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

Michael Untch, Mahdi Rezai, Sibylle Loibl, Peter A. Fasching, Jens Huober, Hans Tesch, Ingo Bauerfeind, Jörn Hilfrich, Holger Eidtmann, Bernd Gerber, Claus Hanusch, Thorsten Kühn, Andreas du Bois, Jens-Uwe Blohmer, Christoph Thomssen, Serban Dan Costa, Christian Jackisch, Manfred Kaufmann, Keyur Mehta, Gunter von Minckwitz

doi:10.1200/jco.2009.23.8451

<jats:sec><jats:title>Purpose</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> 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. </jats:p></jats:sec>

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

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