Pharmacokinetic/pharmacodynamic modeling of 5-fluorouracil by using a biomarker to predict tumor growth in a rat model of colorectal cancer

J Pharm Sci. 2013 Jun;102(6):2056-2067. doi: 10.1002/jps.23547. Epub 2013 Apr 16.

Abstract

We developed a pharmacokinetic/pharmacodynamic (PK/PD) model with the value of the plasma ratio of dihydrouracil (UH2)/uracil (Ura), which is a possible surrogate biomarker of hepatic dihydropyrimidine dehydrogenase activity, determined before 5-fluorouracil (5-FU) treatment to simulate the growth of tumors after 5-FU treatment in rats with colorectal cancer (CRC). In the PK/PD model, the value of the elimination rate constant of 5-FU-ke -was estimated using the plasma UH2/Ura ratio observed before 5-FU treatment for simulating PKs of 5-FU and tumor growth. The PK/PD model with plasma UH2/Ura ratio effectively captured the features of tumor growth and the anticancer effect of 5-FU treatment, which provided reliable parameter estimates. In addition to an appropriate dosing regimen, pretherapeutic assessment of the UH2/Ura ratio in the plasma of CRC patients and PK/PD analysis with the plasma UH2/Ura ratio could enable the development of an optimal therapeutic scheme for each patient.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antimetabolites, Antineoplastic / blood*
  • Antimetabolites, Antineoplastic / pharmacology*
  • Antimetabolites, Antineoplastic / therapeutic use
  • Biomarkers, Tumor / blood
  • Colon / drug effects
  • Colon / pathology
  • Colorectal Neoplasms / blood
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / enzymology
  • Colorectal Neoplasms / pathology
  • Dihydrouracil Dehydrogenase (NADP) / metabolism
  • Fluorouracil / blood*
  • Fluorouracil / pharmacology*
  • Fluorouracil / therapeutic use
  • Male
  • Models, Biological
  • Rats
  • Rats, Wistar
  • Rectum / drug effects
  • Rectum / pathology
  • Uracil / analogs & derivatives*
  • Uracil / blood*

Substances

  • Antimetabolites, Antineoplastic
  • Biomarkers, Tumor
  • dihydrouracil
  • Uracil
  • Dihydrouracil Dehydrogenase (NADP)
  • Fluorouracil