Evidence map›Paper›PMID 39032218›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2024

Impact of age on safety of Busulfan-Melphalan followed by autologous hematopoietic stem-cell transplantation versus standard chemotherapy in the patients of the EURO-E.W.I.N.G. 99 and Ewing 2008 clinical trials.

Xavier Choderlos de Laclos, Séverine Risbourg, Bernadette Brennan, François Bertucci, Nathalie Gaspar, Hans Gelderblom, Douglas S Hawkins, Katherine Janeway, Heribert Juergens, Bernd Kasper and 11 more

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
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

21 authors.

Xavier Choderlos de LaclosOncology Department, Eugène Marquis Centre, Avenue de la Bataille Flandres-Dunkerque, Rennes, France. Electronic address: x.choderlos-de-laclos@rennes.unicancer.fr.
Séverine RisbourgMethodology and Biostatistics Unit, Oscar Lambret Centre, 3 Rue Frédéric Combemale, Lille, France. Electronic address: s-risbourg@o-lambret.fr.
Bernadette BrennanDepartment of paediatric oncology, Royal Manchester Children's Hospital, Manchester, UK. Electronic address: Bernadette.Brennan@mft.nhs.uk.
François BertucciDepartment of Medical Oncology, Paoli-Calmettes Institute, Aix-Marseille Université, 232 Boulevard de Sainte-Marguerite, Marseille, France. Electronic address: BERTUCCIF@ipc.unicancer.fr.
Nathalie GasparDepartment of Oncology for Child and adolescent, Gustave Roussy, 114 rue Edouard Vaillant, Villejuif, France. Electronic address: Nathalie.GASPAR@gustaveroussy.fr.
Hans GelderblomDepartment of Medical Oncology, Leiden University Medical Center, The Netherlands. Electronic address: a.j.gelderblom@lumc.nl.
Douglas S HawkinsDepartment of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, WA, USA. Electronic address: doug.hawkins@seattlechildrens.org.
Katherine JanewayDana-Farber/Boston Children's Cancer and Blood Disorders Center, USA. Electronic address: Katherine_Janeway@dfci.harvard.edu.
Heribert JuergensDepartment of Pediatric Hematology and Oncology, University Children's Hospital Muenster, Germany, West German Cancer Centre (WTZ) Network, Muenster, Germany. Electronic address: jurgh@ukmuenster.de.
Bernd KasperUniversity of Heidelberg, Mannheim University Medical Center, Mannheim Cancer Center (MCC), Sarcoma Unit, Mannheim, Germany. Electronic address: Bernd.Kasper@medma.uni-heidelberg.de.
Mark D KrailoUniversity of Southern California, Los Angeles, CA, USA. Electronic address: mkrailo@childrensoncologygroup.org.
Marie Cécile Le DeleyMethodology and Biostatistics Unit, Oscar Lambret Centre, 3 Rue Frédéric Combemale, Lille, France. Electronic address: m-ledeley@o-lambret.fr.
Perrine Marec-BérardDepartment of Pediatric Oncology, Institut d'Hématologie et d'Oncologie Pédiatrique, 28 Prom. Léa et Napoléon Bullukian, Lyon, France. Electronic address: perrine.marec-berard@ihope.fr.
Martin G McCabeDivision of Cancer Sciences, University of Manchester & The Christie NHS Foundation Trust, Manchester, UK. Electronic address: Martin.McCabe@manchester.ac.uk.
Markus MetzlerDepartment of Pediatrics, University Hospital Erlangen, and NCT WERA, Erlangen, Germany. Electronic address: Markus.Metzler@uk-erlangen.de.
Andreas RanftPediatrics III, University Hospital Essen, Essen, Germany, West German Cancer Centre (WTZ), German Consortium for Translational Cancer Research (DKTK), and National Center for Tumordiseases site Essen, Essen, Germany. Electronic address: Andreas.ranft@uk-essen.de.
Sandra StraussLondon Sarcoma Service, UCL Hospitals NHS Foundation Trust, London, UK. Electronic address: sandra.strauss@nhs.net.
Marie-Dominique TabonePediatric Hematology and Oncology Department, Armand Trousseau Hospital, AP-HP, Sorbonne University, 26 avenue du Docteur Arnold-Netter, Paris, France. Electronic address: marie-dominique.tabone@aphp.fr.
Rachael WindsorLondon Sarcoma Service, UCL Hospitals NHS Foundation Trust, London, UK. Electronic address: rachael.windsor@nhs.net.
Uta DirksenPediatrics III, University Hospital Essen, Essen, Germany, West German Cancer Centre (WTZ), German Consortium for Translational Cancer Research (DKTK), and National Center for Tumordiseases site Essen, Essen, Germany. Electronic address: Uta.Dirksen@uk-essen.de.
Virginie GandemerDepartment of Pediatric Onco-hematology, University Hospital, 16 Bd de Bulgarie, Rennes, France. Electronic address: virginie.gandemer@chu-rennes.fr.

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899
6 · The paper itself

Abstract

introductionEwing sarcoma (ES), is a rare cancer affecting children, adolescents and adults. After VIDE (vincristine-ifosfamide-doxorobucin-etoposide) induction chemotherapy, Busulfan-Melphalan (BuMel) high-dose chemotherapy followed by autologous hematopoietic stem cells transplantation improved outcomes in unfavourable localized ES, but with more toxicities than conventional chemotherapy (VAI: Vincristine-dactinomycin-Ifosfamide). We evaluated whether the risk of acute toxicity associated with BuMel compared to VAI varied according to age in patients recruited in the R2Loc and R2Pulm randomised trials of the Euro-E.W.I.N.G.99 and Ewing-2008 trials.

methodsWe included patients with a localized high-risk disease, or pulmonary or pleural metastasis. We analysed the risk of severe toxicity according to randomised treatment group (VAI versus BuMel) and age group (<12 years, 12-17 years, 18-24 years, ≥25 years). We evaluated the heterogeneity of treatment effects by age group using interaction terms in logistic multivariable models.

resultsThe analysis included 243 patients treated with VAI and 205 with BuMel. Overall, BuMel was associated with a higher risk of severe acute toxicity than VAI particularly haematological, gastrointestinal, liver, sinusoidal occlusive syndrome, and infections. Severe haematological toxicity and lower general condition were significantly more frequent in younger patients, whatever treatment. We did not observe any significant heterogeneity in terms of the excess risk of severe toxicities associated with BuMel compared to VAI according to age group.

conclusionThe excess of acute toxicity associated with BuMel compared to VAI does not vary significantly with age, suggesting the feasibility of BuMel across all age groups.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBusulfanHematopoietic Stem Cell TransplantationMelphalanSarcoma, EwingTransplantation, AutologousAdolescentAdultAge FactorsBone NeoplasmsChildChild, PreschoolEtoposideFemaleHumansIfosfamideBusulfanEtoposideIfosfamideMelphalanVincristineAutologous hematopoietic stem cells transplantationEwing sarcoma (ES)High dose chemotherapySafety

Identifiers

PMID39032218
PMCPMC11331277

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.