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Previous Volume 340:764-771 March 11, 1999 Number 10 Next

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ABSTRACT

Background In patients with persistent fever and neutropenia, amphotericin B is administered empirically for the early treatment and prevention of clinically occult invasive fungal infections. However, breakthrough fungal infections can develop despite treatment, and amphotericin B has substantial toxicity.

Methods We conducted a randomized, double-blind, multicenter trial comparing liposomal amphotericin B with conventional amphotericin B as empirical antifungal therapy.

Results The mean duration of therapy was 10.8 days for liposomal amphotericin B (343 patients) and 10.3 days for conventional amphotericin B (344 patients). The composite rates of successful treatment were similar (50 percent for liposomal amphotericin B and 49 percent for conventional amphotericin B) and were independent of the use of antifungal prophylaxis or colony-stimulating factors. The outcomes were similar with liposomal amphotericin B and conventional amphotericin B with respect to survival (93 percent and 90 percent, respectively), resolution of fever (58 percent and 58 percent), and discontinuation of the study drug because of toxic effects or lack of efficacy (14 percent and 19 percent). There were fewer proved breakthrough fungal infections among patients treated with liposomal amphotericin B (11 patients [3.2 percent]) than among those treated with conventional amphotericin B (27 patients [7.8 percent], P=0.009). With the liposomal preparation significantly fewer patients had infusion-related fever (17 percent vs. 44 percent), chills or rigors (18 percent vs. 54 percent), and other reactions, including hypotension, hypertension, and hypoxia. Nephrotoxic effects (defined by a serum creatinine level two times the upper limit of normal) were significantly less frequent among patients treated with liposomal amphotericin B (19 percent) than among those treated with conventional amphotericin B (34 percent, P<0.001).

Conclusions Liposomal amphotericin B is as effective as conventional amphotericin B for empirical antifungal therapy in patients with fever and neutropenia, and it is associated with fewer breakthrough fungal infections, less infusion-related toxicity, and less nephrotoxicity.

Source Information

From the Division of Clinical Sciences, National Cancer Institute, Bethesda, Md. (T.J.W.); the Division of Infectious Diseases, Dana–Farber Cancer Institute and Brigham and Women's Hospital, Boston (R.W.F.); the Section of Pediatric Hematology–Oncology, Department of Pediatrics, Mayo Clinic and Mayo Foundation, Rochester, Minn. (C.A.); the Division of Bone Marrow Transplantation, H. Lee Moffitt Cancer Center, Tampa, Fla. (J.H.); the Division of Pediatric Hematology–Oncology, Johns Hopkins Medical Institutions, Baltimore (C.S.); the University of Kansas Medical Center, Kansas City (D.B.); the Division of Infectious Diseases, University of Alabama, Birmingham (P.P.); the Division of Hematology–Oncology, Children's National Medical Center, Washington, D.C. (N.S.); the Division of Infectious Diseases, University of Kentucky, Lexington (R.N.G.); the Division of Infectious Diseases, Vanderbilt University, Nashville (S.D.); the Division of Infectious Diseases, Hospital of the University of Pennsylvania, Philadelphia (M.S.); and Children's Hospital and Medical Center, Seattle (J.S.H.). William E. Dismukes, M.D., University of Alabama, Birmingham, was also an author.

Address reprint requests to Dr. Walsh at Bldg. 10, Rm. 13N-240, National Cancer Institute, Bethesda, MD 20892.

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Liposomal Amphotericin B for Fever and Neutropenia
Fischer T., Heußel G., Huber C., Prentice H. G., Kibbler C. C., Patel M. A., Curtis K., Maguire J. H., Wingard J. R., Rakita R., Winston D. J., Schiller G. J., Territo M. C., Walsh T. J., Arndt C., Dismukes W.
Extract | Full Text  
N Engl J Med 1999; 341:1152-1155, Oct 7, 1999. Correspondence

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