JAMA Oncol:延迟靶向术中放疗与全乳放疗对乳腺癌局部复发和存活的影响(TARGIT-A长期结果)

2020-04-04 MedSci MedSci原创

传统的乳癌辅助放射治疗,每天进行为期数周的放射治疗,既繁重又昂贵。有些患者可能不得不选择切除乳房,有些人可能会放弃放疗。研究确定延迟的二次手术靶向术中放疗(TARGIT-IORT)是否比传统外照射放疗

传统的乳癌辅助放射治疗,每天进行为期数周的放射治疗,既繁重又昂贵。有些患者可能不得不选择切除乳房,有些人可能会放弃放疗。研究确定延迟的二次手术靶向术中放疗(TARGIT-IORT)是否比传统外照射放疗(EBRT)在局部控制方面无劣势。

在这项前瞻性、随机(1:1比例)的非劣性试验中,来自9个国家的28个中心的1153名45岁或以上的浸润性乳腺导管型乳腺癌患者,经乳房保存治疗后,年龄在3.5cm以下的浸润性乳腺导管型乳腺癌患者被纳入了这项前瞻性、随机试验。数据锁定在2019年7月3日。

TARGIT-A试验于2000年3月启动;患者在针刺活检后被随机化,在相同的麻醉下接受TARGIT-IORT与EBRT相比,在乳房切除术后立即接受TARGIT-IORT,结果显示效果不差。

TARGIT-A是一项随机、非劣效性试验。招募了年满45岁的浸润性导管癌女性患者,并以1:1的比例随机分配,使其分别接受TARGIT或全乳EBRT,根据中心以及提供术中靶向放疗的时间进行区组分层:随机分组发生在乳腺肿块切除术之前(病理检查前层次,TARGIT与乳腺肿块切除术同时进行)或乳腺肿块切除术之后(病理检查后层次,TARGIT 在重新打开伤口后进行)。如果TARGIT组患者在最终病理检查中检出了未预见到的不良特征,他们将接受补充EBRT(不包括增强),因此该方法称为风险适应放疗。主要预后为保留乳房的局部复发率之间的绝对差异,预先设定的非劣效性界值为5年时2.5%;预先设定的分析包括按照相对于乳腺肿块切除术的随机时间来分层的预后。次要预后包括并发症和死亡率。

在2000年3月24日至2012年6月25日之间,我们从11个国家的33个中心招募了患者。经过随机分配,1721名患者分入TARGIT组,1730名患者分入EBRT组。在接受TARGIT的患者中,有15.2%[239/1571]需要在TARGIT后进行补充EBRT(病理检查前:21.6%,病理检查后:3.6%)。3451名患者的中位随访时间为2年5个月(IQR 12—52个月),2020人为4年,1222人为5年。TARGIT组和EBRT组患者在保留乳房中发生局部复发的5年风险分别为3.3% (95% CI 2.1—5.1)和1.3%(0.7—2.5)(p=0.042)。在乳腺肿块切除术同时进行TARGIT(病理检查前,n=2298)与EBRT的结果大致相同:2.1%(1.1—4.2)比1.1%(0.5—2.5; p=0.31)。其与延迟TARGIT(病理检查后,n=1153)的组间差异大于2.5%(TARGIT 5.4% [3.0—9.7]和EBRT 1.7% [0.6—4.9];p=0.069)。总体而言,各组的乳腺癌死亡率大致相同(TARGIT 2.6% [1.5—4.3]和EBRT 1.9% [1.1—3.2];p=0.56),但TARGIT组的非乳腺癌死亡显著较少(1.4% [0.8—2.5]和3.5% [2.3—5.2];p=0.0086),这是因为该组中因心血管原因和其他癌症造成的死亡较少。TARGIT组与EBRT组的总死亡率分别为3.9%(2.7—5.8)和5.3%(3.9—7.3)(p=0.099)。各组间的伤口相关并发症大致相同,但TARGIT组的3或4级皮肤并发症显著减少(1720人中4例和1731人中13例,p=0.029)。

2004年开始进行了一项平行研究,该文中描述了一项平行研究;使用单独的随机分配表将肿瘤切除后的患者随机分配到接受EBRT或延迟TARGIT-IORT,作为第二次手术,通过重新打开肿瘤切除伤口,接受EBRT或延迟TARGIT-IORT。

主要结果,5年后的局部复发率为2.5%,远期生存率为2.5%,无不良反应。

581名女性患者(平均[SD]年龄,63[7]岁)被随机纳入TARGIT-IORT研究,572名患者(平均[SD]年龄,63[8]岁)被随机纳入EBRT。60名患者(5%)肿瘤大于2cm,或有阳性结节,只有32名(2.7%)年龄小于50岁。延迟TARGIT-IORT的治疗效果不比EBRT差。5年完全随访时的局部复发率为:延迟TARGIT-IORT vs EBRT(延迟TARGIT-IORT vs EBRT(分别为23/581[3.96%]vs 6/572[1.05%];差异,2.91%;90%CI上限,4.4%)。长期随访(中位[IQR],9.0[7.5-10.5]年),局部无复发生存(HR,0.75;95% CI,0.57-1.003;P = . 052)、无乳腺切除术生存(HR,0.88;95% CI,0.65-1.18;P = .38)、远期无病生存(HR,1.00;95% CI,0.72-1.39;P = .98)或总生存(HR,0.96;95% CI,0.68-1.35;P = .80)。

这些长期数据表明,尽管延迟TARGIT-IORT治疗后局部复发的数量增加,但无乳腺切除术后无病生存、远处无病生存或总生存均无统计学意义的下降。

原始出处:

Vaidya JS, Bulsara M, Saunders C, et al. Effect of Delayed Targeted Intraoperative Radiotherapy vs Whole-Breast Radiotherapy on Local Recurrence and SurvivalLong-term Results From the TARGIT-A Randomized Clinical Trial in Early Breast CancerJAMA Oncol. Published online April 02, 2020. doi:10.1001/jamaoncol.2020.0249

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    2020-12-03 minlingfeng
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  4. [GetPortalCommentsPageByObjectIdResponse(id=1865815, encodeId=bc481865815ef, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Thu Dec 03 17:40:36 CST 2020, time=2020-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1928285, encodeId=8423192828585, content=<a href='/topic/show?id=c2b04e602af' target=_blank style='color:#2F92EE;'>#局部复发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47602, encryptionId=c2b04e602af, topicName=局部复发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Mon Sep 28 15:40:36 CST 2020, time=2020-09-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058247, encodeId=39cc205824ea7, content=<a href='/topic/show?id=79271e13708' target=_blank style='color:#2F92EE;'>#TARGIT-A#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17137, encryptionId=79271e13708, topicName=TARGIT-A)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f98e185, createdName=psybestwish, createdTime=Sun Dec 27 17:40:36 CST 2020, time=2020-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1723766, encodeId=f77c1e237663d, content=<a href='/topic/show?id=ac899e0343c' target=_blank style='color:#2F92EE;'>#长期结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97034, encryptionId=ac899e0343c, topicName=长期结果)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ee6a33536665, createdName=zhucaizhong7777, createdTime=Wed Sep 30 03:40:36 CST 2020, time=2020-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405969, encodeId=58b11405969c6, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Mon Apr 06 08:40:36 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036013, encodeId=bb461036013b2, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Sat Apr 04 20:40:36 CST 2020, time=2020-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1038015, encodeId=68e0103801557, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Sat Apr 04 20:40:36 CST 2020, time=2020-04-04, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1865815, encodeId=bc481865815ef, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Thu Dec 03 17:40:36 CST 2020, time=2020-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1928285, encodeId=8423192828585, content=<a href='/topic/show?id=c2b04e602af' target=_blank style='color:#2F92EE;'>#局部复发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47602, encryptionId=c2b04e602af, topicName=局部复发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Mon Sep 28 15:40:36 CST 2020, time=2020-09-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058247, encodeId=39cc205824ea7, content=<a href='/topic/show?id=79271e13708' target=_blank style='color:#2F92EE;'>#TARGIT-A#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17137, encryptionId=79271e13708, topicName=TARGIT-A)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f98e185, createdName=psybestwish, createdTime=Sun Dec 27 17:40:36 CST 2020, time=2020-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1723766, encodeId=f77c1e237663d, content=<a href='/topic/show?id=ac899e0343c' target=_blank style='color:#2F92EE;'>#长期结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97034, encryptionId=ac899e0343c, topicName=长期结果)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ee6a33536665, createdName=zhucaizhong7777, createdTime=Wed Sep 30 03:40:36 CST 2020, time=2020-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405969, encodeId=58b11405969c6, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Mon Apr 06 08:40:36 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036013, encodeId=bb461036013b2, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Sat Apr 04 20:40:36 CST 2020, time=2020-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1038015, encodeId=68e0103801557, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Sat Apr 04 20:40:36 CST 2020, time=2020-04-04, status=1, ipAttribution=)]
    2020-04-06 chg122
  6. [GetPortalCommentsPageByObjectIdResponse(id=1865815, encodeId=bc481865815ef, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Thu Dec 03 17:40:36 CST 2020, time=2020-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1928285, encodeId=8423192828585, content=<a href='/topic/show?id=c2b04e602af' target=_blank style='color:#2F92EE;'>#局部复发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47602, encryptionId=c2b04e602af, topicName=局部复发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Mon Sep 28 15:40:36 CST 2020, time=2020-09-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058247, encodeId=39cc205824ea7, content=<a href='/topic/show?id=79271e13708' target=_blank style='color:#2F92EE;'>#TARGIT-A#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17137, encryptionId=79271e13708, topicName=TARGIT-A)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f98e185, createdName=psybestwish, createdTime=Sun Dec 27 17:40:36 CST 2020, time=2020-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1723766, encodeId=f77c1e237663d, content=<a href='/topic/show?id=ac899e0343c' target=_blank style='color:#2F92EE;'>#长期结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97034, encryptionId=ac899e0343c, topicName=长期结果)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ee6a33536665, createdName=zhucaizhong7777, createdTime=Wed Sep 30 03:40:36 CST 2020, time=2020-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405969, encodeId=58b11405969c6, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Mon Apr 06 08:40:36 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036013, encodeId=bb461036013b2, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Sat Apr 04 20:40:36 CST 2020, time=2020-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1038015, encodeId=68e0103801557, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Sat Apr 04 20:40:36 CST 2020, time=2020-04-04, status=1, ipAttribution=)]
    2020-04-04 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1865815, encodeId=bc481865815ef, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Thu Dec 03 17:40:36 CST 2020, time=2020-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1928285, encodeId=8423192828585, content=<a href='/topic/show?id=c2b04e602af' target=_blank style='color:#2F92EE;'>#局部复发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47602, encryptionId=c2b04e602af, topicName=局部复发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Mon Sep 28 15:40:36 CST 2020, time=2020-09-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058247, encodeId=39cc205824ea7, content=<a href='/topic/show?id=79271e13708' target=_blank style='color:#2F92EE;'>#TARGIT-A#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17137, encryptionId=79271e13708, topicName=TARGIT-A)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f98e185, createdName=psybestwish, createdTime=Sun Dec 27 17:40:36 CST 2020, time=2020-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1723766, encodeId=f77c1e237663d, content=<a href='/topic/show?id=ac899e0343c' target=_blank style='color:#2F92EE;'>#长期结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97034, encryptionId=ac899e0343c, topicName=长期结果)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ee6a33536665, createdName=zhucaizhong7777, createdTime=Wed Sep 30 03:40:36 CST 2020, time=2020-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405969, encodeId=58b11405969c6, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Mon Apr 06 08:40:36 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036013, encodeId=bb461036013b2, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Sat Apr 04 20:40:36 CST 2020, time=2020-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1038015, encodeId=68e0103801557, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Sat Apr 04 20:40:36 CST 2020, time=2020-04-04, status=1, ipAttribution=)]
    2020-04-04 anti-cancer

    谢谢梅斯分享这么多精彩信息

    0

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