Evidence map›Paper›PMID 41841238›Full record

ArticleBritish journal of clinical pharmacology2026

Population pharmacokinetics and pharmacodynamics of intraperitoneal aerosolized nanoparticle albumin-bound paclitaxel (nab-PTX) and metabolites.

Pieter-Jan De Sutter, Louis Sandra, Judith Van Ovost, Leen Van de Sande, Martin Graversen, Michael Bau Mortensen, Sarah Cosyns, Anne Hoorens, Wouter Willaert, Wim Ceelen and 1 more

Abstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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.

Pieter-Jan De SutterDepartment of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Belgium.ORCID https://orcid.org/0000-0003-3858-8017
Louis SandraDepartment of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Belgium.ORCID https://orcid.org/0000-0002-7701-289X
Judith Van OvostLaboratory of Experimental Surgery, Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.ORCID https://orcid.org/0000-0002-2298-0404
Leen Van de SandeLaboratory of Experimental Surgery, Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
Martin GraversenOdense PIPAC center, Department of Surgery, Odense University Hospital, Odense, Denmark.
Michael Bau MortensenOdense PIPAC center, Department of Surgery, Odense University Hospital, Odense, Denmark.
Sarah CosynsLaboratory of Experimental Surgery, Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
Anne HoorensDepartment of Pathology, Ghent University Hospital, Belgium.
Wouter WillaertCancer Research Institute Ghent (CRIG), Ghent University, Ghent, Belgium.
Wim CeelenLaboratory of Experimental Surgery, Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.ORCID https://orcid.org/0000-0001-7692-4419
An VermeulenDepartment of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Belgium.

Funding

Ghent University HospitalKom op tegen Kanker
6 · The paper itself

Abstract

aimsTo characterize the pharmacokinetics (PK), metabolite kinetics and toxicity risk of nanoparticle albumin-bound paclitaxel (Nab-PTX) administered via pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with peritoneal metastasis, using data from a Phase 1 trial.

methodsTwenty patients received two to three Nab-PTX PIPACs at doses ranging from 35 to 140 mg/m

resultsA two-compartment model with zero-order input best describes paclitaxel PK, with an estimated absorption duration of 3.49 h. Bioavailability was estimated at 37.0%. The total apparent volume of distribution of the two-compartment system was 2299 L. The population apparent clearance was 87.3 L/h and was accompanied by moderate variability between subjects and occasions (23.9 and 29.5% CV, respectively). Rate constants of metabolite formation and elimination displayed more extensive variability (52.6%-95.1% CV). Body surface area was incorporated as a covariate on apparent clearance.. Paclitaxel maximum concentrations and total exposure were associated with bilirubin and ALT adverse events, respectively, but not with other hepatotoxicity events. Dosing simulations predicted a low risk (0.8%) of grade 4 neutropenia at the highest investigated dose, with neutrophil nadirs at day 10 and recovery within 3-4 weeks.

conclusionsThe developed model justifies a 140 mg/m

Indexed as

AlbuminsAntineoplastic Agents, PhytogenicModels, BiologicalPaclitaxelAdultAerosolsAgedBiological AvailabilityChemical and Drug Induced Liver InjuryDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedNanoparticlesNeutropenia130-nm albumin-bound paclitaxelAerosolsAlbuminsAntineoplastic Agents, PhytogenicPaclitaxel3‐hydroxy pacxlitaxel6‐hydroxy paclitaxelintraperitoneal drug deliveryneutropeniapaclitaxelPIPACpopulation pharmacokinetics/pharmacodynamics

Identifiers

PMID41841238
PMCPMC13370055

What OpenQuestion holds

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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.