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Článek

Empiric vs Preemptive Antifungal Strategy in High-Risk Neutropenic Patients on Fluconazole Prophylaxis: A Randomized Trial of the European Organization for Research and Treatment of Cancer

Maertens, Johan
Autor Maertens, Johan Department of Hematology, University Hospitals Leuven, Leuven, Belgium
Lodewyck, Tom
Autor Lodewyck, Tom Department of Hematology, Algemeen Ziekenhuis St Jan, Brugge, Belgium
Donnelly, J Peter
Autor Donnelly, J Peter Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands
Chantepie, Sylvain
Autor Chantepie, Sylvain Department of Hematology, Caen University Hospital, Caen, France
Robin, Christine
Autor Robin, Christine Department of Hematology, Centre Hospitalier Universitaire Henri Mondor, Créteil, France
Blijlevens, Nicole
Autor Blijlevens, Nicole Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands
Turlure, Pascal
Autor Turlure, Pascal Department of Hematology, Centre Hospitalier Universitaire Limoges, Limoges, France
Selleslag, Dominik
Autor Selleslag, Dominik Department of Hematology, Algemeen Ziekenhuis St Jan, Brugge, Belgium
Baron, Frédéric
Autor Baron, Frédéric Department of Hematology, University of Liège and University Hospital of Liège, Liège, Belgium
Aoun, Mickael
Autor Aoun, Mickael Department of Internal Medicine, Institut Jules Bordet, Brussels, Belgium

Clinical infectious diseases. 2023 ; 76 (4) : 674-682. [pub] 2023Feb18

Clin Infect Dis
ISSN 1537-6591
Medvik
Zdroj

BACKGROUND: Empiric antifungal therapy is considered the standard of care for high-risk neutropenic patients with persistent fever. The impact of a preemptive, diagnostic-driven approach based on galactomannan screening and chest computed tomography scan on demand on survival and on the risk of invasive fungal disease (IFD) during the first weeks of high-risk neutropenia is unknown. METHODS: Patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and allogeneic hematopoietic cell transplant recipients were randomly assigned to receive caspofungin empirically (arm A) or preemptively (arm B), while receiving fluconazole 400 mg daily prophylactically. The primary end point of this noninferiority study was overall survival (OS) 42 days after randomization. RESULTS: Of 556 patients recruited, 549 were eligible: 275 in arm A and 274 in arm B. Eighty percent of the patients had AML or MDS requiring high-dose chemotherapy, and 93% of them were in the first induction phase. At day 42, the OS was not inferior in arm B (96.7%; 95% confidence interval [CI], 93.8%-98.3%) when compared with arm A (93.1%; 95% CI, 89.3%-95.5%). The rates of IFDs at day 84 were not significantly different, 7.7% (95% CI, 4.5%-10.8%) in arm B vs 6.6% (95% CI, 3.6%-9.5%) in arm A. The rate of patients who received caspofungin was significantly lower in arm B (27%) than in arm A (63%; P < .001). CONCLUSIONS: The preemptive antifungal strategy was safe for high-risk neutropenic patients given fluconazole as prophylaxis, halving the number of patients receiving antifungals without excess mortality or IFDs. Clinical Trials Registration. NCT01288378; EudraCT 2010-020814-27.