title: Amphotericin B lipid complex in pediatric patients with invasive fungal infections.
abstract: BACKGROUND
  Lipid formulations of amphotericin B have been recently introduced for treatment of invasive fungal infections. However, little is known about their role in pediatric populations.
  
  
  METHODS
  We studied the safety and antifungal efficacy of amphotericin B lipid complex (ABLC, Abelcet) in 111 treatment episodes in pediatric patients through an open label, emergency use multicenter study. Patients with invasive fungal infections were enrolled if they had mycoses refractory to conventional antifungal therapy, if they were intolerant of previous systemic antifungal agents or concomitant nephrotoxic drugs or if they had preexisting renal disease.
  
  
  RESULTS
  All 111 treatment episodes were evaluable for safety and 54 were evaluable for efficacy. The mean serum creatinine for the study population did not significantly change between baseline (1.23 +/- 0.11 mg/dl) and cessation of ABLC therapy (1.32 +/- 0.12 mg/dl) during 6 weeks. There were no significant differences observed between initial and end-of-therapy levels of serum potassium, magnesium, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and hemoglobin. However, there was an increase in mean total bilirubin (3.66 +/- 0.73 to 5.31 +/- 1.09 mg/dl) at the end of therapy (P = 0.054). Among 54 cases fulfilling criteria for evaluation of antifungal efficacy, a complete or partial therapeutic response was obtained in 38 patients (70%) after ABLC therapy. Complete or partial therapeutic response was documented in 56% of cases with aspergillosis (n = 25) and in 81% (n = 27) with candidiasis. Among premature infants (n = 8) and allogeneic marrow recipients (n = 14), response rates were 88 and 57%, respectively. Response was similar in those patients enrolled because of intolerance to previous antifungal therapy or because of progressive infection.
  
  
  CONCLUSIONS
  These data support the use of ABLC for treatment of invasive fungal infections in pediatric patients who are intolerant of or refractory to conventional antifungal therapy.
authors.affiliation: Pediatric Oncology Branch, National Cancer Institute, Bethesda, MD 20892, USA.
authors.forename: T J
authors.initials: TJ
authors.lastname: Walsh
authors.forename: N L
authors.initials: NL
authors.lastname: Seibel
authors.forename: C
authors.initials: C
authors.lastname: Arndt
authors.forename: R E
authors.initials: RE
authors.lastname: Harris
authors.forename: M J
authors.initials: MJ
authors.lastname: Dinubile
authors.forename: A
authors.initials: A
authors.lastname: Reboli
authors.forename: J
authors.initials: J
authors.lastname: Hiemenz
authors.forename: S J
authors.initials: SJ
authors.lastname: Chanock
mesh_terms: D000293:Adolescent; D000666:Amphotericin B / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001228:Aspergillosis / Q000188:drug therapy; D002177:Candidiasis / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D003404:Creatinine / Q000097:blood; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009181:Mycoses / Q000188:drug therapy*; D010713:Phosphatidylcholines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010715:Phosphatidylglycerols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D020096:Zygomycosis / Q000188:drug therapy
chemical_list: D000935:Antifungal Agents; D004338:Drug Combinations; D010713:Phosphatidylcholines; D010715:Phosphatidylglycerols; C068538:liposomal amphotericin B; D000666:Amphotericin B; D003404:Creatinine