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Frankfurt am Main, Germany

Knauf W.,Onkologische Gemeinschaftspraxis | Abenhardt W.,Munchner Onkologische Praxis | Dorfel S.,Onkozentrum | Meyer D.,Hamatologisch Onkologische Schwerpunktpraxis | And 4 more authors.
Hematological Oncology | Year: 2015

Various treatment options exist for patients with chronic lymphocytic leukaemia (CLL). Clinical registries provide insight into routine treatment and identify changes in treatment over time. The Tumour Registry Lymphatic Neoplasms prospectively collects data on the treatment of patients with lymphoid B-cell neoplasm as administered by office-based haematologists in Germany. Data on patient and tumour characteristics, co-morbidities, systemic treatments, and outcome parameters are recorded. Eight hundred and six patients with CLL were recruited between May 2009 and August 2013. At the start of first-line treatment, median age was 71years, 64% were male, and 44% had a Binet stage C disease. The most frequently used first-line/second-line regimens were bendamustine+rituximab (BR, 56%/55%), fludarabine+cyclophosphamide+rituximab (FCR, 22%/11%), and bendamustine (B, 5%/9%). Chlorambucil was used in only 7% (first-line) and 6% (second-line) of patients. Patients treated with FCR were younger and healthier than patients treated with BR. Overall, 91% of first-line treatments were successful (40% complete response). Real-life patient populations differ considerably from patients treated in randomized controlled trials. BR and FCR dominate the first-line and second-line treatments of CLL by office-based haematologists in Germany. Future analysis will investigate progression-free and overall survival times. © 2014 The Authors. Hematological Oncology Published by John Wiley & Sons, Ltd. © 2015 John Wiley & Sons, Ltd.

Niederle N.,Medizinische Klinik III Klinikum Leverkusen GGmbH | Megdenberg D.,Medizinische Klinik III Klinikum Leverkusen GGmbH | Balleisen L.,Medizinische Klinik I | Heit W.,Hamatologicum | And 6 more authors.
Annals of Hematology | Year: 2013

Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. This study assessed its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine. Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous systemic regimen (usually chlorambucil-based) were randomized to either receive bendamustine 100 mg/m2 on days 1 and 2 of a 4-week cycle or standard fludarabine treatment consisting of 25 mg/m 2 on days 1 to 5 every 4 weeks. The primary objective was to achieve non-inferior progression-free survival (PFS) with bendamustine. Out of a total of 96 patients randomized, 92 were eligible, 49 allocated to bendamustine and 43 to fludarabine. About half of the patients received six or more cycles. Overall response rates were 76 % on bendamustine and 62 % on fludarabine, with clinical complete response rates of 27 and 9 %, respectively. Median PFS was 20.1 and 14.8 months (hazard ratio, 0.87; 90 % confidence interval, 0.60-1.27), median overall survival 43.8 and 41.0 months (hazard ratio, 0.82). Thrombocytopenia and gastrointestinal toxicities were marginally more frequent on bendamustine, albeit CTC grade 3/4 event incidence was similar. These data suggest at least comparable efficacy of bendamustine vs. fludarabine, pointing to an alternative treatment option in relapsing CLL patients after chlorambucil containing initial chemotherapy. © 2013 Springer-Verlag Berlin Heidelberg.

Herold M.,Onkologisches Zentrum | Scholz C.W.,Klinik fur Innere Medizin | Rothmann F.,Klinik fur Hamatologie | Hirt C.,Universitatsmedizin Greifswald | And 2 more authors.
Journal of Cancer Research and Clinical Oncology | Year: 2015

Purpose: The randomised, controlled OSHO#39 study showed promising results using first-line mitoxantrone, chlorambucil and prednisolone (MCP) chemotherapy plus rituximab in patients with advanced symptomatic follicular lymphoma (FL) in need of therapy. The aim of this long-term follow-up was to investigate whether clinical benefits are maintained after up to 9 years of observation. Methods: Following the 4-year follow-up of OSHO#39, 77 FL patients who received rituximab plus MCP (R-MCP) and 52 patients who received MCP (129 patients alive and not previously censored in total) were followed for 5 additional years in this prospective, non-interventional, observational study. For the efficacy analysis, data were jointly analysed with OSHO#39 data (FL intention-to-treat population: 105 patients R-MCP, 96 MCP). Patients not included in the 5-year follow-up were censored. Results: For surviving patients, median follow-up was 102 months (R-MCP) and 87 months (MCP). Although median overall survival (OS) was not yet reached, OS was longer for patients with R-MCP compared with MCP (p = 0.0057), with 8-year-survival rates of 76.1 versus 55.9 %. Further time-to-event data were substantially longer for the R-MCP group than for MCP alone: median progression-free survival (PFS) was 93.4 versus 34.9 months, and median event-free survival (EFS) 89.6 versus 26.5 months. Unplanned subanalyses of patients with and without interferon maintenance showed improved PFS and EFS without an impact on OS. Conclusions: The addition of rituximab to first-line MCP chemotherapy improves clinical outcomes in advanced FL patients and translates into long-term OS benefits. R-MCP remains a promising standard option for this patient group. © 2015, Springer-Verlag Berlin Heidelberg.

Wehler T.,Universitatsklinikum des Saarlandes | Wehler B.,UCT | Stehle I.,Onkologische Gemeinschaftspraxis
Deutsche Medizinische Wochenschrift | Year: 2015

Monoclonal antibodies against the PD-1 receptor or its ligands result in a recovery of T cell responses against tumor antigens. Nivolumab is the first antibody that has been approved in lung cancer. This mode of action is very intersting, especially because of long term responses and the moderate toxicity. © Georg Thieme Verlag KG, Stuttgart · New York.

Knauf W.,Onkologische Gemeinschaftspraxis | Kellermann L.,OncologyInformation Service | Poenisch W.,University of Leipzig | Einsele H.,Medizinische Klinik II | And 2 more authors.
Onkologie | Year: 2010

Background: The present survey was undertaken to gain insights in the changes of disease management of multiple myeloma (MM) over time and the implementation of new guidelines into daily practice. Patients and Methods: Diagnosis and treatment of MM were evaluated based on a 3-month representative multicentre survey including 386 patients from 35 centres in Germany in 2008. The results were compared to similar surveys in 2004 and 2006. Results: At the time of first diagnosis, most patients (62.5%) were already in stage III (Durie-Salmon). The presence of deletion 13q was determined in 22% of patients only. However, determination of other prognostic factors has become increasingly well established. These include the levels of β2-microglobulin and serum albumin, each of which was determined in more than 2/3 of patients. Overall, 35% of patients were considered for high-dose chemotherapy. As a consequence of the development of innovative substances, there are remarkable shifts in first line, second line, and third line therapy with an increase in the use of bortezomib at all levels of therapy. Conclusions: Regarding diagnostic measures, deviations from recommended guidelines became evident. Also, high-dose chemotherapy with stem cell support was considered in a minority of patients only. Novel substances, however, were rapidly integrated into the treatment of MM. Copyright © 2010 S. Karger AG, Basel.

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