贝伐珠单抗联合FOLFOX,提高RAS突变型肠癌肝转移切除率

2019-10-13 佚名 肿瘤资讯

2019欧洲肿瘤内科学会(ESMO)年会在西班牙巴塞罗那盛大召开。此次大会上,复旦大学附属中山医院的许剑民教授口头报告了一项贝伐珠单抗联合化疗对比单纯化疗用于不可切除的仅限于肝转移的RAS突变型结直肠癌的研究(LBA31)。特邀许教授对该研究的结果进行解读。

2019欧洲肿瘤内科学会(ESMO)年会在西班牙巴塞罗那盛大召开。此次大会上,复旦大学附属中山医院的许剑民教授口头报告了一项贝伐珠单抗联合化疗对比单纯化疗用于不可切除的仅限于肝转移的RAS突变型直肠癌的研究(LBA31)。特邀许教授对该研究的结果进行解读

研究初衷:敬畏生命,为肝转移的RAS突变型肠癌患者带来更大获益

在《临床肿瘤学杂志》(Journal of Clinical Oncology)发表了一项研究,该研究针对无法切除的RAS野生型结肠癌肝转移患者,西妥昔单抗联合FOLFOX(5-FU+奥沙利铂)方案治疗取得了很大的成功,该联合方案较单纯化疗提高了肝转移灶转化切除率以及无进展生存(PFS)和总生存(OS),从而改变了NCCN肠癌临床实践指南的治疗推荐,因为当时的NCCN指南认为RAS野生型肠癌患者西妥昔单抗联用FOLFOX的效果不好。在临床研究和临床实践中,我们发现仅限于肝转移的肠癌患者中有50%是RAS或KRAS突变型,如何基于现有治疗手段使患者更大获益便成为我们思索的问题。有鉴于此,我们设计了这项研究,针对不可切除的仅限于肝转移的RAS突变型直肠癌患者,采用FOLFOX联合贝伐珠单抗方案与单纯化疗进行对比。FOLFOX联合贝伐珠单抗取得了很好的治疗效果。

研究结果:结果喜人,贝伐珠单抗联合化疗显着提高肝转移切除率

研究共入组241例不可切除的仅限于肝脏转移的RAS突变型结直肠癌患者,随机分为化疗联合贝伐珠单抗组(A组,121例)和单纯的化疗组(B组,120例)。主要研究终点是肝转移灶的转化切除率,次要终点包括肿瘤缓解率、生存期和毒性。研究发现,贝伐珠单抗联合化疗组的肝转移灶切除率明显提高,切除率接近25%,而单纯化疗组的转化切除率仅7%~8%,研究达到了主要终点。次要终点包括客观缓解率(ORR)、PFS和OS也均以化疗联合贝伐珠单抗组显着更优。

这个研究告诉我们,RAS突变型患者虽然预后较差,但是我们利用现有的武器,仍然可以很好地提高转化切除率。将来我们还可以做三药联合贝伐珠单抗治疗RAS突变型患者的研究,或者是用两药联合贝伐珠单抗做一个全国的多中心研究,以在国际舞台上展示我们中国的数据,为国际版的指南提供循证医学证据。

研究畅想:多学科综合诊疗,将肠癌肝转移纳入慢病长程管理

在复旦大学附属中山医院,结直肠癌诊疗有我们自己的临床路径。肠癌肝转移患者就诊之后,要通过多学科团队评估:如肝转移灶可切除,可以考虑先做肝脏转移灶切除手术,后续做序贯治疗;如肝转移灶不可切除,我们先评估患者的生存状况和体力状况,如预期生存小于半年,就给予最佳支持治疗,如肝转移灶虽然不可切除但预期生存超过半年,则进入转化治疗。转化治疗之前,一般先做基因检测,包括RAS和BRAF,以及PIK3CA和微卫星不稳定的检测。转化成功者,后续做肝转移灶手术切除,转化不成功者则进入二线甚至三线治疗。我们的理念是,肠癌肝转移已经不是一个晚期的肿瘤,我们可以将患者纳入慢病的全程管理中,让肠癌肝转移患者拥有更美好的明天。

许剑民,博导 主任医师,,复旦大学附属中山医院结直肠癌中心主任、结直肠外科主任,上海结直肠肿瘤微创工程技术研究中心主任,中国医师协会结直肠肿瘤专委会副主任委员及机器人手术专委会主任委员、肛肠外科分会肿瘤转移专委会主任委员、外科分会委员兼结直肠专委会常委兼副秘书长、内镜医师分会委员;,中国临床肿瘤学会( CSCO)结直肠癌专家委员会副主任委员;,中华医学会外科分会结直肠外科学组委员;,中国抗癌协会大肠癌专业委员会常委兼肝转移学组组长、转移委员会常委;肿瘤大数据与真实世界研究专委会副主委;,中国医促会结直肠癌肝转移委员会副主任委员;,中国上海肿瘤防治联盟结直肠癌专业委员会主任委员;,中国研究型医院学会机器人与腹腔镜外科专业委员会副主任委员;,上海市外科协会结直肠学组组长.

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    2021-03-12 ms2000000050996988

    期待突破

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  4. [GetPortalCommentsPageByObjectIdResponse(id=947654, encodeId=453b94e654db, content=期待突破, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=84f85464656, createdName=ms2000000050996988, createdTime=Fri Mar 12 13:20:46 CST 2021, time=2021-03-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1954816, encodeId=03dd195481609, content=<a href='/topic/show?id=e4f39220658' target=_blank style='color:#2F92EE;'>#贝伐珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92206, encryptionId=e4f39220658, topicName=贝伐珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Thu Jun 25 08:28:00 CST 2020, time=2020-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793109, encodeId=87411e9310992, content=<a href='/topic/show?id=ced215146b3' target=_blank style='color:#2F92EE;'>#RAS突变型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15146, encryptionId=ced215146b3, topicName=RAS突变型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9cb02500048, createdName=ms6832696159214430, createdTime=Thu Jan 09 17:28:00 CST 2020, time=2020-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2041390, encodeId=9980204139024, content=<a href='/topic/show?id=baade55002a' target=_blank style='color:#2F92EE;'>#突变型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75500, encryptionId=baade55002a, topicName=突变型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Tue Jun 30 09:28:00 CST 2020, time=2020-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1443849, encodeId=717d14438496f, content=<a href='/topic/show?id=6b058150307' target=_blank style='color:#2F92EE;'>#肝转移#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81503, encryptionId=6b058150307, topicName=肝转移)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ea155117075, createdName=ms6747015003810650, createdTime=Tue Oct 15 05:28:00 CST 2019, time=2019-10-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1455462, encodeId=4856145546276, content=<a href='/topic/show?id=d0cee572e9' target=_blank style='color:#2F92EE;'>#FOLFOX#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7572, encryptionId=d0cee572e9, topicName=FOLFOX)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=12f25658567, createdName=linlin2314, createdTime=Tue Oct 15 05:28:00 CST 2019, time=2019-10-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477043, encodeId=21c414e7043f4, content=<a href='/topic/show?id=c32e9220221' target=_blank style='color:#2F92EE;'>#贝伐#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92202, encryptionId=c32e9220221, topicName=贝伐)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ef557344179, createdName=sunrural_42825359, createdTime=Tue Oct 15 05:28:00 CST 2019, time=2019-10-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1585320, encodeId=47a3158532058, content=<a href='/topic/show?id=792b15145a6' target=_blank style='color:#2F92EE;'>#RAS突变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15145, encryptionId=792b15145a6, topicName=RAS突变)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6f2c17156536, createdName=bioon7, createdTime=Tue Oct 15 05:28:00 CST 2019, time=2019-10-15, status=1, ipAttribution=)]
    2020-06-30 heli0118
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    2019-10-15 linlin2314
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    2019-10-15 bioon7

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