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Prospective Evaluation of the Pharmacokinetics and Toxicity Profile of Docetaxel in the Elderly

From the Erasmus University Medical Center, Rotterdam, the Netherlands; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; and Howard University Cancer Center, Washington, DC

Address reprint requests to Sharyn D. Baker, PharmD, PhD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Bunting-Blaustein Cancer Research Building, 1650 Orleans St, Room 1M87, Baltimore, MD 21231-1000; e-mail: sdbaker{at}jhmi.edu

PURPOSE: To prospectively study the pharmacokinetics and toxicity profile of docetaxel in elderly patients with cancer.

PATIENTS AND METHODS: Docetaxel was administered at a dose 75 mg/m² once every 3 weeks to 25 elderly cancer patients aged 65 years and 26 cancer patients aged younger than 65 years. Pharmacokinetic studies and toxicity assessments were performed during the first cycle of therapy.

RESULTS: Of 51 patients treated, 20 aged 65 years (median, 71 years; range, 65 to 80 years) and 20 aged younger than 65 years (median, 53 years; range, 26 to 64 years) were assessable for pharmacokinetic studies, and 39 were assessable for toxicity. Patient characteristics were similar (P .15) between the two cohorts. Mean docetaxel clearance was not altered in the elderly versus younger patients: 30.1 L/h (standard deviation [SD] 18.3 L/h) v 30.0 L/h (SD, 14.8 L/h; P = .98). The percentage of patients with grade 4 and febrile neutropenia was higher in the elderly (63% and 16%, respectively) versus younger (30% and 0%, respectively) cohort, although this observation did not reach a level of statistical significance (P = .056). From logistic regression analysis, the odds ratio for a patient aged 65 years was 1.98 for developing grade 4 neutropenia compared with a patient aged 50 years (P = .091).

CONCLUSION: Docetaxel plasma pharmacokinetics are unaltered in elderly patients. Patients aged 65 years appear to be more sensitive to docetaxel-induced neutropenia.

Supported by Aventis Pharmaceuticals (Bridgewater, NJ) GIA 19075.

Presented at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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