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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.
- Source :
- Clinical Infectious Diseases; 2/15/2023, Vol. 76 Issue 4, p674-682, 9p
- Publication Year :
- 2023
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- MYELODYSPLASTIC syndromes
ANTIFUNGAL agents
CLINICAL trials
CONFIDENCE intervals
CHEST X rays
CASPOFUNGIN
CANCER chemotherapy
NEUTROPENIA
PATIENTS
MEDICAL screening
RISK assessment
RANDOMIZED controlled trials
SURVIVAL analysis (Biometry)
DESCRIPTIVE statistics
RESEARCH funding
MYCOSES
FLUCONAZOLE
HEMATOPOIETIC stem cell transplantation
STATISTICAL sampling
COMPUTED tomography
CHEMOPREVENTION
TRANSPLANTATION of organs, tissues, etc.
PATIENT safety
DISEASE risk factors
Subjects
Details
- Language :
- English
- ISSN :
- 10584838
- Volume :
- 76
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- Clinical Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 162026151
- Full Text :
- https://doi.org/10.1093/cid/ciac623