German Center for Assessment and Evaluation of Innovative Techniques in Medicine

Neuß, Germany

German Center for Assessment and Evaluation of Innovative Techniques in Medicine

Neuß, Germany
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Gerullis H.,Lukas Hospital | Gerullis H.,University of Duisburg - Essen | Gerullis H.,German Center for Assessment and Evaluation of Innovative Techniques in Medicine
Drugs of Today | Year: 2011

Vinflunine is a novel third-generation bifluorinated semisynthetic vinca alkaloid that has been shown to have activity against a variety of solid tumor types including advanced transitional cell carcinoma of the urothelium. In contrast to other vinca alkaloids, vinflunine shows superior antitumor activity and an excellent safety profile. Vinflunine interacts with tubulin and has a lower affinity to tubulin; it has a high intracellular accumulation rate and therefore significant effects on microtubule dynamics. A large, phase III trial comparing vinflunine with best supportive care versus best supportive care alone showed an improvement in overall survival in the vinflunine arm in preplanned secondary analyses. In addition, the drug has shown a moderate adverse event profile in the phase II and III trials. In September 2009, vinflunine was approved as a second-line treatment for patients with urothelial carcinoma resistant to first-line platinum-containing chemotherapy by the European Medicines Agency. Copyright © 2011 Prous Science, S.A.U. or its licensors. All rights reserved.


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.


Gerullis H.,Lukas Hospital | Gerullis H.,University of Duisburg - Essen | Gerullis H.,German Center for Assessment and Evaluation of Innovative Techniques in Medicine | Eimer C.,Lukas Hospital | And 10 more authors.
Medical Oncology | Year: 2012

This phase II trial assessed temsirolimus, an inhibitor of mammalian target of rapamycin (mTOR), as second-line therapy in patients with metastatic transitional carcinoma of the urothelium (TCCU) after failure of platinum containing therapy. From June/2009 to June/2011, we enrolled 15 patients in this trial. Primary endpoint was overall survival, as secondary endpoints we defined time to disease progression, safety and QoL along treatment. Patients with progressive TCCU after prior platinum-based chemotherapy received weekly 25 mg of temsirolimus for 8 weeks. Evaluation for response was accomplished every 8 weeks according to the RECIST criteria, QoL assessment was done every 4 weeks using the QLQ-C30 questionnaire, adverse events (AEs) were recorded and graded using NCI-CTC criteria. Fifteen patients were enrolled in this study, of whom 14 (93 %) were available for activity, safety and QoL assessment. We treated 10 (71 %) male and 4 female (29 %) patients. Median age was 64,7 years (45-76). Patients received on average 13 (3-15) infusions of temsirolimus. As per protocol, no sufficient benefit on overall survival was observed, we early stopped the study after 14 patients. Median time to progression was 2.5 months (77 days), median overall survival was 3.5 months (107 days). Four patients with stable disease were observed. QoL assessment along treatment revealed a reduction of EORTC-QLQ-C30, Global Health Status subscale, from initial 7.86 to 5.00. Temsirolimus was well tolerated. As Grade 3-4 adverse events, we observed fatigue (n = 2), leukopenia (n = 2) and thrombopenia (n = 2). All other adverse events were graded 1-2 in nature. Temsirolimus seems to have poor activity in patients with progressive metastasized TCCU after failure of platinum containing first-line therapy. © 2012 Springer Science+Business Media, LLC.


Barski D.,Lukas Hospital | Gerullis H.,Lukas Hospital | Gerullis H.,German Center for Assessment and Evaluation of Innovative Techniques in Medicine | Georgas E.,Lukas Hospital | And 8 more authors.
BioMed Research International | Year: 2014

Purpose. Optimized biocompatibility is a major requirement for alloplastic materials currently applied for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) repair. In the preliminary studies the mesh modification by coating with autologous plasma resulted in the increased adherence score in vitro and improved biocompatibility in an animal model. The first use of plasma coated meshes in human is presented. Materials and Methods. Between 04/2013 and 05/2014, 20 patients with the indication for SUI and POP repair were selected in a single institution. The applied meshes were modified by autologous plasma coating prior to implantation. A retrospective chart review for peri- and early postoperative complications was performed. Functional outcome and QoL were evaluated pre- and postoperatively. Results. The functional outcome and QoL improved significantly in all groups. Two reoperations (Grade IIIB) with the release of TVT-mesh in anesthesia due to the obstruction were needed. No other severe complications were registered. Conclusion. For the first time we applied a mesh modification in a human setting according to IDEAL criteria of surgical innovations. The procedure of mesh coating with autologous plasma is safe and a prospective randomized trial proving a positive effect of plasma coating on the biocompatibility and morbidity outcome with long-term registry is planned. © 2014 Dimitri Barski et al.


Gerullis H.,Lukas Hospital Neuss | Gerullis H.,University of Duisburg - Essen | Gerullis H.,German Center for Assessment and Evaluation of Innovative Techniques in Medicine | Ecke T.H.,HELIOS Hospital | And 7 more authors.
Anti-Cancer Drugs | Year: 2011

Relapse after initial first-line chemotherapy shows a poor prognosis in metastatic urothelial cancer. Currently, several chemotherapeutic agents and targeted drugs are under evaluation for platin-resistant advanced urothelial carcinoma. Vinflunine has been approved for second-line treatment in this indication. We present a patient with initial T4 advanced and subsequently metastasized bladder cancer, who has shown prolonged survival of 44 months after radical cystectomy. During her clinical course, the patient received two different platinum-containing therapies, temsirolimus within a phase II protocol and subsequent vinflunine chemotherapy. Treatment duration was 15 weeks with temsirolimus and 9 weeks with vinflunine, respectively, with a stable disease period of 3.8 months under temsirolimus therapy. This case is an example of how patients can derive a survival benefit from adequate sequencing of surgery and medical treatment including the newest therapies, even in advanced disease. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Gerullis H.,University of Duisburg - Essen | Gerullis H.,Lukas Hospital Neuss | Gerullis H.,German Center for Assessment and Evaluation of Innovative Techniques in Medicine | Eimer C.,University of Duisburg - Essen | And 10 more authors.
The Scientific World Journal | Year: 2012

Introduction. Aim of this study was to assess the safety and efficacy of injection of autologous muscle-derived cells into the urinary sphincter for treatment of postprostatectomy urinary incontinence in men and to characterize the injected cells prior to transplantation. Methods. 222 male patients with stress urinary incontinence and sphincter damage after uroloical procedures were treated with transurethral injection of autologous muscle-derived cells. The transplanted cells were investigated after cultivation and prior to application by immunocytochemistry using different markers of myogenic differentiation. Feasibility and functionality assessment was achieved with a follow-up of at least 12 months. Results. Follow-up was at least 12 months. Of the 222 treated patients, 120 responded to therapy of whom 26 patients (12) were continent, and 94 patients (42) showed improvement. In 102 (46) patients, the therapy was ineffective. Clinical improvement was observed on average 4.7 months after transplantation and continued in all improved patients. The cells injected into the sphincter were at least 50 of myogenic origin and representative for early stages of muscle cell differentiation. Conclusions. Transurethral injection of muscle-derived cells into the damaged urethral sphincter of male patients is a safe procedure. Transplanted cells represent different phases of myogenic differentiation. © Copyright 2012 H. Gerullis et al.


Gerullis H.,Lukas Hospital Neuss | Gerullis H.,University of Duisburg - Essen | Gerullis H.,German Center for Assessment and Evaluation of Innovative Techniques in Medicine | Klosterhalfen B.,German Center for Implant Pathology | And 10 more authors.
Surgical Innovation | Year: 2013

Purpose. Mesh surgeries are counted among the most frequently applied surgical procedures. Despite global spread of mesh applying surgeries, there is no current systematic analysis of incidence and possible prevention of adverse events after mesh implantation. Materials and Methods. Based on the recommendations of IDEAL an in vitro test system for biocompatibility of surgical meshes has been generated (Innovation). Coating strategies for biocompatibility optimization have been developed (Development). The native and modified alloplastic materials have been tested in an animal model over 2 years (Exploration and Assessment and Long-term study). Results. In 3 meshes, implanted in sheep and explanted at 4 different time points (a, 3 months; b, 6 months; c, 12 months; and d, 24 months) over 24 months, thickness of inflammatory tissue (TVT a, 35 μm; b, 32 μm; c, 33 μm; d, 28 μm; UltraPro, a, 25 μm; b, 24 μm; c, 21 μm; d, 22 μm; PVDF a, 20 μm; b, 21 μm; c, 14 μm; d, 15μm), connective tissue (TVT a, 37 μm; b, 36 μm; c, 43 μm; d, 41 μm; UltraPro a, 33 μm; b, 32 μm; c, 40 μm; d, 38 μm; PVDF a, 25 μm; b, 22 μm; c, 22 μm; d, 24 μm), and macrophage infiltration (TVT a, 36%; b, 33%; c, 23%; d, 20%; UltraPro a, 34%; b, 28%; c, 25%; d, 22%; PVDF a, 24%; b, 18%; c, 18%; d, 16%) revealed comparable ranking characteristics at every time point after explantation. The in vivo performance of these meshes in a sheep model was predictable with a previously developed in vitro test system. Coating of meshes with autologous plasma prior to implantation seems to have a positive effect on the meshes biocompatibility. Conclusion. We have applied IDEAL criteria on a new innovation for surgical meshes. The results permit the generation of a ranking of currently available meshes with potential to optimize future meshes. © The Author(s) 2013.


Gerullis H.,Lukas Hospital | Gerullis H.,University of Duisburg - Essen | Gerullis H.,German Center for Assessment and Evaluation of Innovative Techniques in Medicine | Quast S.,Lukas Hospital | And 7 more authors.
Journal of Endourology | Year: 2011

Purpose: The aim of this study was to analyze the sphincteric/ perisphincteric lesions and modifications in incontinent patients with iatrogenic damage to the external urethral sphincter after radical prostatectomy (RP). Patients and Methods: We evaluated 169 patients with postprostatectomy urinary incontinence who were referred from 28 German hospitals from December 2004 to March 2009. Inclusion criteria were refractory grade III stress urinary incontinence and duration of incontinence of at least 12 months. Patients underwent clinical, ultrasonographic examination, urethrocystoscopy, and if technically possible, urethrocystomanometry. Sphincteric defects were classified and evaluated with regard to type and localization. Results: Mean duration of incontinence before evalulation was 44.8 (12-156) months. Distribution of the previous prostatectomy technique was 66.9% retropubic RP, 27.8% laparoscopic RP, 3.5% perineal RP, and 1.8% robot-assisted RP. A transection of the sphincter was seen in 65.1% (110/169) of cases, a sphincter penetration in 46.2% (78/169) of cases. A combination of both sphincter injuries was seen in 37% (63/169) of patients. In 87% (147/169) of the cases, the sphincter defect was localized to the lower circumference, and in 13% (22/169) of cases, to the upper circumference. A stricture of the vesicourethral anastomosis was found in 45% (76/169) of cases. Conclusions: Direct iatrogenic damages to the urethral sphincter are a potential reason for postprostatectomy urinary incontinence. They seem to follow a particular local distribution pattern, indicating that apex preparation and building of the urethrovesical anastomosis show an increased risk for these sphincter injuries. Cystoscopic evaluation of the sphincteric region in incontinent patients after surgery may be a valuable tool for examination. © Copyright 2011, Mary Ann Liebert, Inc.


Gerullis H.,Lukas Hospital | Gerullis H.,University of Duisburg - Essen | Gerullis H.,German Center for Assessment and Evaluation of Innovative Techniques in Medicine | Georgas E.,Lukas Hospital | And 9 more authors.
BioMed Research International | Year: 2013

Purpose. To investigate mesh coating modalities with autologous blood components in a recently developed in vitro test system for biocompatibility assessment of alloplastic materials. Materials and Methods. Seven different mesh types, currently used in various indications, were randomly investigated. Meshes were coated prior to cultivation with autologous peripheral blood mononuclear cells (PBMCs), platelets, and blood plasma. Pretreated meshes were incubated over 6 weeks in a minced tissue assay, representative for fibroblasts, muscle cells, and endothelial cells originating from 10 different patients. Adherence of those tissues on the meshes was microscopically investigated and semiquantitatively assessed using a previously described scoring system. Results. Coating with peripheral blood mononuclear cells did not affect the adherence score, whereas coating with platelets and blood plasma increased the score suggesting improved biocompatibility in vitro. The previous ranking of native meshes remained consistent after coating. Conclusion. Plasma coating of meshes improves their biocompatibility score in a novel in vitro test system. © 2013 Holger Gerullis et al.


Gerullis H.,Lukas Hospital Neuss | Gerullis H.,University of Duisburg - Essen | Gerullis H.,German Center for Assessment and Evaluation of Innovative Techniques in Medicine | Georgas E.,Lukas Hospital Neuss | And 8 more authors.
Urologia Internationalis | Year: 2013

Total penectomy results in a disfiguring anatomic situation which may have a devastating effect on the patient's psychologic health. Here we report our experience with construction of a penoid by covering a transpositioned testicle with remaining penile skin after radical penectomy in 2 patients with malignant underlying disease. Copyright © 2012 S. Karger AG, Basel.

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