title: Safety and efficacy of itraconazole compared to amphotericin B as empirical antifungal therapy for neutropenic fever in patients with haematological malignancy.
abstract: BACKGROUND
  Safety, tolerability and efficacy of itraconazole and amphotericin B (AMB) were compared for empirical antifungal treatment of febrile neutropenic cancer patients.
  
  
  METHODS
  In an open, randomised study, 162 patients with at least 72 h of antimicrobial treatment received either intravenous followed by oral itraconazole suspension or intravenous AMB for a maximum of 28 days. Permanent discontinuation of study medication due to any adverse event was the primary safety parameter. Efficacy parameters included response and success rate for both treatment groups.
  
  
  RESULTS
  Significantly fewer itraconazole patients discontinued treatment due to any adverse event (22.2 vs. 56.8% AMB; p < 0.0001). The main reason for discontinuation was a rise in serum creatinine (1.2% itraconazole vs. 23.5% AMB). Renal toxicity was significantly higher and more drug-related adverse events occurred in the AMB group. Intention-to-treat (ITT) analysis showed favourable efficacy for itraconazole: response and success rate were both significantly higher than for AMB (61.7 vs. 42% and 70.4 vs. 49.3%, both p < 0.0001). Treatment failure was markedly reduced in itraconazole patients (25.9 vs. 43.2%), largely due to the better tolerability.
  
  
  CONCLUSIONS
  Itraconazole was tolerated significantly better than conventional AMB and also showed advantages regarding efficacy. This study confirms the role of itraconazole as a useful and safe agent in empirical antifungal therapy of febrile neutropenic cancer patients.
authors: Medizinische Klinik und Poliklinik I, Universitätsklinikum Dresden, Germany. Ulrich.Schuler@uniklininkum-dresden.de
authors: Ulrich
authors: U
authors: Schuler
authors: Susanne
authors: S
authors: Bammer
authors: Walter E
authors: WE
authors: Aulitzky
authors: Claudia
authors: C
authors: Binder
authors: Angelika
authors: A
authors: Böhme
authors: Gerlinde
authors: G
authors: Egerer
authors: Michael
authors: M
authors: Sandherr
authors: Rainer
authors: R
authors: Schwerdtfeger
authors: Gerda
authors: G
authors: Silling
authors: Hannes
authors: H
authors: Wandt
authors: Axel
authors: A
authors: Glasmacher
authors: Gerhard
authors: G
authors: Ehninger
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000009:adverse effects* / Q000627:therapeutic use; D000935:Antifungal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D018592:Cross-Over Studies; D019348:Empiricism; D005260:Female; D005335:Fever of Unknown Origin / Q000188:drug therapy* / Q000209:etiology; D005858:Germany; D019337:Hematologic Neoplasms / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D017964:Itraconazole / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000188:drug therapy*; D009503:Neutropenia / Q000188:drug therapy*; D009894:Opportunistic Infections / Q000188:drug therapy*; D010352:Patient Dropouts / Q000706:statistics & numerical data; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D017964:Itraconazole; D000666:Amphotericin B