Metabolism-based cyclophosphamide dosing for hematopoietic cell transplant

Clin Pharmacol Ther. 2005 Sep;78(3):298-308. doi: 10.1016/j.clpt.2005.05.005.

Abstract

When cyclophosphamide (120 mg/kg) is used for hematopoietic cell transplant, the increased area under the curve of carboxyethylphosphoramide mustard (AUC(CEPM)) is related to liver toxicity and death. We determined the feasibility of dose-adjusting cyclophosphamide to a preset metabolic endpoint (AUC(CEPM), 325 +/- 25 micromol/L.h). In 20 patients blood sampling was done over a 16-hour period after administration of 45 mg/kg cyclophosphamide; AUC(CEPM) from 0 to 16 hours was calculated by noncompartmental analysis. The expected AUC(CEPM) for 0 to 48 hours was estimated, and the second cyclophosphamide dose was determined. The mean second cyclophosphamide dose was 42 mg/kg, and the mean total cyclophosphamide dose was 86 mg/kg (range, 54-120 mg/kg). The mean AUC(CEPM) for the time from 0 to 48 hours was 296 micromol/L.h (95% confidence interval, 275-317 micromol/L.h). A retrospective analysis indicated that AUC(CEPM) could be more accurately predicted by use of a population pharmacokinetic model. We conclude that metabolism-based dosing of cyclophosphamide is feasible and that a lower cyclophosphamide dose does not affect engraftment.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antineoplastic Agents, Alkylating / administration & dosage
  • Antineoplastic Agents, Alkylating / pharmacokinetics*
  • Antineoplastic Agents, Alkylating / therapeutic use*
  • Area Under Curve
  • Bayes Theorem
  • Blood Platelets / drug effects
  • Chemical and Drug Induced Liver Injury / pathology
  • Cohort Studies
  • Cyclophosphamide / administration & dosage
  • Cyclophosphamide / pharmacokinetics*
  • Cyclophosphamide / therapeutic use*
  • Drug Delivery Systems
  • Female
  • Hematopoietic Stem Cell Transplantation*
  • Humans
  • Male
  • Middle Aged
  • Models, Biological
  • Neutrophils / drug effects
  • Phosphoramide Mustards / administration & dosage
  • Phosphoramide Mustards / pharmacokinetics

Substances

  • Antineoplastic Agents, Alkylating
  • Phosphoramide Mustards
  • carboxyethylphosphoramide mustard
  • Cyclophosphamide