Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation
Top Cited Papers
Open Access
- 9 December 2010
- journal article
- research article
- Published by American Society of Hematology in Blood
- Vol. 116 (24), 5111-5118
- https://doi.org/10.1182/blood-2010-02-268151
Abstract
Invasive fungal infection (IFI) is a serious threat after allogeneic hematopoietic cell transplant (HCT). This multicenter, randomized, double-blind trial compared fluconazole (N = 295) versus voriconazole (N = 305) for the prevention of IFI in the context of a structured fungal screening program. Patients undergoing myeloablative allogeneic HCT were randomized before HCT to receive study drugs for 100 days, or for 180 days in higher-risk patients. Serum galactomannan was assayed twice weekly for 60 days, then at least weekly until day 100. Positive galactomannan or suggestive signs triggered mandatory evaluation for IFI. The primary endpoint was freedom from IFI or death (fungal-free survival; FFS) at 180 days. Despite trends to fewer IFIs (7.3% vs 11.2%; P = .12), Aspergillus infections (9 vs 17; P = .09), and less frequent empiric antifungal therapy (24.1% vs 30.2%, P = .11) with voriconazole, FFS rates (75% vs 78%; P = .49) at 180 days were similar with fluconazole and voriconazole, respectively. Relapse-free and overall survival and the incidence of severe adverse events were also similar. This study demonstrates that in the context of intensive monitoring and structured empiric antifungal therapy, 6-month FFS and overall survival did not differ in allogeneic HCT recipients given prophylactic fluconazole or voriconazole. This trial was registered at www.clinicaltrials.gov as NCT00075803.Keywords
This publication has 32 references indexed in Scilit:
- Hallucinations during Voriconazole TherapyClinical Infectious Diseases, 2008
- Treatment of Aspergillosis: Clinical Practice Guidelines of the Infectious Diseases Society of AmericaClinical Infectious Diseases, 2008
- Posaconazole or Fluconazole for Prophylaxis in Severe Graft-versus-Host DiseaseThe New England Journal of Medicine, 2007
- Incidence of voriconazole hepatotoxicity during intravenous and oral treatment for invasive fungal infectionsJournal of Antimicrobial Chemotherapy, 2006
- Adverse Reactions to VoriconazoleClinical Infectious Diseases, 2004
- Itraconazole versus fluconazole for prevention of fungal infections in patients receiving allogeneic stem cell transplantsBlood, 2004
- Cyclophosphamide metabolism is affected by azole antifungalsBlood, 2004
- Intravenous and Oral Itraconazole versus Intravenous and Oral Fluconazole for Long-Term Antifungal Prophylaxis in Allogeneic Hematopoietic Stem-Cell Transplant Recipients: A Multicenter, Randomized TrialAnnals of Internal Medicine, 2003
- Efficacy and Safety of Fluconazole Prophylaxis for Fungal Infections after Marrow Transplantation--A Prospective, Randomized, Double-Blind StudyThe Journal of Infectious Diseases, 1995
- A Controlled Trial of Fluconazole to Prevent Fungal Infections in Patients Undergoing Bone Marrow TransplantationThe New England Journal of Medicine, 1992