Sabine Kürzel1, André-René Blaudszun2, Lilly Stahl2, Stephan Fricke2,3, Mathias Hänel4, Regina Herbst3, Frank Kroschinsky5, Josef Birkmann6, Annette Hänel3, Kerstin Schaefer-Eckart6, Gerhard Ehninger5, Friedrich Fiedler3, Martin Bornhäuser5. 1. Medical Clinic 5, Klinikum Dresden-Neustadt, Dresden, Germany. 2. Department of GMP Process Development/ATMP Design, Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany. 3. Department of Internal Medicine III, Klinikum Chemnitz gGmbH, Flemmingstrasse 1, 09116, Chemnitz, Germany. 4. Department of Internal Medicine III, Klinikum Chemnitz gGmbH, Flemmingstrasse 1, 09116, Chemnitz, Germany. m.haenel@skc.de. 5. Department of Internal Medicine I, University Hospital Carl Gustav Carus, TU, Dresden, Germany. 6. Klinikum Nuernberg, Paracelsus Medical Private University, Medical Clinic 5, Nuremberg, Germany.
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.
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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Authors: Peter Borchmann; Helen Goergen; Carsten Kobe; Andreas Lohri; Richard Greil; Dennis A Eichenauer; Josée M Zijlstra; Jana Markova; Julia Meissner; Michaela Feuring-Buske; Andreas Hüttmann; Judith Dierlamm; Martin Soekler; Hans-Joachim Beck; Wolfgang Willenbacher; Wolf-Dieter Ludwig; Thomas Pabst; Max S Topp; Felicitas Hitz; Martin Bentz; Ulrich Bernd Keller; Dagmar Kühnhardt; Helmut Ostermann; Norbert Schmitz; Bernd Hertenstein; Walter Aulitzky; Georg Maschmeyer; Tom Vieler; Hans Eich; Christian Baues; Harald Stein; Michael Fuchs; Georg Kuhnert; Volker Diehl; Markus Dietlein; Andreas Engert Journal: Lancet Date: 2017-10-20 Impact factor: 79.321
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