Pre-emptive versus empirical antifungal therapy in patients with febrile neutropenia with acute leukaemia: a GIMEMA study

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Abstract Objectives To compare the efficacy of pre-emptive antifungal therapy (PAT) and empirical antifungal therapy (EAT) in patients with febrile neutropenic acute leukaemia (AL) with/without anti-mold prophylaxis. Methods We included 92 patients with AL and neutropenia with fever unresponsive to empiric antibiotics, stratified by posaconazole prophylaxis to receive EAT (n = 40) or PAT (n = 52). In the PAT group, a standardized diagnostic workup for the detection of invasive fungal infection (IFI) was performed. The study endpoints were antifungal therapy initiation, IFI documentation, safety, and cost. Results Posaconazole prophylaxis was equally distributed among the patients (overall 55.4%). Antifungal therapy was started in 58% of the patients in the PAT group versus 100% in the EAT group (P < 0.01; 95% CI: 0.42 [0.28–0.55]). In the EAT and PAT groups, overall proven/probable IFI rates were 2% and 17%, respectively (P = 0.02; 95%CI: −0.14 [−0.26 to −0.03]) and 4% and 10% in patients with posaconazole prophylaxis, respectively (P = 0.3; 95% CI: −0.06 [−0.20–0.07]). At hospital discharge, mortality was 19% in the EAT and 5% in the PAT groups (P = 0.02; 95% CI: −0.14 [−0.26 to −0.03]), unrelated to the use of posaconazole prophylaxis, and no IFI-related death was observed. The mean costs per patient were €7681 and €3344 in the EAT and PAT groups, respectively (P = 0.003; 95% CI: €4337 [€1814–6860]). Adverse reactions to antifungals were similar between the groups. Conclusions In patients with persistently febrile neutropenic AL, PAT was safe and effective and reduced the use and costs of antifungals, irrespective of anti-mold prophylaxis, compared with empirical treatment.

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