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, Lodewyck, Tom, Donnelly, J Peter, Chantepie, Sylvain, Robin, Christine, Blijlevens, Nicole, Turlure, Pascal, Selleslag, Dominik, Baron, Frédéric, Aoun, Mickael, Heinz, Werner J, Bertz, Hartmut, Ráčil, Zdeněk, Vandercam, Bernard, Drgona, Lubos, Coiteux, Valerie, Llorente, Cristina Castilla, Schaefer-Prokop, Cornelia, Paesmans, Marianne, Ameye, Lieveke, Meert, Liv, Cheung, Kin Jip, Hepler, Deborah A, Loeffler, Jürgen, Barnes, Rosemary, Marchetti, Oscar, Verweij, Paul, Lamoth, Frederic, Bochud, Pierre-Yves, Schwarzinger, Michael and Cordonnier, Catherine 2023. 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 76 (4) , pp. 674-682. 10.1093/cid/ciac623

Preview

PDF - Published Version Available under License Creative Commons Attribution. Download (580kB) | Preview

Abstract

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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	Oxford University Press
ISSN:	1058-4838
Date of First Compliant Deposit:	31 March 2023
Date of Acceptance:	22 July 2022
Last Modified:	23 May 2023 08:00
URI:	https://orca.cardiff.ac.uk/id/eprint/158272

Citation Data

Cited 12 times in Scopus. View in Scopus. Powered By Scopus® Data

Actions (repository staff only)

Edit Item