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Cited by 189Antifungal resistance and susceptibilityNeutropenia and Cancer InfectionsOcular Infections and Treatments

A multicenter, randomized trial of fluconazole versus amphotericin B for empiric antifungal therapy of febrile neutropenic patients with cancer

Winston, Drew J, Hathorn, James W, Schuster, Mindy G, Schiller, Gary J, Territo, Mary C·2000·The American Journal of Medicine
DOI 10.1016/s0002-9343(99)00457-x
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Abstract

Purpose To compare the efficacy and safety of fluconazole and amphotericin B as empiric antifungal therapy of febrile neutropenic patients with cancer.Patients and methods A total of 317 neutropenic patients (<500 cells/mm3) with persistent or recrudescent fever despite 4 or more days of antibacterial therapy were randomly assigned to receive either fluconazole (400 mg intravenously once daily) or amphotericin B (0.5 mg/kg once daily). Patients were evaluated for the efficacy and safety of each drug by clinical criteria, frequent cultures and radiological procedures, and laboratory values. A response was classified as satisfactory at the end of therapy if the patient was afebrile, had no clinical or microbiological evidence of fungal infection, and did not require study termination due to lack of efficacy, drug toxicity, or death.Results A satisfactory response occurred in 68% of the patients treated with fluconazole (107 of 158 patients) and in 67% of patients treated with amphotericin B (106 of 159 patients). Progressive or new fungal infections during therapy occurred in 13 (8%) patients treated with fluconazole (8 with Candida, 5 with Aspergillus) and in 10 (6%) patients treated with amphotericin B (5 with Candida, 3 with Aspergillus, 2 with other fungi). Adverse events related to study drug (especially fever, chills, renal insufficiency, electrolyte disturbances, and respiratory distress) occurred more often in patients treated with amphotericin B (128 [81%] of 159 patients) than patients treated with fluconazole (20 [13%] of 158 patients, P = 0.001). Eleven (7%) patients treated with amphotericin B but only 1 (1%) patient treated with fluconazole were terminated from the study owing to an adverse event (P = 0.005). Overall mortality (27 [17%] patients treated with fluconazole versus 34 [21%] patients treated with amphotericin B) and mortality from fungal infection (7 [4%] patients treated with fluconazole versus 5 [3%] patients treated with amphotericin B) were similar in each study group.Conclusions Intravenous fluconazole can be an effective and safe alternative to amphotericin B for empiric antifungal therapy in many febrile neutropenic patients. However, because fluconazole may be ineffective in the treatment of Aspergillus, patients at risk for that infection should be evaluated by chest radiograph, computed tomographic scanning, and cultures before the use of empiric fluconazole therapy.

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  • Fluconazole (400 mg/day) has been used successfully for selected neutropenic patients.

    “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 [158]

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Authors
Winston, D. J., Hathorn, J. W., Schuster, M. G., Schiller, G. J., & Territo, M. C.
Affiliations
  • University of California, Los Angeles (US)
  • Duke University (US)
  • Hospital of the University of Pennsylvania (US)
Corresponding author
Winston, Drew J
ORCID
Venue
The American Journal of Medicine
Publisher
Elsevier BV
Published
2000-03
Volume
108
Issue
4
Pages
282-289
ISSN
0002-9343 (ISSN-L)
DOI
10.1016/s0002-9343(99)00457-x
OpenAlex
W2078654597
Cited by
189
References
38
Citations by year
2023: 2 · 2022: 2 · 2021: 2 · 2020: 1 · 2019: 2 · 2017: 2 · 2016: 2 · 2015: 2 · 2014: 5 · 2013: 8 · 2012: 10
FWCI
10.93
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The American Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
  • Health Sciences › Medicine › Oncology › Neutropenia and Cancer Infections
  • Health Sciences › Medicine › Ophthalmology › Ocular Infections and Treatments
Keywords
fluconazole, amphotericin B, empirical antifungal therapy, febrile neutropenia, cancer patients, candidiasis, aspergillosis, drug toxicity, mortality
MeSH terms
Amphotericin B, Antifungal Agents, Cause of Death, Female, Fever, Humans, Infusions, Intravenous, Male, Middle Aged, Mycoses, Neoplasms, Neutropenia, Fluconazole, Treatment Outcome

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