Titre
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.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Maertens, J.
Auteure/Auteur
Lodewyck, T.
Auteure/Auteur
Donnelly, J.P.
Auteure/Auteur
Chantepie, S.
Auteure/Auteur
Robin, C.
Auteure/Auteur
Blijlevens, N.
Auteure/Auteur
Turlure, P.
Auteure/Auteur
Selleslag, D.
Auteure/Auteur
Baron, F.
Auteure/Auteur
Aoun, M.
Auteure/Auteur
Heinz, W.J.
Auteure/Auteur
Bertz, H.
Auteure/Auteur
Ráčil, Z.
Auteure/Auteur
Vandercam, B.
Auteure/Auteur
Drgona, L.
Auteure/Auteur
Coiteux, V.
Auteure/Auteur
Llorente, C.C.
Auteure/Auteur
Schaefer-Prokop, C.
Auteure/Auteur
Paesmans, M.
Auteure/Auteur
Ameye, L.
Auteure/Auteur
Meert, L.
Auteure/Auteur
Cheung, K.J.
Auteure/Auteur
Hepler, D.A.
Auteure/Auteur
Loeffler, J.
Auteure/Auteur
Barnes, R.
Auteure/Auteur
Marchetti, O.
Auteure/Auteur
Verweij, P.
Auteure/Auteur
Lamoth, F.
Auteure/Auteur
Bochud, P.Y.
Auteure/Auteur
Schwarzinger, M.
Auteure/Auteur
Cordonnier, C.
Auteure/Auteur
Groupes de travail
Infectious Diseases Group and the Acute Leukemia Group of the European Organization for Research and Treatment of Cancer
Liens vers les personnes
Liens vers les unités
ISSN
1537-6591
Statut éditorial
Publié
Date de publication
2023-02-18
Volume
76
Numéro
4
Première page
674
Dernière page/numéro d’article
682
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Randomized Controlled Trial ; Journal Article
Publication Status: ppublish
Publication Status: ppublish
Résumé
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.
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.
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).
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.
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.
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).
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.
PID Serval
serval:BIB_E34CCCFF4BB8
PMID
Open Access
Oui
Date de création
2022-08-25T06:21:00.591Z
Date de création dans IRIS
2025-05-21T05:11:57Z
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35906831_BIB_E34CCCFF4BB8.pdf
Version du manuscrit
published
Licence
https://creativecommons.org/licenses/by/4.0
Taille
566.75 KB
Format
Adobe PDF
PID Serval
serval:BIB_E34CCCFF4BB8.P001
URN
urn:nbn:ch:serval-BIB_E34CCCFF4BB81
Somme de contrôle
(MD5):c959ab06403db4a9e2ae4ba781f7de59