Van Der Graaf W.T.A.,Radboud University Nijmegen |
Blay J.-Y.,Center Leon Berard |
Chawla S.P.,Santa Monica Oncology Center |
Kim D.-W.,Seoul National University |
And 19 more authors.
The Lancet | Year: 2012
Pazopanib, a multitargeted tyrosine kinase inhibitor, has single-agent activity in patients with advanced non-adipocytic soft-tissue sarcoma. We investigated the effect of pazopanib on progression-free survival in patients with metastatic non-adipocytic soft-tissue sarcoma after failure of standard chemotherapy. Methods This phase 3 study was done in 72 institutions, across 13 countries. Patients with angiogenesis inhibitornaive,metastatic soft-tissue sarcoma, progressing despite previous standard chemotherapy, were randomly assigned by an interactive voice randomisation system in a 2:1 ratio in permuted blocks (with block sizes of six) to receive either pazopanib 800 mg once daily or placebo, with no subsequent cross-over. Patients, investigators who gave the treatment, those assessing outcomes, and those who did the analysis were masked to the allocation. The primary endpoint was progression-free survival. Efficacy analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00753688. Findings 372 patients were registered and 369 were randomly assigned to receive pazopanib (n=246) or placebo (n=123). Median progression-free survival was 4·6 months (95% CI 3·7-4·8) for pazopanib compared with 1·6 months (0·9-1·8) for placebo (hazard ratio [HR] 0·31, 95% CI 0·24-0·40; p<0·0001). Overall survival was 12·5 months (10·6-14·8) with pazopanib versus 10·7 months (8·7-12·8) with placebo (HR 0·86, 0·67-1·11; p=0·25). The most common adverse events were fatigue (60 in the placebo group [49%] vs 155 in the pazopanib group [65%]), diarrhoea (20 [16%] vs 138 [58%]), nausea (34 [28%] vs 129 [54%]), weight loss (25 [20%] vs 115 [48%]), and hypertension (8 [7%] vs 99 [41%]). The median relative dose intensity was 100% for placebo and 96% for pazopanib. Interpretation Pazopanib is a new treatment option for patients with metastatic non-adipocytic soft-tissue sarcoma after previous chemotherapy.
Hulse R.,Universitatsklinikum Mannheim |
Wenzel A.,Universitatsklinikum Mannheim |
Sommer J.U.,Universitatsklinikum Mannheim |
Hulse M.,Universitatsklinikum Mannheim |
Hormann K.,Universitatsklinikum Mannheim
Laryngo- Rhino- Otologie | Year: 2017
Numerous laws, guidelines and recommendations govern the handling and reprocessing of semi-critical medical devices in the field of ENT. Although mechanically reprocessing is characterized as a preferential, manual reprocessing is still conducted in most ENT clinics and medical practices for reasons of cost and practicability. In the presented study, we developed an optimized hygienic concept for reprocessing of medical products in the field of ENT. A demand analysis of rigid endoscopes and of ENT equipment was carried out based on hypothesis that only mechanical reprocessing was performed for the entire instrumentation. Additionally, patient-free activities like preparing instrumentation for examination were investigated. As a result, we could demonstrate that such patient-free activities represent a considerable time factor and as a consequence a cost factor in daily patient care. Necessary investments for only mechanical reprocessing of instrumentation including rigid endoscopes are considerably high, since number of endoscopes have to be kept very high. © Georg Thieme Verlag KG Stuttgart · New York.
Wesselmann S.,Deutsche Krebsgesellschaft E.V. |
Winter A.,Deutsche Krebsgesellschaft E.V. |
Ferencz J.,OnkoZert GmbH |
Seufferlein T.,Universitatsklinikum Ulm |
Post S.,Universitatsklinikum Mannheim
International Journal of Colorectal Disease | Year: 2014
Purpose: In order to improve the quality of treatment for cancer patients the German Cancer Society (Deutsche Krebsgesellschaft) implemented a certification system for oncological care institutions. The certified colorectal cancer centers present the structures, processes and results of their network in the framework of an auditing procedure. Methods: The current benchmarking report by the certified centers reflects the centers' reference results over a period of 3 years. The figures included in the benchmarking report reflect the areas of interdisciplinary collaboration, guideline-compliant treatment, and expertise of the main treatment partners. Results: High percentages were shown for indicators reflecting pretreatment and postoperative case presentations in multidisciplinary team meetings (91.8 % or 98.1 %), psycho-oncologic care (54.8 %) as well as social service counseling (77.1 %). Good quality of the TME rectal specimen and adequate lymph-node retrieval (12 lymph nodes at least) was achieved by 93 % or 96.6 % of the centers. Adjuvant chemotherapy (colon, Union for International Cancer Control [UICC] stage III) or neoadjuvant radiotherapy or chemoradiotherapy (rectum, UICC stages II and III) received 73.7 % or 80 % of relevant patients. Quotas of anastomotic leakage in the colon or rectum were 4.4 % or 7.6 %, whereas postoperative mortality amounted to 2.6 %. Conclusions: The present analysis of the results, together with the centers' statements and the auditors' reports, shows that most of the targets for indicator figures are being better met over the course of time. In addition, however, there is a clear potential for improvement and the centers are verifiably addressing this. A transparent presentation of the quality of care and reflection on and discussion of the results among the treatment partners in the certified network and with the auditors during the certification process may contribute to constant quality improvement in oncological care. © 2014 Springer-Verlag Berlin Heidelberg.
Hormann K.,Universitatsklinikum Mannheim |
Verse T.,Asklepios Klinik Harburg
Surgery for Sleep Disordered Breathing | Year: 2010
The treatment of sleep disordered breathing has been enriched by the development of various new and largely surgical techniques. The question of which treatment best suits each individual patient has become a highly sophisticated decision. Among others, the most important factors for selecting the most appropriate treatment modality are the cruelty of the disease, the pathology found within the upper airway, and the sites of obstruction. Therefore, the second edition of this book focuses on both the surgical treatment modalities and the current concepts for treatment decisions. For each procedure, current data (including data for the entirety of 2007) were reanalyzed according to the principles of evidence-based medicine, and are presented in well-arranged tables. Indications, techniques, complications, and specific follow-up treatments in the realm of sleep medicine have been compiled in the form of a primer. New chapters concerning radiofrequency- uvulopalatoplasty and combined soft palate procedures were added. Both authors run prominent otolaryngological sleep laboratories, and perform approximately 1,500 surgical sleep medicine procedures per year. The complete surgical and sleep medicine expertise of the authors, as well as the experience of numerous international courses on sleep surgery, have been incorporated into this volume, making it an indispensable textbook for sleep medicine surgeons. © Springer-Verlag Berlin Heidelberg 2010. All rights are reserved.
Kohnen T.,Goethe University Frankfurt |
Neuhann T.,Praxis Prof. Dr. Thomas Neuhann |
Knorz M.,Universitatsklinikum Mannheim
Ophthalmologe | Year: 2011
The Commission of Refractive Surgery (KRC), which is a combined commission of the German Ophthalmological Society (DOG) and the Professional Association of German Ophthalmologists (BVA), has made an up-to-date evaluation of the operative techniques for correction of refraction errors. In the revised guidelines drawn up by the KRC for evaluation and safeguarding the quality of refractive surgical procedures the description, area of application, limitations, side-effects and complications of each procedure are given according to the published scientific literature. By this means a comprehensive explanation for and investigation of patients should be safeguarded, optimal treatment results achieved and complications avoided. In this article all relevant forms of refractive surgery (photorefractive keratectomy, LASEK, EPI-LASIK, LASIK, Femto-LASIK, RELEX, conductive keratoplasty, astigmatic keratotomy, limbal relaxing incisions, intracorneal ring segments, corneal cross-linking, phakic intraocular lenses, refractive lens exchange, corneal presbyopia implants, INTRACOR) are described in detail and quality guidelines are established. Refractive surgical care and additional medical services possibly arising prior to or following this treatment are not basically covered by the statutory health insurance (GKV). © 2011 Springer-Verlag.
Kienle P.,Universitatsklinikum Mannheim |
Horisberger K.,Universitatsklinikum Mannheim
Chirurg | Year: 2013
Incontinence and constipation can occur in cases of pelvic floor dysfunction. Purely morphological changes without severe clinical symptoms are not an indication for surgery. Abdominal operations can be classified into procedures with dorsal (with or without bowel resection and with or without mesh implantation) and procedures with ventral rectopexy (with mesh). With respect to constipation and incontinence suture rectopexy alone is inferior to all other procedures. Dorsal and ventral mesh rectopexy and resection rectopexy are all comparable with respect to improvement of incontinence. Ventral rectopexy without dorsal mobilization and resection rectopexy are superior to mesh rectopexy with respect to constipation. Due to poor evidential status treatment is carried out from a pragmatic viewpoint. © 2012 Springer-Verlag Berlin Heidelberg.
Schmidt H.,Westpfalz Klinikum |
Hormann K.,Universitatsklinikum Mannheim |
Stasche N.,Westpfalz Klinikum
Laryngo- Rhino- Otologie | Year: 2010
Tracheobronchoscopy allows endoscopic inspection and management of the tracheobronchial system. Material: The recommendation was developed in 1997 and updated in 2004 and 2009. Results: The recommendations comment on indications and contra-indications, instruments, anesthesia and complications of endoscopic tracheobronchoscopy. Discusssion: Rapid technical advances in endoscopy have led to changes in indications for different procedures, especially as pertains to rigid and flexible endoscopy. The recommendations are designed to provide guidance for ENT and affiliated specialties for choosing and processing instruments and sedation methods. © Georg Thieme Verlag KG Stuttgart - New York.
Schneider S.W.,Universitatsklinikum Mannheim
Aktuelle Dermatologie | Year: 2012
It is well known that patients suffering from cancer hold a high risk of thrombosis and that teammates of the coagulation system have a high impact on tumor spreading. Therefore, tumor related thrombotic events dramatically downgrade overall survival of those patients, whereas, an anticoagulatory therapy, i.e. with low molecular heparin, attenuates tumor progression and prolongs overall survival. In this context tumor-endothelial cell interaction plays a pivotal role as tumor-induced endothelial cell activation leads to prothrombotic conditions. However, the mechanism of this interplay is not well known and will be the topic in this study. © Georg Thieme Verlag KG Stuttgart.
Weiss C.,Universitatsklinikum Mannheim
Aktuelle Dermatologie | Year: 2012
Abstract This contribution aims at tracing the development of statistical methods in medical science from the beginning in the 18 th century to modern applications in medical research. First it is outlined how conventional medical practice changed continuously during centuries in relation to the development of statistical sciences. Based on historical examples it is shown how statistical methodology contributed in overcome dogmatic thinking and to verify causal relations. Nowadays, there is a widespread consensus that medical research and its practical application is hardly possible without profound knowledge of statistical methods. The scope and risks related with an uncritical usage of statistical methods are discussed. © Georg Thieme Verlag KG Stuttgart . New York.
Kohler J.,Senckenberg Forschungsinstitut und Naturmuseum Frankfurt |
Kohler J.,Goethe University Frankfurt |
Hahn M.,Universitatsklinikum Mannheim |
Kohler G.,Senckenberg Forschungsinstitut und Naturmuseum Frankfurt
Salamandra | Year: 2012
Divergent evolution of hemipenial morphology between closely related forms appears to be a common phenomenon in mainland anoles. We discuss possible evolutionary scenarios for this finding, based on different lines of evidence from our work on Anolis polylepis and A. osa from southern Costa Rica. Molecular analysis suggests a very recent separation of these two forms and the occurrence of hybridisation in their contact zone. Evidence from crossbreeding experiments supports these assumptions. The results of an examination of female cloacal morphology indicate co-evolution of male and female genital morphologies and thereby contradict functional neutrality of hemipenial morphology. © 2012 Deutsche Gesellschaft für Herpetologie und Terrarienkunde e.V.(DGHT), Mannheim, Germany.