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HER2阳性乳腺癌新辅助化疗方案
方案Ⅰ 曲妥珠单抗联合化疗vs单纯化疗
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T126_302_943_2025_2057_148378.jpg?sign=1739306465-MueV82wDtQlJne3FqAzWqd0L8Xz36syj-0-c02fe7f88b9fff1eec92df9be10c8444)
方案评价
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T126_297_2143_2030_2804_148379.jpg?sign=1739306465-O62AeIGfDArkkryIxeYvq5f8y2YxtpQ7-0-be8f1f2145c253aa1fb2ab20fff9d6b2)
续表
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T127_238_343_1951_1584_90359.jpg?sign=1739306465-SrNplKrsB5P8pkZEhggHdtB8ANg29bRH-0-f0a1dab20fd9b20e41fd3b2ae5a8e83e)
点评
NOAH研究是一项国际多中心Ⅲ期研究,入组局部晚期或炎性乳腺癌患者,其中HER2阳性患者随机分配至接受曲妥珠单抗联合化疗或单纯化疗组。结果显示:曲妥珠单抗联合化疗用于HER2阳性乳腺癌新辅助化疗显著提高了pCR率和无事件生存期,确立了曲妥珠单抗在HER2阳性乳腺癌新辅助治疗的价值。NOAH研究表明曲妥珠单抗联合化疗用于新辅助治疗的病理完全缓解(pCR)率达45%,明显高于单独化疗的病理完全缓解率(23%),曲妥珠单抗能够改善HER2+早期乳腺癌的转归。
(安 欣 史艳侠)
参考文献
[1] GIANNI L,EIERMANN W,SEMIGLAZOV V,et al.Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone,in patients with HER2-positive locally advanced breast cancer(the NOAH trial):a randomised controlled superiority trial with a parallel HER2-negative cohort.Lancet,2010,375(9712):377-384.
方案Ⅱ 帕妥珠单抗、曲妥珠单抗双靶联合化疗
曲妥珠单抗联合化疗的基础上加或不加帕妥珠单抗
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T128_287_528_2018_1666_148383.jpg?sign=1739306465-s7xRh6uVAqeA4nFC12z4PZXoQmcs6VBt-0-eaaa460fa18c47c9d49b55157c54bf82)
注:4周期新辅助化疗后接受根治性手术,术后A、B、D三组继续FEC方案化疗3周期;C组接受多西紫杉醇4周期序贯FEC方案3周期;帕妥珠单抗仅新辅助治疗阶段使用,曲妥珠单抗共1年
方案评价
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T128_297_1905_2007_2822_147969.jpg?sign=1739306465-L5hkCfhrgvw9xQq4M3DadLBWujdEpVl6-0-01627d8731b50c586253906d1901c2d3)
续表
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T129_238_362_1948_1044_90612.jpg?sign=1739306465-7SZegOHOIHIE3OHvWhumKZoJgV06FFjJ-0-57781c587747674bd68de6b73914815f)
点评
本研究为一项Ⅱ期临床研究,旨在比较在曲妥珠单抗联合化疗的基础上加或不加帕妥珠单抗的疗效和安全性。结果显示,帕妥珠单抗和曲妥珠单抗的双靶治疗与化疗联合提高了HER2阳性乳腺癌新辅助化疗的pCR率,包括心脏毒性在内的不良事件发生率没有增加。
(安 欣 史艳侠)
参考文献
[1] GIANNI L,PIENKOWSKI T,IM YH,et al.5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced,inflammatory,or early-stage HER2-positive breast cancer(NeoSphere):a multicentre,open-label,phase 2 randomised trial.Lancet Oncol,2016,17(6):791-800.
方案Ⅲ 曲妥珠单抗、帕妥珠单抗双靶与不同化疗方案联合
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T129_238_2134_1949_2814_147970.jpg?sign=1739306465-nkprylR2Fqlo0Gmt4cLBBlcWid2ZsRqy-0-c9971b4019dde25c54f4572af0749351)
续表
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T130_297_345_2008_1372_147971.jpg?sign=1739306465-p8bFDRnYwpj1uHZwW00WLesRyb6NCpFv-0-b28a3d366b0d81c829e87853d853e9a7)
方案评价
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T130_290_1474_2020_2822_148387.jpg?sign=1739306465-AhGaGLwcvcImAtctjHAgvFSlysQRb1oB-0-443f91f06462744f97fffb6015de7c53)
续表
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T131_238_378_1950_1302_147973.jpg?sign=1739306465-mIwyC0RxZq5ASVGk0qKlkVW3ol6si0Rq-0-1d27299dc43312b0a15ba9e5e5ab5bba)
点评
TRYPHAENA和NeoSphere研究类似,也是一项Ⅱ期临床研究。其研究目的主要包括两点:(1)比较曲妥珠单抗帕妥珠单抗双靶联合含蒽环、紫杉方案(FEC-T)与不含蒽环的紫杉、卡铂方案(TC)的疗效和安全性;(2)曲妥珠单抗、帕妥珠单抗双靶联合含蒽环和紫杉方案时不同用药时机(与蒽环类药物同时使用(FECHP-THP)或推迟至蒽环类药物后与紫杉同时使用(FEC-THP)的疗效和安全性。结果显示在疗效方面双靶联合紫杉、卡铂方案的pCR率略高于含蒽环和紫杉方案,但差异没有达到统计学意义。在心脏毒性方面,双靶联合紫杉、卡铂方案LVEF下降的发生率稍低于联合含蒽环和紫杉方案,但差异仍然没有统计学意义。
帕妥珠单抗和曲妥珠单抗双靶与蒽环类药物同时使用或推迟至蒽环类药物后与紫杉类药物同时使用在PCR率和心脏毒性发生率均未见明显差异。基于这两项研究的结果,FDA于2013年批准帕妥珠单抗联合曲妥珠单抗用于HER2阳性乳腺癌新辅助治疗。
(安 欣 史艳侠)
参考文献
[1] SCHNEEWEISS A,CHIA S,HICKISH T,et al.Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer:a randomized phaseⅡ cardiac safety study(TRYPHAENA).Ann Oncol,2013,24(9):2278-2284.
方案Ⅳ 曲妥珠单抗+帕妥珠单抗双靶联合含蒽环方案vs 非含蒽环方案
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T132_285_349_2018_1354_148391.jpg?sign=1739306465-SDvyVGgssxs4pnxmCYixgBL3CJzFc7wY-0-e5e779eeb7be7dc456f828aa2df53de7)
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T132_282_1381_2018_2829_148394.jpg?sign=1739306465-rw07Retoqo9EuHuw7oNsrNvWYgbMC5cH-0-918a6469f9b6d2a502027c985c7328c1)
续表
![](https://epubservercos.yuewen.com/B8A9D8/22919013101368106/epubprivate/OEBPS/Images/T133_238_365_1947_1064_147975.jpg?sign=1739306465-3dbCXFMIBhU2zCAB3hbxgdSYfWnetPD6-0-de4890e452f845e87b4146973aa83983)
点评
TRAIN-2研究设计的目的是比较含蒽环类药物的化疗方案与非含蒽环方案联合曲妥珠单抗和帕妥珠单抗双靶用于HER2阳性Ⅱ~Ⅲ期乳腺癌的疗效和安全性。结果显示,紫杉醇卡铂方案联合双靶治疗与含蒽环方法联合双靶治疗疗效相当。蒽环类药物增加粒细胞缺少性发热和≥2级的LVEF下降的发生率。因此本研究的结果更推荐紫杉醇、卡铂与抗HER2双靶药物的组合。
(安 欣 史艳侠)
参考文献
[1] VAN RAMSHORST MS,VAN DER VOORT A,VAN WERKHOVEN ED,et al.A phaseⅢ trial of neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2-blockade for HER2+ breast cancer:The TRAIN-2 study.J Clin Oncol,2017,35S:p.ASCO#507.