Empiric versus pre-emptive antifungal strategy in high-risk neutropenic patients on fluconazole prophylaxis: a randomized trial of the European organization for Research and Treatment of cancer (EORTC 65091)
| dc.rights.license | open | en_US |
| dc.contributor.author | MAERTENS, Johan | |
| dc.contributor.author | LODEWYCK, Tom | |
| dc.contributor.author | PETER DONNELLY, J. | |
| dc.contributor.author | CHANTEPIE, Sylvain | |
| dc.contributor.author | ROBIN, Christine | |
| dc.contributor.author | BLIJLEVENS, Nicole | |
| dc.contributor.author | TURLURE, Pascal | |
| dc.contributor.author | SELLESLAG, Dominik | |
| dc.contributor.author | BARON, Frederic | |
| dc.contributor.author | AOUN, Mickael | |
| dc.contributor.author | HEINZ, Werner J. | |
| dc.contributor.author | BERTZ, Hartmut | |
| dc.contributor.author | RACIL, Zdenek | |
| dc.contributor.author | VANDERCAM, Bernard | |
| dc.contributor.author | DRGONA, Lubos | |
| dc.contributor.author | COITEUX, Valerie | |
| dc.contributor.author | LLORENTE, Cristina Castilla | |
| dc.contributor.author | SCHAEFER-PROKOP, Cornelia | |
| dc.contributor.author | PAESMANS, Marianne | |
| dc.contributor.author | AMEYE, Lieveke | |
| dc.contributor.author | MEERT, Liv | |
| dc.contributor.author | CHEUNG, Kin Jip | |
| dc.contributor.author | HEPLER, Deborah A. | |
| dc.contributor.author | LOEFFLER, Jurgen | |
| dc.contributor.author | BARNES, Rosemary | |
| dc.contributor.author | MARCHETTI, Oscar | |
| dc.contributor.author | VERWEIJ, Paul | |
| dc.contributor.author | LAMOTH, Frederic | |
| dc.contributor.author | BOCHUD, Pierre Yves | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | SCHWARZINGER, Michael | |
| dc.contributor.author | CORDONNIER, Catherine | |
| dc.date.accessioned | 2022-10-18T09:45:48Z | |
| dc.date.available | 2022-10-18T09:45:48Z | |
| dc.date.issued | 2022-07-30 | |
| dc.identifier.issn | 1537-6591 (Electronic) 1058-4838 (Linking) | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/170058 | |
| dc.description.abstractEn | BACKGROUND: Empiric antifungal therapy is considered the standard-of-care for high-risk neutropenic patients with persistent fever. The impact of a pre-emptive, diagnostic-driven approach based on galactomannan (GM) screening and chest CT-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), myelodysplastic syndrome (MDS) and allogeneic hematopoietic cell transplant recipients were randomly assigned to receive caspofungin empirically (Arm A) or pre-emptively (Arm B). All patients received fluconazole 400 mg daily as prophylaxis. The primary endpoint of this non-inferiority study was overall survival (OS) 42 days after randomization. RESULTS: Of 556 patients recruited, 549 were eligible: 275 in Arm A, 274 in Arm B. Eighty percent of the patients had AML or MDS requiring high-dose chemotherapy and 93% of them were in 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 to 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 versus 6.6% (95%CI, 3.6-9.5%) in Arm A, respectively. The rate of patients receiving caspofungin was significantly lower in Arm B (27%) than in Arm A (63%) (p < 0.001). CONCLUSIONS: The pre-emptive 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. | |
| dc.language.iso | EN | en_US |
| dc.subject.en | Neutropenia | |
| dc.subject.en | Empiric | |
| dc.subject.en | Preemptive | |
| dc.subject.en | Antifungal | |
| dc.subject.en | Galactomannan | |
| dc.title.en | Empiric versus pre-emptive antifungal strategy in high-risk neutropenic patients on fluconazole prophylaxis: a randomized trial of the European organization for Research and Treatment of cancer (EORTC 65091) | |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1093/cid/ciac623 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 35906831 | en_US |
| bordeaux.journal | Clinical Infectious Diseases | en_US |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.institution | INSERM | en_US |
| bordeaux.team | PHARES_BPH | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| bordeaux.identifier.funderID | Merck Sharp and Dohme | en_US |
| hal.identifier | hal-03819098 | |
| hal.version | 1 | |
| hal.date.transferred | 2022-10-18T09:46:20Z | |
| hal.export | true | |
| dc.rights.cc | Pas de Licence CC | en_US |
| bordeaux.COinS | ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Clinical%20Infectious%20Diseases&rft.date=2022-07-30&rft.eissn=1537-6591%20(Electronic)%201058-4838%20(Linking)&rft.issn=1537-6591%20(Electronic)%201058-4838%20(Linking)&rft.au=MAERTENS,%20Johan&LODEWYCK,%20Tom&PETER%20DONNELLY,%20J.&CHANTEPIE,%20Sylvain&ROBIN,%20Christine&rft.genre=article |
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