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

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 patie...

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Published in:Journal of cancer research and clinical oncology 2022-05, Vol.148 (5), p.1171-1181
Main Authors: Kürzel, Sabine, Blaudszun, André-René, Stahl, Lilly, Herbst, Regina, Kroschinsky, Frank, Birkmann, Josef, Hänel, Annette, Schaefer-Eckart, Kerstin, Ehninger, Gerhard, Fiedler, Friedrich, Bornhäuser, Martin, Fricke, Stephan, Hänel, Mathias
Format: Article
Language:English
Subjects:
Adult
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Autografts
Cancer Research
Carmustine - adverse effects
Chemotherapy
Cisplatin
Cytarabine
Dexamethasone
Dual energy X-ray absorptiometry
ECT
ECT2021-001937-38
Etoposide
Etoposide - adverse effects
Fludarabine
Follow-Up Studies
Hematology
Hodgkin Disease - drug therapy
Hodgkin Disease - pathology
Humans
Immunotherapy
Internal Medicine
Lymphoma
Lymphoma - drug therapy
Lymphoma, Non-Hodgkin
Medicine
Medicine & Public Health
Melphalan
Mitoxantrone
Neoplasm Recurrence, Local - drug therapy
Non-Hodgkin's lymphoma
Oncology
Original Article – Clinical Oncology
Patients
Prospective Studies
Salvage Therapy - methods
Stem cell transplantation
Toxicity
Transplantation
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Summary: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.
ISSN:0171-5216
1432-1335
DOI:10.1007/s00432-021-03702-7