J Clin Oncol:MSS和MGMT缺失转移性结直肠癌(mCRC)使用替莫唑胺以及联合低剂量伊匹木单抗和那武利尤单抗治疗的疗效

2022-03-15 网络 网络

MAYA研究表明,在MSS和MGMT缺失的mCRC中,先用替莫唑胺启动,然后结合低剂量伊匹单抗和那武利尤单抗,可能会产生持久的临床益处。

近期,Journal of Clinical Oncology杂志上发表了一项单臂II期研究结果(MAYA),主要是在经治的转移性结直肠癌(mCRC)伴有MSS和MGMT缺失患者中,使用替莫唑胺增敏以及后续联合低剂量ipilimumab(伊匹木单抗)和 nivolumab(那武利尤单抗)的疗效和安全性。

研究纳入经治的转移性结直肠癌(mCRC),并且经检查伴有MSS状态和MGMT缺失。患者先进行第一部分治疗:替莫唑胺 150mg /sqm,qd,d1-d5,每4周1次,共2周期;2周期后得到控制的患者进入第二部分治疗:替莫唑胺联合低剂量伊匹木单抗(1 mg/kg/次,每 8周为1疗程)和那武利尤单抗(480 mg/次, 每 4周为1疗程)。主要终点是8个月无进展生存(PFS)率(从第二部分治疗开始计算)。

在716名预先筛选的患者中,204例患者(29%)是符合分子特征的,其中135例患者开始了第一个部分治疗。其中102例(76%)因替莫唑胺启动后死亡或疾病进展而停止治疗,而达到疾病控制的33例(24%)患者开始了第二个部分治疗,并代表了最终的研究人群。

中位随访23.1个月(四分位数范围14.9- 24.6个月)后,该研究达到了主要终点:33名患者中有12人达到无进展生存期>8个月,8个月无进展生存率为36% (95% CI, 23 - 57)。中位PFS和OS分别为7.0个月(95% CI, 5.5-8.3)和18.4个月(95% CI, 14.9-不可评估);12个月和18个月的PFS率分别为24% (95% CI, 13 -44)和20% (95% CI, 10 - 41)。

根据RECIST1.1,整个治疗策略的ORR为45% (95% CI, 29 ~ 62), PRs为15例,CRs为0。在33例患者中,26例(79%)观察到肿瘤在任何范围内收缩。探索性分析,仅在第二部分治疗获得的ORR为18% (95% CI, 9 - 34)。根据RECIST1.1,中位DoR为4.8个月(95% CI, 3.8-不可评估)。具体来说,在第一个部分治疗后观察到8个PRs,而其余7个PRs发生在第二个部分治疗。

3-4级免疫相关不良事件为皮疹(6%)、结肠炎(3%)和垂体炎(3%)。无意外不良事件或治疗相关死亡报告。

综上,MAYA研究表明,在MSS和MGMT缺失的mCRC中,先用替莫唑胺启动,然后结合低剂量伊匹单抗和那武利尤单抗,可能会产生持久的临床益处。

 

原始出处:

Morano F, Raimondi A, Pagani F, et al. Temozolomide Followed by Combination With Low-Dose Ipilimumab and Nivolumab in Patients With Microsatellite-Stable, O6-Methylguanine-DNA Methyltransferase-Silenced Metastatic Colorectal Cancer: The MAYA Trial. J Clin Oncol. 2022 Mar 8:JCO2102583. doi: 10.1200/JCO.21.02583. Epub ahead of print. PMID: 35258987.

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    2022-05-30 minlingfeng
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    2023-01-08 yxch36
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    2022-03-18 ms2000001395180151

    学习学习

    0

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  7. [GetPortalCommentsPageByObjectIdResponse(id=1866546, encodeId=741c186654674, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Mon May 30 19:01:40 CST 2022, time=2022-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1827280, encodeId=ff83182e28071, content=<a href='/topic/show?id=52e95194b9' target=_blank style='color:#2F92EE;'>#CRC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5194, encryptionId=52e95194b9, topicName=CRC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4cea26, createdName=yxch36, createdTime=Sun Jan 08 12:01:40 CST 2023, time=2023-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1642764, encodeId=3a531642e64ce, content=<a href='/topic/show?id=b70711396cd' target=_blank style='color:#2F92EE;'>#mCRC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, 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=Sun Jul 10 00:01:40 CST 2022, time=2022-07-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2036802, encodeId=7542203680215, content=<a href='/topic/show?id=7dbc25654c8' target=_blank style='color:#2F92EE;'>#伊匹木单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25654, encryptionId=7dbc25654c8, topicName=伊匹木单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3eaf430, createdName=bsmagic9132, createdTime=Thu Feb 16 09:01:40 CST 2023, time=2023-02-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1203733, encodeId=9edd1203e335e, content=学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a9d6532631, createdName=ms2000001395180151, createdTime=Fri Mar 18 10:35:29 CST 2022, time=2022-03-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386958, encodeId=eb92138695890, 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=Thu Mar 17 07:01:40 CST 2022, time=2022-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1453674, encodeId=374814536e47d, content=<a href='/topic/show?id=098ee8679ad' target=_blank style='color:#2F92EE;'>#结直肠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78679, encryptionId=098ee8679ad, topicName=结直肠)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=9ace5575596, createdName=crystal0564, createdTime=Thu Mar 17 07:01:40 CST 2022, time=2022-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1480627, encodeId=1840148062ea1, content=<a href='/topic/show?id=647d2615939' target=_blank style='color:#2F92EE;'>#低剂量#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26159, encryptionId=647d2615939, topicName=低剂量)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=97b17641126, createdName=ms1292405679162969, createdTime=Thu Mar 17 07:01:40 CST 2022, time=2022-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1202836, encodeId=7198120283668, content=好东西,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d0be2111725, createdName=萌宝嘟嘟, createdTime=Tue Mar 15 19:01:25 CST 2022, time=2022-03-15, status=1, ipAttribution=)]
  8. [GetPortalCommentsPageByObjectIdResponse(id=1866546, encodeId=741c186654674, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Mon May 30 19:01:40 CST 2022, time=2022-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1827280, encodeId=ff83182e28071, content=<a href='/topic/show?id=52e95194b9' target=_blank style='color:#2F92EE;'>#CRC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5194, encryptionId=52e95194b9, topicName=CRC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4cea26, createdName=yxch36, createdTime=Sun Jan 08 12:01:40 CST 2023, time=2023-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1642764, encodeId=3a531642e64ce, content=<a href='/topic/show?id=b70711396cd' target=_blank style='color:#2F92EE;'>#mCRC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, 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=Sun Jul 10 00:01:40 CST 2022, time=2022-07-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2036802, encodeId=7542203680215, content=<a href='/topic/show?id=7dbc25654c8' target=_blank style='color:#2F92EE;'>#伊匹木单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25654, encryptionId=7dbc25654c8, topicName=伊匹木单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3eaf430, createdName=bsmagic9132, createdTime=Thu Feb 16 09:01:40 CST 2023, time=2023-02-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1203733, encodeId=9edd1203e335e, content=学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a9d6532631, createdName=ms2000001395180151, createdTime=Fri Mar 18 10:35:29 CST 2022, time=2022-03-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386958, encodeId=eb92138695890, 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=Thu Mar 17 07:01:40 CST 2022, time=2022-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1453674, encodeId=374814536e47d, content=<a href='/topic/show?id=098ee8679ad' target=_blank style='color:#2F92EE;'>#结直肠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78679, encryptionId=098ee8679ad, topicName=结直肠)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=9ace5575596, createdName=crystal0564, createdTime=Thu Mar 17 07:01:40 CST 2022, time=2022-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1480627, encodeId=1840148062ea1, content=<a href='/topic/show?id=647d2615939' target=_blank style='color:#2F92EE;'>#低剂量#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26159, encryptionId=647d2615939, topicName=低剂量)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=97b17641126, createdName=ms1292405679162969, createdTime=Thu Mar 17 07:01:40 CST 2022, time=2022-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1202836, encodeId=7198120283668, content=好东西,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d0be2111725, createdName=萌宝嘟嘟, createdTime=Tue Mar 15 19:01:25 CST 2022, time=2022-03-15, status=1, ipAttribution=)]
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    2022-03-15 萌宝嘟嘟

    好东西,谢谢分享

    0

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