Nat Med:“靶向化疗”成为可能—卡铂用于治疗BRCA1/2突变及BRCAness表型三阴性乳腺癌的III期TNT研究

2018-05-03 oyasimi 肿瘤资讯

BRCA1/2突变胚系突变在TNBC中的检出率约为10%,BRCA突变细胞对铂类药物具有很高的敏感性。在早期的新辅助研究中,发现铂类单药能使BRCA突变乳腺癌的pCR率提高到60%以上;TBCRC009研究亦显示了其在BRCA突变的晚期乳腺癌中的作用。但尚缺乏大型临床试验对其进行验证。TNT研究作为一项对比卡铂与多西他赛在BRCA1/2突变及BRCAness表型三阴性乳腺癌患者中的有效性研究,填补

BRCA1/2突变胚系突变在TNBC中的检出率约为10%,BRCA突变细胞对铂类药物具有很高的敏感性。在早期的新辅助研究中,发现铂类单药能使BRCA突变乳腺癌的pCR率提高到60%以上;TBCRC009研究亦显示了其在BRCA突变的晚期乳腺癌中的作用。但尚缺乏大型临床试验对其进行验证。TNT研究作为一项对比卡铂与多西他赛在BRCA1/2突变及BRCAness表型三阴性乳腺癌患者中的有效性研究,填补了这个空缺。

背景:三阴性乳腺癌(triple-negative breast cancer, TNBC)是一类整体预后不良的乳腺癌,近年来快速发展的基因组学研究将TNBC这一异质性的疾病更细划分为多个亚型。Lehmann等的TNBC6分型及中国的FUSCC4分型都证实了大多数TNBC为基底样型,其主要特征为同源重组中DNA损伤修复异常导致的基因组不稳定。这类异常也存在于BRCA1受启动子区甲基化调控的mRNA低表达中。BRCA1/2胚系突变乳腺癌即gBRCA-BC,在此类乳腺癌中存在基因同源重组,同源重组可修复由铂类及PARP抑制剂引起的DNA损伤。所谓BRCAness表型乳腺癌,包括BRCA1甲基化,BRCA1 mRNA低表达,同源重组缺陷及基底样型乳腺癌,此类表型乳腺癌在机制上被证明可能对铂类药物敏感。这类BRCA1/2胚系突变及BRCAness表型乳腺癌中均存在的缺陷及其性质为本研究的基础。

TNT研究是一项在TNBC或BRCA1/2突变的晚期乳腺癌中开展的III期临床试验,目的是比较多西他赛与卡铂对特定乳腺癌亚组的疗效,探究“靶向化疗”药物卡铂在DNA损伤修复缺陷亚组的疗效是否优于多西他赛。本试验采用BRCA1/2突变检测、HRD评分、PAM 50等多种工具针对性地对DNA损伤修复异常进行检测,作为亚组分析的生物标志物。

方法:本试验中,共376例晚期TNBC满足入组条件后随机化为两个单药治疗组,多西他赛组188例,卡铂组188例,所有受试者均纳入主要终点分析。试验人群包括338名BRCA突变不详的TNBC患者及43名BRCA1/2胚系突变患者(其中BRCA1突变31名,BRCA2突变12名,ER+患者11人)。

结果:整体而言,主要研究终点ORR在两个治疗组间不存在显着差异(卡铂组31.4%,多西他赛组34.0%,P=0.66,图1)。98.9%的受试者在治疗中出现进展(372/376),卡铂组中位PFS为3.1个月(95%CI, 2.4-4.2个月),多西他赛组中位PFS为4.4个月(95%CI,4.1-5.1个月)。卡铂组OS为12.8个月(95%CI, 10.6-15.3个月),多西他赛组OS为12.0个月(95%CI, 10.2-13.0个月)。两组PFS及OS之间无明显差异。


图1 两组ORR率


图2 两组的PFS曲线

BRCA突变亚组分析:

在BRCA1/2胚系突变亚组中,应用卡铂的ORR优于多西他赛(68.0% vs. 33.3%, P=0.03), 两组的PFS亦存在相似而显着的差异(卡铂组6.8m vs.多西他赛组4.4m,P=0.002),然在OS仅得到阴性结果。

此外,在关于肿瘤BRCA1/2突变,BRCA1甲基化,低表达BRCA mRNA等的亚组分析的尝试中,受样本量较小的限制,均未能得到理想的阳性结果。


图3 BRCA1/2突变,BRCA1甲基化,低表达BRCA mRNA亚组分析(ORR)


图4 BRCA1/2突变,BRCA1甲基化,低表达BRCA mRNA亚组分析(PFS)

同源重组亚组及基底样型亚组分析:

基于本试验的背景,研究者在同源重组缺陷对试验结果的预测上进行了探索,然结果并不理想。组合Myriad HRD assay是一种评估同源重组的试剂盒,通过评分将受试者分为高HRD及低HRD两组,在两组中对卡铂及多西他赛的疗效进行比较,未能得到阳性结果。

而在PAM50基因工具辅助下进行基底样型TNBC亚组分析也同样不顺利,基底样型组中,卡铂或多西他赛对缓解率并无明显影响。然而,有趣的是在非基底样型组中,多西他赛的缓解率明显优于卡铂组(72.2% vs. 16.7%, P=0.002)。

此外,同源缺陷缺陷及免疫组化定义“核心基底”等亚组分析尝试未得到明显的阳性结果。


图5 HRD评分、PAM50基因工具、同源重组缺陷、IHC“核心基底”亚组分析(ORR)


图6 PAM50基因工具、IHC“核心基底”亚组分析(PFS)

结论:在未经选择的TNBC中,卡铂或多西他赛两个治疗方案的ORR、PFS及OS均相似,但在BRCA1/2胚系突变的乳腺癌中,接受卡铂治疗的患者获益为多西他赛的约两倍(ORR: 68.0% vs. 33.3%, P=0.03; PFS: 6.8m vs. 4.4m, P=0.002)。该试验具有改变临床指南的能力,对于BRCA1/2胚系突变乳腺癌,采用卡铂“靶向化疗”不失为一种更优的临床选择。

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objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3687, encryptionId=504c368e51, topicName=BRCA1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7a3d3767712, createdName=caobinglei8080, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1458704, encodeId=cdbb1458e04c0, content=<a href='/topic/show?id=3ef91982030' target=_blank style='color:#2F92EE;'>#三阴性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19820, encryptionId=3ef91982030, topicName=三阴性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a5666112721, createdName=xlysu, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1518978, encodeId=0dd215189e893, content=<a href='/topic/show?id=da4e368832' target=_blank style='color:#2F92EE;'>#BRCA1/2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3688, encryptionId=da4e368832, topicName=BRCA1/2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=63ce11226326, createdName=fangcong, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1535170, encodeId=fb0a15351e095, content=<a href='/topic/show?id=099f9020145' target=_blank style='color:#2F92EE;'>#表型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=90201, encryptionId=099f9020145, topicName=表型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9b6412593156, createdName=tastas, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594030, encodeId=7cb415940306a, content=<a href='/topic/show?id=63cc368459' target=_blank style='color:#2F92EE;'>#BRCA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3684, encryptionId=63cc368459, topicName=BRCA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=)]
    2018-11-03 juliusluan78
  4. 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encodeId=0dd215189e893, content=<a href='/topic/show?id=da4e368832' target=_blank style='color:#2F92EE;'>#BRCA1/2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3688, encryptionId=da4e368832, topicName=BRCA1/2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=63ce11226326, createdName=fangcong, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1535170, encodeId=fb0a15351e095, content=<a href='/topic/show?id=099f9020145' target=_blank style='color:#2F92EE;'>#表型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=90201, encryptionId=099f9020145, topicName=表型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9b6412593156, createdName=tastas, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594030, encodeId=7cb415940306a, content=<a href='/topic/show?id=63cc368459' target=_blank style='color:#2F92EE;'>#BRCA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3684, encryptionId=63cc368459, topicName=BRCA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=)]
    2018-09-30 liye789132251
  5. 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  6. 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05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594030, encodeId=7cb415940306a, content=<a href='/topic/show?id=63cc368459' target=_blank style='color:#2F92EE;'>#BRCA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3684, encryptionId=63cc368459, topicName=BRCA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=2047983, encodeId=e388204e98325, content=<a href='/topic/show?id=12e49e53102' target=_blank style='color:#2F92EE;'>#阴性乳腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97531, encryptionId=12e49e53102, topicName=阴性乳腺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Sat Apr 13 07:52:00 CST 2019, time=2019-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1737570, encodeId=9ee41e37570ca, content=<a href='/topic/show?id=292f965e5b5' target=_blank style='color:#2F92EE;'>#铂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96575, encryptionId=292f965e5b5, topicName=铂)], attachment=null, authenticateStatus=null, createdAvatar=null, 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topicList=[TopicDto(id=12532, encryptionId=3b2112532d8, topicName=Nat)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e6f107, createdName=liye789132251, createdTime=Sun Sep 30 18:52:00 CST 2018, time=2018-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1396290, encodeId=caca139629046, content=<a href='/topic/show?id=9dc636545a4' target=_blank style='color:#2F92EE;'>#卡铂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36545, encryptionId=9dc636545a4, topicName=卡铂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1423304, encodeId=49a7142330434, content=<a href='/topic/show?id=504c368e51' target=_blank style='color:#2F92EE;'>#BRCA1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3687, encryptionId=504c368e51, topicName=BRCA1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7a3d3767712, createdName=caobinglei8080, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1458704, encodeId=cdbb1458e04c0, content=<a href='/topic/show?id=3ef91982030' target=_blank style='color:#2F92EE;'>#三阴性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19820, encryptionId=3ef91982030, topicName=三阴性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a5666112721, createdName=xlysu, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1518978, encodeId=0dd215189e893, content=<a href='/topic/show?id=da4e368832' target=_blank style='color:#2F92EE;'>#BRCA1/2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3688, encryptionId=da4e368832, topicName=BRCA1/2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=63ce11226326, createdName=fangcong, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1535170, encodeId=fb0a15351e095, content=<a href='/topic/show?id=099f9020145' target=_blank style='color:#2F92EE;'>#表型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=90201, encryptionId=099f9020145, topicName=表型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9b6412593156, createdName=tastas, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594030, encodeId=7cb415940306a, content=<a href='/topic/show?id=63cc368459' target=_blank style='color:#2F92EE;'>#BRCA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3684, encryptionId=63cc368459, topicName=BRCA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=)]
    2018-05-05 xlysu
  8. [GetPortalCommentsPageByObjectIdResponse(id=2047983, encodeId=e388204e98325, content=<a href='/topic/show?id=12e49e53102' target=_blank style='color:#2F92EE;'>#阴性乳腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97531, encryptionId=12e49e53102, topicName=阴性乳腺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Sat Apr 13 07:52:00 CST 2019, time=2019-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1737570, encodeId=9ee41e37570ca, content=<a href='/topic/show?id=292f965e5b5' target=_blank style='color:#2F92EE;'>#铂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96575, encryptionId=292f965e5b5, topicName=铂)], attachment=null, authenticateStatus=null, createdAvatar=null, 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encodeId=0dd215189e893, content=<a href='/topic/show?id=da4e368832' target=_blank style='color:#2F92EE;'>#BRCA1/2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3688, encryptionId=da4e368832, topicName=BRCA1/2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=63ce11226326, createdName=fangcong, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1535170, encodeId=fb0a15351e095, content=<a href='/topic/show?id=099f9020145' target=_blank style='color:#2F92EE;'>#表型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=90201, encryptionId=099f9020145, topicName=表型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9b6412593156, createdName=tastas, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594030, encodeId=7cb415940306a, content=<a href='/topic/show?id=63cc368459' target=_blank style='color:#2F92EE;'>#BRCA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3684, encryptionId=63cc368459, topicName=BRCA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=)]
    2018-05-05 fangcong
  9. [GetPortalCommentsPageByObjectIdResponse(id=2047983, encodeId=e388204e98325, content=<a href='/topic/show?id=12e49e53102' target=_blank style='color:#2F92EE;'>#阴性乳腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97531, encryptionId=12e49e53102, topicName=阴性乳腺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Sat Apr 13 07:52:00 CST 2019, time=2019-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1737570, encodeId=9ee41e37570ca, content=<a href='/topic/show?id=292f965e5b5' target=_blank style='color:#2F92EE;'>#铂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96575, encryptionId=292f965e5b5, topicName=铂)], attachment=null, authenticateStatus=null, createdAvatar=null, 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encodeId=0dd215189e893, content=<a href='/topic/show?id=da4e368832' target=_blank style='color:#2F92EE;'>#BRCA1/2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3688, encryptionId=da4e368832, topicName=BRCA1/2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=63ce11226326, createdName=fangcong, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1535170, encodeId=fb0a15351e095, content=<a href='/topic/show?id=099f9020145' target=_blank style='color:#2F92EE;'>#表型#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=90201, encryptionId=099f9020145, topicName=表型)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9b6412593156, createdName=tastas, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594030, encodeId=7cb415940306a, content=<a href='/topic/show?id=63cc368459' target=_blank style='color:#2F92EE;'>#BRCA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3684, encryptionId=63cc368459, topicName=BRCA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat May 05 12:52:00 CST 2018, time=2018-05-05, status=1, ipAttribution=)]
    2018-05-05 tastas
  10. 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    2018-05-05 智智灵药

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