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. 2022 Dec 1;6(12):e808.
doi: 10.1097/HS9.0000000000000808. eCollection 2022 Dec.

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

Friederike Braulke  1 , Florian Zettl  2 , Marita Ziepert  3 , Andreas Viardot  4 , Christoph Kahl  5   6 , Gabriele Prange-Krex  7 , Agnieszka Korfel  8 , Martin Dreyling  9 , Alexander Bott  10 , Ulrich Wedding  11 , Dietmar Reichert  12 , Maike de Wit  13 , Frank Hartmann  14 , Viola Poeschel  15 , Norbert Schmitz  16 , Mathias Witzens-Harig  17 , Wolfram Klapper  18 , Andreas Rosenwald  19 , Gerald Wulf  1 , Bettina Altmann  3 , Lorenz Trümper  1
Affiliations

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

Friederike Braulke et al. Hemasphere. .

Abstract

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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Figures

Figure 1.
Figure 1.
Consort diagram. add. = additional; inv = investigator; pt = patient; R = rituximab; WIC = withdraw of informed consent.
Figure 2.
Figure 2.
EFS, PFS and OS in B-R-ENDA treated patients. Event-free-survival (A, D, G), progression-free survival (B, E, H), and overall survival (C, F, I) in 39 patients aged >80 y (A–C), 29 patients aged 61–80 y (D–F), and for the 68 patients of the full analysis set (G–I).
Figure 3.
Figure 3.
EFS, PFS and OS in elderly B-R-ENDA and RICOVER-60 patients. Event-free-survival (A), progression-free survival (B), and overall survival (C) of B-R-ENDA patients aged >80 y (n = 39) and RICOVER-60 patients (6xCHOP 14 + 8xR) aged 76–80 y (n = 40).
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