J Clin Oncol:mFOLFOXIRI方案联合帕尼单抗治疗RAS/BRAF野生型转移性结直肠癌

2022-06-15 MedSci原创 MedSci原创

mFOLFOXIRI方案联合帕尼单抗治疗不能改善RAS/BRAF野生型转移性结直肠癌患者的生存预后,还会增加胃肠道毒性。

两种细胞毒性药物,氟尿嘧啶、亚叶酸和奥沙利铂 (FOLFOX) 或氟尿嘧啶、亚叶酸和伊立替康 (FOLFIRI) ,联合抗表皮生长因子受体 (EGFR) 抗体 (西妥昔单抗或帕尼单抗) 是不可切除的RAS和BRAF野生型 (wt) 转移性结直肠癌 (mCRC) 患者的一种前期选择。

该研究目的是验证采用这两种方案联合帕尼单抗作为RAS和BRAF野生型 (wt) 转移性结直肠癌 (mCRC) 患者的初治方案时,通过改进的氟尿嘧啶、亚叶酸、奥沙利铂和伊立替康(mFOLFOXIRI)方案强化前期化疗主链,是否能提高氟尿嘧啶、亚叶酸和奥沙利铂的活性。

TRIPLETE是一项前瞻性、开放标签的3期试验,招募了既往未治疗过的不可手术切除的RAS和BRAF野生型转移性结直肠癌患者,1:1随机分至改进的FOLFOX/帕尼单抗组(对照组)或mFOLFOXIRI/帕尼单抗组(实验组),治疗12个疗程后改用氟尿嘧啶/-亚叶酸/帕尼单抗治疗直到病情进展,主要终点是客观缓解率(ORR)。


两组的无进展生存率

2017年9月-2021年9月期间,共435位患者被随机分至对照组(n=217)或实验组(n=218)。实验组有160位(73%)、对照组有165位(76%)患者获得了缓解(优势比[OR] 0.87,p=0.526)。两组的早期肿瘤缩小率和缓解深度均无明显差异(57% vs 58%[p=0.878],48% vs 47%[p=0.845]),R0切除率也无明显差异(25% vs 29%,p=0.317)。在无进展生存期方面,两组也无显著差异(中位无进展生存期:12.7 vs 12.3个月,HR 0.88,p=0.277)。


两组全因不良反应的发生情况

综上,对于RAS和BRAF野生型的转移性结直肠癌患者,强化前期化疗主力与帕尼单抗联用并没有在治疗效果方面提供额外的益处,反而会增加胃肠道毒性。

 

原始出处:

Daniele Rossini, et al. Upfront Modified Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan Plus Panitumumab Versus Fluorouracil, Leucovorin, and Oxaliplatin Plus Panitumumab for Patients With RAS/BRAF Wild-Type Metastatic Colorectal Cancer: The Phase III TRIPLETE Study by GONO. Journal of Clinical Oncology. June 2022. https://ascopubs.org/doi/full/10.1200/JCO.22.00839.

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    2022-06-16 zhaojie88
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  6. 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  7. 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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=42, 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 Jun 16 12:51:49 CST 2022, time=2022-06-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1455477, encodeId=95ce14554e723, content=<a href='/topic/show?id=d0cee572e9' target=_blank style='color:#2F92EE;'>#FOLFOX#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, 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=Thu Jun 16 12:51:49 CST 2022, time=2022-06-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1226664, encodeId=555f122666429, content=坚持学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210313/9df56058b3964a8cac82563f95f0389d/c1b478592e8e4463bef44d32712e98fd.jpg, createdBy=ea905324251, createdName=杨海东, createdTime=Wed Jun 15 21:24:21 CST 2022, time=2022-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1226637, encodeId=7234122663ea8, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Wed Jun 15 18:43:29 CST 2022, time=2022-06-15, status=1, ipAttribution=)]
    2022-06-16 linlin2314
  8. 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    2022-06-15 杨海东

    坚持学习

    0

  9. 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    2022-06-15 医鸣惊人

    认真学习了

    0

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