No effect of dose, hepatic function, or nutritional status on 5-FU clearance following continuous (5-day), 5-FU infusion
1992

Impact of Dose, Liver Function, and Nutrition on 5-FU Clearance

Sample size: 187 publication Evidence: moderate

Author Information

Author(s): R.A. Fleming, G.A. Milano, M.-C. Etienne, N. Renee, A. Thyss, M. Schneider, F. Demard

Primary Institution: Laboratoire d'Oncopharmacologie, Centre Antoine-Lacassagne, Nice, France

Hypothesis

Does 5-FU dose, hepatic function, or nutritional status affect its clearance in patients with head and neck cancer?

Conclusion

5-FU clearance is not affected by dose, hepatic function, or nutritional status.

Supporting Evidence

  • Significant interpatient variability in 5-FU clearance was observed, with a ten-fold range.
  • 5-FU clearance was not modified by dose, indicating linear pharmacokinetics.
  • Laboratory data on hepatic function and nutritional status did not correlate with 5-FU clearance.

Takeaway

This study found that changing the dose of a cancer drug called 5-FU doesn't change how quickly it's cleared from the body, even if the liver isn't working well or if a person isn't eating properly.

Methodology

The study analyzed 222 cycles of therapy in 187 patients with head and neck cancer, measuring 5-FU pharmacokinetics and correlating them with dose, hepatic function, and nutritional status.

Limitations

The study did not assess the impact of 5-FU on toxicities like mucositis and leukopenia, and the population may not reflect patients with severe liver dysfunction.

Participant Demographics

187 patients (155 males, 32 females) with a median age of 62 years (range 35-85).

Statistical Information

P-Value

0.124

Statistical Significance

p<0.05

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