U.S. FDA: About the Center for Drug Evaluation and Research > Carboplatin dosing

Carboplatin dosing

"This communication is to inform members of the oncology community of recent changes in the measurement of serum creatinine which may have an impact on carboplatin dosing. Based on preliminary communications with the National Cancer Institute/Cancer Therapy Evaluation Program, a potential safety issue with carboplatin dosing has been identified. By the end of 2010, all clinical laboratories in the US will use the new standardized Isotope Dilution Mass Spectrometry (IDMS) method to measure serum creatinine. The IDMS method appears to underestimate serum creatinine values compared to older methods when the serum creatinine values are relatively low (e.g., ~0.7 mg/dL). Measurement of serum creatinine by the IDMS-method could result in an overestimation of the Glomerular Filtration Rate (GFR) in some patients with normal renal function. If the total carboplatin dose is calculated based on IDMS-measured serum creatinine using the Calvert formula, carboplatin dosing could be higher than desired and could result in increased drug-related toxicity...."cont'd