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ASCO 2020：新辅助治疗是否改善可切除胰腺癌患者预后？

2020-05-30 曲畅 杨尹默 ioncology

胰腺癌
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当前，胰腺癌治疗理念正从单纯外科学向肿瘤学多学科团队协作，对于可切除胰腺癌患者，如何最大程度改善预后？新辅助治疗方案如何选择？5月29~31日举行的2020年美国临床肿瘤学会（ASCO）在线科学年会为

当前，胰腺癌治疗理念正从单纯外科学向肿瘤学多学科团队协作，对于可切除胰腺癌患者，如何最大程度改善预后？新辅助治疗方案如何选择？5月29~31日举行的2020年美国临床肿瘤学会（ASCO）在线科学年会为我们带来了相关的两项研究进展。北京大学第一医院外科杨尹默、曲畅医生对研究进行了解读。

1. SWOG S1505研究虽为阴性结果，但不足以否定新辅助治疗对于可切除胰腺癌的治疗意义

外科治疗胰腺癌在技术层面已臻极致，改善预后效果有限。对于可切除胰腺癌，如何最大程度改善预后仍是目前热点课题。
来自美国Davendra Sohal教授的一项Ⅱ期随机临床试验比较研究围术期应用mFOLFIRINOX（第1组）或Gem/nabP（第2组）方案化疗对患者预后的影响（Abstract 4504）。该研究历时3年，入组102患者（组织学诊断为胰腺导管腺癌、ECOG PS评分0或1分、病灶可切除）进行围术期化疗（术前12周，术后12周）。主要研究终点为2年总生存期（OS）。结果显示：组1（55例）中位年龄为66岁（44～76），组2（47例）中位年龄64岁（46～76）；两组男性比例分别为65％和51％；ECOG PS评分0分别为34例（62％）和31例（66％）。mFOLFIRINOX组的两年OS率为41.6%（中位生存期为22.4月），Gem/nabP组为48.8%（中位生存期为23.6月）。两组的2年生存率均未高于40％的先验阈值（分别为P=0.42和P=0.12）。组1的DFS为10.9月，组2为14.2个月，无显著差异（P=0.87）。该研究显示出可切除胰腺癌患者的预后数据，提示围手术期化疗虽具安全性且有助于提高手术切除率，但与既往标准治疗相比未能进一步改善总体预后。
目前，对于可切除胰腺癌行新辅助化疗的必要性仍存争议，在2019年ASCO会议上该研究曾报告入组标准，本摘要展示该研究的结果及毒副反应。该研究显示，无论是mFOLFIRINOX还是Gem/nabP方案，与既往传统治疗方式比较均未能使患者生存获益，虽然是阴性结果，但尚不足以否定新辅助治疗对于可切除胰腺癌的治疗意义，关键是入组患者的选择，即对于“可切除”的标准及评价。目前共识及指南性文献认为，可切除胰腺癌的定义应包括两个方面，其一是基于影像学的解剖学评价，如肠系膜血管有无受累等；其二是生物学评价，如CA19-9、淋巴结转移、PetCT之SUV值等，目前更加注重生物学评价指标，提倡对生物学指标严重异常的可切除胰腺癌行新辅助治疗。上述研究以摘要形式呈现，未能详实显示入组患者的前述指标，因而尚难以做出“肯定”或“否定”的评价，此外作为Ⅱ期临床研究，该研究存在局限性，未能设计直接手术组患者作为对照。综上，对于可切除的胰腺癌，应进行分层及开展大样本量的RCT研究，以客观评价其治疗效果。

2. 新辅助治疗较直接手术组生存获益显著，优选方案尚待后续研究揭晓

通过新辅助治疗改善交界可切除胰腺癌患者的预后是目前热点课题。为比较直接手术与三种新辅助治疗方案对患者预后及切除率的影响，英国Paula Ghaneh教授设计实施了这项4臂国际多中心Ⅱ期研究（Abstract 4505）。
该研究在4年内共纳入符合NCCN标准的90例交界可切除胰腺癌患者，其中88例进行随机分配，分别予以直接手术（32例）或在术前接受2周期GEMCAP（20例）或4周期FOLFIRINOX（20例）或50.4Gy放疗联合卡培他滨同步化疗（16例）。经新辅助治疗的患者在治疗4~6周后重新评估，若仍为交界可切除，则行手术探查。患者术后行辅助治疗并随访12月。主要研究终点为招募率和手术切除率（R1/R0）。次要终点为OS和毒副反应。
入组患者中位年龄为63岁，其中44％为男性，中位基线CA19-9为603 kU/ L。直接手术组ECOG PS评分0或1分比例为45％，新辅助组为55％。进行新辅助治疗的患者中，共44例（79％）患者完成了新辅助治疗。每年的招募率是21例患者。直接手术组的切除率为62％，高于新辅助治疗组（55％），但无统计学差异（P=0.668）；直接手术组患者与新辅助组R0切除率分别为15％和23％（P=0.721）；两组一年生存率分别为40％和77％（P<0.001）。51例新辅助治疗患者中，有9例患者共报告了12项3级以上严重不良反应。
虽然各组间切除率无差异，但新辅助治疗组较直接手术组患者有显著生存获益，由以上研究结果，提倡对交界可切除胰腺癌行新辅助治疗。上述研究以摘要形式呈现，未能显示不同新辅助治疗组之间是否存在差异，因此对新辅助治疗的方案选择，尚难以评价。

参考文献

1. Davendra Sohal, Mai T. Duong, et al. SWOG S1505: Results of perioperative chemotherapy (peri-op CTx) with mfolfirinox versus gemcitabine/nab-paclitaxel (Gem/nabP) for resectable pancreatic ductal adenocarcinoma (PDA). 2020 ASCO Virtual Scientific Program, Abstract 4504. May 29-31.

2. Paula Ghaneh, Daniel H. Palmer, et al. ESPAC-5F: Four-arm, prospective, multicenter, international randomized phase II trial of immediate surgery compared with neoadjuvant gemcitabine plus capecitabine (GEMCAP) or FOLFIRINOX or chemoradiotherapy (CRT) in patients with borderline resectable pancreatic cancer. 2020 ASCO Virtual Scientific Program, Abstract 4505. May 29-31.

专家简介

杨尹默

北京大学第一医院外科主任医师,教授,博士生导师，美国外科学院会员（FACS）

中华医学会外科学分会胰腺学组副组长，

中华医学会外科学分会第十八届委员会委员，

中华医学会肿瘤学分会第十一届委员会委员，

北京医师学会普通外科专家委员会副主任委员，

北京医学会外科学分会常委，

北京医学会肿瘤学分会常委，

北京大学肝癌诊疗研究中心副主任。

中华肝胆外科杂志副主编，国际外科学杂志副主编。中华外科杂志、中华医学杂志、中国实用外科杂志、英国医学杂志中文版(BMJ)、Langenbeck Archives of Surgery等杂志编委。

曲畅

北京大学医学部2018级专业型研究生，师从杨尹默教授

目前于北京大学第一医院临床轮转学习

主要研究方向：胰腺外科临床及基础研究

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    2021-03-13 随梦飞扬

    提倡对交界可切除胰腺癌行新辅助治疗

    0

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    2020-06-22 zhaojie88

    #患者预后#

    0

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    2020-06-02 quxin068

    #ASC#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=947920, encodeId=12f994e92013, content=提倡对交界可切除胰腺癌行新辅助治疗, beContent=null, objectType=article, channel=null, level=null, likeNumber=165, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/02/7354b3539aae6a0ccb1e0fff04c12084.jpg, createdBy=205b1984786, createdName=随梦飞扬, createdTime=Sat Mar 13 20:35:03 CST 2021, time=2021-03-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1692135, encodeId=08d2169213512, content=<a href='/topic/show?id=a450530853c' target=_blank style='color:#2F92EE;'>#患者预后#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53085, encryptionId=a450530853c, topicName=患者预后)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Mon Jun 22 07:26:35 CST 2020, time=2020-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1939066, encodeId=70c019390660b, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=152, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Tue Jun 02 17:26:35 CST 2020, time=2020-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1678630, encodeId=3c7f16e863001, content=<a href='/topic/show?id=110c5869153' target=_blank style='color:#2F92EE;'>#新辅助#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58691, encryptionId=110c5869153, topicName=新辅助)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=941f27706894, createdName=charl1234576, createdTime=Sat Dec 05 16:26:35 CST 2020, time=2020-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=601604, encodeId=99d5601604f7, content=<a href='/topic/show?id=04b5839e6a9' target=_blank style='color:#2F92EE;'>#胰腺癌#</a>在新辅助治疗中，是不是也需要增加免疫治疗？, beContent=null, objectType=article, channel=null, level=null, likeNumber=205, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83976, encryptionId=04b5839e6a9, topicName=胰腺癌)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sat Jun 06 11:50:58 CST 2020, time=2020-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1344233, encodeId=00b3134423303, content=<a href='/topic/show?id=7649283021' target=_blank style='color:#2F92EE;'>#ASCO 2020#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2830, encryptionId=7649283021, topicName=ASCO 2020)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/656F31B644588474D1C46903A7F84373/100, createdBy=4e842500199, createdName=ms24272190615788285182, createdTime=Mon Jun 01 12:26:35 CST 2020, time=2020-06-01, status=1, ipAttribution=)]
    2020-12-05 charl1234576

    #新辅助#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=947920, encodeId=12f994e92013, content=提倡对交界可切除胰腺癌行新辅助治疗, beContent=null, objectType=article, channel=null, level=null, likeNumber=165, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/02/7354b3539aae6a0ccb1e0fff04c12084.jpg, createdBy=205b1984786, createdName=随梦飞扬, createdTime=Sat Mar 13 20:35:03 CST 2021, time=2021-03-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1692135, encodeId=08d2169213512, content=<a href='/topic/show?id=a450530853c' target=_blank style='color:#2F92EE;'>#患者预后#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53085, encryptionId=a450530853c, topicName=患者预后)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Mon Jun 22 07:26:35 CST 2020, time=2020-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1939066, encodeId=70c019390660b, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=152, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Tue Jun 02 17:26:35 CST 2020, time=2020-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1678630, encodeId=3c7f16e863001, content=<a href='/topic/show?id=110c5869153' target=_blank style='color:#2F92EE;'>#新辅助#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58691, encryptionId=110c5869153, topicName=新辅助)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=941f27706894, createdName=charl1234576, createdTime=Sat Dec 05 16:26:35 CST 2020, time=2020-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=601604, encodeId=99d5601604f7, content=<a href='/topic/show?id=04b5839e6a9' target=_blank style='color:#2F92EE;'>#胰腺癌#</a>在新辅助治疗中，是不是也需要增加免疫治疗？, beContent=null, objectType=article, channel=null, level=null, likeNumber=205, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83976, encryptionId=04b5839e6a9, topicName=胰腺癌)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sat Jun 06 11:50:58 CST 2020, time=2020-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1344233, encodeId=00b3134423303, content=<a href='/topic/show?id=7649283021' target=_blank style='color:#2F92EE;'>#ASCO 2020#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2830, encryptionId=7649283021, topicName=ASCO 2020)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/656F31B644588474D1C46903A7F84373/100, createdBy=4e842500199, createdName=ms24272190615788285182, createdTime=Mon Jun 01 12:26:35 CST 2020, time=2020-06-01, status=1, ipAttribution=)]
    2020-06-06 lovetcm

    #胰腺癌#在新辅助治疗中，是不是也需要增加免疫治疗？

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=947920, encodeId=12f994e92013, content=提倡对交界可切除胰腺癌行新辅助治疗, beContent=null, objectType=article, channel=null, level=null, likeNumber=165, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/02/7354b3539aae6a0ccb1e0fff04c12084.jpg, createdBy=205b1984786, createdName=随梦飞扬, createdTime=Sat Mar 13 20:35:03 CST 2021, time=2021-03-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1692135, encodeId=08d2169213512, content=<a href='/topic/show?id=a450530853c' target=_blank style='color:#2F92EE;'>#患者预后#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53085, encryptionId=a450530853c, topicName=患者预后)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Mon Jun 22 07:26:35 CST 2020, time=2020-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1939066, encodeId=70c019390660b, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=152, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Tue Jun 02 17:26:35 CST 2020, time=2020-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1678630, encodeId=3c7f16e863001, content=<a href='/topic/show?id=110c5869153' target=_blank style='color:#2F92EE;'>#新辅助#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58691, encryptionId=110c5869153, topicName=新辅助)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=941f27706894, createdName=charl1234576, createdTime=Sat Dec 05 16:26:35 CST 2020, time=2020-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=601604, encodeId=99d5601604f7, content=<a href='/topic/show?id=04b5839e6a9' target=_blank style='color:#2F92EE;'>#胰腺癌#</a>在新辅助治疗中，是不是也需要增加免疫治疗？, beContent=null, objectType=article, channel=null, level=null, likeNumber=205, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83976, encryptionId=04b5839e6a9, topicName=胰腺癌)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sat Jun 06 11:50:58 CST 2020, time=2020-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1344233, encodeId=00b3134423303, content=<a href='/topic/show?id=7649283021' target=_blank style='color:#2F92EE;'>#ASCO 2020#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2830, encryptionId=7649283021, topicName=ASCO 2020)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/656F31B644588474D1C46903A7F84373/100, createdBy=4e842500199, createdName=ms24272190615788285182, createdTime=Mon Jun 01 12:26:35 CST 2020, time=2020-06-01, status=1, ipAttribution=)]
    2020-06-01 ms24272190615788285182

    #ASCO 2020#

    0

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ASCO 2020：大会摘要

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