Evidence map›Paper›PMID 39988750›Full record

Observational studyBritish journal of clinical pharmacology2025

Feasibility and population exposure of 5-fluorouracil using therapeutic drug monitoring (PREDICT-5FU): A multicentre clinical trial.

Sarah Glewis, Michael Michael, Howard Gurney, Ian Olver, Nicholas Zdenkowski, Stephen Ackland, Craig Kukard, Madawa Jayawardana, S Sandun M Silva, Marliese Alexander and 3 more

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in British journal of clinical pharmacology, 2025. 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
–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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Observational
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

13 authors.

Sarah GlewisDepartment of Pharmacy, Peter MacCallum Cancer Centre, Melbourne, Australia.ORCID https://orcid.org/0000-0002-7764-5427
Michael MichaelSir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.
Howard GurneyFaculty of Medicine and Health Sciences, Macquarie University, New South Wales, Australia.
Ian OlverFaculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.
Nicholas ZdenkowskiSchool of Medicine and Public Health, University of Newcastle, New South Wales, Australia.
Stephen AcklandSchool of Medicine and Public Health, University of Newcastle, New South Wales, Australia.
Craig KukardCentral Coast Cancer Centre, University of Newcastle, New South Wales, Australia.
Madawa JayawardanaSir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.
S Sandun M SilvaCentre for Health Systems and Safety Research, Australian Institute of Health Innovation, Macquarie University, New South Wales, Australia.
Marliese AlexanderDepartment of Pharmacy, Peter MacCallum Cancer Centre, Melbourne, Australia.
Jeanne TieSir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.
Peter GalettisSchool of Medicine and Public Health, University of Newcastle, New South Wales, Australia.
Jennifer H MartinSchool of Medicine and Public Health, University of Newcastle, New South Wales, Australia.

Funding

Cancer Council New South Wales PW 18-01
6 · The paper itself

Abstract

aimPREDICT-5FU aimed to document 5-fluorouracil (5FU) exposure in a cancer population and to evaluate the feasibility of 5FU and capecitabine therapeutic drug monitoring (TDM) in patients receiving standard doses and schedules.

methodsMulticentre, prospective, observational single-arm study. Eligible adult patients received 5FU (infusional ≥24 h) or capecitabine. Patients were treated for gastrointestinal, breast and head-and-neck cancers at four Australian hospitals. TDM was performed in consecutive cycles until target area under the curve (AUC) was reached. Pharmacogenetic testing was performed for all patients.

resultsFifty patients (24 males, 26 females) were recruited. Median age was 63 years; common diagnoses were lower gastrointestinal cancers 40% (20/50) and metastatic disease 80% (40/50). The majority received 5FU (38/50, 76%) over 46 h. Only 36% of 5FU patients achieved target AUC when dosed based on body surface area; 61% were below and 3% above target range. Post TDM-adjusted dosing, target AUC was achieved in 58% of patients (22% absolute increase vs. BSA dosing, p = 0.03), within median three cycles (range 1-5). DPYD variant allele carriers (3/4) had upfront reduced dosing due to heterozygosity; all were below the target AUC and one experienced Grade 3 toxicity. There was no correlation between dihydrouracil: uracil ratio [UH2/U] or uracilemia [U] and DPYD genotype. TDM results were reported with an average of 4 days from sampling.

conclusionTDM dosing is feasible and increases the proportion of patients reaching target AUC. Findings are relevant across all cancers treated with 5FU, and particularly for DPYD variant allele carriers receiving upfront dose reductions.

Indexed as

Antimetabolites, AntineoplasticDrug MonitoringFluorouracilAdultAgedAged, 80 and overArea Under CurveAustraliaBreast NeoplasmsCapecitabineDihydrouracil Dehydrogenase (NADP)Feasibility StudiesFemaleGastrointestinal NeoplasmsHead and Neck NeoplasmsHumansAntimetabolites, AntineoplasticCapecitabineDihydrouracil Dehydrogenase (NADP)FluorouracilAUCDPDfinger prickfluoropyrimidinespharmacokinetics

Identifiers

PMID39988750
PMCPMC12199125

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.