Evidence map›Paper›PMID 34060065›Full record

Trial reportBritish journal of haematology2021

Evaluation of the pharmacokinetics of prednisolone in paediatric patients with acute lymphoblastic leukaemia treated according to Dutch Childhood Oncology Group protocols and its relation to treatment response.

Sebastiaan D T Sassen, Ron A A Mathôt, Rob Pieters, Valérie de Haas, Gertjan J L Kaspers, Cor van den Bos, Wim J E Tissing, D Maroeska W W Te Loo, Marc B Bierings, Inge M van der Sluis and 1 more

Open access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in British journal of haematology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 21% 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

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. 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

11 authors at 9 institutions in 1 country.

Sebastiaan D T SassenDepartment of Pediatric Oncology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.ORCID 0000-0002-4525-638X
Ron A A MathôtDepartment of Hospital Pharmacy, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Rob PietersPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Valérie de HaasPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Gertjan J L KaspersPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Cor van den BosPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Wim J E TissingPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
D Maroeska W W Te LooDepartment of Pediatric Hemato-Oncology, Radboud University Nijmegen Medical Center, Nijmegen, Utrecht, the Netherlands.
Marc B BieringsPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Inge M van der SluisPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
C Michel ZwaanDepartment of Pediatric Oncology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.
Princess Máxima Center · NLAmsterdam UMC Location University of Amsterdam · NLAmsterdam University Medical Centers · NLEmma Kinderziekenhuis · NLErasmus MC - Sophia Children’s Hospital · NLRadboud University Nijmegen · NLStichting Kinderoncologie Nederland · NLUniversity Medical Center Groningen · NLUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Glucocorticoids form the backbone of paediatric acute lymphoblastic leukaemia (ALL) treatment. Many studies have been performed on steroid resistance; however, few studies have addressed the relationship between dose, concentration and clinical response. The aim of the present study was to evaluate the pharmacokinetics of prednisolone in the treatment of paediatric ALL and the correlation with clinical parameters. A total of 1028 bound and unbound prednisolone plasma concentrations were available from 124 children (aged 0-18 years) with newly diagnosed ALL enrolled in the Dutch Childhood Oncology Group studies. A population pharmacokinetic model was developed and post hoc area under the curve (AUC) was tested against treatment outcome parameters. The pharmacokinetics of unbound prednisolone in plasma was best described with allometric scaling and saturable binding to proteins. Plasma protein binding decreased with age. The AUC of unbound prednisolone was not associated with any of the disease parameters or treatment outcomes. Unbound prednisolone plasma concentrations correlated with age. No effect of exposure on clinical treatment outcome parameters was observed and does not substantiate individualised dosing. Poor responders, high-risk and relapsed patients showed a trend towards lower exposure compared to good responders. However, the group of poor responders was small and requires further research.

Indexed as

AdolescentAntineoplastic Agents, HormonalArea Under CurveChildChild, PreschoolFemaleHumansInfantMaleNetherlandsPrecursor Cell Lymphoblastic Leukemia-LymphomaPrednisoloneProspective StudiesTreatment OutcomeAntineoplastic Agents, HormonalPrednisoloneacute lymphoblastic leukaemiadexamethasoneNONMEMpaediatricspharmacokinetics/pharmacodynamicsprednisolone

Identifiers

PMID34060065
PMCPMC8362215
OpenAlexW3163988002

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.