Objectives: To investigate the incidence, treatment and outcome of breakthrough invasive fungal infections (IFIs) in adult acute myeloid leukaemia (AML) patients after posaconazole prophylaxis. Methods: From January 2010 to April 2012, all consecutive patients with newly diagnosed AML were prospect- ively registered at 33 participating Italian centres. All cases of IFIs occurring within 30 days after the end of the ﬁrst induction chemotherapy were recorded. The strategy of antifungal treatment (empirical, pre-emptive or tar- geted) and the drugs used were analysed. ClinicalTrials.gov code: NCT01315925. Results: In total, 1192 patients with newly diagnosed AML were enrolled in the study, of whom 510 received posaconazole prophylaxis and were included in the present analysis. Of these patients, 140 (27%) needed sys- temic antifungal treatment. Among the 127 evaluable cases, an empirical approach was utilized in 102 patients (80%), a pre-emptive approach in 19 patients (15%) and targeted therapy in 6 patients (5%). Only ﬁve patients died of IFIs (three in the empirical group and two in the targeted group; 4%). A critical review of IFI diagnoses at 30 days demonstrated that among the patients treated empirically, 30% were not affected by IFIs but rather only by fever of unidentiﬁed origin. A comparison between the empirical and the pre-emptive groups showed no signiﬁcant differences regarding the attributable and overall mortalities. Conclusions: This study conﬁrms that posaconazole prophylaxis reduces the incidence of breakthrough IFIs and does not modify the efﬁcacy of subsequent systemic antifungal treatment, regardless of the approach (empirical or pre-emptive) or the antifungal drug used.
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