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Lenvatinib is a substrate of cytochrome P450 (CYP) 3A and ATP-binding cassette (ABC) transporters. In this study, we aimed to evaluate how  CYP3A4/5  and  ABC  transporter polymorphisms affected the mean steady-state dose-adjusted plasma trough concentrations (C 0 ) of lenvatinib in a cohort of 40 Japanese patients with thyroid cancer.  CYP3A4  20230G > A ( *1G ),  CYP3A5  6986A > G ( *3 ),  ABCB1  1236C > T,  ABCB1  2677G > T/A,  ABCB1  3435C > T,  ABCC2  −24C > T, and  ABCG2  421C > A genotypes were determined using polymerase chain reaction-restriction fragment length polymorphism. In univariate analysis, there were no significant differences in the mean dose-adjusted C 0  values of lenvatinib between the  ABCB1 ,  ABCG2 , and  CYP3A5  genotypes. However, the mean dose-adjusted C 0  values of lenvatinib in patients with the  CYP3A4*1/*1  genotype and  ABCC2  −24T allele were significantly higher than those in patients with the  CYP3A4*1G  allele and −24C/C genotype, respectively ( P  = 0.018 and 0.036, respectively). In multivariate analysis,  CYP3A4  genotype and total bilirubin were independent factors influencing the dose-adjusted C 0  of lenvatinib ( P  = 0.010 and 0.046, respectively). No significant differences were found in the incidence rates of hypertension, proteinuria, and hand-foot syndrome following treatment with lenvatinib between the genotypes of  CYP3A4/5  and  ABC  transporters. Lenvatinib pharmacokinetics were significantly influenced by the  CYP3A4*1G  polymorphism. If the target plasma concentration of lenvatinib for efficacy or toxicity is determined, elucidation of the details of the  CYP3A4*1G  genotype may facilitate decision-making related to the appropriate initial lenvatinib dosage to achieve optimal plasma concentrations.

Influence of CYP3A4/5 and ABC transporter polymorphisms on lenvatinib plasma trough concentrations in Japanese patients with thyroid cancer