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Fluconazole versus amphotericin B as empirical antifungal therapy of unexplained fever in granulocytopenic cancer patients: a pragmatic, multicentre, prospective and randomised clinical trial
Abstract
Amphotericin B, despite its intrinsic servere toxicity, is the most commonly used empirical antifungal therapy in cancer patients with unexplained fever not responding to empirical antibacterial therapy. The aim of this study was to show whether fluconazole was as effective as, and less toxic than, amphotericin, with no effort made to compare the antifungal activity of the two drugs. A group of 112 persistently febrile (> 38 degrees C) and granulocytopenic (< 1000 cells/mm3) cancer patients, not receiving any absorbable antifungal antibiotic for prophylaxis, with a mean age of 27 years (range 1-73 years), undergoing chemotherapy for a variety of malignancies and with a diagnosis of unexplained fever after at least 96 h of empirical antibacterial therapy, were randomised to receive either fluconazole (6 mg/kg/day up to 400 mg/day) or amphotericin B (0.8 mg/kg/day) as empirical antifungal treatment. Patients were required to have normal chest X-rays at randomisation, no previous history of aspergillosis and negative surveillance cultures for Aspergillus. The intention-to-treat analysis showed defervescence and survival without treatment modification in 42 of 56 patients (75%) in the fluconazole group and in 37 of 56 (66%) in the amphotericin B group (P = 0.4). Duration of therapy was 6 days (95% CI = 4-8 days) in both groups. Death occurred in 3 patients (5%) in the fluconazole and in 2 (4%) in the amphotericin B group. No fungal death was documented in either group. Adverse ev…
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“Fluconazole (400 mg/day) has been used successfully for selected patients (A-I) [156-158]”
From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [157]
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Metadata
- Authors
- Viscoli, C., Castagnola, E., Van Lint, M. T., Moroni, C., Garaventa, A., Rossi, M. R., Fanci, R., Menichetti, F., Caselli, D., Giacchino, M., & Congiu, M.
- Affiliations
- University of Geneva (CH)
- Istituto Giannina Gaslini (IT)
- University of Pavia (IT)
- Azienda Ospedaliero-Universitaria Careggi (IT)
- University of Perugia (IT)
- University of Milan (IT)
- Ospedale Regina Margherita (IT)
- Ospedale Policlinico San Martino (IT)
- Corresponding author
- Viscoli, C.
- Venue
- European Journal of Cancer
- Publisher
- Elsevier BV
- Published
- 1996-05
- Volume
- 32
- Issue
- 5
- Pages
- 814-820
- ISSN
- 0959-8049 (ISSN-L)
- OpenAlex
- W2068893995
- Cited by
- 122
- References
- 29
- Citations by year
- 2022: 1 · 2021: 2 · 2018: 1 · 2017: 3 · 2016: 3 · 2014: 3 · 2013: 1 · 2012: 5
- FWCI
- 5.21
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Cancer (publishedVersion)
- PubMed (publishedVersion)
- CINECA IRIS Institutial research information system (University of Pisa) (submittedVersion)
- Florence Research (University of Florence) (submittedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
- Health Sciences › Medicine › Oncology › Neutropenia and Cancer Infections
- Health Sciences › Medicine › Infectious Diseases › Fungal Infections and Studies
- Keywords
- fluconazole, amphotericin B, empirical antifungal therapy, fever of unknown origin, febrile neutropenia, chemotherapy toxicity, antifungal toxicity, invasive fungal infections, Aspergillus, defervescence, treatment discontinuation, adverse events
- MeSH terms
- Adolescent, Adult, Aged, Agranulocytosis, Amphotericin B, Antifungal Agents, Child, Child, Preschool, Female, Fever, Humans, Infant, Male, Middle Aged, Mycoses, Neoplasms, Opportunistic Infections, Prospective Studies, Fluconazole, Immunocompromised Host, Treatment Outcome
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