Ann Oncol:Alpelisib+氟维司群治疗PIK3CA突变型HR+HER2-晚期乳腺癌的疗效

2021-01-19 Nebula MedSci原创

通过PIK3CA突变激活磷脂酰肌醇-3-激酶(PI3K)通路在激素受体阳性(HR+)、人表皮生长因子受体-2阴性(HER2-)的晚期乳腺癌(ABC)中的发生率约28%-46%,与患者预后不良有关

通过PIK3CA突变激活磷脂酰肌醇-3-激酶(PI3K)通路在激素受体阳性(HR+)、人表皮生长因子受体-2阴性(HER2-)的晚期乳腺癌(ABC)中的发生率约28%-46%,与患者预后不良有关。SOLAR-1试验表明,在氟维司群(PIK3CA突变的靶向药)治疗的基础上加用alpelisib(阿培利司,PI3K抑制剂)可为PIK3CA突变、HR+、HER2-ABC患者提供具有统计学意义和临床意义的无进展生存(PFS)益处。

本研究将芳香化酶抑制剂(AI)治疗或治疗后病情进展为HR+HER2-ABC男性和绝经后女性患者按1:1随机分至两组,接受阿培利司(300 mg/天)+氟维司群(500 mg,1次/28天,第15天用药)或安慰剂+氟维司群。主要终点为总生存期(OS)。

总人群患者预后

在PIK3CA突变队列(n=341)中,阿培利司+氟维司群组和安慰剂+氟维司群组的中位OS分别为39.3个月(95% CI 34.1-44.9)和31.4个月(26.8-41.3)(危险比[HR] 0.86, 95% CI 0.64-1.15;P=0.15)。OS结果没有超过预先指定的疗效阈值。

肺/肝转移的患者预后

阿培利司组和安慰剂组存在肺和/或肝转移患者的中位OS分别为37.2个月和22.8个月(HR 0.68),中位化疗时间分别为23.3个月和14.8个月(HR 0.72)。在长期随访过程中,未观察到新的安全问题。

总之,虽然该研究结果没有超过预定的界限,但在对PIK3CA突变的HR+HER2-ABC患者进行全面治疗时,加入阿培利司后,患者的中位数OS延长了7.9个月。总体而言,该研究结果进一步支持了阿培利司联合氟维司群在该人群中观察到的PFS获益。

原始出处:

F. Andre, et al. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2–negative advanced breast cancer: final overall survival results from SOLAR-1. Annals of Oncology. November 24, 2020.

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    2021-03-05 xinmeili
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CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032769, encodeId=1c681032e694d, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Tue Jan 19 18:44:09 CST 2021, time=2021-01-19, status=1, ipAttribution=)]
    2021-10-12 minlingfeng
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topicList=[TopicDto(id=75500, encryptionId=baade55002a, topicName=突变型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Tue Sep 21 08:44:09 CST 2021, time=2021-09-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2036019, encodeId=db992036019c9, content=<a href='/topic/show?id=01482345fc' target=_blank style='color:#2F92EE;'>#ALP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2345, encryptionId=01482345fc, topicName=ALP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5c82369, createdName=jiekemin, createdTime=Sat Aug 28 19:44:09 CST 2021, time=2021-08-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728785, encodeId=87ed1e2878534, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Tue Mar 16 04:44:09 CST 2021, time=2021-03-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982535, encodeId=98ec1982535a6, content=<a href='/topic/show?id=da628e19d5' target=_blank style='color:#2F92EE;'>#HER2-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8719, encryptionId=da628e19d5, topicName=HER2-)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, createdName=luwei00, createdTime=Fri Mar 26 12:44:09 CST 2021, time=2021-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1605243, encodeId=078a160524305, content=<a href='/topic/show?id=fe7f2346eb' target=_blank style='color:#2F92EE;'>#Alpelisib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2346, encryptionId=fe7f2346eb, topicName=Alpelisib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=859419357438, createdName=12498561m38(暂无昵称), createdTime=Thu Jan 21 06:44:09 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1625847, encodeId=721b162584ef9, content=<a href='/topic/show?id=bc29140196e' target=_blank style='color:#2F92EE;'>#PEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14019, encryptionId=bc29140196e, topicName=PEL)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=399320916411, createdName=tidiq, createdTime=Thu Jan 21 06:44:09 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032769, encodeId=1c681032e694d, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Tue Jan 19 18:44:09 CST 2021, time=2021-01-19, status=1, ipAttribution=)]
  5. 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objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Tue Mar 16 04:44:09 CST 2021, time=2021-03-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982535, encodeId=98ec1982535a6, content=<a href='/topic/show?id=da628e19d5' target=_blank style='color:#2F92EE;'>#HER2-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8719, encryptionId=da628e19d5, topicName=HER2-)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, createdName=luwei00, createdTime=Fri Mar 26 12:44:09 CST 2021, time=2021-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1605243, encodeId=078a160524305, content=<a href='/topic/show?id=fe7f2346eb' target=_blank style='color:#2F92EE;'>#Alpelisib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2346, encryptionId=fe7f2346eb, topicName=Alpelisib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=859419357438, createdName=12498561m38(暂无昵称), createdTime=Thu Jan 21 06:44:09 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1625847, encodeId=721b162584ef9, content=<a href='/topic/show?id=bc29140196e' target=_blank style='color:#2F92EE;'>#PEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14019, encryptionId=bc29140196e, topicName=PEL)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=399320916411, createdName=tidiq, createdTime=Thu Jan 21 06:44:09 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032769, encodeId=1c681032e694d, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Tue Jan 19 18:44:09 CST 2021, time=2021-01-19, status=1, ipAttribution=)]
    2021-08-28 jiekemin
  6. [GetPortalCommentsPageByObjectIdResponse(id=2007523, encodeId=b05b200e52386, content=<a href='/topic/show?id=fe2b142e95c' target=_blank style='color:#2F92EE;'>#PIK3CA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14279, encryptionId=fe2b142e95c, topicName=PIK3CA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f49517, createdName=xinmeili, createdTime=Fri Mar 05 21:44:09 CST 2021, time=2021-03-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1710579, encodeId=a08f1e10579aa, content=<a href='/topic/show?id=4ad0142806f' target=_blank style='color:#2F92EE;'>#PIK3CA突变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14280, encryptionId=4ad0142806f, topicName=PIK3CA突变)], attachment=null, authenticateStatus=null, createdAvatar=null, 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content=<a href='/topic/show?id=fe7f2346eb' target=_blank style='color:#2F92EE;'>#Alpelisib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2346, encryptionId=fe7f2346eb, topicName=Alpelisib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=859419357438, createdName=12498561m38(暂无昵称), createdTime=Thu Jan 21 06:44:09 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1625847, encodeId=721b162584ef9, content=<a href='/topic/show?id=bc29140196e' target=_blank style='color:#2F92EE;'>#PEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14019, encryptionId=bc29140196e, topicName=PEL)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=399320916411, createdName=tidiq, createdTime=Thu Jan 21 06:44:09 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032769, encodeId=1c681032e694d, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Tue Jan 19 18:44:09 CST 2021, time=2021-01-19, status=1, ipAttribution=)]
    2021-03-16 feather89
  7. 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content=<a href='/topic/show?id=fe7f2346eb' target=_blank style='color:#2F92EE;'>#Alpelisib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2346, encryptionId=fe7f2346eb, topicName=Alpelisib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=859419357438, createdName=12498561m38(暂无昵称), createdTime=Thu Jan 21 06:44:09 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1625847, encodeId=721b162584ef9, content=<a href='/topic/show?id=bc29140196e' target=_blank style='color:#2F92EE;'>#PEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14019, encryptionId=bc29140196e, topicName=PEL)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=399320916411, createdName=tidiq, createdTime=Thu Jan 21 06:44:09 CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032769, encodeId=1c681032e694d, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Tue Jan 19 18:44:09 CST 2021, time=2021-01-19, status=1, ipAttribution=)]
    2021-03-26 luwei00
  8. 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CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032769, encodeId=1c681032e694d, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Tue Jan 19 18:44:09 CST 2021, time=2021-01-19, status=1, ipAttribution=)]
    2021-01-21 tidiq
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CST 2021, time=2021-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032769, encodeId=1c681032e694d, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Tue Jan 19 18:44:09 CST 2021, time=2021-01-19, status=1, ipAttribution=)]
    2021-01-19 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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