Evaluation of the practice of antifungal prophylaxis use in newly diagnosed Acute Myeloid Leukemia patients: Results from the SEIFEM 2010-B Registry.

Background. To analyze the efficacy of antifungal prophylaxis (AFP) with posaconazole and itraconazole in a "real life" setting of patients with acute myeloid leukemia (AMLs) during the first induction of remission.Methods. From January 2010 to June 2011, all newly diagnosed AML patients were consecutively registered and prospectively monitored at 30 Italian hematological centers. Our analysis focused on adult cases that received intensive chemotherapy and a mold-active AFP for at least 5 days. To determine the efficacy of prophylaxis, invasive fungal disease (IFD) incidence, IFD-attributable mortality and overall survival were evaluated.Results. In total, 515 patients were included in the present analysis. Posaconazole was the most frequently prescribed drug (260/515, 50%) followed by fluconazole (148, 29%) and itraconazole (93, 18%). When comparing the groups taking posaconazole and itraconazole there were no significant differences in the baseline clinical characteristics, while there were significant differences in the percentage of breakthrough IFDs (18.9% with posaconazole and 38.7% with itraconazole, p<0.001). The same trend was observed when only proven/probable mold infections were considered (posaconazole 2.7% vs. itraconazole 10.7%, p=0.02). There were no significant differences in the IFD associated mortality rate, while posaconazole prophylaxis had a significant impact on overall survival at day 90 (p=0.002).Conclusions. During the last years, the use of posaconazole prophylaxis in high-risk pts has significantly increased. Although our study was not randomized, it demonstrates in a "real life" setting that posaconazole prophylaxis confers an advantage in terms of both breakthrough IFDs and overall survival compared to itraconazole prophylaxis.