Neoadjuvant Treatment With Trastuzumab in HER2-Positive Breast Cancer: Results From the GeparQuattro Study
Neoadjuvant Treatment With Trastuzumab in HER2-Positive Breast Cancer: Results From the GeparQuattro Study
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DOI：
10.1200/jco.2009.23.8451
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发表时间：
2010-04-20
影响因子：
45.3
通讯作者：
von Minckwitz, Gunter
中科院分区：
文献类型：
--
作者：
Untch, Michael;Rezai, Mahdi;von Minckwitz, Gunter
目的曲妥珠单抗是一种人源化的抗人表皮生长因子受体2(HER2)抗体，已显示出对乳腺癌的高效治疗作用。患者和方法HER2阳性的可手术或局部晚期肿瘤患者术前接受4个周期的表阿霉素/环磷酰胺治疗，然后在所有化疗周期中每3周接受4个周期的多西紫杉醇联合或不联合卡培他滨(EC-T[X])和曲妥珠单抗6 mg/kg(负荷量8 mg/kg)治疗。结果在1,509名参与者中，445名HER2阳性肿瘤患者接受曲妥珠单抗和化疗治疗。病理完全缓解率为31.7%，高于对照组(15.7%)。HER2阳性患者对前四个周期的EC无反应，其PCR率出人意料地高达16.6%(参照组为3.3%)。保乳率为63.1%，与对照组(64.7%)相当。EC-T(X)联合曲妥珠单抗与发热性中性粒细胞减少症和结膜炎有关，但其短期心脏毒性与参照组相似。结论本试验证实曲妥珠单抗联合以蒽环类紫杉烷为基础的新辅助化疗有较高的PCR率，且没有临床相关的早期毒性。当对HER2阳性乳腺癌患者进行新辅助治疗时，应考虑联合化疗和曲妥珠单抗。J Clin Oncol28：2024-2031。(C)2010年美国临床肿瘤学会
PurposeTrastuzumab, a humanized antibody against the human epidermal growth factor receptor type 2 (HER2), has shown high efficacy in breast cancer. We prospectively investigated its efficacy given simultaneously with anthracycline-taxane-based neoadjuvant chemotherapy.Patients and MethodsPatients with operable or locally advanced, HER2-positive tumors were treated preoperatively with four cycles of epirubicin/cyclophosphamide followed by four cycles of docetaxel with or without capecitabine (EC-T[X]) and trastuzumab 6 mg/kg (with a loading dose of 8 mg/kg) every 3 weeks during all chemotherapy cycles. Patients with HER2-negative tumors treated in the same study with the same chemotherapy but without trastuzumab were used as a reference group.ResultsOf 1,509 participants, 445 had HER2-positive tumors treated with trastuzumab and chemotherapy. Pathologic complete response (pCR; defined as no invasive or in situ residual tumors in the breast) rate was 31.7%, which was 16% higher than that in the reference group (15.7%). HER2-positive patients without response to the first four cycles of EC showed an unexpectedly high pCR rate of 16.6% (3.3% in the reference group). Breast conservation rate was 63.1% and comparable to that of the reference group (64.7%). EC-T(X) plus trastuzumab was associated with more febrile neutropenia and conjunctivitis, but with a comparable short-term cardiac toxicity profile as the reference group.ConclusionThis trial confirms that combining trastuzumab with anthracycline-taxane-based neoadjuvant chemotherapy results in a high pCR rate without clinically relevant early toxicity. Combination of chemotherapy with trastuzumab should be considered when neoadjuvant treatment is given to patients with HER2-positive breast cancer. J Clin Oncol 28: 2024-2031. (C) 2010 by American Society of Clinical Oncology