Impact of age and gender on the pharmacokinetics of gemtuzumab ozogamicin

Study Objective. To determine the pharmacokinetic parameters of the compone nts of gemtuzumab ozogamicin and to assess the possible influence of age an d gender on the values. Design. Phase II, multicenter, open-label, nonrandomized, parallel study Setting. Hospitals and outpatient oncology clinics. Patients. Fifty-eight patients with acute myeloid leukemia in first relapse participated. Demographic data included 29 men and 29 women; 34 were young er than 60 years of age (mean age 53 +/- 16 yrs). Intervention. Patients received gemtuzumab ozogamicin as a single 2-hour in fusion of 9 mg/m(2). Serial plasma samples were collected over 10 days afte r the beginning of the infusion. Measurements and Main Results. Plasma concentrations of components of gemtu zumab ozogamicin (hP67.6 antibody, total and unconjugated calicheamicin der ivatives) were measured by validated enzyme-linked immunosorbent assays. Ph armacokinetic parameters were determined by noncompartmental methods and co mparisons between groups were made by analysis of variance. No significant differences were seen between men and women or between those over 60 and th ose less than 60 years of age in maximum concentration, time to maximum con centration, area under the curve, clearance, or volume of distribution for components of gemtuzumab ozogamicin. Conclusion. No differences occur in the pharmacokinetics of the components of gemtuzumab ozogamicin (hP67.6 or calicheamicin) based on gender or age.