Evidence map›Paper›PMID 32519032›Full record

Trial reportCancer chemotherapy and pharmacology2020

Pharmacokinetics of tablet and liquid formulations of oral 6-mercaptopurine in children with acute lymphoblastic leukemia.

Rikke Hebo Larsen, Lisa Lyngsie Hjalgrim, Kathrine Grell, Kim Kristensen, Line Gerner Pedersen, Emilie Damgaard Brünner, Bodil Als-Nielsen, Kjeld Schmiegelow, Jacob Nersting

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01906671 (Plasma Kinetics of Tablet and Liquid Formulations of 6-mercaptopurine in Childhood Acute Lymphoblastic Leukemia.), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.8field-weighted citation impact, top 14% 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.

NCT01906671 phase4unknown statusnot on this map

Plasma Kinetics of Tablet and Liquid Formulations of 6-mercaptopurine in Childhood Acute Lymphoblastic Leukemia.

TypeinterventionalSponsorKjeld SchmiegelowRan2013 to 2018Enrolled16ConditionsAcute Lymphoblastic Leukemia, 6-mercaptopurine TherapyArmsXaluprine, Puri-Nethol
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Advances in Thiopurine Drug Delivery: The Current State-of-the-Art.European journal of drug metabolism and pharmacokinetics · 2021
    Review
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 4 institutions in 1 country.

Rikke Hebo LarsenDepartment of Pediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.
Lisa Lyngsie HjalgrimDepartment of Pediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.
Kathrine GrellDepartment of Pediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.
Kim KristensenDiscovery and Development PKPD, Novo Nordisk, Copenhagen, Denmark.
Line Gerner PedersenDepartment of Pediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.
Emilie Damgaard BrünnerDepartment of Pediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.
Bodil Als-NielsenDepartment of Pediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.
Kjeld SchmiegelowDepartment of Pediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.ORCID http://orcid.org/0000-0002-0829-4993
Jacob NerstingDepartment of Pediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark. jacob.nersting@regionh.dk.ORCID http://orcid.org/0000-0001-9144-7972
Rigshospitalet · DKUniversity of Copenhagen · DKCopenhagen University Hospital · DKNovo Nordisk (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMercaptopurine (6MP) is essential to cure childhood acute lymphoblastic leukemia (ALL). A liquid 6MP formulation was recently introduced to facilitate oral 6MP administration, especially to children. Its approval and bioequivalence with 6MP tablet were based on comparative pharmacokinetics in 60 healthy adults. Due to potential pharmacokinetic differences between healthy adults and children with ALL, we compared pharmacokinetics of tablet and liquid 6MP formulations in children with ALL.

methodsPharmacokinetics of 50 mg 6MP tablet (Puri-Nethol

resultsLiquid 6MP formulation resulted in a 26% lower AUC (p = 0.02) compared with tablet (median 1215 vs. 1805 h × nmol/l). No significant differences were observed for C

conclusionNon-inferiority of liquid 6MP formulation compared with 6MP tablet was not demonstrated. Yet, maintenance therapy doses are adjusted by degree of myelosuppression and not by 6MP dose. Thus, in spite of a lower bioavailability, a liquid 6MP formulation is still desirable in a clinical setting, especially for children. However, if shifting between 6MP formulation is indicated, dose adjustments should be anticipated to maintain equivalent treatment intensity in children with ALL. The study is registered on clinicaltrials.gov (NCT01906671). Date of registration: 24.07.13.

Indexed as

Administration, OralAntimetabolites, AntineoplasticArea Under CurveBiological AvailabilityChildChild, PreschoolCross-Over StudiesFemaleHumansMaleMercaptopurinePrecursor Cell Lymphoblastic Leukemia-LymphomaTabletsAntimetabolites, AntineoplasticMercaptopurineTabletsCancerChildhood acute lymphoblastic leukemiaLeukemiaMercaptopurinePharmacokinetics

Identifiers

PMID32519032
OpenAlexW3034001204

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.