Abstract | BACKGROUND: 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.
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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)
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Copyright | Copyright 2003 American Cancer Society. |
Chemical References |
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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
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