[PDF][PDF] Population pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer.

R Bruno, D Hille, A Riva, N Vivier… - Journal of clinical …, 1998 - Citeseer
R Bruno, D Hille, A Riva, N Vivier, WW ten Bokkel Huinnink, AT Van Oosterom, SB Kaye…
Journal of clinical oncology, 1998Citeseer
Conclusion: First-course docetaxel PK is a predictor of first-course hematologic toxicity, but
also of fluid retention, which is cumulative in nature. Patients with elevated hepatic enzymes
have a 27% reduction in docetaxel CL and are at a higher risk of toxicity. A starting dose of
75 mg/m 2 is currently being evaluated in this population. Prospective implementation of
largescale population PK/PD evaluation is feasible in early drug development and this
approach generates clinically relevant findings.
Conclusion: First-course docetaxel PK is a predictor of first-course hematologic toxicity, but also of fluid retention, which is cumulative in nature. Patients with elevated hepatic enzymes have a 27% reduction in docetaxel CL and are at a higher risk of toxicity. A starting dose of 75 mg/m 2 is currently being evaluated in this population. Prospective implementation of largescale population PK/PD evaluation is feasible in early drug development and this approach generates clinically relevant findings.
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