von Tobias Hebel ; Michael Grözinger ; Michael Landgrebe ; Frank Padberg ; Martin Schecklmann ; Thomas Schläpfer ; Carlos José Schönfeldt Lecuona ; Heiko Ullrich ; Peter M. Zwanzger ; Berthold Langguth ; Malek Bajbouj ; Bettina Bewernick ; Klaus Brinkmann ; Joachim Cordes ; Jan Di Pauli ; Peter Eichhammer ; Nils Freundlieb ; Göran Hajak ; Jacqueline Höppner-Buchmann ; René Hurlemann ; Daniel Kamp ; Sarah Kayser ; Bernhard Kis ; Peter M. Kreuzer ; Jens Kuhn ; Melisande Lammers ; Beatrix Lugmayer ; Clemens Mielacher ; Thomas Nickl-Jockschat ; Christian Nunhofer ; Ulrich Palm ; Timm B. Poeppl ; Thomas Polak ; Katrin Sakreida ; Alexander Sartorius ; Christoph Silberbauer ; David Zilles-Wegner
von Albrecht Stenzinger ; Cornelis M. van Tilburg ; Ghazaleh Tabatabai ; Florian Länger ; Norbert Graf ; Frank Griesinger ; Lukas Heukamp ; Michael Hummel ; Thomas Klingebiel ; Simone Hettmer ; Christian Oliver Vokuhl ; Sabine Merkelbach-Bruse ; Friedrich Overkamp ; Peter Reichardt ; Monika Scheer ; Wilko Weichert ; C. Benedikt Westphalen ; Carsten Bokemeyer ; Philipp Ivanyi ; Sonja Loges ; Peter Schirmacher ; Bernhard Wörmann ; Stefan Bielack ; Thomas Seufferlein
Gesehen am 06.07.2021 ; Online publiziert: 30. November 2020
NTRK-Genfusionen sind seltene genetische Alterationen, die tumorentitätenübergreifend vorkommen können. Während sie in den meisten soliden Tumoren nur sehr niederfrequent vorkommen, lassen sie sich in bestimmten Tumoren wie dem infantilen Fibrosarkom, dem kongenitalen mesoblastischen Nephrom und dem sekretorischen Mamma- oder Speicheldrüsenkarzinom jedoch häufig nachweisen. NTRK-Genfusionen bzw. TRK-Fusionsproteine gelten als starke onkogene Treiber. Bei Nachweis von NTRK-Genfusionen können TRK-Inhibitoren unabhängig von der Tumorentität eingesetzt werden. Vertreter sind Entrectinib und Larotrectinib. Bislang ist nur Larotrectinib in der Europäischen Union zugelassen. Für beide wurden Wirksamkeit und Verträglichkeit in Phase-I- und Phase-II-Studien gezeigt. Die Seltenheit der TRK-Fusionstumoren stellt diagnostische und klinische Prozesse vor große Herausforderungen: Einerseits sollen alle Patienten mit TRK-Fusionstumoren identifiziert werden, andererseits sind epidemiologische und histologische Aspekte sowie Ressourcen zu berücksichtigen. Basierend auf diesen Punkten möchten wir einen Diagnosealgorithmus für TRK-Fusionstumoren vorschlagen, außerdem stellen wir aktuelle Daten zu den TRK-Inhibitoren vor.
Der Pathologe Berlin : Springer, 1994 42(2021), 1, Seite 103-115 Online-Ressource
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
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