SY13-3 - Relationships between sorafenib exposure and clinical safety and efficacy

Abstract

Sorafenib is an orally active multikinase inhibitor for a variety of cellular molecules including VEGFR-2, PDGFR, c-KIT, FLT-3, and BRAF. The recommended dose of sorafenib in patients with renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and thyroid cancer is 400 mg twice daily. Notably, sorafenib shows a large inter-individual pharmacokinetic variability after oral administration. Therefore, a suboptimal exposure to sorafenib could result in a decreased anti-tumor activity, while a greater exposure to sorafenib could be related to the development of sorafenib-induced adverse events such as hand-foot skin reaction and hypertension. However, it has not been adequately examined the association between pharmacokinetics and pharmacodynamics of sorafenib under real-life practice conditions. In this symposium, we will summarize recent findings on the relationships between sorafenib exposure and clinical safety and efficacy in the clinical setting.