Evidence map›Paper›PMID 24727815›Full record

Trial reportHaematologica2014

Dexamethasone (6 mg/m2/day) and prednisolone (60 mg/m2/day) were equally effective as induction therapy for childhood acute lymphoblastic leukemia in the EORTC CLG 58951 randomized trial.

Carine Domenech, Stefan Suciu, Barbara De Moerloose, Françoise Mazingue, Geneviève Plat, Alina Ferster, Anne Uyttebroeck, Nicolas Sirvent, Patrick Lutz, Karima Yakouben and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Haematologica, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00003728 (The Value of Dexamethasone Versus Prednisolone During Induction and Maintenance Therapy of Prolonged Versus Conventional Duration of L-Asparaginase Therapy During Consolidation and Late Intensification, and of Corticosteroid + VCR Pulses During Maintenance in Acute Lymphoblastic Leukemia and Lymphoblastic Non-Hodgkin Lymphoma of Childhood), which is not on this map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
9.0field-weighted citation impact, top 2% 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.

NCT00003728 phase3unknown statusnot on this map

The Value of Dexamethasone Versus Prednisolone During Induction and Maintenance Therapy of Prolonged Versus Conventional Duration of L-Asparaginase Therapy During Consolidation and Late Intensification, and of Corticosteroid + VCR Pulses During Maintenance in Acute Lymphoblastic Leukemia and Lymphoblastic Non-Hodgkin Lymphoma of Childhood

TypeinterventionalSponsorEuropean Organisation for Research and Treatment of Cancer - EORTCRan1998Enrolled1,500ConditionsLeukemia, LymphomaArmsasparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 81 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Improved CNS Control of Childhood Acute Lymphoblastic Leukemia Without Cranial Irradiation: St Jude Total Therapy Study 16.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
    Trial
  4. ProlongedHaematologica · 2017
    Trial
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Article
  10. Biomedicines · 2024
    Review
  11. Review
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  14. Review
  15. Article
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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

21 authors at 11 institutions in 2 countries.

Carine DomenechInstitute of Hematology and Oncology Pediatrics, Hospices Civils de Lyon, University Claude Bernard Lyon I, France carine.halfon-domenech@chu-lyon.fr.
Stefan SuciuEORTC Headquarters, Brussels, Belgium.
Barbara De MoerlooseDepartment of Pediatric Hematology-Oncology, Ghent University Hospital, Belgium.
Françoise MazingueDepartment of Pediatric Hematology-Oncology, CHR, Lille, France.
Geneviève PlatDepartment of Hematology, Children's Hospital, Toulouse, France.
Alina FersterDepartment of Pediatrics, University Hospital Gasthuisberg, Leuven, Belgium.
Anne UyttebroeckDepartment of Hemato-Oncology, HUDERF Brussels, Belgium.
Nicolas SirventDepartment of Hemato-Oncology, A Villeneuve Hospital, Montpellier, France.
Patrick LutzDepartment of Hematology, Hautepierre, Strasbourg, France.
Karima YakoubenDepartment of Hematology, Robert Debré Hospital, Paris, France.
Martine MunzerDepartment of Hematology, American Hospital, Reims, France.
Pierre RöhrlichDepartment of Hemato-Oncology, CHRU, Besançon, France.
Dominique PlantazDepartment of Pediatrics, CHR La Tronche, Grenoble, France.
Frederic MillotDepartment of Hematology, J Bernard Hospital, Poitiers, France.
Pierre PhilippetDepartment of Pediatrics, CHC-Esperance, Montegnée, Belgium.
Nicole DastugueDepartment of Hematology, Children's Hospital, Toulouse, France.
Sandrine GirardDepartment of Hematology, Edouard Herriot Hospital, Hospices Civils de Lyon, France.
Hélène CavéDepartment of Genetics, Robert-Debré Hospital, Paris, France.
Yves BenoitDepartment of Pediatric Hematology-Oncology, Ghent University Hospital, Belgium.
Yves BertrandforInstitute of Hematology and Oncology Pediatrics, Hospices Civils de Lyon, University Claude Bernard Lyon I, France.
Children's Leukemia Group (CLG) of European Organisation for Research and Treatment of Cancer (EORTC)
Ghent University Hospital · BEHôpital Robert-Debré · FRUniversité Claude Bernard Lyon 1 · FRCentre Hospitalier Universitaire de Besançon · FRCentre Jean Bernard · FRClinic of Hope · BEEuropean Organisation for Research and Treatment of Cancer · BEHôpital d'Hautepierre · FRHospices Civils de Lyon · FRQueen Fabiola Children's University Hospital · BEUniversitair Ziekenhuis Leuven · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Dexamethasone could be more effective than prednisolone at similar anti-inflammatory doses in the treatment of childhood acute lymphoblastic leukemia. In order to check if this "superiority" of dexamethasone might be dose-dependent, we conducted a randomized phase III trial comparing dexamethasone (6 mg/m(2)/day) to prednisolone (60 mg/m(2)/day) in induction therapy. All newly diagnosed children and adolescents with acute lymphoblastic leukemia in the 58951 EORTC trial were randomized on prephase day 1 or day 8. The main endpoint was event-free survival; secondary endpoints were overall survival and toxicity. A total of 1947 patients with acute lymphoblastic leukemia were randomized. At a median follow-up of 6.9 years, the 8-year event-free survival rate was 81.5% in the dexamethasone arm and 81.2% in the prednisolone arm; the 8-year overall survival rates were 87.2% and 89.0% respectively. The 8-year incidences of isolated or combined central nervous system relapse were 2.9% and 4.5% in the dexamethasone and prednisolone arms, respectively. The incidence of grade 3-4 toxicities during induction and the frequency of osteonecrosis were similar in the two arms. In conclusion, dexamethasone and prednisolone, used respectively at the doses of 6 and 60 mg/m(2)/day during induction, were equally effective and had a similar toxicity profile. Dexamethasone decreased the 8-year central nervous system relapse incidence by 1.6%. This trial was registered at www.clinicaltrials.gov as #NCT00003728.

Indexed as

AdolescentAntineoplastic Combined Chemotherapy ProtocolsChildChild, PreschoolDexamethasoneFemaleHumansImmunophenotypingInduction ChemotherapyInfantInfant, NewbornMalePrecursor Cell Lymphoblastic Leukemia-LymphomaPrednisoloneRisk FactorsTreatment OutcomeDexamethasonePrednisolone

Identifiers

PMID24727815
PMCPMC4077084
OpenAlexW2167086064

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.