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81.
Wolfram Pönisch Bruno Holzvogt Madlen Plötze Marc Andrea Malvina Bourgeois Simone Heyn Thomas Zehrfeld Doreen Hammerschmidt Maik Schwarz Thomas Edelmann Cornelia Becker Franz Albert Hoffmann Andreas Schwarzer Ute Kreibich Kerstin Gutsche Kolja Reifenrath Cornelia Winkelmann Rainer Krahl Yvonne Remane Evelin Hennig Thomas Schliwa Tom Lindner Thorsten Kaiser Vladan Vucinic Gerhard Behre Dietger Niederwieser 《Journal of cancer research and clinical oncology》2014,140(11):1947-1956
Introduction
Bortezomib is a proteasome inhibitor that has shown important clinical efficacy either as a single agent or in combination in patients with multiple myeloma (MM). In the present protocol, bortezomib was combined with bendamustine and prednisone, in order to assess the efficacy and safety of this combination therapy in patients with newly diagnosed/untreated MM.Methods
Between June 2006 and October 2013, 49 patients with newly diagnosed/untreated MM were treated with bendamustine 60 mg/m2 on days 1 and 2, bortezomib 1.3 mg/m2 on days 1, 4, 8 and 11, and prednisone 100 mg on days 1, 2, 4, 8 and 11 bendamustine, prednisone and bortezomib (BPV) once every 21 days. Patients were divided into three groups: group A (n = 19) consisted of patients with normal renal function or mild dysfunction (eGFR ≥60 ml/min), group B (n = 15) patients with moderate or severe renal dysfunction (eGFR 15–59 ml/min) and group C (n = 15) patients with renal failure/dialysis (eGFR <15 ml/min).Results
A median number of two (range 1–5) BPV treatment cycles were given to the patients. The majority of the patients (n = 40, 82 %) responded after at least one cycle of BPV therapy with five stringent complete responses (CRs), nine near complete responses, 12 very good partial responses and 14 partial responses. Five patients had MR, three stable and one progressive disease. After a median observation time of 13 months, progression-free survival (PFS) and overall survival (OS) at 12 months were 92 and 94 %, respectively, for patients with normal renal function or mild renal dysfunction (group A) and 83 and 93 %, respectively, for patients with moderate or severe renal dysfunction (group B). Outcome for these patients was slightly better but not statistically significantly better than that for patients with renal failure/dialysis (group C), who had a PFS, and OS of 66 % (p = 0.08) and 73 % (p = 0.05), respectively.Summary
These results indicate that this BPV combination is feasible, effective and well tolerated in patients with newly diagnosed MM and normal or impaired renal function. 相似文献82.
Markus Pfirrmann Susanne Saussele Andreas Hochhaus Andreas Reiter Ute Berger Dieter K. Hossfeld Christoph Nerl Christof Scheid Karsten Spiekermann Jiri Mayer Andrzej Hellmann Klaus Lechner Christiane Falge Herbert G. Sayer Donald Bunjes Arnold Ganser Dietrich W. Beelen Helen Baldomero Urs Schanz Hermann Heimpel Hans-Jochem Kolb Joerg Hasford Alois Gratwohl Rüdiger Hehlmann 《Journal of cancer research and clinical oncology》2014,140(8):1367-1381
Purpose
In the two consecutive German studies III and IIIA on chronic myeloid leukemia, between 1995 and 2004, 781 patients were randomized to receive either allogeneic hematopoietic stem cell transplantation with a related donor or continued drug treatment. Despite comparable transplantation protocols and most centers participating in both studies, the post-transplant survival probabilities for patients transplanted in first chronic phase were significantly higher in study IIIA (144 patients) than in study III (113 patients). Prior to the decision on a combined analysis of both studies, reasons for this discrepancy had to be investigated.Methods
The Cox proportional hazard cure model was used to identify prognostic factors for post-transplant survival.Results
Donor–recipient matching for human leukocyte antigen, patient age, time between diagnosis and transplantation, and calendar time showed a significant influence on survival and/or the incidence of cure. Added as a further factor, affiliation to study IIIA had no significant impact any longer.Conclusions
Discrepancies in influential prognostic factors explained the different post-transplant survival probabilities between the studies. The significance of calendar time suggests a lack of consistency of transplantation practice over time. Accordingly, the prerequisite for a common assessment of overall survival in the two randomized transplantation arms was not met. Moreover, our analyses provide an independent validation of established prognostic factors and their cutoffs. The statistical approach in investigating and modeling potential prognostic factors for survival sets an example for the examination of studies with unexpected outcome differences in concurrent treatment arms. 相似文献83.
Sascha Dietrich Jürgen G. Okun Kathrin Schmidt Christine S. Falk Andreas H. Wagner Suzan Karamustafa Aleksandar Radujkovic Ute Hegenbart Anthony D. Ho Peter Dreger Thomas Luft 《Haematologica》2014,99(3):541-547
Steroid-refractory graft-versus-host disease is a life-threatening complication after allogeneic stem cell transplantation. Evidence is accumulating that steroid-refractory graft-versus-host disease is associated with endothelial distress. Endothelial cell homeostasis is regulated by nitric oxide, and serum nitrates are derived from nitric oxide synthase activity or dietary sources. In this retrospective study based on 417 patients allografted at our institution we investigated whether quantification of serum nitrates could predict steroid-refractory graft-versus-host disease. Elevated pre-transplant levels of serum nitrates (>26.5 μM) predicted steroid-refractory graft-versus-host disease (P=0.026) and non-relapse mortality (P=0.028), particularly in combination with high pre-transplant angiopoietin-2 levels (P=0.0007 and P=0.021, respectively). Multivariate analyses confirmed serum nitrates as independent predictors of steroid-refractory graft-versus-host disease and non-relapse mortality. Differences in serum nitrate levels did not correlate with serum levels of tumor necrosis factor or C-reactive protein or expression of inducible nitric oxide synthase in blood cells. Patients with high pre-transplant nitrate levels had significantly reduced rates of refractory graft-versus-host disease (P=0.031) when pravastatin was taken. In summary, patients at high risk of developing steroid-refractory graft-versus-host disease could be identified prior to transplantation by serum markers linked to endothelial cell function. Retrospectively, statin medication was associated with a reduced incidence of refractory graft-versus-host disease in this endothelial high-risk cohort. 相似文献
84.
Pekka Jaako Shubhranshu Debnath Karin Olsson Ute Modlich Michael Rothe Axel Schambach Johan Flygare Stefan Karlsson 《Haematologica》2014,99(12):1792-1798
Diamond-Blackfan anemia is a congenital erythroid hypoplasia caused by functional haploinsufficiency of genes encoding ribosomal proteins. Mutations involving the ribosomal protein S19 gene are detected in 25% of patients. Enforced expression of ribosomal protein S19 improves the overall proliferative capacity, erythroid colony-forming potential and erythroid differentiation of hematopoietic progenitors from ribosomal protein S19-deficient patients in vitro and in vivo following xenotransplantation. However, studies using animal models are needed to assess the therapeutic efficacy and safety of the viral vectors. In the present study we have validated the therapeutic potential of gene therapy using mouse models of ribosomal protein S19-deficient Diamond-Blackfan anemia. Using lentiviral gene transfer we demonstrated that enforced expression of ribosomal protein S19 cures the anemia and lethal bone marrow failure in recipients transplanted with ribosomal protein S19-deficient cells. Furthermore, gene-corrected ribosomal protein S19-deficient cells showed an increased pan-hematopoietic contribution over time compared to untransduced cells without signs of vector-mediated toxicity. Our study provides a proof of principle for the development of clinical gene therapy to cure ribosomal protein 19-deficient Diamond-Blackfan anemia. 相似文献
85.
Efstathios Kastritis Ashutosh Wechalekar Stefan Schönland Vaishali Sanchorawala Giampaolo Merlini Giovanni Palladini Monique Minnema Murielle Roussel Arnaud Jaccard Ute Hegenbart Shaji Kumar Maria T. Cibeira Joan Blade Meletios A. Dimopoulos 《British journal of haematology》2020,190(3):346-357
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-associated coronavirus disease 2019 (COVID-19) is primarily manifested as a respiratory tract infection, but may affect and cause complications in multiple organ systems (cardiovascular, gastrointestinal, kidneys, haematopoietic and immune systems), while no proven specific therapy exists. The challenges associated with COVID-19 are even greater for patients with light chain (AL) amyloidosis, a rare multisystemic disease affecting the heart, kidneys, liver, gastrointestinal and nervous system. Patients with AL amyloidosis may need to receive chemotherapy, which probably increases infection risk. Management of COVID-19 may be particularly challenging in patients with AL amyloidosis, who often present with cardiac dysfunction, nephrotic syndrome, neuropathy, low blood pressure and gastrointestinal symptoms. In addition, patients with AL amyloidosis may be more susceptible to toxicities of drugs used to manage COVID-19. Access to health care may be difficult or limited, diagnosis of AL amyloidosis may be delayed with detrimental consequences and treatment administration may need modification. Both patients and treating physicians need to adapt in a new reality. 相似文献
86.
Ute Thyen Anke Lux Martina Jürgensen Olaf Hiort Birgit Köhler 《Journal of general internal medicine》2014,29(3):752-759
BACKGROUND
Disorders of sex development (DSD) are a heterogeneous group of rare genetic disorders of sex determination or differentiation. Evidence-based guidelines concerning gender assignment and surgical and hormonal treatment are limited for many DSD entities, and health care is highly fragmented across various sub-specialties and settings. A lack of informed consent, secrecy about the condition, shame, and impaired sexual and psychosocial functioning may affect satisfaction with care.OBJECTIVES
The main goal of this study was to describe satisfaction with care in individuals with DSD and to identify factors associated with low satisfaction with care.METHODS / MAIN MEASURES
Using both biological (chromosomes) and social categories (sex of rearing), we classified participants according to the nomenclature of the European Society for Pediatric Endocrinology/Lawson Wilkins Pediatric Endocrine Society (ESPE/LWPES) consensus statement. We used standardized measures to assess satisfaction with care (CSQ-8), health-related quality of life (SF-36), psychological symptoms (BSI), and gender identity (FGI), in addition to self-constructed questionnaires probing experiences with health care and access to self-help groups.PARTICIPANTS
A total of 110 adults were recruited between January 2005 and December 2007 in four study centers in Germany, Austria, and German-speaking Switzerland.RESULTS
Reports of half the participants scored below the cut-off indicating low quality of care. Women with XX DSD conditions and virilization (i.e., congenital adrenal hyperplasia) reported the highest scores for satisfaction with care, and women with XY DSD conditions and complete lack of androgen effects reported the lowest scores. Satisfaction with care was positively associated with indicators of psychological well-being.CONCLUSIONS
Satisfaction with care is lowest among participants with the rarest conditions, highlighting the lack of evidence-based recommendations and the lack of coordination of care. Associations of satisfaction and well-being indicate the need to ensure access to mental health services.87.
Arijit Biswas Vytautas Ivaskevicius Anne Thomas Michael Varvenne Brigitte Brand Hannelore Rott Iris Haussels Heiko Ruehl Ute Scholz Robert Klamroth Johannes Oldenburg 《Annals of hematology》2014,93(10):1665-1676
Mild FXIII deficiency is an under-diagnosed disorder because the carriers of this deficiency are often asymptomatic and reveal a phenotype only under special circumstances like surgery or induced trauma. Mutational reports from this type of deficiency have been rare. In this study, we present the phenotypic and genotypic data of nine patients showing mild FXIII-A deficiency caused by eight novel heterozygous missense mutations (Pro166Leu, Arg171Gln, His342Tyr, Gln415Arg, Leu529Pro, Gln601Lys, Arg703Gln and Arg715Gly) in the F13A1 gene. None of these variants were seen in 200 healthy controls. In silico structural analysis of the local wild-type protein structures (activated and non-activated) from X-ray crystallographic models downloaded from the protein databank identified potential structural/functional effects for the identified mutations. The missense mutations in the core domain are suggested to be directly influencing the catalytic triad. Mutations on other domains might influence other critical factors such as activation peptide cleavage or the barrel domain integrity. In vitro expression and subsequent biochemical studies in the future will be able to confirm the pathophysiological mechanisms proposed for the mutations in this article. 相似文献
88.
Walter Fiedler Joerg Chromik Stefanie Amberg Maxim Kebenko Felicitas Thol Vera Schlipfenbacher Anne Christine Wilke Franziska Modemann Melanie Janning Hubert Serve Arnold Ganser Carsten Bokemeyer Susann Theile Ute Deppermann Anne L. Kranich Michael Heuser 《British journal of haematology》2020,190(3):e169-e173
89.
Serif Senturk Zhan Yao Matthew Camiolo Brendon Stiles Trushar Rathod Alice M. Walsh Alice Nemajerova Matthew J. Lazzara Nasser K. Altorki Adrian Krainer Ute M. Moll Scott W. Lowe Luca Cartegni Raffaella Sordella 《Proceedings of the National Academy of Sciences of the United States of America》2014,111(32):E3287-E3296
90.