Evidence map›Paper›PMID 27837256›Full record

ArticleCancer chemotherapy and pharmacology2016

Pharmacokinetics, immunogenicity, and safety of weekly dosing of brentuximab vedotin in pediatric patients with Hodgkin lymphoma.

Jamie E Flerlage, Monika L Metzger, Jianrong Wu, John C Panetta

Abstract read
In one paragraph

Article 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 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Commonly Reported Adverse Events Associated With Pediatric Immunotherapy: A Systematic Review From the Children's Oncology GroupJournal of pediatric oncology nursing : official journal of the Association of Pediatric Oncology Nurses
    Pooled it
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  9. Clinical Pharmacology of Antibody-Drug Conjugates.Antibodies (Basel, Switzerland) · 2021
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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

4 authors.

Jamie E FlerlageDepartment of Oncology, St. Jude Children's Research Hospital, The University of Tennessee Health Science Center, 262 Danny Thomas Pl, Mailstop 260, Memphis, TN, 38105, USA. jamie.flerlage@stjude.org.
Monika L MetzgerDepartment of Oncology, St. Jude Children's Research Hospital, The University of Tennessee Health Science Center, 262 Danny Thomas Pl, Mailstop 260, Memphis, TN, 38105, USA.
Jianrong WuDepartment of Biostatistics, St. Jude Children's Research Hospital, The University of Tennessee Health Science Center, Memphis, TN, USA.
John C PanettaPharmaceutical Sciences, St. Jude Children's Research Hospital, The University of Tennessee Health Science Center, Memphis, TN, USA.

Funding

Viral Vector Technology (VVTSR)P30CA021765 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI CHARLES ROBERTS · 1985 to 2026
$166.9M
NCI NIH HHS P30 CA021765
6 · The paper itself

Abstract

purposeBecause of the observed success of phase I/II trials, the novel anti-CD30 agent brentuximab vedotin is now being evaluated as a frontline agent in the high-risk pediatric Hodgkin lymphoma trial HLHR13. The objectives of this study were to evaluate the pharmacokinetic variability during weekly dosing of 1.2 mg/kg of brentuximab vedotin, determine factors that may explain this variability, compare our drug exposure with published data, and evaluate toxicity of brentuximab vedotin in the pediatric population.

methodsBrentuximab vedotin, MMAE and anti-therapeutic antibody levels were measured in the serum samples of 16 pediatric patients with Hodgkin lymphoma. A compartmental pharmacokinetic model was fit to the data by using nonlinear mixed-effects modeling.

resultsClearance and volume of brentuximab vedotin were significantly correlated with weight (p < .001), which was responsible for over 60% of the parameters inter-individual variability. Clearance and volume were higher in boys compared to girls (p = 0.08 and p = 0.03, respectively). Brentuximab vedotin's AUC and C

conclusionsAs in previous studies, weight continues to be the most significant factor explaining brentuximab vedotin's pharmacokinetic variability in pediatric patients. Exposure to weekly dosing appears to be safe and tolerable in pediatric patients.

Indexed as

AdolescentArea Under CurveBrentuximab VedotinChildFemaleHodgkin DiseaseHumansImmunoconjugatesMaleBrentuximab VedotinImmunoconjugatesBrentuximab vedotinHodgkin lymphomaPediatricPharmacokinetics

Identifiers

PMID27837256
PMCPMC5206991

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Registered trials

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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.