Comparison of amphotericin B lipid complex (ABLC) vs. AmBisome in the treatment of suspected or documented fungal infections in patients with leukemia

Fungal infections remain a major cause of treatment failure and death in ac ute leukemia. New liposomal preparations of amphotericin B are now availabl e. While less tonic, their comparative efficacy and toxicity profiles are u nknown. In this study the comparative efficacy and safety of ABLC vs. AmBis ome was evaluated in seventy-five patients with leukemia who developed 82 e pisodes of suspected or documented mycosis, and were treated (1:1) with eit her ABLC (n=43) or AmBisome (n=39). Both drugs were dosed accordingly from 3 to 5mg/kg/day. Using an intent-to-treat analysis, the overall response to therapy was 27/43 (63%) for ABLC and 15/39 (39%) for AmBisome (p=0.03). Me dian doss and duration of treatment was 10 days at 3mg/kg for ABLC and 15 d ays at 4 mg/kg for AmBisome. Acute, not dose-limiting infusion side effects were seen in 70% vs. 36% (p=0.002). ABLC vs. AmBisome. Increase of bilirub in > 1.5 times from baseline was 38% vs. 59%. ABLC vs. AmBisome (p=0.05). A BLC and AmBisome were squally effective for the treatment of suspected or d ocumented fungal infections. While, acute infusion-toxicity was greater wit h ABLC, infusion tonicity requiring discontinuation was similar for both dr ugs. AmBisome was better tolerated than ABLC but was associated with mild a bnormalities in liver function tests at the end of therapy.