ArticleEuropean journal of drug metabolism and pharmacokinetics2026
Evaluating Oxaliplatin Exposure in Adults with Advanced Colorectal Cancer: Development and Validation of Methods with Enhanced Bioanalytical Specificity and Clinical Applicability.
Article in European journal of drug metabolism and pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
BACKGROUND AND
aimsThe clinical efficacy and adverse effects of oxaliplatin [Pt(DACH)(oxalato)] (DACH = 1R,2R-cyclohexanediamine) may depend upon systemic drug exposure quantified as the area under the plasma concentration versus time curve (AUC). Most previous oxaliplatin pharmacokinetic studies measured total platinum exposure without separating intact oxaliplatin [Pt(DACH)oxalato] from its inactive biotransformation products, and estimated AUC using intensive sampling methods unsuitable for routine clinical application. In the current study, we aimed to (1) evaluate systemic exposure to intact oxaliplatin and (2) develop and validate enhanced methods for estimating oxaliplatin AUC in adults with advanced colorectal cancer.
methodsTwo oxaliplatin clinical pharmacokinetic datasets were analyzed. The first dataset included 19 patients and 38 treatment cycles from our previous clinical trial (ATCRN12611000738921). The second dataset included ten patients from an independent published clinical study. In both datasets, oxaliplatin 85 or 130 mg/m
resultsIntact oxaliplatin plasma concentration had almost reached steady state (> 95%) and most systemic exposure (70%) had already occurred by the end of infusion. Intact oxaliplatin accounted for 77% of the AUC of total unbound platinum. Intact oxaliplatin AUCs were dose-proportional, moderately variable between individuals (%CV = 18%), and linearly related to end of infusion plasma concentrations (y = 2.231x, R
conclusionsIntact oxaliplatin was the major pharmacologically active platinum species present in the systemic circulation of adults with advanced colorectal cancer in this study. Intact oxaliplatin AUC estimation from the end of infusion plasma concentration multiplied by the infusion duration offers a clinically practicable and potentially reliable method with enhanced bioanalytical specificity for evaluating oxaliplatin systemic exposure.
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