Pharmacokinetics and safety of cetuximab in a patient with renal dysfunction.

Introduction: In the literature, data on the effect of renal impairment on the pharmacokinetics of anticancer drugs are scarce. Here, we report a 68-year-old metastatic osteosarcoma patient with impaired renal function due to prior chemotherapy, who was treated on compassionate use basis with 400 mg/m(2) cetuximab.

Material And Methods: Pharmacokinetic parameters after the first dose, including dose-normalised AUC from time zero to day 7, clearance, elimination half-life (t(1/2)), were estimated using trapezoidal non-compartmental methods and compared to pharmacokinetic data from a study population with normal kidney function.

Results: The results showed that the pharmacokinetics of cetuximab in this patient with renal failure was similar to that with adequate renal function.

Conclusion: This study suggests that cetuximab can be safely used in cancer patients with renal impairment without dose adjustment.