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

ABSTRACT:

Aim

PREDICT-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.

Methods

Multicentre, 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.

Results

Fifty patients (24 males, 26 females) were recruited. Median age was 63 years; common diagnoses were lower gastrointestinal cancers 40% (20/50) an

SUBMITTER: Glewis S 

PROVIDER: S-EPMC12199125 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature