Evidence map›Paper›PMID 27641152›Full record

Trial reportClinical pharmacokinetics2017

Towards a Model-Based Dose Recommendation for Doxorubicin in Children.

Swantje Völler, Georg Hempel, Gudrun Würthwein, Alan V Boddy, Miriam Krischke, Nicolas André, Maurizio D'Incalci, Gianni Bisogno, Joachim Boos

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Clinical pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 25% 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, 13 citations in OpenAlex.

  1. Article
  2. Article
  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

9 authors at 5 institutions in 5 countries.

Swantje VöllerDepartment of Pharmaceutical and Medical Chemistry-Clinical Pharmacy, University of Münster, Corrensstraße 48, 48149, Münster, Germany.
Georg HempelDepartment of Pharmaceutical and Medical Chemistry-Clinical Pharmacy, University of Münster, Corrensstraße 48, 48149, Münster, Germany.
Gudrun WürthweinCentre for Clinical Trials, ZKS Münster (BMBF 01KN1105), University Hospital Muenster, Von-Esmarch-Straße 62, 48149, Münster, Germany.
Alan V BoddyNorthern Institute for Cancer Research, Paul O'Gorman Building, Medical School, Newcastle University, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.
Miriam KrischkeCentre for Clinical Trials, ZKS Münster (BMBF 01KN1105), University Hospital Muenster, Von-Esmarch-Straße 62, 48149, Münster, Germany.
Nicolas AndréINSERM UMR 911, Centre de Recherche en Oncologie biologique et en Oncopharmacologie, Aix-Marseille Univ, Marseille, France.
Maurizio D'IncalciDepartment of Oncology, IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Via La Masa 19, 20156, Milan, Italy.
Gianni BisognoClinica di Oncoematologia, Dipartimento di Pediatria, via Giustiniani 3, 35100, Padua, Italy.
Joachim BoosPaediatric Haematology and Oncology, University Hospital Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149, Münster, Germany. boosj@uni-muenster.de.
University Hospital Münster · DEUniversity of Münster · DEInserm · FRMario Negri Institute for Pharmacological Research · ITNewcastle University · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Following the publication of our paper regarding a population-based model of doxorubicin pharmacokinetics in children in Clinical Pharmacokinetics last year (Voller et al. 54:1139-1149, 2015), we have received many inquiries on the practical clinical consequences of this model; however, a population-based model is only one of the aspects to be taken into account when developing dosing algorithms. In addition, any new method of dose calculation would need clinical validation and, subsequently, a new clinical trial. However, such a trial, especially with regard to burden to the children involved, requires optimal preparation and the selection of the best hypotheses. The European Paediatric Oncology Off-Patent Medicines Consortium (EPOC), represented by the authors, would therefore like to initiate an interdisciplinary discussion on the clinical and pharmacological goals for dose calculation. This current opinion summarizes the existing knowledge on the pharmacokinetics and pharmacodynamics of doxorubicin. Our aim was to define the clinical needs as precisely as possible, with the intention of stimulating discussion between the clinical pediatric oncologist and the pediatric pharmacologist. By doing so, we hope to define surrogates for best practice of a common doxorubicin dose in children. The intent is for a trial to validate a rational dose calculation rule, leading to a regulatory process and subsequent labeling.

Indexed as

Models, BiologicalAdolescentAntibiotics, AntineoplasticChildChild, PreschoolDose-Response Relationship, DrugDoxorubicinFemaleHumansInfantMaleNeoplasmsAntibiotics, AntineoplasticDoxorubicin

Identifiers

PMID27641152
PMCPMC5315724
OpenAlexW2519602797

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.