Annals of Oncology Advance Access published online on June 9, 2006
Annals of Oncology, doi:10.1093/annonc/mdl128
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1 Department of Hematology, Oncology, and Transfusion Medicine, Charité-Campus Benjamin Franklin, Berlin, Germany
* To whom correspondence should be addressed. Background: We performed a prospective, randomized, open-label trial to evaluate the efficacy of low-dose liposomal amphotericin B (L-AmB) to reduce the incidence of invasive fungal infections (IFI) in patients with hematological malignancies and prolonged neutropenia (>10 days) following intensive chemotherapy. Patients and methods: In 219 neutropenic episodes (NE) of 132 patients randomization was performed. Patients received either 50 mg L-AmB every other day (arm A) or no systemic antifungal prophylaxis (arm B). Results: In the first NE of each patient the incidence of proven or probable IFI (primary end point) was five of 75 patients (6.7%) in arm A and 20 of 57 patients (35%) in arm B (P = 0.001). Invasive aspergillosis occurred less frequently in patients receiving L-AmB-prophylaxis (P = 0.0057), whereas the reduction of invasive candidiasis did not reach statistical significance (P = 0.0655). In all NE the incidence of IFI was five of 110 NE (4.6%) in arm A versus 22 of 109 NE (20.2%) in arm B (P <0.01). Adverse events, possibly related to L-AmB, were observed in five NE (4.6%) and L-AmB was discontinued in three NE (2.8%). No grade 3 or 4 toxicities were observed. Conclusions: Antifungal prophylaxis with low-dose L-AmB proved to be feasible and effective in our trial.
Received January 28, 2006
Revised April 20, 2006
Accepted April 27, 2006
original article
Low-dose liposomal amphotericin B in the prevention of invasive fungal infections in patients with prolonged neutropenia: results from a randomized, single-center trial
O. Penack 1 *,
S. Schwartz 1,
P. Martus 2,
M. Reinwald 1,
M. Schmidt-Hieber 1,
E. Thiel 1,
and
I. W. Blau 1
2 Department of Biostatistics and Clinical Epidemiology, Charité-Campus Benjamin Franklin, Berlin, Germany
O. Penack, E-mail: olaf.penack{at}charite.de
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