70P Fluoropyrimidine (FP) dose individualization based on pretreatment uracil levels: Safety and pharmacokinetic (PK) analysis from the Alpe2U study

Abstract

Risk of severe adverse events (AEs) during FP treatment can be significantly reduced through dose reduction in patients (pts) with dihydropyrimidine dehydrogenase (DPD) deficiency, the main FP metabolizing enzyme. Hence, in 2020 EMA stated that screening for DPD deficiency should be performed before FP treatment by DPYD genotyping, or by DPD phenotyping using plasma uracil (U) levels. Based on previous studies, pts with U >16 ng/ml are considered DPD deficient. However, a specific dosing strategy for these pts is missing.