Velten, Germany
Velten, Germany
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Jackisch C.,Sana Klinikum Offenbach GmbH | Schoenegg W.,Practice | Reichert D.,Practice | Welslau M.,Practice | And 6 more authors.
BMC Cancer | Year: 2014

Background: Trastuzumab was registered in 2000 for the treatment of metastatic breast cancer, both as monotherapy and combination therapy with paclitaxel. In this prospective, non-interventional observation study, the 10-year experience with trastuzumab in the routine management of HER2-positive breast cancer was reviewed. Methods: Between 2000 and 2010, 1843 evaluable patients with advanced HER2-positive breast cancer were recruited in 223 institutions across Germany. Patients were prospectively monitored for about one year. Additional information on long-term outcomes, progression-free survival (PFS), and overall survival (OS) were retrieved at several follow-up points. There were no restrictions with respect to diagnostic or therapeutic procedures. Patients were stratified into three cohorts depending on the treatment regimen, i.e. trastuzumab monotherapy (n =228, 12%), trastuzumab combined with chemotherapy (n =1346, 73%), or trastuzumab combined with endocrine therapy (n =269, 15%). Results: Median age was 59.5 years with a proportion of 28% being older than 65 years. Over a maximum follow-up period of more than 10 years, 1538 PFS events were documented in 83% of patients, resulting in an estimated median PFS of 11.8 months. Median OS, based on recorded death in 64% of patients, amounted to 34.4 months, with 48% (95% confidence intervals 45-50%) still alive after three years. The subgroup selected for a treatment combination with endocrine drugs only had distinctly longer PFS and OS than the other two groups, achieving medians of 23.3 months and 56.3 months, respectively. Median PFS and OS in elderly patients over 65 years of age was 11.4 months and 28.3 months, respectively. Adverse reactions, including cardiac toxicity, of severity grade 3 or 4 were rare. Conclusions: The superior outcome of treatment strategies including trastuzumab in HER2 overexpressing breast cancer, proven in pivotal studies, was confirmed in the management of advanced breast cancer in Germany in the routine setting. Our data suggest a comparable clinical benefit of treatment with trastuzumab in elderly patients (>65 years), who are typically under-represented in randomized clinical studies. © 2014 Jackisch et al.

Krause L.,Municipal Hospital Dessau | Yousif T.,Practice | Pohl K.,Novartis
Current Medical Research and Opinion | Year: 2013

Objective: Neovascular or wet age-related macular degeneration (AMD) is one of the leading causes of blindness in industrialized countries; however, there is a lack of recent epidemiological data from Germany. The aim of this study was to collect epidemiological data from patients in Germany with suspected neovascular AMD and evaluate the diagnostic procedures performed and treatments used at clinics. Methods: This was a Germany-based, multicentre, retrospective review of data from patients with suspected neovascular AMD visiting ophthalmology clinics over an 18 month period in 2008-10. Clinical characteristics, functional symptoms and examination results were recorded. In addition, ophthalmologists completed a questionnaire on neovascular AMD diagnosis and treatment. Results: Ten sites collected data from 2498 patients (64.0% female) with a mean decimal visual acuity of 0.4 ± 0.3 at the time of diagnosis of neovascular AMD. The mean age at the time of diagnosis was 76.9 ± 8.9 years for patients with the right eye affected and 77.0 ± 8.3 years for patients with the left eye affected. The most frequent pathological findings detected by routine ophthalmic examination were old lesions (31.2%), intra/subretinal fluid (18.1%), new lesions (13.0%), and intra/subretinal haemorrhage (11.4%). A confirmed diagnosis of neovascular AMD was most frequently based on fundoscopy (67.3%), fluorescein angiography (39.6%), and biomicroscopy (35.7%) tests but rarely on optical coherence tomography (8.9%). The most frequently documented comorbidity with neovascular AMD was hypertension and other cardiovascular diseases (57.5%). Seven ophthalmologists completed the questionnaire with the majority of ophthalmologists agreeing that regular ophthalmic examination can prevent the development of late-stage neovascular AMD. Conclusion: Neovascular AMD is a frequent diagnosis in German ophthalmology clinics. As visual acuity is already poor in most patients with suspected neovascular AMD, regular preventive ophthalmologic examinations should be considered in high risk patients. Study limitations: Limitations of the study include the lack of a comparator cohort, which limited the amount of analyses that could be performed. Additionally, a study eye was not defined and information was collected separately for each affected eye and therefore analysed separately. Furthermore, a small number of ophthalmologists completed the questionnaire, limiting the objectivity. © 2013 All rights reserved.

A case of a young man with myopathy, elevated serum aminotransferase and serum creatinine levels is presented. He had a polymyositis-like-syndrome caused by hashimoto thyroiditis with hypothyroidism. Thyroid hormone replacement therapy led to improvement in both the clinical and laboratory abnormalities. With the established tests for estimating the glomerular filtration rate we cannot determine if there was really a reversible acute renal failure or not.

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