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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
J. Maertens, T. Lodewyck, JP. Donnelly, S. Chantepie, C. Robin, N. Blijlevens, P. Turlure, D. Selleslag, F. Baron, M. Aoun, WJ. Heinz, H. Bertz, Z. Ráčil, B. Vandercam, L. Drgona, V. Coiteux, CC. Llorente, C. Schaefer-Prokop, M. Paesmans, L....
Language English Country United States
Document type Randomized Controlled Trial, Journal Article, Research Support, Non-U.S. Gov't
PubMed
35906831
DOI
10.1093/cid/ciac623
Knihovny.cz E-resources
- MeSH
- Leukemia, Myeloid, Acute * drug therapy MeSH
- Antifungal Agents therapeutic use MeSH
- Fluconazole therapeutic use MeSH
- Caspofungin therapeutic use MeSH
- Humans MeSH
- Myelodysplastic Syndromes * MeSH
- Mycoses * drug therapy MeSH
- Hematopoietic Stem Cell Transplantation * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
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.
Department of Hematology Algemeen Ziekenhuis St Jan Brugge Belgium
Department of Hematology Caen University Hospital Caen France
Department of Hematology Centre Hospitalier Universitaire Henri Mondor Créteil France
Department of Hematology Centre Hospitalier Universitaire Limoges Limoges France
Department of Hematology Gustave Roussy Cancer Campus Villejuif France
Department of Hematology Oncology Caritas Hospital Bad Mergentheim Germany
Department of Hematology Radboud University Medical Center Nijmegen The Netherlands
Department of Hematology University Hospitals Leuven Leuven Belgium
Department of Hematology University of Liège and University Hospital of Liège Liège Belgium
Department of Infection Immunity and Biochemistry Cardiff University Cardiff United Kingdom
Department of Infectious Diseases Ensemble Hospitalier de la Côte Morges Switzerland
Department of Internal Medicine 2 Universitaetsklinikum Würzburg Germany
Department of Internal Medicine Infectious Diseases Cliniques Universitaires St Luc Brussels Belgium
Department of Internal Medicine Institut Jules Bordet Brussels Belgium
Department of Medicine Lausanne University Hospital Lausanne Switzerland
Department of Oncohematology Comenius University and National Cancer Institute Bratislava Slovakia
European Organisation for Research and Treatment of Cancer Headquarters Brussels Belgium
Merck and Co Inc Kenilworth New Jersey USA
Service des maladies du sang Centre Hospitalier Régional Universitaire Lille Lille France
Translational Health Economics Network Bordeaux University Hospital Bordeaux France
References provided by Crossref.org
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- $a 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.
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