Pharmacokinetics and safety of cetuximab in a patient with renal dysfunction

Cancer Chemother Pharmacol. 2014 Jun;73(6):1303-6. doi: 10.1007/s00280-014-2462-4. Epub 2014 Apr 6.


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.

Publication types

  • Case Reports
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antibodies, Monoclonal, Humanized / administration & dosage
  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Antibodies, Monoclonal, Humanized / pharmacokinetics*
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / pharmacokinetics*
  • Bone Neoplasms / drug therapy
  • Bone Neoplasms / metabolism
  • Cetuximab
  • Humans
  • Osteosarcoma / drug therapy
  • Osteosarcoma / metabolism
  • Renal Dialysis
  • Renal Insufficiency / metabolism*
  • Renal Insufficiency / therapy


  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents
  • Cetuximab