Clin Cancer Res:氟维司群联合维奈托克治疗CDK4/6抑制剂难治性ER+转移性乳腺癌

2022-06-24 MedSci原创 MedSci原创

氟维司群联合维奈托克治疗CDK4/6抑制剂难治性ER+转移性乳腺癌的临床效果

激素受体(ER)阳性、HER2阴性乳腺癌约占所有乳腺癌的70%,是乳腺癌相关死亡的主要原因。这类乳腺癌的标准一线和二线疗法包括多种内分泌治疗和选择性ER降解剂(如氟维司群)。尽管B细胞淋巴瘤2 (BCL2) 抑制剂维奈托克在造血系统恶性肿瘤中具有良好的抗癌活性,但其在实体瘤中的疗效尚不清楚。

VERONICA研究是一项随机的2期临床试验,评估了维奈托克联合氟维司群在激素受体(ER)阳性、HER2阴性、采用细胞周期依赖性激酶(CDK)4/6抑制剂治疗后进展的转移性乳腺癌中的疗效和安全性。本文汇报了VERONICA研究预先指定的主要分析结果。

在该研究中,年满18岁的绝经前和绝经后的女性患者随机(1:1)接受维奈托克(800 mg/天,口服)+氟维司群(500 mg,第1个疗程的第1天和第15天,随后每疗程的第1天,28天为一疗程)或单用氟维司群治疗。主要终点是临床获益率(CBR);次要终点包括无进展生存期(PFS)、总生存期(OS)和安全性。探索性生物标志物分析包括BCL2和BCL超大(BCLXL)肿瘤表达,以及PIK3CA循环肿瘤DNA突变状态。


两组的PFS和OS

截止2020年8月5日,共有102位患者接受研究治疗(每组各51位)。中位随访了9.9个月,与单用氟维司群相比,维奈托克联合氟维司群治疗未能明显提高患者的临床获益率(11.8% vs 13.7%;风险差:-1.96%)。维奈托克+氟维司群组和氟维司群组的中位PFS分别是2.69个月和1.94个月(分层HR 0.94,p=0.7853);中位OS分别是16.76个月和未达到(HR 2.56)。


生物标志物对临床获益率的影响

在有强BCL2表达(IHC3+)、BCL2/BCLXL组织评分比≥1或PIK3CA野生型肿瘤患者中也未观察到临床获益率及PFS的显著改善。

综上所述,该研究结果未能证明维奈托克联合氟维司群在内分泌治疗耐药、CDK4/6抑制剂难治性转移性乳腺癌中的临床效用,但提示在这种情况下可能会增加对BCLXL的依赖。

 

原始出处:

Geoffrey J. Lindeman, Tharu M. Fernando, Rebecca Bowen, et al. VERONICA: Randomized Phase II Study of Fulvestrant and Venetoclax in ER-Positive Metastatic Breast Cancer Post-CDK4/6 Inhibitors – Efficacy, Safety, and Biomarker Results. Clin Cancer Res 2022; https://doi.org/10.1158/1078-0432.CCR-21-3811.

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    2022-09-07 jklm09
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    2022-11-29 soongzhihua
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    2022-06-25 zhouqu_8
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    2022-06-25 zhangj7111
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    2022-06-25 freve
  7. [GetPortalCommentsPageByObjectIdResponse(id=1853002, encodeId=b66b1853002f9, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Wed Sep 07 23:26:06 CST 2022, time=2022-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1703118, encodeId=82921e0311864, content=<a href='/topic/show?id=98b24402bb' target=_blank style='color:#2F92EE;'>#CDK4#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4402, encryptionId=98b24402bb, topicName=CDK4)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=166330479856, createdName=soongzhihua, createdTime=Tue Nov 29 12:26:06 CST 2022, time=2022-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1387004, encodeId=79f4138e00472, 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=39, 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=Sat Jun 25 13:26:06 CST 2022, time=2022-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1435564, encodeId=59c51435564a7, content=<a href='/topic/show?id=09dc439915' target=_blank style='color:#2F92EE;'>#CDK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4399, encryptionId=09dc439915, topicName=CDK)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Sat Jun 25 13:26:06 CST 2022, time=2022-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490720, encodeId=fbf01490e204e, content=<a href='/topic/show?id=2765440372' target=_blank style='color:#2F92EE;'>#CDK4/6#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4403, encryptionId=2765440372, topicName=CDK4/6)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c7068807080, createdName=zhangj7111, createdTime=Sat Jun 25 13:26:06 CST 2022, time=2022-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528882, encodeId=bd96152888297, content=<a href='/topic/show?id=74b798601a1' target=_blank style='color:#2F92EE;'>#难治性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98601, encryptionId=74b798601a1, topicName=难治性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ef11916292, createdName=freve, createdTime=Sat Jun 25 13:26:06 CST 2022, time=2022-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1228562, encodeId=872412285628d, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=eb726508526, createdName=ms9000001798672821, createdTime=Sat Jun 25 09:20:05 CST 2022, time=2022-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1228519, encodeId=e1d31228519ed, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, 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=Fri Jun 24 22:24:55 CST 2022, time=2022-06-24, status=1, ipAttribution=)]
    2022-06-25 ms9000001798672821

    学习了

    0

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    2022-06-24 医鸣惊人

    认真学习了

    0

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