ArticleCancer chemotherapy and pharmacology2025
Simulation of perioperative Ibrutinib withdrawal using a population pharmacokinetic model and sparse clinical concentration data.
Article in Cancer chemotherapy and pharmacology, 2025. 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
purposeTreatment with the Bruton tyrosine kinase inhibitor ibrutinib carries a significant risk of bleeding; therefore, the risk-benefit assessment regarding withholding ibrutinib pre- and post-surgery should be considered based on the type of surgery being planned. However, there is no optimal rationale regarding ibrutinib withdrawal during the perioperative period. This exploratory study aimed to generate hypotheses regarding perioperative management of ibrutinib therapy by simulating individual pharmacokinetic profiles using a previously reported population pharmacokinetic (PopPK) model.
methodsPlasma levels of ibrutinib were measured in patients receiving ibrutinib and at high risk of bleeding at Saga University Hospital. Using Phoenix NLME, Bayesian estimation, based on a previously reported PopPK model incorporating actual plasma concentrations measured in individual patients, was employed to simulate perioperative withdrawal scenarios.
resultsFive patients were enrolled. After a withdrawal period of 3-7 days there were no bleeding events in patients that underwent surgery with a low bleeding risk; however, bleeding events occurred in one patient that underwent gastrectomy with moderate or higher bleeding risk. The AUC
conclusionPerioperative withdrawal of ibrutinib was explored using a previously reported PopPK model in combination with sparse plasma concentration data obtained from patients in real-world clinical settings, including those undergoing surgery. This exploratory study suggests that reliance on plasma concentration data alone might be inadequate for determining the optimal perioperative withdrawal period of ibrutinib.
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