Evidence map›Paper›PMID 27770238›Full record

Trial reportCancer chemotherapy and pharmacology2016

Pharmacokinetic and pharmacodynamic study of doxorubicin in children with cancer: results of a "European Pediatric Oncology Off-patents Medicines Consortium" trial.

Miriam Krischke, Georg Hempel, Swantje Völler, Nicolas André, Maurizio D'Incalci, Gianni Bisogno, Wolfgang Köpcke, Matthias Borowski, Ralf Herold, Alan V Boddy and 1 more

Open access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
2.5field-weighted citation impact, top 10% 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

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. AnNano letters · 2019
    Article
  14. 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 5 institutions in 5 countries.

Miriam KrischkePediatric Hematology and Oncology, University Hospital Münster, Albert-Schweitzer-Campus 1, Building A1, 48149, Münster, Germany.
Georg HempelDepartment of Pharmaceutical and Medical Chemistry, Clinical Pharmacy, Westfälische Wilhelms-Universität Münster, Corrensstraße 48, 48149, Münster, Germany.
Swantje VöllerDepartment of Pharmaceutical and Medical Chemistry, Clinical Pharmacy, Westfälische Wilhelms-Universität Münster, Corrensstraße 48, 48149, Münster, Germany.
Nicolas AndréINSERM UMR 911, Centre de Recherche en Oncologie biologique et en Oncopharmacologie, Aix-Marseille University, Marseille, France.
Maurizio D'IncalciDepartment of Oncology, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Via La Masa, 19, 20156, Milan, Italy.
Gianni BisognoDipartimento di Pediatria, Clinica di Oncoematologia, via Giustiniani, 3, 35100, Padua, Italy.
Wolfgang KöpckeInstitute of Biostatistics and Clinical Research, Westfälische Wilhelms-Universität Münster, Schmeddingstraße 56, 48149, Münster, Germany.
Matthias BorowskiInstitute of Biostatistics and Clinical Research, Westfälische Wilhelms-Universität Münster, Schmeddingstraße 56, 48149, Münster, Germany.
Ralf HeroldEuropean Medicines Agency (EMA), 30 Churchill Place, Canary Wharf, London, E14 5EU, UK.
Alan V BoddyNorthern Institute for Cancer Research, Newcastle University, Paul O'Gorman Building, Medical School, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.
Joachim BoosPediatric Hematology and Oncology, University Hospital Münster, Albert-Schweitzer-Campus 1, Building A1, 48149, Münster, Germany. boosj@uni-muenster.de.
University of Münster · DEUniversity Hospital Münster · DEAix-Marseille Université · FRMario Negri Institute for Pharmacological Research · ITUniversity of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDoxorubicin is a key component in many pediatric oncology treatment regimens; still pharmacology data on which current dosing regimens are based are very limited.

methodsWe conducted a multinational pharmacokinetic study investigating age dependency of doxorubicin metabolism and elimination in children with cancer. One hundred and one patients treated with doxorubicin according to a cancer-specific national or European therapeutic trial were recruited. Doses of doxorubicin ranged from 10.4 to 57.7 mg/m

resultsAge dependence of doxorubicin clearance was demonstrated, with children less than 3 years having a statistically significant lower clearance (21.1 ± 5.8 l/h/m

conclusionIn the European framework of funding and regulatory support, an add-on study to existing therapeutic trials was developed. The pediatric need concerning missing PK data could be addressed with limited burden for the patients. Empirically used dose adaptations for infants were generally found to be justified based on our PK analyses.

Indexed as

AdolescentAntibiotics, AntineoplasticChildChild, PreschoolDoxorubicinFemaleHeartHumansInfantMaleNeoplasmsPolymorphism, GeneticTroponinAntibiotics, AntineoplasticDoxorubicinTroponinCancerCardiotoxicityChildrenDoxorubicinPharmacokinetic

Identifiers

PMID27770238
PMCPMC5114325
OpenAlexW2535758124

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.