Feasibility and population exposure of 5-fluorouracil using therapeutic drug monitoring (PREDICT-5FU): A multicentre clinical trial
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View abstract on PubMed
Summary
This summary is machine-generated.Therapeutic drug monitoring (TDM) for 5-fluorouracil (5FU) and capecitabine is feasible and improves patient outcomes. TDM helps more cancer patients reach target drug exposure levels, especially DPYD variant carriers.
Area Of Science
- Oncology
- Pharmacology
- Clinical Pharmacy
Background
- 5-fluorouracil (5FU) and capecitabine are standard chemotherapy agents.
- Optimizing 5FU exposure is crucial for efficacy and safety in cancer treatment.
- Standard dosing based on body surface area (BSA) often results in suboptimal drug exposure.
Purpose Of The Study
- To assess the feasibility of therapeutic drug monitoring (TDM) for 5-fluorouracil (5FU) and capecitabine.
- To document 5FU exposure in a diverse cancer patient population.
- To evaluate the impact of TDM-guided dosing on achieving target drug exposure.
Main Methods
- A multicentre, prospective, observational study involving adult cancer patients receiving 5FU or capecitabine.
- Therapeutic drug monitoring (TDM) was conducted over consecutive cycles to achieve target area under the curve (AUC).
- Pharmacogenetic testing, including DPYD genotyping, was performed for all participants.
Main Results
- Only 36% of patients achieved target 5FU AUC with standard BSA dosing; 61% were below target.
- TDM-adjusted dosing increased the proportion of patients achieving target AUC to 58% (p = 0.03).
- DPYD variant carriers receiving reduced upfront doses remained below target AUC, with one experiencing toxicity.
Conclusions
- Therapeutic drug monitoring (TDM) for 5FU and capecitabine is feasible in clinical practice.
- TDM significantly increases the likelihood of achieving target drug exposure (AUC) in cancer patients.
- Findings are particularly relevant for DPYD variant carriers and support TDM for optimizing chemotherapy.
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