ASCO GI 2021:帕博利珠单抗可显著改善MSI-H/dMMR mCRC患者的PFS(KEYNOTE-177研究)

2021-01-20 MedSci原创 MedSci原创

美国当地时间1月15~18日,胃肠道肿瘤领域世界顶级学术盛会——美国临床肿瘤学会胃肠道肿瘤研讨会(ASCO-GI)将以线上会议的形式召开。KEYNOTE-177研究最终PFS结

美国当地时间1月15~18日,胃肠道肿瘤领域世界顶级学术盛会——美国临床肿瘤学会胃肠道肿瘤研讨会(ASCO-GI)将以线上会议的形式召开。KEYNOTE-177研究最终PFS结果出炉,下面是详细报道。

背景和方法:

KEYNOTE-177是一项III期随机开放标签临床研究,旨在评估一线帕博利珠单抗或化疗±贝伐珠单抗或西妥昔单抗治疗(微卫星高度不稳定/错配修复缺陷)MSI-H/dMMR转移性结直肠癌(mCRC)的疗效。本次会议公布了最终PFS和PFS2结果。

研究纳入ECOG评分0-1分、MSI-H/dMMR mCRC患者,并按1:1比例随机分配接受帕博利珠单抗(200mg,Q3W,至多2年)或研究者选择的mFOLFOX6或FOLFIRI±贝伐珠单抗或西妥昔单抗,直至疾病进展或出现不可耐受的毒性,或患者/研究者退出研究。化疗组患者疾病进展后可交叉至帕博利珠单抗组。主要终点为无进展生存期(PFS)(RECIST1.1,中心评估)和总生存期(OS),次要终点包括客观缓解率(ORR)(RECIST1.1,中心评估)和安全性。探索性终点包括缓解持续时间(DoR)、PFS2(从随机至二线治疗进展或任何原因导致死亡的时间)、健康相关生活质量(HRQoL)。数据分析截止时间为2020年2月19日。

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主要结果:

数据截止时,研究共纳入307例患者,帕博利珠单抗组和化疗组分别有153例和154例。中位随访32.4个月时,帕博利珠单抗组的PFS显著优于化疗组,分别为16.5个月 和8.2个月(HR=0.60)( P=0.0002)。帕博利珠单抗组和化疗组的1年和2年PFS率分别为55.3%和48.3%、37.3%和18.6%,两组的ORR分别为43.8%和33.1%,中位DoR分别为未达到和10.6个月。帕博利珠单抗组的PFS2更长(未达到 vs 23.5个月)(HR=0.63)。

2.png

3.png

帕博利珠单抗组和化疗组中,≥3级治疗相关不良事件发生率分别为22%和66%。帕博利珠单抗组无5级治疗相关不良事件发生,化疗组1例患者出现5级不良事件(肠穿孔)。此外,帕博利珠单抗组的HRQoL评分优于化疗组。

结论:

与化疗组相比,帕博利珠单抗组可显著改善MSI-H/dMMR mCRC患者的PFS,且治疗相关不良事件发生率更低,此外,帕博利珠单抗组也可显著改善MSI-H/dMMR mCRC患者的PFS2。

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    2021-11-30 147e4706m08暂无昵称

    学习了

    0

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    2021-04-10 quxin068
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  4. 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GetPortalCommentsPageByObjectIdResponse(id=2056873, encodeId=cf8620568e398, content=<a href='/topic/show?id=7ca2484816b' target=_blank style='color:#2F92EE;'>#帕博利珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48481, encryptionId=7ca2484816b, topicName=帕博利珠)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8ebc122, createdName=yankaienglish, createdTime=Sat May 15 20:42:18 CST 2021, time=2021-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1642754, encodeId=8d891642e544a, content=<a href='/topic/show?id=b70711396cd' target=_blank style='color:#2F92EE;'>#mCRC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11396, encryptionId=b70711396cd, topicName=mCRC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8c9723008141, createdName=LShY0906_98743851, createdTime=Fri Jul 16 17:42:18 CST 2021, time=2021-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1827265, encodeId=096a182e26515, content=<a href='/topic/show?id=52e95194b9' target=_blank style='color:#2F92EE;'>#CRC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5194, encryptionId=52e95194b9, topicName=CRC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4cea26, createdName=yxch36, createdTime=Wed Dec 15 21:42:18 CST 2021, time=2021-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1703443, encodeId=3b921e03443b5, content=<a href='/topic/show?id=2fdf10464e6' target=_blank style='color:#2F92EE;'>#KEYNOTE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10464, encryptionId=2fdf10464e6, topicName=KEYNOTE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=94e330506057, createdName=tm10051991, createdTime=Fri Apr 23 16:42:18 CST 2021, time=2021-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1448671, encodeId=972c14486e1db, content=<a href='/topic/show?id=aaf21412e7e' target=_blank style='color:#2F92EE;'>#PFS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14127, encryptionId=aaf21412e7e, topicName=PFS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=47f75418389, createdName=jeanqiuqiu, createdTime=Thu Jan 21 22:42:18 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555896, encodeId=27931555896dc, content=<a href='/topic/show?id=28c512040bb' target=_blank style='color:#2F92EE;'>#MMR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12040, encryptionId=28c512040bb, topicName=MMR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=dde614671787, createdName=vividelife, createdTime=Thu Jan 21 22:42:18 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581115, encodeId=20df158111586, content=<a href='/topic/show?id=a8ec122803c' target=_blank style='color:#2F92EE;'>#MSI#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12280, encryptionId=a8ec122803c, topicName=MSI)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f65a16715482, createdName=小几洁, createdTime=Thu Jan 21 22:42:18 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=918831, encodeId=e94b91883153, content=帕博利珠单抗 学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Thu Jan 21 21:54:31 CST 2021, time=2021-01-21, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1075270, encodeId=47d210e52702c, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cb355252510, createdName=147e4706m08暂无昵称, createdTime=Tue Nov 30 05:53:35 CST 2021, time=2021-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1939129, encodeId=23c41939129b9, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, 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=Sat Apr 10 12:42:18 CST 2021, time=2021-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056873, encodeId=cf8620568e398, content=<a href='/topic/show?id=7ca2484816b' target=_blank style='color:#2F92EE;'>#帕博利珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48481, encryptionId=7ca2484816b, topicName=帕博利珠)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8ebc122, createdName=yankaienglish, createdTime=Sat May 15 20:42:18 CST 2021, time=2021-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1642754, encodeId=8d891642e544a, content=<a href='/topic/show?id=b70711396cd' target=_blank style='color:#2F92EE;'>#mCRC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11396, encryptionId=b70711396cd, topicName=mCRC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8c9723008141, createdName=LShY0906_98743851, createdTime=Fri Jul 16 17:42:18 CST 2021, time=2021-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1827265, encodeId=096a182e26515, content=<a href='/topic/show?id=52e95194b9' target=_blank style='color:#2F92EE;'>#CRC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5194, encryptionId=52e95194b9, topicName=CRC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4cea26, createdName=yxch36, createdTime=Wed Dec 15 21:42:18 CST 2021, time=2021-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1703443, encodeId=3b921e03443b5, content=<a href='/topic/show?id=2fdf10464e6' target=_blank style='color:#2F92EE;'>#KEYNOTE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10464, encryptionId=2fdf10464e6, topicName=KEYNOTE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=94e330506057, createdName=tm10051991, createdTime=Fri Apr 23 16:42:18 CST 2021, time=2021-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1448671, encodeId=972c14486e1db, content=<a href='/topic/show?id=aaf21412e7e' target=_blank style='color:#2F92EE;'>#PFS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14127, encryptionId=aaf21412e7e, topicName=PFS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=47f75418389, createdName=jeanqiuqiu, createdTime=Thu Jan 21 22:42:18 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555896, encodeId=27931555896dc, content=<a href='/topic/show?id=28c512040bb' target=_blank style='color:#2F92EE;'>#MMR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12040, encryptionId=28c512040bb, topicName=MMR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=dde614671787, createdName=vividelife, createdTime=Thu Jan 21 22:42:18 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581115, encodeId=20df158111586, content=<a href='/topic/show?id=a8ec122803c' target=_blank style='color:#2F92EE;'>#MSI#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12280, encryptionId=a8ec122803c, topicName=MSI)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f65a16715482, createdName=小几洁, createdTime=Thu Jan 21 22:42:18 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=918831, encodeId=e94b91883153, content=帕博利珠单抗 学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Thu Jan 21 21:54:31 CST 2021, time=2021-01-21, status=1, ipAttribution=)]
    2021-12-15 yxch36
  6. [GetPortalCommentsPageByObjectIdResponse(id=1075270, encodeId=47d210e52702c, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cb355252510, createdName=147e4706m08暂无昵称, createdTime=Tue Nov 30 05:53:35 CST 2021, time=2021-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1939129, encodeId=23c41939129b9, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, 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=Sat Apr 10 12:42:18 CST 2021, time=2021-04-10, status=1, ipAttribution=), 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topicList=[TopicDto(id=10464, encryptionId=2fdf10464e6, topicName=KEYNOTE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=94e330506057, createdName=tm10051991, createdTime=Fri Apr 23 16:42:18 CST 2021, time=2021-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1448671, encodeId=972c14486e1db, content=<a href='/topic/show?id=aaf21412e7e' target=_blank style='color:#2F92EE;'>#PFS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14127, encryptionId=aaf21412e7e, topicName=PFS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=47f75418389, createdName=jeanqiuqiu, createdTime=Thu Jan 21 22:42:18 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555896, encodeId=27931555896dc, content=<a href='/topic/show?id=28c512040bb' target=_blank style='color:#2F92EE;'>#MMR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12040, encryptionId=28c512040bb, topicName=MMR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=dde614671787, createdName=vividelife, createdTime=Thu Jan 21 22:42:18 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581115, encodeId=20df158111586, content=<a href='/topic/show?id=a8ec122803c' target=_blank style='color:#2F92EE;'>#MSI#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12280, encryptionId=a8ec122803c, topicName=MSI)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f65a16715482, createdName=小几洁, createdTime=Thu Jan 21 22:42:18 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=918831, encodeId=e94b91883153, content=帕博利珠单抗 学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Thu Jan 21 21:54:31 CST 2021, time=2021-01-21, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1075270, encodeId=47d210e52702c, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cb355252510, createdName=147e4706m08暂无昵称, createdTime=Tue Nov 30 05:53:35 CST 2021, time=2021-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1939129, encodeId=23c41939129b9, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, 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=Sat Apr 10 12:42:18 CST 2021, time=2021-04-10, status=1, ipAttribution=), 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createdBy=8c9723008141, createdName=LShY0906_98743851, createdTime=Fri Jul 16 17:42:18 CST 2021, time=2021-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1827265, encodeId=096a182e26515, content=<a href='/topic/show?id=52e95194b9' target=_blank style='color:#2F92EE;'>#CRC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5194, encryptionId=52e95194b9, topicName=CRC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4cea26, createdName=yxch36, createdTime=Wed Dec 15 21:42:18 CST 2021, time=2021-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1703443, encodeId=3b921e03443b5, content=<a href='/topic/show?id=2fdf10464e6' target=_blank style='color:#2F92EE;'>#KEYNOTE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10464, encryptionId=2fdf10464e6, topicName=KEYNOTE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=94e330506057, createdName=tm10051991, createdTime=Fri Apr 23 16:42:18 CST 2021, time=2021-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1448671, encodeId=972c14486e1db, content=<a href='/topic/show?id=aaf21412e7e' target=_blank style='color:#2F92EE;'>#PFS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14127, encryptionId=aaf21412e7e, topicName=PFS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=47f75418389, createdName=jeanqiuqiu, createdTime=Thu Jan 21 22:42:18 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555896, encodeId=27931555896dc, content=<a href='/topic/show?id=28c512040bb' target=_blank style='color:#2F92EE;'>#MMR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12040, encryptionId=28c512040bb, topicName=MMR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=dde614671787, createdName=vividelife, createdTime=Thu Jan 21 22:42:18 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581115, encodeId=20df158111586, content=<a href='/topic/show?id=a8ec122803c' target=_blank style='color:#2F92EE;'>#MSI#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12280, encryptionId=a8ec122803c, topicName=MSI)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f65a16715482, createdName=小几洁, createdTime=Thu Jan 21 22:42:18 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=918831, encodeId=e94b91883153, content=帕博利珠单抗 学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Thu Jan 21 21:54:31 CST 2021, time=2021-01-21, status=1, ipAttribution=)]
    2021-01-21 jeanqiuqiu
  8. 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    2021-01-21 vividelife
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    2021-01-21 小几洁
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    2021-01-21 zb1235672

    帕博利珠单抗 学习了

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