First-line Treatment With Bendamustine and Rituximab for Old and Frail Patients With Aggressive Lymphoma: Results of the B-R-ENDA Trial

The incidence of aggressive B-cell lymphomas increases with age, but for elderly or frail patients not eligible for doxorubicin-containing treatment standard therapy remains to be defined. In this prospective, multicenter, phase-2 B-R-ENDA trial, we investigated the feasibility, toxicity, and effica...

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Main Authors: Friederike Braulke, Florian Zettl, Marita Ziepert, Andreas Viardot, Christoph Kahl, Gabriele Prange-Krex, Agnieszka Korfel, Martin Dreyling, Alexander Bott, Ulrich Wedding, Dietmar Reichert, Maike de Wit, Frank Hartmann, Viola Poeschel, Norbert Schmitz, Mathias Witzens-Harig, Wolfram Klapper, Andreas Rosenwald, Gerald Wulf, Bettina Altmann, Lorenz Trümper
Format: Article
Language:English
Published: Wiley 2022-12-01
Series:HemaSphere
Online Access:http://journals.lww.com/10.1097/HS9.0000000000000808
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author Friederike Braulke
Florian Zettl
Marita Ziepert
Andreas Viardot
Christoph Kahl
Gabriele Prange-Krex
Agnieszka Korfel
Martin Dreyling
Alexander Bott
Ulrich Wedding
Dietmar Reichert
Maike de Wit
Frank Hartmann
Viola Poeschel
Norbert Schmitz
Mathias Witzens-Harig
Wolfram Klapper
Andreas Rosenwald
Gerald Wulf
Bettina Altmann
Lorenz Trümper
author_facet Friederike Braulke
Florian Zettl
Marita Ziepert
Andreas Viardot
Christoph Kahl
Gabriele Prange-Krex
Agnieszka Korfel
Martin Dreyling
Alexander Bott
Ulrich Wedding
Dietmar Reichert
Maike de Wit
Frank Hartmann
Viola Poeschel
Norbert Schmitz
Mathias Witzens-Harig
Wolfram Klapper
Andreas Rosenwald
Gerald Wulf
Bettina Altmann
Lorenz Trümper
author_sort Friederike Braulke
collection DOAJ
description The incidence of aggressive B-cell lymphomas increases with age, but for elderly or frail patients not eligible for doxorubicin-containing treatment standard therapy remains to be defined. In this prospective, multicenter, phase-2 B-R-ENDA trial, we investigated the feasibility, toxicity, and efficacy of 8 cycles rituximab combined with 6 cycles bendamustine (BR) in elderly or frail aggressive B-cell lymphoma patients: 39 patients aged >80 years and 29 patients aged 61–80 years with elevated Cumulative Illness Rating Scalescore >6 were included. Progression-free survival (PFS) and overall survival (OS) at 2 years were 45% (95% confidence interval [CI], 28%-61%) and 46% (28%-63%) for the patients age >80, as well 32% (13%-51%) and 37% (17%-57%) for frail patients age 64–80, respectively. In a preplanned retrospective analysis, we found no significant differences in PFS and OS comparing the outcome of the 39 patients age >80 years with 40 patients aged 76–80 years treated with 6xR-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) and 2 x rituximab in the RICOVER-60 trial (DSHNHL 1999-1, NCT00052936, EU-20243), yet we detected lower rates of infections and treatment-related deaths in the BR-treated patients. We demonstrate that older and frail patients with aggressive B-cell lymphoma who are not able to receive standard CHOP-based therapy can benefit from anthracycline-free therapy as a feasible and effective therapeutic option.
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spelling doaj.art-454022e1c0504a2caa116000c0379a952024-03-03T05:56:04ZengWileyHemaSphere2572-92412022-12-01612e80810.1097/HS9.0000000000000808202212000-00012First-line Treatment With Bendamustine and Rituximab for Old and Frail Patients With Aggressive Lymphoma: Results of the B-R-ENDA TrialFriederike Braulke0Florian Zettl1Marita Ziepert2Andreas Viardot3Christoph Kahl4Gabriele Prange-Krex5Agnieszka Korfel6Martin Dreyling7Alexander Bott8Ulrich Wedding9Dietmar Reichert10Maike de Wit11Frank Hartmann12Viola Poeschel13Norbert Schmitz14Mathias Witzens-Harig15Wolfram Klapper16Andreas Rosenwald17Gerald Wulf18Bettina Altmann19Lorenz Trümper201 Department of Hematology and Medical Oncology, University Medical Center Goettingen, Germany; current address: Comprehensive Cancer Center, University Medical Center Goettingen, Germany2 Department of Hematology and Oncology, Klinikum Traunstein, Germany3 Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University of Leipzig, Germany4 Department of Internal Medicine III, University Hospital Ulm, Germany5 Department of Hematology, Oncology and Palliative Care, Klinikum Magdeburg, Germany7 Onkologische Gemeinschaftspraxis, Dresden, Germany8 Department of Hematology and Oncology, Charité University Hospital Berlin, Germany; current address: Medical Department Oncology, Lilly GmbH, Bad Homburg, Germany9 Department of Medicine III, University Hospital Ludwig Maximilians University, Munich, Germany10 Department of Hematology and Medical Oncology, Paracelsus Medical University, Nuermberg, Germany11 Department of Palliative Care, Jena University Hospital, Jena, Germany12 Outpatient Center for Oncology, Westerstede, Germany13 Klinik für Innere Medizin - Hämatologie, Onkologie und Palliativmedizin, Vivantes Klinikum Neukölln, Berlin, Germany14 Department of Hematology and Oncology, Klinikum Lippe, Lemgo, Germany15 Medicine 1 (Oncology, Hematology, Clinical Immunology, and Rheumatology), Saarland University Medical School, Homburg/Saar, Germany16 Medical Department A, Hematology and Oncology, University Medicine of Muenster, Germany17 Department of Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Germany18 Department of Pathology, Hematopathology Section and Lymph Node Registry Kiel, University Hospital Schleswig-Holstein, Kiel, Germany19 Institute of Pathology, Comprehensive Cancer Center Mainfranken, University of Würzburg, Germany1 Department of Hematology and Medical Oncology, University Medical Center Goettingen, Germany; current address: Comprehensive Cancer Center, University Medical Center Goettingen, Germany3 Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University of Leipzig, Germany1 Department of Hematology and Medical Oncology, University Medical Center Goettingen, Germany; current address: Comprehensive Cancer Center, University Medical Center Goettingen, GermanyThe incidence of aggressive B-cell lymphomas increases with age, but for elderly or frail patients not eligible for doxorubicin-containing treatment standard therapy remains to be defined. In this prospective, multicenter, phase-2 B-R-ENDA trial, we investigated the feasibility, toxicity, and efficacy of 8 cycles rituximab combined with 6 cycles bendamustine (BR) in elderly or frail aggressive B-cell lymphoma patients: 39 patients aged >80 years and 29 patients aged 61–80 years with elevated Cumulative Illness Rating Scalescore >6 were included. Progression-free survival (PFS) and overall survival (OS) at 2 years were 45% (95% confidence interval [CI], 28%-61%) and 46% (28%-63%) for the patients age >80, as well 32% (13%-51%) and 37% (17%-57%) for frail patients age 64–80, respectively. In a preplanned retrospective analysis, we found no significant differences in PFS and OS comparing the outcome of the 39 patients age >80 years with 40 patients aged 76–80 years treated with 6xR-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) and 2 x rituximab in the RICOVER-60 trial (DSHNHL 1999-1, NCT00052936, EU-20243), yet we detected lower rates of infections and treatment-related deaths in the BR-treated patients. We demonstrate that older and frail patients with aggressive B-cell lymphoma who are not able to receive standard CHOP-based therapy can benefit from anthracycline-free therapy as a feasible and effective therapeutic option.http://journals.lww.com/10.1097/HS9.0000000000000808
spellingShingle Friederike Braulke
Florian Zettl
Marita Ziepert
Andreas Viardot
Christoph Kahl
Gabriele Prange-Krex
Agnieszka Korfel
Martin Dreyling
Alexander Bott
Ulrich Wedding
Dietmar Reichert
Maike de Wit
Frank Hartmann
Viola Poeschel
Norbert Schmitz
Mathias Witzens-Harig
Wolfram Klapper
Andreas Rosenwald
Gerald Wulf
Bettina Altmann
Lorenz Trümper
First-line Treatment With Bendamustine and Rituximab for Old and Frail Patients With Aggressive Lymphoma: Results of the B-R-ENDA Trial
HemaSphere
title First-line Treatment With Bendamustine and Rituximab for Old and Frail Patients With Aggressive Lymphoma: Results of the B-R-ENDA Trial
title_full First-line Treatment With Bendamustine and Rituximab for Old and Frail Patients With Aggressive Lymphoma: Results of the B-R-ENDA Trial
title_fullStr First-line Treatment With Bendamustine and Rituximab for Old and Frail Patients With Aggressive Lymphoma: Results of the B-R-ENDA Trial
title_full_unstemmed First-line Treatment With Bendamustine and Rituximab for Old and Frail Patients With Aggressive Lymphoma: Results of the B-R-ENDA Trial
title_short First-line Treatment With Bendamustine and Rituximab for Old and Frail Patients With Aggressive Lymphoma: Results of the B-R-ENDA Trial
title_sort first line treatment with bendamustine and rituximab for old and frail patients with aggressive lymphoma results of the b r enda trial
url http://journals.lww.com/10.1097/HS9.0000000000000808
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