Radiation and Dose-densification of R-CHOP in Aggressive B-cell Lymphoma With Intermediate Prognosis: The UNFOLDER Study

Autor: Lorenz Thurner, Marita Ziepert, Christian Berdel, Christian Schmidt, Peter Borchmann, Dominic Kaddu-Mulindwa, Andreas Viardot, Mathias Witzens-Harig, Judith Dierlamm, Mathias Haenel, Bernd Metzner, Gerald Wulf, Eva Lengfelder, Ulrich B. Keller, Norbert Frickhofen, Maike Nickelsen, Tobias Gaska, Frank Griesinger, Rolf Mahlberg, Reinhard Marks, Ofer Shpilberg, Hans-Walter Lindemann, Martin Soekler, Ludwig Fischer von Weikersthal, Michael Kiehl, Eva Roemer, Martin Bentz, Beate Krammer-Steiner, Ralf Trappe, Peter de Nully Brown, Massimo Federico, Francesco Merli, Marianne Engelhard, Bertram Glass, Norbert Schmitz, Lorenz Truemper, Moritz Bewarder, Frank Hartmann, Niels Murawski, Stephan Stilgenbauer, Andreas Rosenwald, Bettina Altmann, Heinz Schmidberger, Jochen Fleckenstein, Markus Loeffler, Viola Poeschel, Gerhard Held, on behalf of German Lymphoma Alliance (GLA)
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: HemaSphere, Vol 7, Iss 7, p e904 (2023)
Druh dokumentu: article
ISSN: 2572-9241
00000000
DOI: 10.1097/HS9.0000000000000904
Popis: 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).
Databáze: Directory of Open Access Journals
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