Real-life analysis of the role of antifungal prophylaxis in preventing invasive aspergillosis in AML patients undergoing consolidation therapy: Sorveglianza Epidemiologica Infezioni nelle Emopatie (SEIFEM) 2016 study

Background: We evaluated the incidence of proven/probable invasive aspergillosis (IA) and the role of antifun- gal prophylaxis (AP) in a ‘real-life’ setting of patients with AML receiving intensive consolidation therapy. Methods: Cases of IA, observed during consolidation in adult/paediatric patients with AML between 2011 and 2015, were retrospectively collected in a multicentre Italian study. Results: Of 2588 patients, 56 (2.2%) developed IA [43 probable (1.7%) and 13 proven (0.5%)]. IA was diagnosed in 34 of 1137 (2.9%) patients receiving no AP and in 22 of 1451 (1.5%) who were given AP (P"0.01). Number- needed-to-treat calculation indicates that, on average, 71 patients should have received AP (instead of no AP) for one additional patient to not have IA. Initial antifungal therapy was ‘pre-emptive’ in 36 (64%) patients and ‘targeted’ in 20 (36%) patients. A good response to first-line therapy was observed in 26 (46%) patients, mainly those who received AP [16 of 22 (73%) versus 10 of 34 (29%); P"0.001]. The overall mortality rate and the mor- tality rate attributable to IA by day 120 were 16% and 9%, respectively. In multivariate analysis, age 60 years (OR"12.46, 95% CI"1.13–136.73; P"0.03) and high-dose cytarabine treatment (OR"10.56, 95% CI"1.95– 116.74; P"0.04) independently affected outcome.