MAERTENS, Johan, Tom LODEWYCK, J Peter DONNELLY, Sylvain CHANTEPIE, Christine ROBIN, Nicole BLIJLEVENS, Pascal TURLURE, Dominik SELLESLAG, Frederic BARON, Mickael AOUN, Werner J HEINZ, Hartmut BERTZ, Zdeněk RÁČIL, Bernard VANDERCAM, Lubos DRGONA, Valerie COITEUX, Cristina Castilla LLORENTE, Cornelia SCHAEFER-PROKOP, Marianne PAESMANS, Lieveke AMEYE, Liv MEERT, Kin Jip CHEUNG, Deborah A HEPLER, Juergen LOEFFLER, Rosemary BARNES, Oscar MARCHETTI, Paul VERWEIJ, Frederic LAMOTH, Pierre-Yves BOCHUD, Michael SCHWARZINGER and Catherine CORDONNIER. 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. Clinical Infectious Diseases. CARY: OXFORD UNIV PRESS INC, 2023, vol. 76, No 4, p. 674-682. ISSN 1058-4838. Available from: https://dx.doi.org/10.1093/cid/ciac623.
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Basic information
Original name 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
Authors MAERTENS, Johan (guarantor), Tom LODEWYCK, J Peter DONNELLY, Sylvain CHANTEPIE, Christine ROBIN, Nicole BLIJLEVENS, Pascal TURLURE, Dominik SELLESLAG, Frederic BARON, Mickael AOUN, Werner J HEINZ, Hartmut BERTZ, Zdeněk RÁČIL (203 Czech Republic, belonging to the institution), Bernard VANDERCAM, Lubos DRGONA, Valerie COITEUX, Cristina Castilla LLORENTE, Cornelia SCHAEFER-PROKOP, Marianne PAESMANS, Lieveke AMEYE, Liv MEERT, Kin Jip CHEUNG, Deborah A HEPLER, Juergen LOEFFLER, Rosemary BARNES, Oscar MARCHETTI, Paul VERWEIJ, Frederic LAMOTH, Pierre-Yves BOCHUD, Michael SCHWARZINGER and Catherine CORDONNIER.
Edition Clinical Infectious Diseases, CARY, OXFORD UNIV PRESS INC, 2023, 1058-4838.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30204 Oncology
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 11.800 in 2022
RIV identification code RIV/00216224:14110/23:00130259
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1093/cid/ciac623
UT WoS 000843548400001
Keywords in English neutropenia; empiric; preemptive; antifungal; galactomannan
Tags 14110212, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 26/1/2024 10:56.
Abstract
The initiation of antifungal therapy with caspofungin based on serum galactomannan screening and computed tomography scan when required in profound and prolonged neutropenic patients given fluconazole prophylaxis was found to be noninferior to a fever-driven empiric approach. 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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