• Michael Untch, Peter A Fasching, Gottfried E Konecny, Stephan Hasmüller, Annette Lebeau, Rolf Kreienberg, Oumar Camara, Volkmar Müller, Andreas du Bois, Thorsten Kühn, Elmar Stickeler, Nadia Harbeck, Cornelia Höss, Steffen Kahlert, Thomas Beck, Werner Fett, Keyur M Mehta, Gunter von Minckwitz, and Sibylle Loibl.
• Helios Klinikum Berlin-Buch, Schwanebecker Chaussee 50, 13125 Berlin, Germany. michael.untch@helios-kliniken.de
• J. Clin. Oncol. 2011 Sep 1;29(25):3351-7.

PurposeTo evaluate efficacy and safety of epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab as neoadjuvant treatment in patients with human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer.Patients And MethodsPatients with centrally confirmed HER2-overexpressing breast cancer (≥ 2 cm or inflammatory) received four 3-week cycles epirubicin and cyclophosphamide (90/600 mg/m(2)) followed by four 3-week cycles paclitaxel (175 mg/m(2)) and trastuzumab (6 mg/kg) before surgery. Trastuzumab was continued after surgery to complete 1 year of treatment. Primary end point was pathologic complete response (pCR) defined as no residual invasive tumor in breast and lymphatic tissue.ResultsThirty-nine percent of 217 enrolled patients achieved a pCR. Breast conservation was possible in 64% of patients. Three-year disease-free survival (DFS) was 88% in patients with pCR compared to 73% in patients without pCR (P = .01). Three-year overall survival (OS) was 96% in patients with pCR compared to 86% in patients without pCR (P = .025). pCR was the only significant prognostic factor for DFS (hazard ratio [HR] 2.5; 95% CI, 1.2 to 5.1; P = .013) and OS (HR, 4.9; 95% CI, 1.4 to 17.4; P = .012) in multivariable analysis. Cardiac toxicity was reported in eight patients (3.7%) of whom six presented with an asymptomatic left ventricular ejection fraction decrease and two with symptomatic chronic heart failure.ConclusionNeoadjuvant combination of trastuzumab and chemotherapy resulted in a high pCR rate in HER2-overexpressing primary breast cancer. Patients with a pCR after neoadjuvant anti-HER2 therapy in combination with chemotherapy followed by maintenance trastuzumab have an improved long-term outcome. Patients without a pCR had an increased risk for relapse and death.

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