von Eileen Moritz ; Gabriele Jedlitschky ; Josefine Negnal ; Mladen V. Tzvetkov ; Günter Daum ; Marcus Dörr ; Stephan Felix ; Henry Völzke ; Matthias Nauck ; Edzard Schwedhelm ; Peter Meisel ; Thomas Kocher ; Bernhard H. Rauch ; Birte Holtfreter
von Julia Duerschlag ; Wiebke Mohr ; Timothy G. Ferdelman ; Julie LaRoche ; Dhwani Desai ; Peter L. Croot ; Daniela Voß ; Oliver Zielinski ; Gaute Lavik ; Sten Littmann ; Clara Martinez-Perez ; Bernhard Tschitschko ; Nina Bartlau ; Helena Osterholz ; Thorsten Dittmar ; Marcel M. M. Kuypers
von Pablo Urrutia Cordero ; Silke Langenheder ; Maren Striebel ; Peter Eklöv ; David G. Angeler ; Stefan Berilsson ; Bianka Csitári ; Lars-Anders Hansson ; Egle Kelpsiene ; Hjalmar Laudon ; Maria Lundgren ; Omneya Ahmed Osman ; Linda Parkefelt ; Helmut Hillebrand
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, 1965 147(2021) vom: Apr., Seite 40-50
von Philipp Eckert ; Philine Marchetta ; Marie Kristin Manthey ; Michael H. Walter ; Saša Jovanović ; Daria Savitska ; Wibke Singer ; Michele H. Jacob ; Lukas Rüttiger ; Thomas Schimmang ; Ivan Milenković ; Peter K. D. Pilz ; Marlies Knipper
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 Soyeon Bae ; Lea Heidrich ; Shaun R. Levick ; Martin M. Gossner ; Sebastian Seibold ; Wolfgang W. Weisser ; Paul Magdon ; Alla Serebryanyk ; Claus Bässler ; Deborah Schäfer ; Ernst-Detlef Schulze ; Inken Dörfler ; Jörg Müller ; Kirsten Jung ; Marco Heurich ; Markus Fischer ; Nicolas Roth ; Peter Schall ; Steffen Boch ; Stephan Wöllauer ; Swen C. Renner ; Jörg Müller
von Christian Deppner ; Waldemar Herr ; Merle Cornelius ; Peter Stromberger ; Tammo Sternke ; Christoph Grzeschik ; Alexander Grote ; Jan Rudolph ; Sven F. Herrmann ; Markus Krutzik ; André Wenzlawski ; Robin Corgier ; Eric Charron ; David Guéry-Odelin ; Naceur Gaaloul ; Claus Lämmerzahl ; Achim Peters ; Patrick Windpassinger ; Ernst Maria Rasel