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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

  • Original Article – Clinical Oncology
  • Published:
Journal of Cancer Research and Clinical Oncology Aims and scope Submit manuscript

A Correction to this article was published on 09 September 2022

This article has been updated

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.

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Data availability

Data and study documentation are located in the respective study centers and are stored in accordance with legal requirements. However, the datasets generated during and/or analyzed during the current study are not publicly available due to individual privacy rights, but are available from the corresponding author on reasonable request.

Code availability

Not applicable.

Change history

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Acknowledgements

We thank all patients and partners of the participating study centers. We greatly appreciate the support of Dr. S. Ibach from the X-act Cologne Clinical Research GmbH, Cologne, Germany for statistical analysis of the survival data.

Funding

The study was supported by the Carl Gustav Carus University Hospital of the Technical University Dresden and the Klinikum Chemnitz gGmbH.

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Authors

Contributions

FK, GE, JB, FF and MH designed the study; RH, FK, JB, AH, KSE, GE, JB, FF and MH performed the study; SK, ARB, LS, FK, JB, MB, SF and MH analyzed the results; all the authors created the figures and wrote the manuscript.

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Correspondence to Mathias Hänel.

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All the procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Eligible patients were registered at the Medical and Outpatient’s clinic I of the Carl Gustav Carus University Hospital of the Technical University Dresden, where the trial was designed and approved by the local ethics committee in 2001 (11 January 2001; number of registration: EK155102000).

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Kürzel, S., Blaudszun, AR., Stahl, L. et al. 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. J Cancer Res Clin Oncol 148, 1171–1181 (2022). https://doi.org/10.1007/s00432-021-03702-7

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