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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

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