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.
RCT Entities:
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.
Authors: Oliver A Cornely; Angelika Böhme; Dieter Buchheidt; Hermann Einsele; Werner J Heinz; Meinolf Karthaus; Stefan W Krause; William Krüger; Georg Maschmeyer; Olaf Penack; Jörg Ritter; Markus Ruhnke; Michael Sandherr; Michal Sieniawski; Jörg-Janne Vehreschild; Hans-Heinrich Wolf; Andrew J Ullmann Journal: Haematologica Date: 2008-12-09 Impact factor: 9.941
Authors: Christopher C Dvorak; Brian T Fisher; Lillian Sung; William J Steinbach; Michael Nieder; Sarah Alexander; Theoklis E Zaoutis Journal: Pediatr Blood Cancer Date: 2011-11-18 Impact factor: 3.167
Authors: Thomas Lehrnbecher; Konrad Bochennek; Thomas Klingebiel; Silke Gastine; Georg Hempel; Andreas H Groll Journal: Clin Microbiol Rev Date: 2019-05-15 Impact factor: 26.132