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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; [...]

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

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  • Medientyp: E-Artikel
  • Titel: Radiation and Dose-densification of R-CHOP in Aggressive B-cell Lymphoma With Intermediate Prognosis: The UNFOLDER Study
  • Beteiligte: 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; [...]
  • Erschienen: Wiley, 2023
  • Erschienen in: HemaSphere
  • Sprache: Englisch
  • DOI: 10.1097/hs9.0000000000000904
  • ISSN: 2572-9241
  • Schlagwörter: Hematology
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:p>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%; <jats:italic toggle="yes">P</jats:italic> = 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%; <jats:italic toggle="yes">P</jats:italic> = 0.22) and overall survival (OS) (93% versus 93%; <jats:italic toggle="yes">P</jats:italic> = 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).</jats:p>
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