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doi:10.22028/D291-43543
Titel: | Radiation and Dose-densification of R-CHOP in Aggressive B-cell Lymphoma With Intermediate Prognosis: The UNFOLDER Study |
VerfasserIn: | Thurner, Lorenz Ziepert, Marita Berdel, Christian Schmidt, Christian Borchmann, Peter Kaddu-Mulindwa, Dominic Viardot, Andreas Witzens-Harig, Mathias Dierlamm, Judith Haenel, Mathias Metzner, Bernd Wulf, Gerald Lengfelder, Eva Keller, Ulrich B. Frickhofen, Norbert Nickelsen, Maike Gaska, Tobias Griesinger, Frank Mahlberg, Rolf Marks, Reinhard Shpilberg, Ofer Lindemann, Hans-Walter Soekler, Martin Fischer von Weikersthal, Ludwig Kiehl, Michael Roemer, Eva Bentz, Martin Krammer-Steiner, Beate Trappe, Ralf de Nully Brown, Peter Federico, Massimo Merli, Francesco Engelhard, Marianne Glass, Bertram Schmitz, Norbert Truemper, Lorenz Bewarder, Moritz Hartmann, Frank Walter Michael Murawski, Niels Stilgenbauer, Stephan Rosenwald, Andreas Altmann, Bettina Schmidberger, Heinz Fleckenstein, Jochen Loeffler, Markus Poeschel, Viola Held, Gerhard |
Sprache: | Englisch |
Titel: | HemaSphere : open access journal of the European Hematology Association |
Bandnummer: | 7 |
Heft: | 7 |
Verlag/Plattform: | Wolters Kluwer |
Erscheinungsjahr: | 2023 |
DDC-Sachgruppe: | 540 Chemie |
Dokumenttyp: | Journalartikel / Zeitschriftenartikel |
Abstract: | UNFOLDER (Unfavorable Young Low-Risk Densification of R-Chemo Regimens) is an international phase-3 trial in patients 18-60 years with aggressive B-cell lymphoma and intermediate prognosis defined by age-adjusted International Prognostic Index (aaIPI) of 0 and bulky disease (≥7.5 cm) or aaIPI of 1. In a 2 × 2 factorial design patients were randomized to 6× R-CHOP-14 or 6× R-CHOP-21 (rituximab, cyclophosphamide, doxorubicin, vincristine, and prediso[lo]ne) and to consolidation radiotherapy to extralymphatic and bulky disease or observation. Response was assessed according to the standardized response criteria published in 1999, not including F-18 fluordesoxyglucose positron emission tomography/computed tomography (FDG-PET). Primary endpoint was event-free survival (EFS). A total of 695 of 700 patients were eligible for the intention-to-treat analysis. Totally 467 patients qualified for radiotherapy of whom 305 patients were randomized to receive radiotherapy (R-CHOP-21: 155; R-CHOP-14: 150) and 162 to observation (R-CHOP-21: 81, R-CHOP-14: 81). Two hundred twenty-eight patients not qualifying for radiotherapy were randomized for R-CHOP-14 versus R-CHOP-21. After a median observation of 66 months 3-year EFS was superior in the radiotherapy-arm versus observation-arm (84% versus 68%; P = 0.0012), due to a lower rate of partial responses (PR) (2% versus 11%). PR often triggered additional treatment, mostly radiotherapy. No significant difference was observed in progression-free survival (PFS) (89% versus 81%; P = 0.22) and overall survival (OS) (93% versus 93%; P = 0.51). Comparing R-CHOP-14 and R-CHOP-21 EFS, PFS and OS were not different. Patients randomized to radiotherapy had a superior EFS, largely due to a lower PR rate requiring less additional treatment (NCT00278408, EUDRACT 2005-005218-19). |
DOI der Erstveröffentlichung: | 10.1097/HS9.0000000000000904 |
URL der Erstveröffentlichung: | https://journals.lww.com/hemasphere/fulltext/2023/07000/radiation_and_dose_densification_of_r_chop_in.10.aspx |
Link zu diesem Datensatz: | urn:nbn:de:bsz:291--ds-435433 hdl:20.500.11880/39020 http://dx.doi.org/10.22028/D291-43543 |
ISSN: | 2572-9241 |
Datum des Eintrags: | 22-Nov-2024 |
Fakultät: | NT - Naturwissenschaftlich- Technische Fakultät |
Fachrichtung: | NT - Chemie |
Professur: | NT - Prof. Dr. Markus Gallei |
Sammlung: | SciDok - Der Wissenschaftsserver der Universität des Saarlandes |
Dateien zu diesem Datensatz:
Datei | Beschreibung | Größe | Format | |
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radiation_and_dose_densification_of_r_chop_in.10.pdf | 2,23 MB | Adobe PDF | Öffnen/Anzeigen |
Diese Ressource wurde unter folgender Copyright-Bestimmung veröffentlicht: Lizenz von Creative Commons