Radiation and Dose-densification of R-CHOP in Aggressive B-cell Lymphoma With Intermediate Prognosis : The UNFOLDER Study
Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association..
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).
Medienart: |
E-Artikel |
---|
Erscheinungsjahr: |
2023 |
---|---|
Erschienen: |
2023 |
Enthalten in: |
Zur Gesamtaufnahme - volume:7 |
---|---|
Enthalten in: |
HemaSphere - 7(2023), 7 vom: 30. Juli, Seite e904 |
Sprache: |
Englisch |
---|
Links: |
---|
Themen: |
---|
Anmerkungen: |
Date Revised 18.07.2023 published: Electronic-eCollection ClinicalTrials.gov: NCT00278408 Citation Status PubMed-not-MEDLINE |
---|
doi: |
10.1097/HS9.0000000000000904 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM359281907 |
---|
LEADER | 01000naa a22002652 4500 | ||
---|---|---|---|
001 | NLM359281907 | ||
003 | DE-627 | ||
005 | 20231226080535.0 | ||
007 | cr uuu---uuuuu | ||
008 | 231226s2023 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1097/HS9.0000000000000904 |2 doi | |
028 | 5 | 2 | |a pubmed24n1197.xml |
035 | |a (DE-627)NLM359281907 | ||
035 | |a (NLM)37427146 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Thurner, Lorenz |e verfasserin |4 aut | |
245 | 1 | 0 | |a Radiation and Dose-densification of R-CHOP in Aggressive B-cell Lymphoma With Intermediate Prognosis |b The UNFOLDER Study |
264 | 1 | |c 2023 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Revised 18.07.2023 | ||
500 | |a published: Electronic-eCollection | ||
500 | |a ClinicalTrials.gov: NCT00278408 | ||
500 | |a Citation Status PubMed-not-MEDLINE | ||
520 | |a Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association. | ||
520 | |a 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) | ||
650 | 4 | |a Journal Article | |
700 | 1 | |a Ziepert, Marita |e verfasserin |4 aut | |
700 | 1 | |a Berdel, Christian |e verfasserin |4 aut | |
700 | 1 | |a Schmidt, Christian |e verfasserin |4 aut | |
700 | 1 | |a Borchmann, Peter |e verfasserin |4 aut | |
700 | 1 | |a Kaddu-Mulindwa, Dominic |e verfasserin |4 aut | |
700 | 1 | |a Viardot, Andreas |e verfasserin |4 aut | |
700 | 1 | |a Witzens-Harig, Mathias |e verfasserin |4 aut | |
700 | 1 | |a Dierlamm, Judith |e verfasserin |4 aut | |
700 | 1 | |a Haenel, Mathias |e verfasserin |4 aut | |
700 | 1 | |a Metzner, Bernd |e verfasserin |4 aut | |
700 | 1 | |a Wulf, Gerald |e verfasserin |4 aut | |
700 | 1 | |a Lengfelder, Eva |e verfasserin |4 aut | |
700 | 1 | |a Keller, Ulrich B |e verfasserin |4 aut | |
700 | 1 | |a Frickhofen, Norbert |e verfasserin |4 aut | |
700 | 1 | |a Nickelsen, Maike |e verfasserin |4 aut | |
700 | 1 | |a Gaska, Tobias |e verfasserin |4 aut | |
700 | 1 | |a Griesinger, Frank |e verfasserin |4 aut | |
700 | 1 | |a Mahlberg, Rolf |e verfasserin |4 aut | |
700 | 1 | |a Marks, Reinhard |e verfasserin |4 aut | |
700 | 1 | |a Shpilberg, Ofer |e verfasserin |4 aut | |
700 | 1 | |a Lindemann, Hans-Walter |e verfasserin |4 aut | |
700 | 1 | |a Soekler, Martin |e verfasserin |4 aut | |
700 | 1 | |a Fischer von Weikersthal, Ludwig |e verfasserin |4 aut | |
700 | 1 | |a Kiehl, Michael |e verfasserin |4 aut | |
700 | 1 | |a Roemer, Eva |e verfasserin |4 aut | |
700 | 1 | |a Bentz, Martin |e verfasserin |4 aut | |
700 | 1 | |a Krammer-Steiner, Beate |e verfasserin |4 aut | |
700 | 1 | |a Trappe, Ralf |e verfasserin |4 aut | |
700 | 1 | |a de Nully Brown, Peter |e verfasserin |4 aut | |
700 | 1 | |a Federico, Massimo |e verfasserin |4 aut | |
700 | 1 | |a Merli, Francesco |e verfasserin |4 aut | |
700 | 1 | |a Engelhard, Marianne |e verfasserin |4 aut | |
700 | 1 | |a Glass, Bertram |e verfasserin |4 aut | |
700 | 1 | |a Schmitz, Norbert |e verfasserin |4 aut | |
700 | 1 | |a Truemper, Lorenz |e verfasserin |4 aut | |
700 | 1 | |a Bewarder, Moritz |e verfasserin |4 aut | |
700 | 1 | |a Hartmann, Frank |e verfasserin |4 aut | |
700 | 1 | |a Murawski, Niels |e verfasserin |4 aut | |
700 | 1 | |a Stilgenbauer, Stephan |e verfasserin |4 aut | |
700 | 1 | |a Rosenwald, Andreas |e verfasserin |4 aut | |
700 | 1 | |a Altmann, Bettina |e verfasserin |4 aut | |
700 | 1 | |a Schmidberger, Heinz |e verfasserin |4 aut | |
700 | 1 | |a Fleckenstein, Jochen |e verfasserin |4 aut | |
700 | 1 | |a Loeffler, Markus |e verfasserin |4 aut | |
700 | 1 | |a Poeschel, Viola |e verfasserin |4 aut | |
700 | 1 | |a Held, Gerhard |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t HemaSphere |d 2017 |g 7(2023), 7 vom: 30. Juli, Seite e904 |w (DE-627)NLM29509902X |x 2572-9241 |7 nnns |
773 | 1 | 8 | |g volume:7 |g year:2023 |g number:7 |g day:30 |g month:07 |g pages:e904 |
856 | 4 | 0 | |u http://dx.doi.org/10.1097/HS9.0000000000000904 |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 7 |j 2023 |e 7 |b 30 |c 07 |h e904 |