The Pharmacokinetics and Pharmacodynamics of Fludarabine Phosphate in Patients with Renal Impairment: A Prospective Dose Adjustment Study.

Autor: Lichtman, Stuart M., Etcubanas, Erlinda, Budman, Daniel R., Eisenberg, Peter, Zervos, George, D'Amico, Paul, O'Mara, Vivian, Musgrave, Kimberly, Cascella, Peter, Melikian, Armen, Hinderling, Peter H., Ferrer, Jorge M., Williams, Gary J.
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Zdroj: Cancer Investigation; Oct2002, Vol. 20 Issue 7/8, p904-913, 10p, 3 Charts
Abstrakt: A significant number of chronic lymphocytic leukemia, follicular non-Hodgkin's lymphoma and Waldenström's macroglobulinemia patients, treated with fludarabine phosphate (fludarabine), are elderly with diminished renal function. Since the kidney eliminates approximately 60% of fludarabine's primary metabolite (F-ara-A), dose modification is necessary for all patients with impaired renal function including elderly patients. In this study, 22 patients with varying levels of renal function received a single intravenous dose of fludarabine (25 mg/m3), followed one week later by five (one per day) doses that were adjusted according to three predefined creatinine clearance (CLcr) levels. Relationships between renal function and F-ara-A clearance, F-ara-A exposure and F-ara-A -related toxicities were examined. The results demonstrate that total F-ara-A clearance correlated with CLcr and that F-ara-A exposure levels and patient toxicity profiles were similar across treatment groups. In conclusion, the CLcr-based fludarabine dose adjustments used in this study provided reasonably equivalent F-ara-A exposure with acceptable safety in patients with varying degrees of renal function. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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