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Journal of Cancer Research and Clinical Oncology

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01-05-2022 | Lymphoma | Original Article – Clinical Oncology

Dexa-BEAM versus MIFAP as salvage regimen for recurrent lymphoma: a prospective randomized multicenter phase II trial with a median follow-up of 14.4 years

Authors: Sabine Kürzel, André-René Blaudszun, Lilly Stahl, Regina Herbst, Frank Kroschinsky, Josef Birkmann, Annette Hänel, Kerstin Schaefer-Eckart, Gerhard Ehninger, Friedrich Fiedler, Martin Bornhäuser, Stephan Fricke, Mathias Hänel

Published in: Journal of Cancer Research and Clinical Oncology | Issue 5/2022

Abstract

Purpose

The aim of this study was to prospectively compare the MIFAP protocol, which had been shown to be effective in patients with relapsed and refractory Hodgkin’s lymphoma (HL) or aggressive non-Hodgkin’s lymphoma (NHL), to an established regimen like Dexa-BEAM.

Methods

Seventy-three adult patients with HL (N = 25) or aggressive NHL (N = 48) suffering from relapse or refractory disease were randomly allocated to receive two cycles of Dexa-BEAM (dexamethasone, carmustine, etoposide, cytarabine, melphalan; N = 37) or MIFAP (mitoxantrone, fludarabine, cytarabine, cisplatin; N = 36) prior to a consolidating high-dose therapy and hematopoietic cell transplantation (HCT). Primary endpoint was the overall response rate (ORR) [complete response (CR) and partial response (PR)] after two courses of salvage chemotherapy.

Results

The ORR was 51% (CR 38%) and 53% (CR 36%) in the Dexa-BEAM arm and in the MIFAP arm (both not significant), respectively. There was a significantly higher grade 3–4 toxicity after MIFAP compared to Dexa-BEAM. Thirty-five patients were consolidated by autologous (N = 29), allogeneic (N = 1) or sequential autologous/allogeneic (N = 5) HCT. No significant differences were found in progression-free survival (PFS) and overall survival (OS) between the Dexa-BEAM and the MIFAP arms.

Conclusion

Compared to Dexa-BEAM, MIFAP is associated with a higher toxicity and does not improve the outcome of patients with recurrent HL or aggressive NHL. For those patients, innovative treatment concepts like recently developed immunotherapies are necessary.

Trial registration number

EudraCT number 2021-001937-38.

Date of registration

7 April 2021, retrospectively registered.

Available only for authorised users

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Title: Dexa-BEAM versus MIFAP as salvage regimen for recurrent lymphoma: a prospective randomized multicenter phase II trial with a median follow-up of 14.4 years
Authors: Sabine Kürzel
André-René Blaudszun
Lilly Stahl
Regina Herbst
Frank Kroschinsky
Josef Birkmann
Annette Hänel
Kerstin Schaefer-Eckart
Gerhard Ehninger
Friedrich Fiedler
Martin Bornhäuser
Stephan Fricke
Mathias Hänel
Publication date: 01-05-2022
Publisher: Springer Berlin Heidelberg
Keywords: Lymphoma
Dexamethasone
Published in: Journal of Cancer Research and Clinical Oncology / Issue 5/2022
Print ISSN: 0171-5216
Electronic ISSN: 1432-1335
DOI: https://doi.org/10.1007/s00432-021-03702-7

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