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Pharmacokinetics and Toxicity of Weekly Docetaxel in Older Patients

Authors' Affiliations: ¹ Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York City, New York and ² Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland

Requests for reprints: Arti Hurria, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021. Phone: 212-639-3263; Fax: 212-717-3821; E-mail: hurriaa{at}mskcc.org.

Purpose: To evaluate the pharmacokinetics of weekly docetaxel in a cohort of older patients with metastatic cancer and to explore the relationship of pharmacokinetic variables, Erythromycin Breath Test results, age, geriatric assessment variables, and toxicity to therapy.

Experimental Design: Twenty patients ages 65 years with metastatic breast, prostate, or lung cancer entered an Institutional Review Board–approved protocol to evaluate the pharmacokinetics of weekly docetaxel administered at 35 mg/m² i.v. for 3 weeks followed by a 1-week break. The Erythromycin Breath Test and geriatric assessment were done before the first dose. Blood samples were collected for pharmacokinetic analysis with the first dose of docetaxel.

Results: Of the 20 patients who entered the study, 19 were evaluable. There were no age-related differences in the pharmacokinetics of weekly docetaxel. Fifty-eight percent (11 of 19) experienced grade 3 toxicity: 16% (3 of 19) grade 3 hematologic toxicity, and 53% (10 of 19) grade 3 nonhematologic toxicity. There was an association between the Erythromycin Breath Test results and docetaxel pharmacokinetic variables; however, there was no association between Erythromycin Breath Test results or docetaxel pharmacokinetics with frequency of grade 3 toxicity.

Conclusions: Despite no statistically significant age-related differences in weekly docetaxel pharmacokinetics, over half of these older patients experienced a grade 3 toxicity at the 35 mg/m² starting dose. We advocate a starting dose of 26 mg/m² on this weekly schedule and dose escalating if no toxicity.

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