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Steinau an der Straße, Germany

Warm M.,University of Cologne | Kates R.,REK Consulting | Overkamp F.,Day Clinic for Hematology and Oncology | Thomas A.,Charite - Medical University of Berlin | Harbeck N.,University of Cologne
Breast Cancer Research and Treatment | Year: 2011

Response to fulvestrant and survival in postmenopausal hormone-sensitive advanced breast cancer was investigated within a non-randomized, In-Practice Evaluation Program, with the aim of optimizing treatment decisions. 848 patients (median age 64 years; 52% co-morbidity; 78% prior palliative therapy; median 4 prior regimens) received monthly fulvestrant injections (250 mg/month) and were followed-up three-monthly for 9 months. Clinical benefit (PFS ≥ 24 weeks) occurred in 532/848 (62.7%); stable disease (SD) in 627/848 patients (74%), including 62 complete and 177 partial responses. Best response was delayed in 115 patients. Estimated 9-month overall survival (OS) was 89%; 9-month event-free survival (EFS) was 71%. Indicators of disease aggressiveness affected response and survival, but number of fulvestrant cycles was the key OS and EFS determinant. The patients with SD at 3 months benefitted from continued fulvestrant. Excluding deaths, 7 serious adverse events occurred (none attributable to fulvestrant). No new or unexpected safety issues arose; 90% of the patients and physicians rated fulvestrant tolerability as "very good" or "good". In the largest prospective, fulvestrant-treated cohort to date, advanced breast cancer patients achieving SD or better after 3 months of treatment gained survival benefit by prolonging fulvestrant therapy-independent of disease and treatment history. © 2010 Springer Science+Business Media, LLC. Source

Helmer T.,BMW AG | Kates R.,REK Consulting
19th Intelligent Transport Systems World Congress, ITS 2012 | Year: 2012

This paper presents a detailed statistical analysis of a large, representative accident dataset with the aim of obtaining characteristics of vehicle accidents involving cyclists. To this end, using the German In-Depth Accident Study (GIDAS) and national databases, current national trends in accident scenarios, statistics, and characteristics are evaluated and analyzed in terms of frequency, impact, and contributing factors. The scenarios of cyclist accidents are qualitatively similar to those of pedestrian collisions; in particular, crossing conflict scenarios are the most important both in terms of prevalence and severity-weighting. The scenario analysis also implies that vehicle-based measures focusing on the vehicle front-both by means of active and passive safety-could have a large impact on cyclist as well as pedestrian accidents and their consequences. The typically higher cyclist speeds in all scenarios pose important challenges for potential engineering approaches to vehicle-cyclist accident reduction. Source

Warm M.,University of Cologne | Duda V.,University of Marburg | Eichler C.,University of Cologne | Harbeck N.,University of Cologne | And 6 more authors.
Anticancer Research | Year: 2011

Background: The objective was the investigation of a possible predictive quantitative impact of initial tumor sphericity, measured by 3D sonography, on response to pre-operative chemotherapy. Patients and Methods: This 3D ultrasound study was conducted on 41 consecutive primary breast cancer patients who received pre-operative epirubicin and paclitaxel chemotherapy; the tumors were measured by 3D sonography and by pathology after chemotherapy. Sphericity was defined as the ratio of the smallest to the largest extent by 3D sonography. Results: A predictive impact of initial tumor sphericity on response to pre-operative chemotherapy was quantitatively identified for the first time. Sphericity was a significant predictor of pathological complete remission with a rank difference of 0.34 or about 1/3 i.e., spherical tumors were more likely to show successful remission. Conclusion: Tumor sphericity as defined from 3D sonography could be predictive of response to pre-operative chemotherapy regimens; prospective investigation is suggested. Source

Helmer T.,BMW AG | Scullion P.,George Washington University | Samaha R.R.,George Washington University | Ebner A.,BMW AG | Kates R.,REK Consulting
17th ITS World Congress | Year: 2010

For proposed pedestrian protection systems, evaluation of safety benefits is required as an integral part of the design and optimization phases. Stochastic ("Monte-Carlo") simulation techniques are currently being utilized to predict safety benefits in terms of physics; however, converting physics to human benefits requires injury and fatality risk models. To this end, multivariate predictive models for pedestrian fatalities and for injury severity on the ISS scale are estimated using the US Pedestrian Crash Data Study (PCDS). Although numerous parameters are correlated with injury and fatality risk in univariate analysis, many of these correlations can be attributed to an association with collision speed, which is the most important single explanatory variable. In addition to collision speed, age, pedestrian physiological characteristics and vehicle parameters are significant multivariate predictors. The in-sample predictive quality is remarkably high. The models provide an interface to large-scale stochastic simulation and virtual testing of proposed vehicle-based active safety systems for pedestrian protection. Source

Warm M.,University of Cologne | Kates R.,REK Consulting | Grosse-Onnebrink E.M.,University of Cologne | Stoff-Khalili M.,University of Cologne | And 4 more authors.
Anticancer Research | Year: 2010

Background: The central objective of this study was to determine the predictive impact of several established tumor biological factors (PgR, ER, HER2 and Ki-67) on response to pre-operative chemotherapy in primary breast cancer. Patients and Methods: 59 primary M0 breast cancer patients received pre-operative sequential dose-dense epirubicin and cyclophosphamide followed by docetaxel (19 patients at dosage 100 mg/m2, 40 patients at 75 mg/m2). Results: Pathological complete remission (pCR) occurred in 17 patients (29%) and at least partial remission in 42 (71%). Higher proliferation (Ki-67) and lack of hormone receptors (either or both) were significant predictive factors for pCR; moreover, 8/11 (73%) patients with triple-negative tumors (HER2-/ER-/PgR-) had pCR (p=0.001). Breast conserving surgery was achieved in 46/59 patients (78%). Hand-foot syndrome occurred in 12/19 patients treated at the higher docetaxel dosage but only 1/40 of the remaining patients. Higher docetaxel dosage was associated with improved pCR in the non-triple-negative subgroup. Conclusion: The tumor biology of hormone receptor-negative, especially triple-negative, and highly proliferating breast cancer is associated with strongly positive response to dose-dense, pre-operative epirubicin/cyclophosphamide/docetaxel chemotherapy. Source

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