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• W4361949105 abstract "<div>Abstract<p><b>Purpose:</b> Irinotecan, the prodrug of SN-38, is extensively metabolized by cytochrome P450-3A4 (CYP3A4). A randomized trial was done to assess the utility of an algorithm for individualized irinotecan dose calculation based on a priori CYP3A4 activity measurements by the midazolam clearance test.</p><p><b>Experimental Design:</b> Patients were randomized to receive irinotecan at a conventional dose level of 350 mg/m² (group A) or doses based on an equation consisting of midazolam clearance, γ-glutamyl-transferase, and height (group B). Pharmacokinetics and toxicities were obtained during the first treatment course.</p><p><b>Results:</b> Demographics of 40 evaluable cancer patients were balanced between both groups, including <i>UGT1A1*28</i> genotype and smoking status. The absolute dose of irinotecan ranged from 480 to 800 mg in group A and 380 to 1,060 mg in group B. The mean absolute dose and area under the curve of irinotecan and SN-38 were not significantly different in either group (<i>P</i> > 0.18). In group B, the interindividual variability in the area under the curve of irinotecan and SN-38 was reduced by 19% and 25%, respectively (<i>P</i> > 0.22). Compared with group A, the incidence of grades 3 to 4 neutropenia was >4-fold lower in group B (45 versus 10%; <i>P</i> = 0.013). The incidence of grades 3 to 4 diarrhea was equal in both groups (10%).</p><p><b>Conclusions:</b> Incorporation of CYP3A4 phenotyping in dose calculation resulted in an improved predictability of the pharmacokinetic and toxicity profile of irinotecan, thereby lowering the incidence of severe neutropenia. In combination with <i>UGT1A1*28</i> genotyping, CYP3A4 phenotype determination should be explored further as a strategy for the individualization of irinotecan treatment. Clin Cancer Res; 16(2); 736–42</p></div>" @default.
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• W4361949105 date "2023-03-31" @default.
• W4361949105 modified "2023-10-14" @default.
• W4361949105 title "Data from A CYP3A4 Phenotype–Based Dosing Algorithm for Individualized Treatment of Irinotecan" @default.
• W4361949105 doi "https://doi.org/10.1158/1078-0432.c.6517789.v1" @default.
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