Fluconazole coadministration concurrent with cyclophosphamide conditioning may reduce regimen-related toxicity postmyeloablative hematopoietic cell transplantation

Biol Blood Marrow Transplant. 2007 Jul;13(7):760-4. doi: 10.1016/j.bbmt.2007.03.005. Epub 2007 Apr 30.

Abstract

In a previous study comparing fluconazole and itraconazole administered as antifungal prophylaxis in hematopoietic cell transplant (HCT) recipients, we found that fluconazole administration concurrent with cyclophosphamide (CY)-based conditioning was associated with fewer early toxicities compared to itraconazole. Fluconazole inhibits cytochrome P450 2C9, which is involved with the activation of CY, and so might provide protection from CY-related toxicities. To investigate this further, we compared CY and CY-metabolite data from patients who received fluconazole (n = 56) concurrent with CY-containing conditioning and in patients who did not (n = 17). The fluconazole group had greater exposure to CY, and lower peak serum concentration of CY-metabolite 4-hydroxycyclophosphamide. In a separate cohort, we examined outcomes in patients randomized to receive either fluconazole (n = 152) or placebo (n = 147) concurrent with CY-containing conditioning in a prior randomized trial. Patients who received fluconazole experienced less hepatic and renal toxicity, and had lower mortality. No difference in relapsed malignancy was apparent. These data support the hypothesis that fluconazole, when coadministered with CY, decreases CY-related toxicities by inhibiting cytochrome P450 2C9 metabolism.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Antifungal Agents / adverse effects
  • Antifungal Agents / pharmacokinetics*
  • Aryl Hydrocarbon Hydroxylases / antagonists & inhibitors*
  • Aryl Hydrocarbon Hydroxylases / metabolism
  • Chemical and Drug Induced Liver Injury
  • Cohort Studies
  • Cyclophosphamide / adverse effects
  • Cyclophosphamide / pharmacokinetics*
  • Cytochrome P-450 CYP2C9
  • Female
  • Fluconazole / adverse effects
  • Fluconazole / pharmacokinetics*
  • Hematopoietic Stem Cell Transplantation* / mortality
  • Humans
  • Kidney Diseases / chemically induced
  • Kidney Diseases / mortality
  • Kidney Diseases / prevention & control
  • Liver Diseases / mortality
  • Liver Diseases / prevention & control
  • Male
  • Mycoses / prevention & control*
  • Myeloablative Agonists / adverse effects
  • Myeloablative Agonists / pharmacokinetics*
  • Transplantation Conditioning* / mortality
  • Transplantation, Homologous

Substances

  • Antifungal Agents
  • Myeloablative Agonists
  • Cyclophosphamide
  • Fluconazole
  • CYP2C9 protein, human
  • Cytochrome P-450 CYP2C9
  • Aryl Hydrocarbon Hydroxylases