TY - JOUR
T1 - Amphotericin B Lipid Complex as Prophylaxis of Invasive Fungal Infections in Patients with Acute Myelogenous Leukemia and Myelodysplastic Syndrome Undergoing Induction Chemotherapy
AU - Mattiuzzi, Gloria N.
AU - Kantarjian, Hagop
AU - Faderl, Stefan
AU - Lim, Jo Ann
AU - Kontoyiannis, Dimitrios
AU - Thomas, Deborah
AU - Wierda, William
AU - Raad, Isaam
AU - Garcia-Manero, Guillermo
AU - Zhou, Xian
AU - Ferrajoli, Alexandra
AU - Bekele, Nebiyou
AU - Estey, Elihu
PY - 2004/2/1
Y1 - 2004/2/1
N2 - 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.
AB - 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.
KW - Acute leukemia
KW - Amphotericin B
KW - Amphotericin B lipid complex
KW - Antifungal prophylaxis
KW - Fungal infection
KW - Liposomal amphotericin B
KW - Myelodysplastic syndrome
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U2 - 10.1002/cncr.11936
DO - 10.1002/cncr.11936
M3 - Article
C2 - 14745876
AN - SCOPUS:9144238092
SN - 0008-543X
VL - 100
SP - 581
EP - 589
JO - Cancer
JF - Cancer
IS - 3
ER -