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Clinical Trial
. 2004 Dec;48(12):4808-12.
doi: 10.1128/AAC.48.12.4808-4812.2004.

Liposomal nystatin in patients with invasive aspergillosis refractory to or intolerant of amphotericin B

Fritz Offner  1 , Vladimir Krcmery, Marc Boogaerts, Chantal Doyen, Dan Engelhard, Patricia Ribaud, Catherine Cordonnier, Ben de Pauw, Simon Durrant, Jean-Pierre Marie, Philippe Moreau, Harry Guiot, George Samonis, Richard Sylvester, Raoul Herbrecht; EORTC Invasive Fungal Infections Group
Affiliations
Clinical Trial

Liposomal nystatin in patients with invasive aspergillosis refractory to or intolerant of amphotericin B

Fritz Offner et al. Antimicrob Agents Chemother. 2004 Dec.

Abstract

We assessed the activity and safety of liposomal nystatin, a broad-spectrum antifungal agent, for invasive aspergillosis in patients refractory to or intolerant of amphotericin B. Thirty-three patients were enrolled, received at least one dose of the study drug, and were evaluable for safety. Twenty-six patients had confirmed probable or definite aspergillosis and were fully eligible. Most patients had a hematological malignancy (53.8%) or hematopoietic stem cell transplantation (23.0%), were neutropenic (61.5%), and were refractory to previous amphotericin B (92.3%). The median duration of previous amphotericin B treatment was 16.5 days (range, 5 to 64 days). Aspergillosis was definite in 3 cases and probable in 23 cases. Liposomal nystatin was initiated at a dose of 4 mg/kg of body weight/day. Twenty-five patients were evaluable for response: a complete response was achieved for one patient, and a partial response was achieved for six. Thus, the overall response rate is 7 of 25 (28%; 95% confidence interval, 12 to 49%). Seventeen (68.0%) of the 25 evaluable patients died during therapy or within 1 month after the end of therapy. The primary cause of death was invasive aspergillosis for nine patients and underlying malignancy for eight patients. The most frequent side effects included chills, shivering, and fever, leading to discontinuation of therapy for two patients. Grade 1 decline in renal function was seen for 10 (30.3%) patients, and hypokalemia was seen for 13 (39.4%). We conclude that liposomal nystatin can be effective for salvage therapy of invasive aspergillosis. Infusion-related adverse events have been observed frequently.

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