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新辅助化疗联合贝伐单抗治疗HER2阴性乳腺癌
Neoadjuvant Chemotherapy and Bevacizumab for HER2-Negative Breast Cancer


Gunter von Minckwitz ... 肿瘤 • 2012.01.26
相关阅读
• 贝伐珠单抗治疗BRCA1/2 突变型三阴性乳腺癌 • 需要化疗的乳腺癌患者较少 • 腋窝淋巴结清扫术对于前哨淋巴结阳性的乳腺癌患者而言并无必要 • 贝伐珠单抗作为三阴性乳腺癌的辅助疗法

摘要


背景

贝伐单抗是一种抗血管内皮生长因子A(VEGF-A)的单克隆抗体,已在人类表皮生长因子受体2(HER2)阴性的转移性乳腺癌患者中显示出临床疗效。本研究根据病理完全缓解率(乳房和腋窝淋巴结内无浸润性或导管内病变)来评估了新辅助化疗加用贝伐单抗在早期乳腺癌中的疗效及其安全性。


方法

本研究将1,948名触诊时肿瘤大小中位数为40 mm的患者随机分配接受表柔比星、环磷酰胺序贯多西他赛的新辅助化疗,联合或不联合贝伐单抗。入组对象须满足以下条件:患HER2阴性乳腺癌且未经治疗,同时肿瘤体积大,激素受体阴性,或激素受体阳性伴可触及的淋巴结或前哨淋巴结活检阳性,且出现心血管事件或出血的风险较低。


结果

总体来说,采用表柔比星、环磷酰胺序贯多西他赛联合或不联合贝伐单抗治疗的病理完全缓解率分别为18.4%和14.9%(联合贝伐单抗治疗的比值比为1.29,95%可信区间为1.02~1.65,P=0.04)。在663名三阴乳腺癌患者中,相应的病理完全缓解率分别为39.3%和27.9%(P=0.003),在1262名激素受体阳性患者中分别为7.7%和7.8%(P=1.00)。两组中有66.6%的患者可接受保乳手术。与单纯的新辅助化疗相比,采用联合贝伐单抗治疗与3级或4级毒性反应(中性粒细胞减少性发热、黏膜炎、手足综合征、感染和高血压)的发生率高有关,但两者手术并发症的发生率相似。


结论

在新辅助化疗中加入贝伐单抗可显著增加HER2阴性早期乳腺癌的病理学完全缓解率,但疗效主要局限于三阴性乳腺癌,在这类患者中病理完全缓解被认为是长期结局的可靠的预测因素(本研究由赛诺菲-安万特公司[Sanofi-Aventis]和罗氏公司的德国分公司资助,ClinicalTrials.gov注册号为NCT00567554)。





作者信息

Gunter von Minckwitz, M.D., Holger Eidtmann, M.D., Mahdi Rezai, M.D., Peter A. Fasching, M.D., Hans Tesch, M.D., Holm Eggemann, M.D., Iris Schrader, M.D., Kornelia Kittel, M.D., Claus Hanusch, M.D., Rolf Kreienberg, M.D., Christine Solbach, M.D., Bernd Gerber, M.D., Christian Jackisch, M.D., Georg Kunz, M.D., Jens-Uwe Blohmer, M.D., Jens Huober, M.D., Maik Hauschild, M.D., Tanja Fehm, M.D., Berit Maria Müller, M.D., Carsten Denkert, M.D., Sibylle Loibl, M.D., Valentina Nekljudova, Ph.D., and Michael Untch, M.D., for the German Breast Group and the Arbeitsgemeinschaft Gynäkologische Onkologie–Breast Study Groups
From the Headquarters, German Breast Group, Neu-Isenburg (G.M., S.L., V.N.), Universitäts-Frauenklinik, Kiel (H. Eidtmann), Luisenkrankenhaus, Düsseldorf (M.R.), the Department of Gynecology and Obstetrics, University Hospital Erlangen, Friedrich Alexander University Erlangen–Nuremberg, Comprehensive Cancer Center Erlangen–Nuremberg, Erlangen (P.A.F.), Onkologie Bethanien, Frankfurt (H.T.), Universitäts-Frauenklinik, Magdeburg (H. Eggemann), Henrietten-Stiftung, Hannover (I.S.), Onkologische Praxis (K.K.), St. Gertrauden Krankenhaus (J.-U.B.), and the Institute of Pathology, Charité (B.M.M., C.D.) — all in Berlin, Klinikum zum Roten Kreuz, Munich (C.H.), Universitäts-Frauenklinik, Ulm (R.K.), Universitäts-Frauenklinik, Frankfurt (C.S.), Universitäts-Frauenklinik, Rostock (B.G.), Städtische Kliniken, Offenbach (C.J.), St. Johannes Hospital, Dortmund (G.K.), Frauenklinik, Rheinfelden (M.H.), Universitätsfrauenklinik, Tübingen (T.F.), and Helios-Klinikum, Berlin-Buch (M.U.) — all in Germany, and Kantonsspital, St. Gallen, Switzerland (J.H.). Address reprint requests to Dr. von Minckwitz at the German Breast Group, c/o GBG Forschungs, Martin-Behaim-Str. 12, 63263 Neu-Isenburg, Germany, or at gunter.vonminckwitz@germanbreastgroup.de.

 

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