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Untch M.,Helios Klinikum Berlin Buch | Untch M.,Frauenklinik des Universitatsklinikums Erlangen | Untch M.,Ludwig Maximilians University of Munich | Untch M.,Technical University Mu Nchen | And 186 more authors.
Journal of Clinical Oncology | Year: 2011

Purpose: To 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 Methods: Patients with centrally confirmed HER2-overexpressing breast cancer (≥ 2 cm or inflammatory) received four 3-week cycles epirubicin and cyclophosphamide (90/600 mg/m2) followed by four 3-week cycles paclitaxel (175 mg/m2) 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. Results: Thirty-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. Conclusion: Neoadjuvant 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. © 2011 by American Society of Clinical Oncology.


Niesel A.,Klinik Preetz | Richter D.-U.,Universitatsfrauenklinik Rostock Am Klinikum Sudstadt | Watermann D.,Universitatsfrauenklinik Freiburg
Geburtshilfe und Frauenheilkunde | Year: 2010

Purpose: Suburethral tapes are widely used in urogynecology. Aim of the study was to evaluate the mechanical characteristics of frequently used implants for the treatment of urinary stress incontinence. Material and Methods: The static and dynamic characteristics of seven tapes used in urogynecology were compared with each other. Parameters included breaking strength, flexural stiffness, weight, pore size, porosity, distension, width of support with and without tension, thickness of the thread and capillary properties. Results: The mechanical characteristics of the implants differ considerably. These differences were present with regard to both static and dynamic properties, and the differences are influenced by the quantity of filaments within the thread. In addition to the mono- or oligofilamentary, macroporous structure of the tapes there is a tendency in recent implants to a higher porosity and reduced distension. Conclusion: To date, the mechanical criteria for implants in urogynecology have not been extensively defined. Although all tested tapes consist of polypropylene, this study indicates a great variability with regard to individual mechanical characteristics. © Georg Thieme Verlag KG Stuttgart - New York.

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