Neoadjuvant Treatment With Trastuzumab in HER2-Positive Breast Cancer: Results From the GeparQuattro Study

作者：Untch Michael; Rezai Mahdi; Loibl Sibylle; Fasching Peter A; Huober Jens; Tesch Hans; Bauerfeind Ingo; Hilfrich Joern; Eidtmann Holger; Gerber Bernd; Hanusch Claus; Kuehn Thorsten; du Bois Andreas; Blohmer Jens Uwe; Thomssen Christoph; Costa Serban Dan; Jackisch Christian; Kaufmann Manfred; Mehta Keyur; von Minckwitz Gunter^*

来源：Journal of Clinical Oncology, 2010, 28(12): 2024-2031.

DOI：10.1200/JCO.2009.23.8451

Purpose
Trastuzumab, 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 Methods
Patients 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.
Results
Of 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.
Conclusion
This 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.

• 出版日期2010-4-20