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


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.


CONCLUSIONS
This study suggests that cetuximab can be safely used in cancer patients with renal impairment without dose adjustment.
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, PO Box 9600 NL, 2300 RC, Leiden, The Netherlands, l.l.krens@lumc.nl.
L L
LL
Krens
J M
JM
Baas
M C
MC
Verboom
G
G
Paintaud
C
C
Desvignes
H J
HJ
Guchelaar
H
H
Gelderblom
D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000378:metabolism; D000068818:Cetuximab; D006801:Humans; D012516:Osteosarcoma / Q000188:drug therapy / Q000378:metabolism; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000378:metabolism* / Q000628:therapy
D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068818:Cetuximab