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Lookup NU author(s): Professor Herbie Newell, Huw ThomasORCiD, Professor Alan Calvert
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The bioequivalence of etoposide phosphate, a prodrug of etoposide, to etoposide was assessed in a randomized crossover study in 29 patients with histologically established solid tumors that had failed conventional treatment. Cohorts of patients received one treatment course each of etoposide and etoposide phosphate which consisted of a 100 mg/m2 per day etoposide equivalent dose infused iv over 1 hr on a Day 1 to 5 schedule of treatment. The second course was administered 21 days later or on recovery of blood cell counts. Plasma and urine samples were collected over 24 hr on Day 1 of each course and assayed for etoposide content by a validated HPLC/UV method. Resulting data were subjected to noncompartmental pharmacokinetic analysis. Hematology profiles were obtained by collecting blood samples prior to the first course and twice a week after each course. The pharmacodynamics and pharmacokinetics of etoposide were virtually identical after the two treatments. The point estimates (90% confidence intervals) for nadir WBC, granulocytes, hemoglobin, and platelets expressed as % decrease from the baseline, and/or pharmacokinetic parameters, C(max) and AUC(0-∞), after intravenous etoposide phosphate relative to etoposide were 100% (96%, 105%) 97% (91%, 103%). 95% (82%, 109%), 95% (84%, 106%) 107% (101% 113%), and 113% (107%, 119%), respectively. Therefore, etoposide phosphate is bioequivalent to etoposide based an pharmacokinetic and pharmacodynamic assessments.
Author(s): Mummaneni V, Kaul S, Igwemezie L, Newell DR, Porter D, Thomas HD, Calvert AH, Winograd B, Barbhaiya R
Publication type: Article
Publication status: Published
Journal: Journal of Pharmacokinetics and Biopharmaceutics
Year: 1996
Volume: 24
Issue: 4
Pages: 313-325
Print publication date: 01/08/1996
ISSN (print): 1567-567X
ISSN (electronic): 1573-8744
URL: http://dx.doi.org/10.1007/BF02353515
DOI: 10.1007/BF02353515
PubMed id: 9044163
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