探讨这项研究的结果。

近日,2018 ESMO大会在德国慕尼黑隆重召开。在本次ESMO大会上,由北京大学肿瘤医院沈琳教授牵头的JS001治疗晚期神经内分泌肿瘤的IB期研究的结果得以口头报告公布。JS001是我国君实生物自主研发具有全球知识产权的重组人源化PD-1单抗,前期临床研究表明JS001在多个瘤种中均具有一定疗效。特别采访到沈琳教授及其团队的李洁教授和张盼盼博士,共同解读与探讨这项研究的结果。

沈琳教授、博导、主任医师/北京肿瘤医院副院长/北京市肿瘤防治研究所副所长/消化肿瘤内科主任/I期临床病房主任/任中国抗癌协会肿瘤药物临床研究专业委员会主任委员/中国医师协会外科医师分会MDT专委会主任委员/中国抗癌协会癌专业委员会秘书长及内科组组长/中国抗癌协会大肠癌专业委员会副主任委员/中国抗癌协会肿瘤精准治疗专委会候任主任委员等职务/一直致力于消化系统肿瘤精准药物治疗、抗肿瘤新药的I-IV期临床试验与基础转化研究,担任科技部国家重点研发计划“癌靶向治疗新技术研究”项目首席专家。

李洁教授、主任医师/北京大学肿瘤医院/中国老年学学会老年肿瘤专业委员会执行委员会委员/中国老年学学会老年肿瘤专业委员会胃肠分委会常务委员/中国女医师协会临床肿瘤学专家委员会常务委员/中国抗癌协会胃癌专业委员会青年委员/中国临床肿瘤学会胃肠神经内分泌瘤专家委员会委员

张盼盼医学博士北京大学肿瘤医院 /北京大学医学部肿瘤学院 博士研究生/北京大学肿瘤医院消化肿瘤内科 医师 研究领域 胃肠胰神经内分泌肿瘤多学科诊疗/胃肠胰神经内分泌肿瘤分子遗传学以第一作者发表论着近10篇,参译医学专着2本。荷兰Erasmus MC中心交流学习。

复发或转移性神经内分泌肿瘤属于相对罕见肿瘤。介绍一下复发或转移性神经内分泌肿瘤的治疗现状和面临的挑战

神经内分泌肿瘤被认为是一类发病率较低的罕见肿瘤,但近年确实发病在增加,我们收治的新发病例越来越多。而目前,不论是分化好的神经内分泌瘤还是分化差的神经内分泌癌,其治疗选择和药物仍然有限,例如针对分化好的神经内分泌瘤可以选择的生长抑素类似物,靶向药物伊维莫司、舒尼替尼等,对一线化疗进展的分化差的神经内分泌癌的后续治疗尚无标准方案。近年来,免疫检查点抑制剂相关研究异常火爆,在Keynote-028研究中进行了神经内分泌肿瘤治疗的初步尝试。我们团队也参与了一些免疫检查点抑制剂的临床研究,在一些不限瘤种的I期试验中入组了少量神经内分泌肿瘤患者,观察到一定的疗效。基于现有资料,我们团队希望开展PD-1单抗JS001治疗神经内分泌肿瘤的临床试验来探索其疗效,因此设计了这一ⅠB期研究。

本次的ESMO大会报道了抗PD-1单抗JS001治疗晚期神经内分泌肿瘤的非随机、开放IB期研究的结果。该研究过程中遇到的哪些困难?

神经内分泌肿瘤是一类可以发生在多种器官的肿瘤,而不仅限于消化系统,还包括胸部的肺、纵隔以及其它各个系统。本研究入组的患者,肿瘤病灶多来自于胃肠以外的器官,包括胰腺和其它多器官来源的神经内分泌肿瘤。虽然神经内分泌肿瘤的异质性很强,但不同原发部位的肿瘤有着不同的免疫环境,其生物学特征也会有所不同。因此在选择患者时,首先要弄清肿瘤的原发部位、生物学特征等,我们这个PD-1单抗的研究所入组的患者为常规治疗失败(包括生长抑素类似物、靶向药物以及化疗),即二/三线甚至多线治疗失败的患者,目前患者的选择方面暂无规律可循,仅有小样本报道,因此是一个重点研究问题,在研究开展过程中,李洁教授、陆明教授都努力做了很多工作,包括患者的初筛、患者的特征搜集、一般状况及试验质量的把控和治疗过程中的问题处理,体现了团队合作的重要性。本次ESMO大会由张盼盼博士进行口头报告,她是整个会场最年轻的讲者之一。当我们重新审视相关文献及自己的研究结果时,会有很多收获与提升。而且能与众多国外专家同台沟通交流,也得到很多锻炼与成长,这对于肿瘤内分泌肿瘤这一学科的可持续发展具有很大的帮助。未来,我们还会遇到一个又一个的困难,需要继续努力,克服难关。

基于JS001治疗神经内分泌肿瘤的研究结果,其疗效并不算非常好,但通过亚组分析中观察到PD-L1阳性与阴性患者的疗效差别,不同原发部位的肿瘤也存在疗效差别,因此PD-L1阳性可能是JS001疗效阳性的标记物。但是,神经内分泌肿瘤的免疫治疗Biomarker的探索还有很长的路要走,未来仍需开展相关的转化医学研究。另外,联合治疗方案如免疫治疗联合PRRT疗法、靶向药物或抗血管生成药物等,或许能为患者带来更好的生存的获益。两位教授,请你们也谈谈抗PD-1单抗JS001治疗晚期神经内分泌肿瘤的前景展望?

今天在ESMO现场,K. Oberg教授的点评也提到了盼盼博士所说的问题,有些观点我也十分同意,但是有些见解现在仍未能下定论。神经内分泌肿瘤的免疫治疗,未来的路还很长而且将会非常困难。但是不管怎样,目前的研究结果表明免疫检查点抑制剂对部分患者是有效的,只是对于胃肠道的神经内分泌肿瘤的疗效不太好,但是对于胃肠以外的肿瘤是否有效,是我们未来需要探索的。对于Biomarker的探索,包括我们正在研究的PD-L1,包括TMB、TIM3和CD8等,未来都能嫁接到神经内分泌肿瘤的免疫治疗研究中。对于异质性特别强的神经内分泌肿瘤,我们必须要找准靶人群,才考虑如何开展药物联合,如联合化疗药、抗血管生成药,甚至与在中国刚刚起步的PRRT疗法联合。基于中国的治疗现状与诊疗常规,目前开展一个全国多中心研究还是比较困难,但努力开展中国特有的能够可及的药物临床研究是非常重要的。未来的路还很长,需要大家有兴趣、有信心去完成。今天我们的研究结果是encouraging result,我们有信心继续前进。

本次ESMO大会上,各个session都涉及到免疫治疗这一领域,我认为其应用与人群的精准选择关系密切。正如沈院长提到的,找准人群、筛选Biomarker,才能继续深入研究。未来的路也许很难,但总得有人去尝试、去做,我们要思考如何尽可能地少走弯路。

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  3. [GetPortalCommentsPageByObjectIdResponse(id=1763493, encodeId=c7eb1e6349349, content=<a href='/topic/show?id=3fc83035361' target=_blank style='color:#2F92EE;'>#内分泌肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30353, encryptionId=3fc83035361, topicName=内分泌肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=763a37536718, createdName=1249898am27暂无昵称, createdTime=Mon May 13 09:27:00 CST 2019, time=2019-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1953737, encodeId=0c121953e37f0, content=<a href='/topic/show?id=9bdbe41946e' target=_blank style='color:#2F92EE;'>#神经内分泌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74194, encryptionId=9bdbe41946e, topicName=神经内分泌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8143398, createdName=lily1616, createdTime=Sat Jun 29 22:27:00 CST 2019, time=2019-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1682474, encodeId=f82a16824e4a7, content=<a href='/topic/show?id=d4d031e8074' target=_blank style='color:#2F92EE;'>#分泌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=31780, encryptionId=d4d031e8074, topicName=分泌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0da227938338, createdName=gwc392, createdTime=Thu Jan 24 04:27:00 CST 2019, time=2019-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2024825, encodeId=8ea420248254e, content=<a href='/topic/show?id=c27516459de' target=_blank style='color:#2F92EE;'>#SMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16459, encryptionId=c27516459de, topicName=SMO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6779163, createdName=liuhuangbo, createdTime=Mon Aug 26 07:27:00 CST 2019, time=2019-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1703313, encodeId=46e01e0331376, content=<a href='/topic/show?id=dba720e31b7' target=_blank style='color:#2F92EE;'>#专访#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20731, encryptionId=dba720e31b7, topicName=专访)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=070a30497323, createdName=flyingeagle87, createdTime=Sun Aug 18 09:27:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1280970, encodeId=6c8c12809e0d1, content=<a href='/topic/show?id=50d6e0215a' target=_blank style='color:#2F92EE;'>#ESMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7021, encryptionId=50d6e0215a, topicName=ESMO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7460166, createdName=zhang92560, createdTime=Wed Oct 31 06:27:00 CST 2018, time=2018-10-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1031955, encodeId=c8a9103195512, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon Oct 29 18:27:00 CST 2018, time=2018-10-29, status=1, ipAttribution=)]
    2019-01-24 gwc392
  4. [GetPortalCommentsPageByObjectIdResponse(id=1763493, encodeId=c7eb1e6349349, content=<a href='/topic/show?id=3fc83035361' target=_blank style='color:#2F92EE;'>#内分泌肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30353, encryptionId=3fc83035361, topicName=内分泌肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=763a37536718, createdName=1249898am27暂无昵称, createdTime=Mon May 13 09:27:00 CST 2019, time=2019-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1953737, encodeId=0c121953e37f0, content=<a href='/topic/show?id=9bdbe41946e' target=_blank style='color:#2F92EE;'>#神经内分泌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74194, encryptionId=9bdbe41946e, topicName=神经内分泌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8143398, createdName=lily1616, createdTime=Sat Jun 29 22:27:00 CST 2019, time=2019-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1682474, encodeId=f82a16824e4a7, content=<a href='/topic/show?id=d4d031e8074' target=_blank style='color:#2F92EE;'>#分泌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=31780, encryptionId=d4d031e8074, topicName=分泌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0da227938338, createdName=gwc392, createdTime=Thu Jan 24 04:27:00 CST 2019, time=2019-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2024825, encodeId=8ea420248254e, content=<a href='/topic/show?id=c27516459de' target=_blank style='color:#2F92EE;'>#SMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16459, encryptionId=c27516459de, topicName=SMO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6779163, createdName=liuhuangbo, createdTime=Mon Aug 26 07:27:00 CST 2019, time=2019-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1703313, encodeId=46e01e0331376, content=<a href='/topic/show?id=dba720e31b7' target=_blank style='color:#2F92EE;'>#专访#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20731, encryptionId=dba720e31b7, topicName=专访)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=070a30497323, createdName=flyingeagle87, createdTime=Sun Aug 18 09:27:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1280970, encodeId=6c8c12809e0d1, content=<a href='/topic/show?id=50d6e0215a' target=_blank style='color:#2F92EE;'>#ESMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7021, encryptionId=50d6e0215a, topicName=ESMO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7460166, createdName=zhang92560, createdTime=Wed Oct 31 06:27:00 CST 2018, time=2018-10-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1031955, encodeId=c8a9103195512, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon Oct 29 18:27:00 CST 2018, time=2018-10-29, status=1, ipAttribution=)]
    2019-08-26 liuhuangbo
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    2018-10-31 zhang92560
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    2018-10-29 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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