Amphotericin B lipid complex as prophylaxis of invasive fungal infections in patients with acute myelogenous leukemia and myelodysplastic syndrome undergoing induction chemotherapy

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Abstract
BACKGROUND: The optimal antifungal prophylactic regimen for patients with acute myelogenous leukemia (AML) or high‐risk myelodysplastic syndrome (MDS) undergoing induction chemotherapy has yet to be identified. A prospective historical control study evaluated the efficacy and safety of amphotericin B lipid complex (ABLC) in this patient population.METHODS: Newly diagnosed patients with AML or high‐risk MDS who were undergoing induction chemotherapy received prophylactic ABLC 2.5 mg/kg intravenously 3 times weekly. This treatment group was compared with a historical control group that had similar baseline characteristics and received prophylactic liposomal amphotericin B (L‐AmB) 3 mg/kg 3 times weekly. The primary endpoint was the incidence of documented or suspected fungal infections during and up to 4 weeks after cessation of prophylaxis. Reported adverse events were used to assess tolerability.RESULTS: The overall efficacy of antifungal prophylaxis was similar in patients who received ABLC and patients who received L‐AmB (P = 0.95). Among 131 ABLC‐treated patients and 70 L‐AmB‐treated patients who ere assessed for efficacy and safety, 49% of patients in each group completed therapy without developing a documented or suspected fungal infection. Documented fungal infections occurred in 5% of ABLC‐treated patients and in 4% of L‐AmB‐treated patients. Alternative antifungal strategies were required because of persistent fever or pneumonia of unknown pathogen in 28% and 32% of ABLC‐treated and L‐AmB‐treated patients, respectively. Grade 3 and 4 adverse events, therapy discontinuations due to adverse events, and survival rates also were similar between treatment groups.CONCLUSIONS: ABLC and L‐AmB appeared to have similar efficacy and were tolerated well as antifungal prophylaxis in patients with AML and high‐risk MDS who were undergoing induction chemotherapy. Cancer 2004. © 2003 American Cancer Society.

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