Evidence map›Paper›PMID 34176014›Full record

Trial reportJournal of cancer research and clinical oncology2022

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.

Sabine Kürzel, André-René Blaudszun, Lilly Stahl, Regina Herbst, Frank Kroschinsky, Josef Birkmann, Annette Hänel, Kerstin Schaefer-Eckart, Gerhard Ehninger, Friedrich Fiedler and 3 more

Erratum issuedOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 91% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 1 country.

Sabine Kürzel *Medical Clinic 5, Klinikum Dresden-Neustadt, Dresden, Germany.
André-René Blaudszun *Department of GMP Process Development/ATMP Design, Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany.ORCID http://orcid.org/0000-0002-0208-6894
Lilly Stahl *Department of GMP Process Development/ATMP Design, Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany.
Regina HerbstDepartment of Internal Medicine III, Klinikum Chemnitz gGmbH, Flemmingstrasse 1, 09116, Chemnitz, Germany.
Frank KroschinskyDepartment of Internal Medicine I, University Hospital Carl Gustav Carus, TU, Dresden, Germany.ORCID http://orcid.org/0000-0002-4235-7580
Josef BirkmannKlinikum Nuernberg, Paracelsus Medical Private University, Medical Clinic 5, Nuremberg, Germany.
Annette HänelDepartment of Internal Medicine III, Klinikum Chemnitz gGmbH, Flemmingstrasse 1, 09116, Chemnitz, Germany.
Kerstin Schaefer-EckartKlinikum Nuernberg, Paracelsus Medical Private University, Medical Clinic 5, Nuremberg, Germany.
Gerhard EhningerDepartment of Internal Medicine I, University Hospital Carl Gustav Carus, TU, Dresden, Germany.ORCID http://orcid.org/0000-0003-0056-0422
Friedrich FiedlerDepartment of Internal Medicine III, Klinikum Chemnitz gGmbH, Flemmingstrasse 1, 09116, Chemnitz, Germany.
Martin BornhäuserDepartment of Internal Medicine I, University Hospital Carl Gustav Carus, TU, Dresden, Germany.
Stephan Fricke *Department of GMP Process Development/ATMP Design, Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany.
Mathias Hänel *Department of Internal Medicine III, Klinikum Chemnitz gGmbH, Flemmingstrasse 1, 09116, Chemnitz, Germany. m.haenel@skc.de.ORCID http://orcid.org/0000-0002-4767-3275
Klinikum Chemnitz · DEFraunhofer Institute for Cell Therapy and Immunology · DEUniversity Hospital Carl Gustav Carus · DEParacelsus Medizinische Privatuniversität · DEStädtisches Klinikum Dresden · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe 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.

methodsSeventy-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.

resultsThe 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.

conclusionCompared 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.

Indexed as

Hodgkin DiseaseLymphomaLymphoma, Non-HodgkinAdultAntineoplastic Combined Chemotherapy ProtocolsCarmustineCytarabineDexamethasoneEtoposideFollow-Up StudiesHumansMelphalanNeoplasm Recurrence, LocalProspective StudiesSalvage TherapyCarmustineCytarabineDexamethasoneEtoposideMelphalanCAR T cellsHematopoietic cell transplantationHodgkin’s lymphomaNon-Hodgkin’s lymphomaSalvage therapy

Identifiers

PMID34176014
PMCPMC11800919
OpenAlexW3173824394

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.