title: Impact of age and gender on the pharmacokinetics of gemtuzumab ozogamicin.
abstract: OBJECTIVE
  To determine the pharmacokinetic parameters of the components of gemtuzumab ozogamicin and to assess the possible influence of age and gender on the values.
  
  
  METHODS
  Phase II, multicenter, open-label, nonrandomized, parallel study
  
  
  METHODS
  Hospitals and outpatient oncology clinics.
  
  
  METHODS
  Fifty-eight patients with acute myeloid leukemia in first relapse participated. Demographic data included 29 men and 29 women; 34 were younger than 60 years of age (mean age 53+/-16 yrs).
  
  
  METHODS
  Patients received gemtuzumab ozogamicin as a single 2-hour infusion of 9 mg/m2. Serial plasma samples were collected over 10 days after the beginning of the infusion.
  
  
  RESULTS
  Plasma concentrations of components of gemtuzumab ozogamicin (hP67.6 antibody, total and unconjugated calicheamicin derivatives) were measured by validated enzyme-linked immunosorbent assays. Pharmacokinetic parameters were determined by noncompartmental methods and comparisons between groups were made by analysis of variance. No significant differences were seen between men and women or between those over 60 and those less than 60 years of age in maximum concentration, time to maximum concentration, area under the curve, clearance, or volume of distribution for components of gemtuzumab ozogamicin.
  
  
  CONCLUSIONS
  No differences occur in the pharmacokinetics of the components of gemtuzumab ozogamicin (hP67.6 or calicheamicin) based on gender or age.
authors.affiliation: Department of Clinical Pharmacokinetics, Wyeth-Ayerst Research, Philadelphia, Pennsylvania 19101, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Korth-Bradley
authors.forename: J A
authors.initials: JA
authors.lastname: Dowell
authors.forename: S P
authors.initials: SP
authors.lastname: King
authors.forename: H
authors.initials: H
authors.lastname: Liu
authors.forename: M S
authors.initials: MS
authors.lastname: Berger
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging / Q000502:physiology; D000617:Aminoglycosides; D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics*; D000911:Antibodies, Monoclonal / Q000493:pharmacokinetics*; D061067:Antibodies, Monoclonal, Humanized; D019540:Area Under Curve; D005260:Female; D000079982:Gemtuzumab; D006207:Half-Life; D006801:Humans; D008297:Male; D008875:Middle Aged; D012727:Sex Characteristics
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000079982:Gemtuzumab