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Krefeld, Germany

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

Leischker A.H.,Alexianer Krefeld GmbH | Kolb G.F.,Klinik fur Innere Medizin
Zeitschrift fur Gerontologie und Geriatrie | Year: 2015

The prevalence of vitamin B12 deficiency increases with age. Patients with dementia and spouses of patients with dementia are at special risk for the development of vitamin B12 deficiency. In a normal diet this vitamin is present only in animal source foods; therefore, vegans frequently develop vitamin B12 deficiency if not using supplements or foods fortified with cobalamin. Apart from dementia, most of these manifestations are completely reversible under correct therapy; therefore it is crucial to identify and to treat even atypical presentations of vitamin B12 deficiency as early as possible.This article deals with the physiology and pathophysiology of vitamin B12 metabolism. A practice-oriented algorithm which also considers health economic aspects for a rational laboratory diagnosis of vitamin B12 deficiency is presented.In cases with severe neurological symptoms, therapy should be parenteral, especially initially. For parenteral treatment, hydroxocobalamin is the drug of choice. © 2014, Springer-Verlag Berlin Heidelberg. Source

Galsky M.D.,Mount Sinai School of Medicine | Krege S.,Alexianer Krefeld GmbH | Lin C.-C.,National Taiwan University Hospital | Hahn N.,Indiana University | And 6 more authors.
Urologic Oncology: Seminars and Original Investigations | Year: 2014

Purpose: Cisplatin-based chemotherapy is standard first-line treatment for metastatic urothelial carcinoma. However, cisplatin is frequently avoided in elderly patients due to concerns regarding toxicities. We analyzed the efficacy, and tolerability, of cisplatin-based chemotherapy in elderly patients. Methods: Individual patient data were pooled from 8 phase II and III trials evaluating cisplatin-based first-line chemotherapy in patients with metastatic urothelial carcinoma. Adverse events, treatment delivery, response proportions, and survival outcomes were compared between patients aged<70 vs.≥70 years. Results: Of the 543 patients included, 162 patients (30%) were≥70 years old. The majority (93%) of elderly patients were aged 70 to 79 years. There was no significant difference in the proportions of patients experiencing Grade 3 to 4 renal failure, febrile neutropenia, or treatment-related death between younger and older patient cohorts. The median survival of the patients≥70 years was 12.1 months compared to 12.8 months for patients<70 years (P = 0.91). There was no significant difference in survival between age groups when controlling for baseline performance status or the presence of visceral metastases or both. Conclusions: Fit septuagenarians, with adequate renal function, tolerate cisplatin-based chemotherapy similarly to their younger counterparts and achieve comparable clinical outcomes. © 2014 Elsevier Inc. Source

Gortz P.,Heinrich Heine University Dusseldorf | Siebler M.,Heinrich Heine University Dusseldorf | Ihl R.,Heinrich Heine University Dusseldorf | Ihl R.,Alexianer Krefeld GmbH | And 4 more authors.
Biochemical and Biophysical Research Communications | Year: 2013

Pathological cerebrospinal fluid (CSF) alterations like changes in amyloid-β1-42 and tau protein concentration are typical in Alzheimer's disease (AD). However, it remains unclear, if the composition of known or unknown pathological factors in native CSF has a functional significance in AD. In this pilot study, we used multielectrode array (MEA) neurochips to determine whether CSF of individuals with AD (AD-CSF) may have distinct neurofunctional properties that may distinguish it from that of individuals with mild cognitive impairment (MCI) - a differential diagnosis of high clinical importance. MEAs are neuronal cultures coupled to a multisite electrical recording system with the ability to reflect pharmacological or toxicological alterations on the functional level of whole neuronal networks. Collective rhythmical electrical activity was substantially enhanced after exposure to CSF of cognitively healthy subjects (controls) and of MCI individuals (MCI-CSF) alike. However, this activity increment was significantly reduced when MEAs were exposed to AD-CSF compared to MCI-CSF. Moreover, following AD-CSF exposure, networks showed significantly enhanced burst durations and less synchronous bursting, respectively. Thus, AD-CSF and MCI-CSF could be distinguished by characteristic changes of the network firing pattern on MEAs. When data of MCI individuals and AD patients were pooled, the network suppression correlated significantly with the degree of cognitive decline. The findings of this pilot study may set the stage for a unique and straightforward diagnostic bioassay of AD with particular value in the differential diagnosis to MCI and as a much needed biomarker for clinical trials. © 2013 Elsevier Inc. Source

Ihl R.,Alexianer Krefeld GmbH
International Journal of Psychiatry in Clinical Practice | Year: 2013

Objective. We review four randomised, controlled trials investigating the efficacy of Ginkgo biloba extract EGb 761® in elderly patients with Alzheimer or vascular dementia with neuropsychiatric features. Methods. Patients with a total score of 9-23 in the Syndrom-Kurz test (SKT) cognitive test battery (cognitive domain) and with a composite score 6 and greater in the Neuropsychiatric Inventory (NPI; behavioural domain) were included. Three trials compared 2 × 120 mg/day or 1 × 240 mg/day EGb 761® to placebo while one used donepezil as an active control. The duration of randomised treatment was 22 or 24 weeks. Results. One thousand, two hundred and ninety-four patients were analysed for efficacy. Patients treated with EGb 761® showed improvements of cognitive performance and behavioural symptoms that were associated with advances in activities of daily living and a reduced burden to caregivers. Placebo-treated patients, on the other hand, showed only minimal improvements or signs of progression. In each placebo-controlled trial, EGb 761® was significantly superior in all mentioned domains (p < 0.01). In the actively controlled trial, EGb 761® and donezepil as well as a combination of both drugs had similar effects. Conclusions. The review supports the efficacy of EGb 761 ® in age-related dementia with neuropsychiatric features. The drug was safe and well-tolerated. © 2013 Informa Healthcare. Source

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