title: An EORTC international multicenter randomized trial (EORTC number 19923) comparing two dosages of liposomal amphotericin B for treatment of invasive aspergillosis.
abstract: This is the first completed prospective randomized clinical efficacy trial of antifungals in the treatment of invasive aspergillosis (IA) and the first to compare the clinical efficacy of two dosages of liposomal amphotericin B (L-AmB) for IA in neutropenic patients with cancer or those undergoing bone marrow transplantation. Eighty-seven of 120 patients were eligible and evaluable. Clinical responses were documented for 26 (64%) of 41 patients receiving 1 mg/(kg.d) (L-AmB-1) and 22 (48%) of 46 receiving 4 mg/(kg.d) (L-AmB-4). Radiologic response rates were similar: 24 (58%) of the L-AmB-1 recipients and 24(52%) of the L-AmB-4 recipients. The six-month survival rates were 43% (L-AmB-1) and 37% (L-AmB-4). These differences were not significant. The numbers of deaths directly due to IA at 6 months were similar: 9 (22%) of 41 L-AmB-1 recipients and 9 (20%) of 46 L-AmB-4 recipients. No other variable independently influenced survival, apart from central nervous system IA. L-AmB is effective in treating approximately 50%-60% of patients who have IA. A 1-mg/(kg.d) dosage is as effective as a 4-mg/(kg.d) dosage, and no advantages to use of the higher, more expensive, dosage has been observed.
authors.affiliation: European Organisation for Research and Treatment of Cancer (EORTC), Invasive Fungal Infections Cooperative Group, Brussels, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Ellis
authors.forename: D
authors.initials: D
authors.lastname: Spence
authors.forename: B
authors.initials: B
authors.lastname: de Pauw
authors.forename: F
authors.initials: F
authors.lastname: Meunier
authors.forename: A
authors.initials: A
authors.lastname: Marinus
authors.forename: L
authors.initials: L
authors.lastname: Collette
authors.forename: R
authors.initials: R
authors.lastname: Sylvester
authors.forename: J
authors.initials: J
authors.lastname: Meis
authors.forename: M
authors.initials: M
authors.lastname: Boogaerts
authors.forename: D
authors.initials: D
authors.lastname: Selleslag
authors.forename: V
authors.initials: V
authors.lastname: Krcmery
authors.forename: W
authors.initials: W
authors.lastname: von Sinner
authors.forename: P
authors.initials: P
authors.lastname: MacDonald
authors.forename: C
authors.initials: C
authors.lastname: Doyen
authors.forename: B
authors.initials: B
authors.lastname: Vandercam
mesh_terms: D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000008:administration & dosage / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001228:Aspergillosis / Q000188:drug therapy*; D004337:Drug Carriers; D005260:Female; D006801:Humans; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D004337:Drug Carriers; D008081:Liposomes; D000666:Amphotericin B