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.