Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines
Patients exhibiting a genetically determined disorder (DPYD*2A) in the metabolic degradation
of the frequently used anticancer agents capecitabine and 5-FU (fluoropyrimidines) are at
high risk of development of severe and life-threatening toxicity during standard treatment
with these compounds. Treatment and recovery of this fluoropyrimidine-induced severe
toxicity often requires prolonged periods of hospitalization.
Screening for DPYD*2A in patients to treat with fluoropyrimidine drugs with subsequent dose
adjustments in mutant individuals prior to start of therapy will possibly reduce the number
of severe toxicity events. Furthermore, by reducing the frequency and/or duration of
hospitalization, substantial medical costs can be saved, making this a cost-effective
strategy.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
safety
during fluoropyrimidine treatment of the patient
Yes
Jan HM Schellens, MD, PhD
Principal Investigator
Netherlands Cancer Institute, Amsterdam, the Netherlands
Netherlands: Medical Ethics Review Committee (METC)
NKI-AVL_M07PFU
NCT00838370
May 2007
August 2009
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