A randomized, double-blind comparative trial evaluating the safety of liposomal amphotericin B versus amphotericin B lipid complex in the empirical treatment of febrile neutropenia

In this double-blind study to compare safety of 2 lipid formulations of amphotericin B, neutropenic patients with unresolved fever after 3 days of antibacterial therapy were randomized (1:1:1) to receive amphotericin B lipid complex (ABLC) at a dose of 5 mg/kg/d (n = 78), liposomal amphotericin B (L Amph) at a dose of 3 mg/kg/d (n = 85), or L Amph at a dose of 5 mg/kg/d (n = 81). L Amph (3 mg/kg/d and 5 mg/kg/d) had lower rates of fever (23.5% and 19.8% vs. 57.7% on day 1; P < .001), chills/rigors (18.8% and 23.5% vs. 79.5% on day 1; P <.001), nephrotoxicity (14.1% and 14.8% vs. 42.3%; P<.01), and toxicity-related discontinuations of therapy (12.9% and 12.3% vs. 32.1%; P = .004). After day 1, infusional reactions were less frequent with ABLC, but chills/rigors were still higher (21.0% and 24.3% vs. 50,7%; P < .001). Therapeutic success was similar in all 3 groups.

Duke Scholars

Author Susan Gail Kreissman Pediatrics, Hematology-Oncology