Evidence map›Paper›PMID 21933851›Full record

Trial reportHaematologica2012

The role of matched sibling donor allogeneic stem cell transplantation in pediatric high-risk acute myeloid leukemia: results from the AML-BFM 98 study.

Jan-Henning Klusmann, Dirk Reinhardt, Martin Zimmermann, Bernhard Kremens, Josef Vormoor, Michael Dworzak, Ursula Creutzig, Thomas Klingebiel

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Haematologica, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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

35 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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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

8 authors.

Jan-Henning KlusmannDepartment of Pediatric Hematology and Oncology University Children's Hospital Albert-Schweitzer-Campus 1, 48149 Muenster, Germany.
Dirk Reinhardt
Martin Zimmermann
Bernhard Kremens
Josef Vormoor
Michael Dworzak
Ursula Creutzig
Thomas Klingebiel

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe role of allogeneic stem cell transplantation in post-remission management of children with high-risk acute myeloid leukemia remains controversial. In the multi-center AML-BFM 98 study we prospectively evaluated the impact of allogeneic stem cell transplantation in children with high-risk acute myeloid leukemia in first complete remission. DESIGN AND

methodsHLA-typed patients with high-risk acute myeloid leukemia, who achieved first complete remission (n = 247), were included in this analysis. All patients received double induction and consolidation. Based on the availability of a matched-sibling donor, patients were allocated by genetic chance to allogeneic stem cell transplantation (n = 61) or chemotherapy-only (i.e. intensification and maintenance therapy; n = 186). The main analysis was done on an intention-to-treat basis according to this allocation.

resultsIntention-to-treat analysis did not show a significantly different 5-year disease-free survival (49 ± 6% versus 45 ± 4%, P(log rank) = 0.44) or overall survival (68 ± 6% versus 57 ± 4%, P(log rank) = 0.17) between the matched-sibling donor and no-matched-sibling donor groups, whereas late adverse effects occurred more frequently after allogeneic stem cell transplantation (72.5% versus 31.8%, P(Fischer)<0.01). These results were confirmed by as-treated analysis corrected for the time until transplantation (5-year overall survival: 72 ± 8% versus 60 ± 4%, P(Mantel-Byar) 0.21). Subgroup analysis demonstrated improved survival rates for patients with 11q23 aberrations allocated to allogeneic stem cell transplantation (5-year overall survival: 94 ± 6% versus 52 ± 7%, P(log-rank) = 0.01; n = 18 versus 49) in contrast to patients without 11q23 aberrations (5-year overall survival: 58 ± 8% versus 55 ± 5%, P(log-rank) = 0.66).

conclusionsOur analyses defined a genetic subgroup of children with high-risk acute myeloid leukemia who benefited from allogeneic stem cell transplantation in the prospective multi-center AML-BFM 98 study. For the remainder of the pediatric high-risk acute myeloid leukemia patients the prognosis was not improved by allogeneic stem cell transplantation, which was, however, associated with a higher rate of late sequelae.

Indexed as

Hematopoietic Stem Cell TransplantationTissue DonorsAdolescentAntineoplastic Combined Chemotherapy ProtocolsChildChild, PreschoolFemaleGraft vs Host DiseaseHumansInfantInfant, NewbornLeukemia, Myeloid, AcuteMaleRemission InductionSiblingsSurvival Analysis

Identifiers

PMID21933851
PMCPMC3248927

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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.