Nürnberg, Germany
Nürnberg, Germany

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PubMed | Klinikum Oldenburg, University Hospital of Tuebingen, HELIOS Klinikum Berlin Buch, University of Regensburg and 20 more.
Type: Journal Article | Journal: Haematologica | Year: 2016

Autologous transplantation is controversial for older patients with multiple myeloma. The role of age-adjusted high-dose melphalan and the impact of induction chemotherapy cycles is still unclear. A total of 434 patients aged 60-70 years were randomly assigned to 4 cycles of standard anthracycline-based induction chemotherapy or no induction. For all patients, double autologous transplantation after melphalan 140 mg/m


Engert A.,University of Cologne | Plutschow A.,University of Cologne | Eich H.T.,University of Cologne | Lohri A.,Swiss Group for Clinical Cancer Research | And 21 more authors.
New England Journal of Medicine | Year: 2010

BACKGROUND: Whether it is possible to reduce the intensity of treatment in early (stage I or II) Hodgkin's lymphoma with a favorable prognosis remains unclear. We therefore conducted a multicenter, randomized trial comparing four treatment groups consisting of a combination chemotherapy regimen of two different intensities followed by involved-field radiation therapy at two different dose levels. METHODS: We randomly assigned 1370 patients with newly diagnosed early-stage Hodgkin's lymphoma with a favorable prognosis to one of four treatment groups: four cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by 30 Gy of radiation therapy (group 1), four cycles of ABVD followed by 20 Gy of radiation therapy (group 2), two cycles of ABVD followed by 30 Gy of radiation therapy (group 3), or two cycles of ABVD followed by 20 Gy of radiation therapy (group 4). The primary end point was freedom from treatment failure; secondary end points included efficacy and toxicity of treatment. RESULTS: The two chemotherapy regimens did not differ significantly with respect to freedom from treatment failure (P = 0.39) or overall survival (P = 0.61). At 5 years, the rates of freedom from treatment failure were 93.0% (95% confidence interval [CI], 90.5 to 94.8) with the four-cycle ABVD regimen and 91.1% (95% CI, 88.3 to 93.2) with the two-cycle regimen. When the effects of 20-Gy and 30-Gy doses of radiation therapy were compared, there were also no significant differences in freedom from treatment failure (P = 1.00) or overall survival (P = 0.61). Adverse events and acute toxic effects of treatment were most common in the patients who received four cycles of ABVD and 30 Gy of radiation therapy (group 1). CONCLUSIONS: In patients with early-stage Hodgkin's lymphoma and a favorable prognosis, treatment with two cycles of ABVD followed by 20 Gy of involved-field radiation therapy is as effective as, and less toxic than, four cycles of ABVD followed by 30 Gy of involved-field radiation therapy. Long-term effects of these treatments have not yet been fully assessed. (Funded by the Deutsche Krebshilfe and the Swiss Federal Government; ClinicalTrials.gov number, NCT00265018.) Copyright © 2010 Massachusetts Medical Society.


Coiffier B.,Hospices Civils de Lyon | Pro B.,Thomas Jefferson University | Prince H.M.,University of Melbourne | Foss F.,Yale Cancer Center | And 13 more authors.
Journal of Hematology and Oncology | Year: 2014

Background: Romidepsin is a structurally unique, potent, bicyclic class 1 selective histone deacetylase inhibitor approved by the US Food and Drug Administration for the treatment of patients with cutaneous T-cell lymphoma who have received ≥ 1 prior systemic therapy and patients with peripheral T-cell lymphoma (PTCL) who have received ≥ 1 prior therapy. Approval for PTCL was based on results (n = 130; median follow-up, 13.4 months) from the pivotal study of romidepsin for the treatment of relapsed/refractory PTCL. The objective is to present updated data (median follow-up, 22.3 months) and to characterize patients who achieved long-term responses (≥ 12 months) to romidepsin. Methods. Patients with PTCL who relapsed from or were refractory to ≥ 1 prior systemic therapy received romidepsin 14 mg/m§ssup§2§esup§ as a 4-hour intravenous infusion on days 1, 8, and 15 every 28 days for up to 6 cycles; patients with response or stable disease could continue romidepsin beyond 6 cycles. The primary endpoint was rate of confirmed/unconfirmed complete response (CR/CRu) determined by an Independent Review Committee. Secondary endpoints included objective response rate (ORR) and duration of response (DOR). For patients who achieved CR/CRu, baseline characteristics by DOR (≥ 12 vs < 12 months) were examined. Results: The ORR to romidepsin was 25%, including 15% with CR/CRu. The median DOR for all responders was 28 months (range, < 1-48+) and was not reached for those who achieved CR/CRu. Patients with lack of response or transient response to prior therapy achieved durable responses with romidepsin. Of the 19 patients who achieved CR/CRu, 10 had long-term (≥ 12 months) responses; none of the baseline characteristics examined - including heavy pretreatment, response to prior therapy, or advanced disease - precluded long-term responses to romidepsin. With a median progression-free survival of 29 months, patients who achieved CR/CRu for ≥ 12 months had significantly longer survival vs those with CR/CRu for < 12 months or < CR/CRu. Extended treatment and longer follow-up did not affect the reported safety profile of romidepsin. Conclusions: Treatment with romidepsin leads to highly durable responses in a subset of patients with relapsed/refractory PTCL, with responses ongoing as long as 48 months. Trial registration. NCT00426764. © 2014 Coiffier et al.; licensee BioMed Central Ltd.


Itakura E.,University of California at Los Angeles | Huang R.-R.,University of California at Los Angeles | Wen D.-R.,University of California at Los Angeles | Paul E.,Klinikum Nurnberg Nord | And 2 more authors.
Modern Pathology | Year: 2011

Downregulation of the immune system facilitates tumor progression at different stages of cutaneous melanoma. Sentinel nodes, the first lymph nodes on lymphatics draining directly from a primary melanoma, are immune downregulated by tumor-generated immunosuppressive cytokines, including interleukin-10 (IL-10). To better understand the kinetics of sentinel node suppression, we investigated IL-10 expression by melanoma cells and tumor-associated macrophages and lymphocytes at different stages of primary melanoma evolution. We used reverse-transcriptase in situ PCR to identify the cellular sources of IL-10 mRNA in 39 melanomas. IL-10 mRNA was identified in tumor cells of 2 of 6 melanomas in situ (33%), of 17 of 21 invasive melanomas (81%) and of 11 of 12 metastatic melanomas (92%). Higher IL-10 expression correlates with tumor progression, with differences between melanoma in situ, invasive melanoma and metastatic melanoma. In primary melanomas, the IL-10 mRNA content of tumor cells correlates with Clark's level. There was significantly more IL-10 mRNA in vertical growth-phase melanoma cells than in radial growth-phase cells. In a logistic regression model, moderate-to-high IL-10 mRNA expression by tumor cells was significantly associated with vertical growth-phase melanoma. IL-10 mRNA was detected in melanoma-associated macrophages and lymphocytes. In invasive melanomas, IL-10 mRNA reactivity of macrophages decreased as Clark's level increased. Alterations of immunity by IL-10 derived from melanoma cells and melanoma-associated macrophages and lymphocytes potentially facilitate evolution of the primary melanoma and render regional lymph nodes susceptible to metastases. © 2011 USCAP, Inc. All rights reserved.


Evangelatos N.,Klinikum Nurnberg Nord | Carayannis E.,George Washington University
International Journal of Social Ecology and Sustainable Development | Year: 2014

The phenomenon of diffusion has been extensively studied from different disciplines in the natural and social sciences and has been used in the study of innovation dynamics. Diffusion plays also a central role to the study of disease-spread within a population, being an essential element of epidemiological research. In case of disease-diffusion, the contagious agents spread among susceptible individuals, thus rendering them infected. Those individuals can in turn communicate the disease to other susceptible community members and start an epidemic. These characteristics of disease-spread have been successfully studied by epidemiological theoretical tools. Patent citations, traditionally used as indicators for R&D output, signal the acquisition of knowledge and, in that sense, facilitate diffusion of innovation. In this paper the authors argue that patent citations could be seen as contagious agents and the diffusion of innovation could be studied with tools from the field of epidemiology. In this direction the authors draw a theoretical framework for future original research. Copyright © 2014, IGI Global.


Brucker C.,Klinikum Nurnberg Nord | Hedon B.,Hopital Arnaud de Villeneuve | The H.S.,St. Antonius Ziekenhuis | Hoschen K.,Grunenthal GmbH | And 2 more authors.
Contraception | Year: 2010

Objective: This study was conducted to assess the long-term efficacy and safety of a low-dose monophasic combined oral contraceptive (COC) containing 0.02 mg ethinylestradiol (EE) and 2 mg chlormadinone acetate (CMA) in a novel regimen administered daily for 24 days followed by a 4-day placebo interval. Study Design: In this multicenter, uncontrolled, Phase III trial, 1665 subjects took the COC 0.02 mg EE/2 mg CMA for up to 21 cycles. The overall Pearl Index was the primary end point; cycle control, safety, effect on acne and seborrhea, and changes in body weight and libido were secondary end points. Results: Contraceptive efficacy was analyzed for 1653 subjects completing 21,495 cycles. Six pregnancies occurred during trial duration with one attributable to method failure. The overall Pearl Index for the first year of use was 0.33 (95% confidence interval, 0.09-0.85). The mean number of bleeding/spotting days during six 90-day reference periods (RPs) decreased from 17.0 (RP 1) to 11.7 (RP 6), and the number of bleeding episodes per RP decreased from 3.8 (RP 1) to 2.7 (RP 6). Among subjects who presented with acne at the baseline visit, a decrease of papules/pustules and comedones was observed during the course of the trial. The most common "at least possibly related" adverse events were headache, breast discomfort and nausea. The tolerability and well-being was reported as being excellent or good in the majority of trial subjects (84.6% and 80.2%, respectively). Conclusions: The low-dose COC 0.02 mg EE/2 mg CMA administered daily for 24 days followed by a 4-day placebo interval provides high contraceptive efficacy combined with an adequate cycle control and safety profile, beneficial effects on acne, and is well tolerated. © 2010 Elsevier Inc. All rights reserved.


Schweigert M.,Klinikum Nurnberg Nord | Solymosi N.,Szent Istvan University | Dubecz A.,Klinikum Nurnberg Nord | Stadlhuber R.J.,Klinikum Nurnberg Nord | And 3 more authors.
Annals of the Royal College of Surgeons of England | Year: 2013

INTRODUCTION Intrathoracic anastomotic leakage following oesophagectomy is a crushing condition. Until recently, surgical re-exploration was the preferred way of dealing with this life threatening complication. However, mortality remained significant. We therefore adopted endoscopic stent implantation as the primary treatment option. The aim of this study was to investigate the feasibility and results of endoscopic stent implantation as well as potential hazards and pitfalls. METHODS Between January 2004 and December 2011, 292 consecutive patients who underwent an oesophagectomy at a single high volume centre dedicated to oesophageal surgery were included in this retrospective study. Overall, 38 cases with anastomotic leakage were identified and analysed. RESULTS A total of 22 patients received endoscopic stent implantation as primary treatment whereas a rethoracotomy was mandatory in 15 cases. There were no significant differences in age, frequency of neoadjuvant therapy or ASA grade between cases with and without a leak. However, patients with a leak were five times more likely to have a fatal outcome (odds ratio: 5.10, 95% confidence interval: 2.06-12.33, p<0.001). Stent migration occurred but endoscopic reintervention was feasible. In 17 patients (77%) definite closure and healing of the leak was achieved, and the stent was removed subsequently. Two patients died owing to severe sepsis despite sufficient stent placement. Moreover, stent related aortic erosion with consecutive fatal haemorrhage occurred in three cases. CONCLUSIONS Stent implantation for intrathoracic oesophageal anastomotic leaks is feasible and compares favourably with surgical re-exploration. It is an easily available, minimally invasive procedure that may reduce leak related mortality. However, it puts the already well-known risk of stent-related vascular erosion on the spot. Awareness of this life threatening complication is therefore mandatory.


Schweigert M.,Klinikum Nurnberg Nord | Dubecz A.,Klinikum Nurnberg Nord | Ofner D.,Paracelsus Medical University | Stein H.J.,Klinikum Nurnberg Nord
Ulster Medical Journal | Year: 2013

Abnormalities of the major airways are uncommon congenital conditions which occur in approximately 2% of the adult population. Usually aberrant bronchi are asymptomatic and are only found by coincidence. We present the rare case of a 49-years-old woman with a tracheal bronchus associated with recurrent pneumonia of the right upper lobe. © The Ulster Medical Society, 2013.


Schweigert M.,Klinikum Nurnberg Nord | Dubecz A.,Klinikum Nurnberg Nord | Beron M.,Klinikum Nurnberg Nord | Ofner D.,Paracelsus Medical University | Stein H.J.,Klinikum Nurnberg Nord
Irish Journal of Medical Science | Year: 2013

Background: Pulmonary infections occasionally present with infectious pseudotumour of the lung not easily distinguishable from true pulmonary neoplasm. In such cases, radiographic findings and clinical manifestation are highly suggestive of lung cancer. These inflammatory lung lesions cause significant diagnostic problems and appropriate therapy is often considerably delayed. We therefore report on our experience with infectious pseudotumour of the lung caused by bacterial, mycobacterial and fungal pulmonary infections. Methods: In a retrospective case series, patients with lung infections simulating pulmonary carcinoma were identified. Clinical presentation, radiological features, surgical procedures and outcome were analysed. Results: There were seven male and six female patients with a mean age of 53 years. Presumed pulmonary carcinoma and hemoptysis were main reasons for hospital admission. Procedures performed were video-assisted thoracoscopic wedge resection (6), lobectomy (5), video-assisted thoracoscopic lobectomy and open wedge resection each in one case. Pathologic examination of the obtained specimens revealed tuberculoma (5), aspergilloma (3), pulmonary actinomycosis related pseudotumour (3) and coccidioidoma (2). Following definite diagnosis, patients with tuberculosis and fungal infections received antituberculotic and antifungal medications, respectively. Patients suffering from pulmonary actinomycosis received penicillin. There was no in-hospital mortality. One re-thoracotomy was mandatory because of pleural empyema. Conclusions: Pulmonary infections simulating lung cancer require surgical removal both for establishing definite diagnosis and to manage complications like haemoptysis and ongoing contamination of the airways by infectious agents. Whenever feasible, limited thoracoscopic resections are preferable. Following definite diagnosis antimicrobial drug therapy for a sufficient length of time is mandatory. © 2012 Royal Academy of Medicine in Ireland.


Schweigert M.,Klinikum Nurnberg Nord | Beron M.,Klinikum Nurnberg Nord | Dubecz A.,Klinikum Nurnberg Nord | Stadlhuber R.,Klinikum Nurnberg Nord | Stein H.,Klinikum Nurnberg Nord
Thoracic and Cardiovascular Surgeon | Year: 2012

Objective Thoracic injury is a life-threatening condition with advanced age being an independent risk factor for both higher morbidity and mortality. Furthermore, elderly patients often have severe comorbidity and in case of chest trauma with rib fractures and hemothorax, their clinical condition is likely to deteriorate fast. Aim of this study is to investigate the feasibility and results of video-assisted thoracoscopy for the treatment of posttraumatic hemothorax in very elderly patients of 80 years or more. MethodsThe outcomes of 60 consecutive patients who received video-assisted thoracoscopic surgery for posttraumatic hemothorax in a German tertiary referral hospital between 2006 and 2010 were reviewed in a retrospective case study. Patients older than 80 years were identified. ResultsThere were 39 male and 21 female patients. The median age was 63.2 years. The in-hospital-mortality was 1.7% (1/60). Fifteen of the 60 patients were 80 years or older (8091). Main reason for hemothorax was blunt chest trauma. Altogether 23 patients had fractures of three or more ribs including six octogenarians. Elderly patients suffered from preexisting cardiopulmonary disease and were often referred to the thoracic surgeon with considerable delay. Video-assisted thoracoscopic surgery was feasible and all octogenarian patients finally recovered well without in-hospital-mortality. ConclusionsVideo-assisted thoracoscopic surgery for treatment of posttraumatic hemothorax shows excellent results in very elderly patients of 80 years or more. Despite severe comorbidity and often delayed surgery all patients recovered. We therefore conclude that advanced age is no contraindication for surgical management of posttraumatic hemothorax by means of video-assisted thoracoscopy. © Georg Thieme Verlag KG · Stuttgart · New York.

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