Evidence map›Paper›PMID 38383713›Full record

Trial reportBone marrow transplantation2024

Fludarabine-treosulfan versus fludarabine-melphalan or busulfan-cyclophosphamide conditioning in older AML or MDS patients - A clinical trial to registry data comparison.

Dietrich Wilhelm Beelen, Simona Iacobelli, Linda Koster, Dirk-Jan Eikema, Anja van Biezen, Friedrich Stölzel, Fabio Ciceri, Wolfgang Bethge, Peter Dreger, Eva-Maria Wagner-Drouet and 6 more

Open access · hybridAbstract readComparative StudyRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Bone marrow transplantation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.2field-weighted citation impact, top 8% 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

7 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
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  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 14 institutions in 7 countries.

Dietrich Wilhelm BeelenDepartment of Haematology and Stem Cell Transplantation, West German Cancer Center, University Hospital of Essen, University of Duisburg-Essen, Essen, Germany. dietrich.beelen@uk-essen.de.ORCID 0000-0001-5050-220X
Simona IacobelliDepartment of Biology, University Tor Vergata of Rome, Rome, Italy.
Linda KosterEBMT Data Office Leiden, Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, Netherlands.
Dirk-Jan EikemaEBMT Data Office Leiden, Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, Netherlands.
Anja van BiezenEBMT Data Office Leiden, Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, Netherlands.
Friedrich StölzelDivision of Stem Cell Transplantation and Cellular Immunotherapies, Department of Internal Medicine 2, University Hospital Schleswig-Holstein, Kiel, Kiel University, Kiel, Germany.ORCID 0000-0003-0653-5332
Fabio CiceriHematology and Bone Marrow Transplantation Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.ORCID 0000-0003-0873-0123
Wolfgang BethgeDepartment of Hematology and Oncology, University Hospital Tübingen, Tübingen, Germany.ORCID 0000-0001-6052-2618
Peter DregerDepartment of Internal Medicine V, University of Heidelberg, Heidelberg, Germany.ORCID 0000-0002-7429-8570
Eva-Maria Wagner-DrouetThird Department of Medicine - Hematology, Internal Oncology & Pneumology, Johannes Gutenberg-University Medical Center, Mainz, Germany.ORCID 0000-0002-0728-2253
Péter ReményiSt. István and St. László Hospital of Budapest, Budapest, Hungary.
Matthias StelljesDepartment of Medicine A, Hematology, Oncology, Hemostaseology and Pneumology, University Hospital Münster, Münster, Germany.
Miroslaw MarkiewiczDepartment of Hematology, Institute of Medical Sciences, College of Medical Sciences, University of Rzeszow, Rzeszow, Poland.ORCID 0000-0002-8550-8908
Donal P McLornanUniversity College London Hospital, London, UK.ORCID 0000-0003-1224-091X
Ibrahim Yakoub-AghaCentre Hospitalier Universitaire de Lille, Université Lille, INSERM U1286, Infinite, Lille, France.
Mohamad MohtyHospital Saint-Antoine, Sorbonne Université, Centre de Recherche Saint-Antoine (CRSA), Paris, France.ORCID 0000-0002-7264-808X
Leiden University Medical Center · NLChristian-Albrechts-Universität zu Kiel · DEEssen University Hospital · DEHeidelberg University · DEInserm · FRJohannes Gutenberg University Mainz · DESorbonne Université · FRUnified Szent István and Szent László Hospital · HUUniversity Children's Hospital Tübingen · DEUniversity College Hospital · GBUniversity Hospital Münster · DEUniversity of Rome Tor Vergata · ITUniversity of Rzeszów · PLVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A randomized study (acronym: MC-FludT.14/L Trial II) demonstrated that fludarabine plus treosulfan (30 g/m²) was an effective and well tolerated conditioning regimen for allogeneic hematopoietic cell transplantation (allo-HCT) in older patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). To further evaluate this regimen, all 252 study patients aged 50 to 70 years were compared with similar patients, who underwent allo-HCT after fludarabine/melphalan (140 mg/m²) (FluMel) or busulfan (12.8 mg/kg)/cyclophosphamide (120 mg/kg) (BuCy) regimens and whose data was provided by the European Society for Blood and Marrow Transplantation registry. In 1:1 propensity-score matched-paired analysis (PSA) of AML patients, there was no difference in 2-year-relapse-incidence after FluTreo compared with either FluMel (n = 110, p = 0.28) or BuCy (n = 78, p = 0.98). However, 2-year-non-relapse-mortality (NRM) was lower compared with FluMel (p = 0.019) and BuCy (p < 0.001). Consequently, 2-year-overall-survival (OS) after FluTreo was higher compared with FluMel (p = 0.04) and BuCy (p < 0.001). For MDS patients, no endpoint differences between FluTreo and FluMel (n = 30) were evident, whereas 2-year-OS after FluTreo was higher compared with BuCy (n = 25, p = 0.01) due to lower 2-year-NRM. Multivariate sensitivity analysis confirmed all significant results of PSA. Consequently, FluTreo (30 g/m²) seems to retain efficacy compared with FluMel and BuCy, but is better tolerated by older patients.

Indexed as

BusulfanCyclophosphamideLeukemia, Myeloid, AcuteMelphalanMyelodysplastic SyndromesRegistriesTransplantation ConditioningVidarabineAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleHematopoietic Stem Cell TransplantationHumansMaleMiddle AgedBusulfanCyclophosphamidefludarabineMelphalantreosulfanVidarabine

Identifiers

PMID38383713
PMCPMC11073976
OpenAlexW4391996353

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.