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Berlin, Germany

von Minckwitz G.,German Breast Group | Eidtmann H.,University of Kiel | Loibl S.,German Breast Group | Blohmer J.-U.,St Gertrauden Hospital | And 11 more authors.
Annals of Oncology | Year: 2011

Background: Safety data for combining bevacizumab, everolimus, or lapatinib with anthracycline- and taxane-based neoadjuvant chemotherapy for breast cancer are limited. Patients and methods: The neoadjuvant GeparQuinto trial investigates the addition of (i) bevacizumab to four cycles epirubicin/cyclophosphamide (EC) followed by four cycles docetaxel (Taxotere) in patients with human epithelial growth factor receptor (HER)2-negative tumors, (ii) everolimus to weekly paclitaxel in patients with HER2-negative tumors not responding to EC ± bevacizumab, and (iii) lapatinib instead of trastuzumab to EC-docetaxel in patients with HER2-positive tumors to improve the rate of pathological complete response. Tolerable dose, need for supportive treatments, and early signals for toxic effect were evaluated in a planned safety analysis of 270 patients. Results: Treatment with chemotherapy plus bevacizumab, everolimus, or lapatinib was discontinued in 23.0%, 25.8%, and 34.5% compared with chemotherapy alone or plus trastuzumab in 19.4%, 24.1%, 3.2%, respectively. More leukopenia, infections, mucositis, and hypertension but less edema was observed by adding bevacizumab; a trend toward more thrombocytopenia, leukopenia, skin changes, and hyperlipidemia by adding everolimus; and more diarrhea, skin changes, and hot flushes but no cardiac events by substituting trastuzumab by lapatinib. Conclusions: Adding bevacizumab and everolimus to chemotherapy appeared feasible. Lapatinib at 1250 mg resulted in an increased rate of treatment discontinuations and was subsequently dose reduced to 1000 mg. © The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source


Gerullis H.,Lukas Hospital | Gerullis H.,German Center for Assessment and Evaluation of Innovative Techniques in Medicine | Eimer C.,Lukas Hospital | Ecke T.H.,Helios Hospital | And 4 more authors.
Anti-Cancer Drugs | Year: 2013

The role of pazopanib in the second-line setting of refractory metastatic transitional cell carcinoma of the urothelium has not been defined clearly. The aim of this phase I/II trial was to assess the safety, tolerability, and efficacy of combining pazopanib and vinflunine in patients with metastatic transitional cell carcinoma of the urothelium after failure of first-line platinum-containing therapy. From May 2011 to December 2011, five patients were enrolled in this trial. Pazopanib was the investigated compound; four levels were planned (200, 400, 600, and 800 mg/day). Vinflunine was dosed at 280 mg/m for the first dose and 320 mg/m every 3 weeks thereafter. After the definition of a tolerated dose for the combined therapy, a subsequent phase II study was planned. At the starting level, pazopanib 200 mg/day, dose-limiting toxicities were observed in two of five patients. One patient experienced grade 4 febrile neutropenia, which led to treatment discontinuation. A second patient showed grade 3 hepatobiliary disorder with an increase in γ-glutamyltransferase. The study was interrupted at dose level 1 for safety reasons. The initially planned phase II study was therefore not carried out. This phase I study showed that combined therapy of daily pazopanib (200 mg) and vinflunine (280/320 mg/m) every 3 weeks is poorly tolerated in patients with refractory advanced urothelial cancer. © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Source


Stroh C.,SRH Hospital Gera | Stroh C.,University Hospital | Groh C.,Helios Hospital | Weiner R.,Sachsenhausen Hospital | And 5 more authors.
Obesity Surgery | Year: 2013

Background: Since 1 January 2005, the situation of bariatric surgery has been examined in Germany. All data are registered prospectively in cooperation with the Institute of Quality Assurance in Surgery at the Otto-von-Guericke University Magdeburg. Methods: Data collection on the results of gastric banding procedures was started in 2005, and the data are registered in an online database. Follow-up data were collected once a year. Participation in the quality assurance study is voluntary. Results: Since 2005, 3,453 gastric banding procedures have been performed at 88 hospitals. The mean age of patients was 40.7 years, and the mean body mass index (BMI) was 45.2 kg/m2. BMI and comorbidities are significantly higher in male patients. Regarding gender-specific aspects, there are no significant differences in the perioperative complication rates. The amelioration rate of comorbidities in male patients is lower than in female patients. Conclusion: Gastric banding in Germany is generally performed in patients with a BMI below 45 kg/m2. The perioperative complication rate is low. Data from the nationwide survey of the German Bariatric Surgery Registry show significant differences in preoperative comorbidities and their amelioration between male and female patients. There is a need for further evaluation of gender-specific aspects of gastric banding procedures to optimize patient selection, reduce specific postoperative complications, and achieve long-term effects on weight loss and remission of comorbidities. © 2013 Springer Science+Business Media New York. Source


Gross U.,University of Gottingen | Amuzu S.K.,Holy Family Hospital | de Ciman R.,St. Francis Xavier University | Kassimova I.,St. Martin de Porres Hospital | And 6 more authors.
Emerging Infectious Diseases | Year: 2011

Bacterial distribution and antimicrobial drug resistance were monitored in patients with bacterial bloodstream infections in rural hospitals in Ghana. In 2001?2002 and in 2009, Salmonella enterica serovar Typhi was the most prevalent pathogen. Although most S. enterica serovar Typhi isolates were chloramphenicol resistant, all isolates tested were susceptible to ciprofloxacin. Source


Galsky M.D.,Mount Sinai School of Medicine | Moshier E.,Mount Sinai School of Medicine | Krege S.,Alexianer Krefeld GmbH | Lin C.-C.,National Taiwan University Hospital | And 6 more authors.
Cancer | Year: 2013

BACKGROUND The current study was conducted to develop a pretreatment prognostic model for patients with unresectable and/or metastatic urothelial cancer who were treated with first-line, cisplatin-based chemotherapy. METHODS Individual data were pooled from 399 patients who were enrolled on 8 phase 2 and 3 trials evaluating cisplatin-based, first-line chemotherapy in patients with metastatic urothelial carcinoma. Variables selected for inclusion in the model were combined in a Cox proportional hazards model to produce a points-based nomogram with which to predict the median, 1-year, 2-year, and 5-year survival. The nomogram was validated externally using data from a randomized trial of the combination of methotrexate, vinblastine, doxorubicin plus cisplatin versus docetaxel plus cisplatin. RESULTS The median survival of the development cohort was 13.8 months (95% confidence interval, 12.1 months-16.0 months); 68.2% of the patients had died at the time of last follow-up. On multivariable analysis, the number of visceral metastatic sites, Eastern Cooperative Oncology Group performance status, and leukocyte count were each found to be associated with overall survival (P <.05), whereas the site of the primary tumor and the presence of lymph node metastases were not. All 5 variables were included in the nomogram. When subjected to internal validation, the nomogram achieved a bootstrap-corrected concordance index of 0.626. When applied to the external validation cohort, the nomogram achieved a concordance index of 0.634. Calibration plots suggested that the nomogram was well calibrated for all predictions. CONCLUSIONS Based on routinely measured pretreatment variables, a nomogram was constructed that predicts survival in patients with unresectable and/or metastatic urothelial cancer who are treated with cisplatin-based chemotherapy. This model may be useful in patient counseling and clinical trial design. © 2013 American Cancer Society. Source

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