Pharmacokinetics of Capecitabine and Four Metabolites in a Heterogeneous Population of Cancer Patients: A Comprehensive Analysis
Capecitabine is an oral prodrug of the anticancer drug 5‐fluorouracil (5‐FU). The primary aim of this study was to develop a pharmacokinetic model for capecitabine and its metabolites, 5′‐deoxy‐5‐fluorocytidine (dFCR), 5′‐deoxy‐5‐fluorouridine (dFUR), 5‐FU, and fluoro‐β‐alanine (FBAL) using data fro...
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| Published in | CPT: pharmacometrics and systems pharmacology Vol. 8; no. 12; pp. 940 - 950 |
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| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
John Wiley & Sons, Inc
01.12.2019
John Wiley and Sons Inc Wiley |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2163-8306 2163-8306 |
| DOI | 10.1002/psp4.12474 |
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| Abstract | Capecitabine is an oral prodrug of the anticancer drug 5‐fluorouracil (5‐FU). The primary aim of this study was to develop a pharmacokinetic model for capecitabine and its metabolites, 5′‐deoxy‐5‐fluorocytidine (dFCR), 5′‐deoxy‐5‐fluorouridine (dFUR), 5‐FU, and fluoro‐β‐alanine (FBAL) using data from a heterogeneous population of cancer patients (n = 237) who participated in seven clinical studies. A four‐transit model adequately described capecitabine absorption. Capecitabine, dFCR, and FBAL pharmacokinetics were well described by two‐compartment models, and dFUR and 5‐FU were subject to flip‐flop pharmacokinetics. Partial and total gastrectomy were associated with a significantly faster capecitabine absorption resulting in higher capecitabine and metabolite peak concentrations. Patients who were heterozygous polymorphic for a genetic mutation encoding dihydropyrimidine dehydrogenase, the DPYD*2A mutation, demonstrated a 21.5% (relative standard error 11.2%) reduction in 5‐FU elimination. This comprehensive population model gives an extensive overview of capecitabine and metabolite pharmacokinetics in a large and heterogeneous population of cancer patients. |
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| AbstractList | Capecitabine is an oral prodrug of the anticancer drug 5‐fluorouracil (5‐FU). The primary aim of this study was to develop a pharmacokinetic model for capecitabine and its metabolites, 5′‐deoxy‐5‐fluorocytidine (dFCR), 5′‐deoxy‐5‐fluorouridine (dFUR), 5‐FU, and fluoro‐β‐alanine (FBAL) using data from a heterogeneous population of cancer patients (n = 237) who participated in seven clinical studies. A four‐transit model adequately described capecitabine absorption. Capecitabine, dFCR, and FBAL pharmacokinetics were well described by two‐compartment models, and dFUR and 5‐FU were subject to flip‐flop pharmacokinetics. Partial and total gastrectomy were associated with a significantly faster capecitabine absorption resulting in higher capecitabine and metabolite peak concentrations. Patients who were heterozygous polymorphic for a genetic mutation encoding dihydropyrimidine dehydrogenase, the DPYD*2A mutation, demonstrated a 21.5% (relative standard error 11.2%) reduction in 5‐FU elimination. This comprehensive population model gives an extensive overview of capecitabine and metabolite pharmacokinetics in a large and heterogeneous population of cancer patients. Capecitabine is an oral prodrug of the anticancer drug 5‐fluorouracil (5‐FU). The primary aim of this study was to develop a pharmacokinetic model for capecitabine and its metabolites, 5′‐deoxy‐5‐fluorocytidine (dFCR), 5′‐deoxy‐5‐fluorouridine (dFUR), 5‐FU, and fluoro‐β‐alanine (FBAL) using data from a heterogeneous population of cancer patients (n = 237) who participated in seven clinical studies. A four‐transit model adequately described capecitabine absorption. Capecitabine, dFCR, and FBAL pharmacokinetics were well described by two‐compartment models, and dFUR and 5‐FU were subject to flip‐flop pharmacokinetics. Partial and total gastrectomy were associated with a significantly faster capecitabine absorption resulting in higher capecitabine and metabolite peak concentrations. Patients who were heterozygous polymorphic for a genetic mutation encoding dihydropyrimidine dehydrogenase, the DPYD*2A mutation, demonstrated a 21.5% (relative standard error 11.2%) reduction in 5‐FU elimination. This comprehensive population model gives an extensive overview of capecitabine and metabolite pharmacokinetics in a large and heterogeneous population of cancer patients. Capecitabine is an oral prodrug of the anticancer drug 5‐fluorouracil (5‐FU). The primary aim of this study was to develop a pharmacokinetic model for capecitabine and its metabolites, 5′‐deoxy‐5‐fluorocytidine (dFCR), 5′‐deoxy‐5‐fluorouridine (dFUR), 5‐FU, and fluoro‐β‐alanine (FBAL) using data from a heterogeneous population of cancer patients ( n = 237) who participated in seven clinical studies. A four‐transit model adequately described capecitabine absorption. Capecitabine, dFCR, and FBAL pharmacokinetics were well described by two‐compartment models, and dFUR and 5‐FU were subject to flip‐flop pharmacokinetics. Partial and total gastrectomy were associated with a significantly faster capecitabine absorption resulting in higher capecitabine and metabolite peak concentrations. Patients who were heterozygous polymorphic for a genetic mutation encoding dihydropyrimidine dehydrogenase, the DPYD *2A mutation, demonstrated a 21.5% (relative standard error 11.2%) reduction in 5‐FU elimination. This comprehensive population model gives an extensive overview of capecitabine and metabolite pharmacokinetics in a large and heterogeneous population of cancer patients. Capecitabine is an oral prodrug of the anticancer drug 5-fluorouracil (5-FU). The primary aim of this study was to develop a pharmacokinetic model for capecitabine and its metabolites, 5'-deoxy-5-fluorocytidine (dFCR), 5'-deoxy-5-fluorouridine (dFUR), 5-FU, and fluoro-β-alanine (FBAL) using data from a heterogeneous population of cancer patients (n = 237) who participated in seven clinical studies. A four-transit model adequately described capecitabine absorption. Capecitabine, dFCR, and FBAL pharmacokinetics were well described by two-compartment models, and dFUR and 5-FU were subject to flip-flop pharmacokinetics. Partial and total gastrectomy were associated with a significantly faster capecitabine absorption resulting in higher capecitabine and metabolite peak concentrations. Patients who were heterozygous polymorphic for a genetic mutation encoding dihydropyrimidine dehydrogenase, the DPYD*2A mutation, demonstrated a 21.5% (relative standard error 11.2%) reduction in 5-FU elimination. This comprehensive population model gives an extensive overview of capecitabine and metabolite pharmacokinetics in a large and heterogeneous population of cancer patients.Capecitabine is an oral prodrug of the anticancer drug 5-fluorouracil (5-FU). The primary aim of this study was to develop a pharmacokinetic model for capecitabine and its metabolites, 5'-deoxy-5-fluorocytidine (dFCR), 5'-deoxy-5-fluorouridine (dFUR), 5-FU, and fluoro-β-alanine (FBAL) using data from a heterogeneous population of cancer patients (n = 237) who participated in seven clinical studies. A four-transit model adequately described capecitabine absorption. Capecitabine, dFCR, and FBAL pharmacokinetics were well described by two-compartment models, and dFUR and 5-FU were subject to flip-flop pharmacokinetics. Partial and total gastrectomy were associated with a significantly faster capecitabine absorption resulting in higher capecitabine and metabolite peak concentrations. Patients who were heterozygous polymorphic for a genetic mutation encoding dihydropyrimidine dehydrogenase, the DPYD*2A mutation, demonstrated a 21.5% (relative standard error 11.2%) reduction in 5-FU elimination. This comprehensive population model gives an extensive overview of capecitabine and metabolite pharmacokinetics in a large and heterogeneous population of cancer patients. |
| Author | Meulendijks, Didier Schellens, Jan H.M. Deenen, Maarten J. Joerger, Markus Cats, Annemieke Vries, Niels Beijnen, Jos H. Rosing, Hilde Huitema, Alwin D.R. Jacobs, Bart A.W. |
| AuthorAffiliation | 6 Department of Gastrointestinal Oncology The Netherlands Cancer Institute Amsterdam The Netherlands 8 Department of Clinical Pharmacy University Medical Center Utrecht Utrecht The Netherlands 1 Department of Clinical Pharmacology The Netherlands Cancer Institute Amsterdam The Netherlands 5 Dutch Medicines Evaluation Board Utrecht The Netherlands 3 Department of Clinical Pharmacy Catharina Hospital Eindhoven The Netherlands 4 Department of Clinical Pharmacology and Toxicology Leiden University Medical Centre Leiden The Netherlands 2 Department of Pharmacy & Pharmacology The Netherlands Cancer Institute Amsterdam The Netherlands 7 Division of Pharmaco‐epidemiology & Clinical Pharmacology Science Faculty Utrecht Institute for Pharmaceutical Sciences Utrecht University Utrecht The Netherlands |
| AuthorAffiliation_xml | – name: 4 Department of Clinical Pharmacology and Toxicology Leiden University Medical Centre Leiden The Netherlands – name: 8 Department of Clinical Pharmacy University Medical Center Utrecht Utrecht The Netherlands – name: 6 Department of Gastrointestinal Oncology The Netherlands Cancer Institute Amsterdam The Netherlands – name: 2 Department of Pharmacy & Pharmacology The Netherlands Cancer Institute Amsterdam The Netherlands – name: 3 Department of Clinical Pharmacy Catharina Hospital Eindhoven The Netherlands – name: 7 Division of Pharmaco‐epidemiology & Clinical Pharmacology Science Faculty Utrecht Institute for Pharmaceutical Sciences Utrecht University Utrecht The Netherlands – name: 5 Dutch Medicines Evaluation Board Utrecht The Netherlands – name: 1 Department of Clinical Pharmacology The Netherlands Cancer Institute Amsterdam The Netherlands |
| Author_xml | – sequence: 1 givenname: Bart A.W. surname: Jacobs fullname: Jacobs, Bart A.W. email: b.jacobs@nki.nl organization: The Netherlands Cancer Institute – sequence: 2 givenname: Maarten J. surname: Deenen fullname: Deenen, Maarten J. organization: Leiden University Medical Centre – sequence: 3 givenname: Markus surname: Joerger fullname: Joerger, Markus organization: The Netherlands Cancer Institute – sequence: 4 givenname: Hilde surname: Rosing fullname: Rosing, Hilde organization: The Netherlands Cancer Institute – sequence: 5 givenname: Niels surname: Vries fullname: Vries, Niels organization: The Netherlands Cancer Institute – sequence: 6 givenname: Didier surname: Meulendijks fullname: Meulendijks, Didier organization: Dutch Medicines Evaluation Board – sequence: 7 givenname: Annemieke surname: Cats fullname: Cats, Annemieke organization: The Netherlands Cancer Institute – sequence: 8 givenname: Jos H. surname: Beijnen fullname: Beijnen, Jos H. organization: Utrecht University – sequence: 9 givenname: Jan H.M. surname: Schellens fullname: Schellens, Jan H.M. organization: Utrecht University – sequence: 10 givenname: Alwin D.R. surname: Huitema fullname: Huitema, Alwin D.R. organization: University Medical Center Utrecht |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31652031$$D View this record in MEDLINE/PubMed |
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| SubjectTerms | Cytotoxicity Dehydrogenases Drug dosages Enzymes Esophageal cancer Gastric cancer Metabolites Mutation Patients Pharmacokinetics Radiation therapy Studies |
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| Title | Pharmacokinetics of Capecitabine and Four Metabolites in a Heterogeneous Population of Cancer Patients: A Comprehensive Analysis |
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