von Nadia Harbeck ; Andreas Schneeweiss ; Peter Thuss-Patience ; Kurt Miller ; Claus Garbe ; Frank Griesinger ; Wilfried E. E. Eberhardt ; Jens P. Klussmann ; Barbara Wollenberg ; Marc-Oliver Grimm ; Thomas Zander ; Diana Lüftner
Health technology assessment (HTA) of clinical and economic value of a new intervention is an integral step in providing the access of patients to innovative cancer care and treatment. Overall survival (OS) is the preferred criterion for demonstrating the therapeutic efficacy in HTA given its direct clinical and patient relevance. However, with often long life expectancy of patients with early cancer, analysis of OS becomes less practical. Partially due to this reason, pathological complete response (pCR) and time-to-event end-points like disease-free survival are frequently incorporated into the pivotal clinical trials in the neoadjuvant and adjuvant settings. However, there exists a discrepancy between different national HTA bodies regarding the acknowledgement of patient relevance of these end-points. In this article, we analysed the perspectives of patients on different aspects of end-points used in clinical trials in early cancer. Gathered evidence strongly suggests that complete tumour eradication and reduced risk of recurrence provide important psychological benefits thus signifying that pCR and time-to-event end-points are directly relevant to patients. Additionally, we reviewed opinions on patient relevance of neoadjuvant and adjuvant therapy end-points adopted by HTA bodies during the recent evaluations. We found that improvements in end-points used in the adjuvant setting were commonly considered as valuable to patients. In contrast, opinions on patient relevance of neoadjuvant therapy end-points varied between the national HTA bodies. Universal acknowledgement of patient relevance of therapeutic end-points for early cancer by HTA bodies is necessary to balance the inequality in uptake of innovative therapies into national healthcare systems.
European journal of cancer Amsterdam [u.a.] : Elsevier, 1992 147(2021) vom: Apr., Seite 40-50
Online first: 8 January 2021 ; Gesehen am 16.07.2021
First-line therapy for younger patients with peripheral T-cell non-Hodgkin lymphoma (T-NHL) consists of 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with or without etoposide (CHOEP), consolidated by high-dose therapy and autologous stem cell transplantation (auto-SCT). We hypothesized that allogeneic stem cell transplantation (allo-SCT) could improve outcomes. 104 patients with peripheral T-cell non-Hodgkin lymphoma, except ALK+ anaplastic large cell lymphoma, 18 to 60 years, all stages, and all age adjusted International Prognostic Index scores, except 0 and stage I, were randomized to 4 cycles of CHOEP and 1 cycle of dexamethasone, cytosine-arabinoside, and platinum (DHAP) followed by high-dose therapy and auto-SCT or myeloablative conditioning and allo-SCT. The primary end point was event-free survival (EFS) at 3 years. After a median follow-up of 42 months, the 3-year EFS after allo-SCT was 43%, as compared with 38% after auto-SCT. Overall survival at 3 years was 57% vs 70% after allo- or auto-SCT, without significant differences between treatment arms. None of the 21 responding patients proceeding to allo-SCT relapsed, as opposed to 13 of 36 patients (36%) proceeding to auto-SCT. Eight of 26 patients (31%) and none of 41 patients died of transplant-related toxicity after allo- and auto-SCT, respectively. The strong graft-versus-lymphoma effect after allo-SCT was counterbalanced by transplant-related mortality. This trial is registered at www.clinicaltrials.gov as #NCT00984412.
Blood Washington, DC : American Society of Hematology, 1946 137(2021), 19 vom: 13. Mai, Seite 2646-2656 Online-Ressource
von Daniel Thomas-Rüddel ; Peter Hoffmann ; Daniel Schwarzkopf ; Christian Scheer ; Friedhelm Bach ; Marcus Komann ; Herwig Gerlach ; Manfred Weiss ; Matthias Lindner ; Hendrik Rüddel ; Philipp Simon ; Sven-Olaf Kuhn ; Reinhard Wetzker ; Michael Bauer ; Konrad Reinhart ; Frank Bloos ; Anja Diers ; Florian Jelschen ; Andreas Weyland
von Tobias R. Overbeck ; Stefan Hans Peter Wenleder ; Bernhard Christoph Danner ; Wolfgang Körber ; Karin Töpelt ; Bernhard Hemmerlein ; Christina Perske ; Markus Falk ; Markus Tiemann ; Claudia Tomala ; Elke Stitz ; Frank Griesinger
Journal of pulmonology and respiratory research East Windsor CT, USA : Heighten Science Publications Inc., 2017 5(2021), 1 vom: 28. Jan., Seite 1-18 Online-Ressource
Available online: 2 October 2019 ; Gesehen am 08.07.2020
penumbra; photon
For any detector to be used for the determination of absorbed dose at the point of measurement in water a basic equation is required to convert the reading of the detector into absorbed dose in water. The German DIN 6800 part 1 provides a general formalism for that. A further differentiated formalism applicable to photon dosimetry is suggested in this work. This modified formalism presents the two following still general and at the same time fundamental properties of any dosimetry detector: a) a clear distinction of correction factors with respect to the physical processes involved during the measurement, and b) the fact that the process of energy absorption in the detector is determined by the spectral distribution of the fluence of the secondary charged particles. It is concluded that based on the modified formalism and knowing this spectral distribution within the detector a general method is available with benefits for ionization chambers as well as for any other dosimetry detector and which is applicable at reference as well as non-reference conditions without any preconditions.
Zeitschrift für medizinische Physik Amsterdam [u.a.] : Elsevier, 1990 30(2020), 1, Seite 24-39
von Insa Seeger ; Andreas Klausen ; Stefan Thate ; Frank Flake ; Oliver Peters ; Walter Rempe ; Michael Peter ; Frank Scheinichen ; Ulf Günther ; Rainer Röhrig ; Andreas Weyland
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