Low dose liposomal amphotericin B (L-AmB) as prophylaxis of invasive fungal infections (IFI) in neutropenic patients (pts): a phase-III trial

O. Penack, M. Reinwald, M. Schmidt-Hieber, P. Martus, S. Schwartz, E. Thiel and I. W. Blau

Author address: 

Charite Campus Benjamin Franklin, Hematology, Oncology and Transfusion Medicine, Berlin, Germany

Abstract: 

Background: This trial was designed to evaluate the efficacy of L-AmB prophylaxis in high-risk neutropenic patients. Methods: 231 pts with hematological malignancies and expected neutropenia (N) of more than 10 days (D) following intensive chemotherapy or autologous stem cell transplantation were enrolled, 219 pts became neutropenic and were randomized to receive either 50 mg L-AmB i.v. every second D (arm A) or no systemic antifungal prophylaxis (arm B). Treatment with L-AmB started 13 D before onset of N and was continued until neutrophil recovery, breakthrough IFI, intolerable toxicity or death. With 82 eligible pts in each arm the study had 0.80 power to detect 50% difference in the incidence of proven or probable IFI (primary endpoint). P-values were twosided. Results: Pt. characteristics: Eligible pts 219; arm A: 110; arm B: 109. Reasons for exclusion were: absence of N (eight), infection prior neutropenia (three) and patient’s decision (one). Baseline characteristics were balanced for age (mean 53.8 years), underlying disease (119 AML, 27 ALL, 64 NHL, nine other), duration of N (mean 14.8 D) and treatment modality (primary 149, secondary 42, transplant 28). Primary endpoint: The incidence of IFI was five of 110 pts (4.6%) in arm A and 22 of 109 pts (20.2%) in arm B (P = 0.001, RR = 2.9, CI 1.36.5). Key secondary endpoints: pneumonia of unknown origin occurred in six pts (5.5%) vs. 28 pts (25.7%) (P
2005

abstract No: 

O1.3

Full conference title: 

2nd Trends in Medical Mycology
    • TIMM 2nd (2010)