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

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 were 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.

• Authors: Gloria N Mattiuzzi, Hagop Kantarjian, Stefan Faderl, JoAnn Lim, Dimitrios Kontoyiannis, Deborah Thomas, William Wierda, Isaam Raad, Guillermo Garcia-Manero, Xian Zhou, Alexandra Ferrajoli, Nebiyou Bekele, Elihu Estey
• Journal: Cancer (Cancer) Vol. 100 Issue 3 Pg. 581-9 (Feb 01 2004) ISSN: 0008-543X [Print] United States
• PMID: 14745876 (Publication Type: Clinical Trial, Comparative Study, Controlled Clinical Trial, Journal Article)
• Copyright: Copyright 2003 American Cancer Society.

Chemical References

• Liposomes
• Amphotericin B

Topics

• Adult
• Aged
• Aged, 80 and over
• Amphotericin B (administration & dosage)
• Analysis of Variance
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Fungemia (etiology, prevention & control)
• Humans
• Infusions, Intravenous
• Leukemia, Myeloid, Acute (drug therapy, mortality, pathology)
• Liposomes
• Male
• Middle Aged
• Myelodysplastic Syndromes (drug therapy, mortality, pathology)
• Primary Prevention (methods)
• Probability
• Prognosis
• Remission Induction
• Risk Assessment
• Single-Blind Method
• Survival Analysis
• Treatment Outcome