An EORTC international multicenter randomized trial (EORTC number 19923) comparing two dosages of liposomal amphotericin B for treatment of invasive aspergillosis

This is the first completed prospective randomized clinical efficacy trial of antifungals in the treatment of invasive aspergillosis (IA) and the firs t to compare the clinical efficacy of two dosages of liposomal amphotericin B (L-AmB) for IA in neutropenic patients with cancer or those undergoing b one marrow transplantation. Eighty-seven of 120 patients were eligible and evaluable. Clinical responses were documented for 26 (64%) of 41 patients r eceiving 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 rec ipients and 24 (52%) of the L-AmB-4 recipients. The six-month survival rate s were 43% (L-AmB-1) and 37% (L-AmB-4). These differences were not signific ant. 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 othe r variable independently influenced survival, apart from central nervous sy stem IA. L-AmB is effective in treating similar to 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 observe d.