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High dose single-agent paclitaxel in a hemodialysis patient with advanced ovarian cancer: a case report with pharmacokinetic analysis and review of the literature
  1. M. BAUR*,,
  2. B. FAZENY-DOERNER,
  3. S. J. OLSEN§ and
  4. C. DITTRICH*,
  1. *Applied Cancer Research—Institution for Translational Research Vienna, (ACR-ITR VIEnna)
  2. 3rd Medical Department—Centre for Oncology and Haematology, Ludwig Boltzmann-Institute for Applied Cancer Research (LBI-ACR VIEnna), Kaiser Franz Josef-Spital
  3. Department of Internal Medicine I, University of Vienna, Vienna, Austria
  4. §Department of Human Pharmacology, Bristol-Myers Squibb—Pharmaceutical Research Institute (BMS-PRI), Princeton, New Jersey
  1. Address correspondence and reprint requests to: Christian Dittrich, MD, Ludwig Boltzmann-Institute for Applied Cancer Research, 3rd Medical Department—Centre for Oncology and Haematology, Kaiser Franz Josef-Spital, Kundratstrasse 3, A-1100 Vienna, Austria. Email: christian.dittrich{at}wienkav.at

Abstract

There exists only scarce data on the pharmacokinetics of paclitaxel in patients with renal insufficiency. A 53-year-old woman on hemodialysis was treated with paclitaxel for relapsed ovarian cancer. Paclitaxel was administered as a 3-h infusion at 175, 225, and 300 mg/m2 on nonhemodialysis days. The pharmacokinetic analysis revealed independence of the pharmacokinetic parameters for paclitaxel from the extent of renal (dys-)function. The peak plasma concentration of the 300 mg/m2 dose level before and after dialysis was 23.05 and 21.01 ng/mL, respectively, proving that paclitaxel was not dialysable. The area under the plasma concentration versus time curve for the standard and highest dose of paclitaxel was 12,200 ng·h/mL in mean and 40,936 ng·h/mL, respectively. The absence of marked side effects at all dose levels was in line with the independence of the pharmacokinetic parameters for paclitaxel from renal function. No objective response was found, but a marked improvement of symptoms from gastrointestinal obstruction as well as a decrease in the serum CA125 level were observed. Patients with terminal renal failure undergoing hemodialysis tolerate conventional and even high doses of paclitaxel without experiencing severe toxicity.

  • hemodialysis
  • paclitaxel
  • pharmacokinetics
  • renal insufficiency
  • ovarian cancer

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Footnotes

  • Paclitaxel was supplied by Bristol-Myers Squibb (Vienna, Austria).

  • The author S.J.O. was an employee of BMS-PRI at the time when the analyses were performed.