Liposomal amphotericin B versus the combination of fluconazole and itraconazole as prophylaxis for invasive fungal infections during induction

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Abstract
BACKGROUND Fungal infections are a major cause of morbidity and mortality in patients undergoing induction chemotherapy for acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). The authors evaluated the efficacy and toxicity of liposomal amphotericin B (L‐AmB) compared with a combination of fluconazole plus itraconazole (F+I) as prophylaxis in this setting. METHODS Patients with newly diagnosed AML or high‐risk MDS who were undergoing initial induction chemotherapy were randomized to receive either F+I (fluconazole 200 mg orally every 12 hours plus itraconazole tablets 200 mg orally every 12 hours) or L‐AmB (3 mg/kg intravenously 3 times per week) in this prospective, open‐label study. RESULTS Seventy‐two L‐AmB‐treated patients and 67 F+I‐treated patients were enrolled in the study. Of these, 47% of patients completed antifungal prophylaxis without a change in therapy for proven or suspected fungal infection. Three patients in each arm developed a proven fungal infection. Twenty‐three percent of the L‐AmB‐treated patients and 24% of the F+I‐treated patients were changed to alternative antifungal therapy because of persistent fever (P value not significant). Nine percent of the L‐AmB‐treated patients developed pneumonia of unknown etiology compared with 16% of the F+I‐treated patients (P value not significant). Increases in serum creatinine levels to > 2 mg/dL (20% for the L‐AmB arm vs. 6% for the F+I arm; P = 0.012) and increases in serum bilirubin levels to > 2 mg/dL (43% vs. 22%, respectively; P = 0.021) were more common with L‐AmB. Infusion‐related reactions were noted in five L‐AmB‐treated patients. Responses to chemotherapy and induction mortality rates were similar for the two arms. CONCLUSIONS L‐AmB and F+I appear similar in their efficacy as antifungal prophylaxis during induction chemotherapy for patients with AML and MDS. L‐AmB was associated with higher rates of increased serum bilirubin and creatinine levels. Cancer 2003;97:450–6. © 2003 American Cancer Society. DOI 10.1002/cncr.11094

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