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Previous Volume 347:408-415 August 8, 2002 Number 6 Next

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ABSTRACT

Background Voriconazole is a broad-spectrum triazole that is active against aspergillus species. We conducted a randomized trial to compare voriconazole with amphotericin B for primary therapy of invasive aspergillosis.

Methods In this randomized, unblinded trial, patients received either intravenous voriconazole (two doses of 6 mg per kilogram of body weight on day 1, then 4 mg per kilogram twice daily for at least seven days) followed by 200 mg orally twice daily or intravenous amphotericin B deoxycholate (1 to 1.5 mg per kilogram per day). Other licensed antifungal treatments were allowed if the initial therapy failed or if the patient had an intolerance to the first drug used. A complete or partial response was considered to be a successful outcome.

Results A total of 144 patients in the voriconazole group and 133 patients in the amphotericin B group with definite or probable aspergillosis received at least one dose of treatment. In most of the patients, the underlying condition was allogeneic hematopoietic-cell transplantation, acute leukemia, or other hematologic diseases. At week 12, there were successful outcomes in 52.8 percent of the patients in the voriconazole group (complete responses in 20.8 percent and partial responses in 31.9 percent) and 31.6 percent of those in the amphotericin B group (complete responses in 16.5 percent and partial responses in 15.0 percent; absolute difference, 21.2 percentage points; 95 percent confidence interval, 10.4 to 32.9). The survival rate at 12 weeks was 70.8 percent in the voriconazole group and 57.9 percent in the amphotericin B group (hazard ratio, 0.59; 95 percent confidence interval, 0.40 to 0.88). Voriconazole-treated patients had significantly fewer severe drug-related adverse events, but transient visual disturbances were common with voriconazole (occurring in 44.8 percent of patients).

Conclusions In patients with invasive aspergillosis, initial therapy with voriconazole led to better responses and improved survival and resulted in fewer severe side effects than the standard approach of initial therapy with amphotericin B.

Source Information

From the Hôpital de Hautepierre, Strasbourg, France (R.H.); the University of Manchester, Manchester, United Kingdom (D.W.D.); the University of Texas Health Science Center, San Antonio (T.F.P.); the National Institute of Allergy and Infectious Diseases, Bethesda, Md. (J.E.B.); Massachusetts General Hospital, Boston (R.E.G.); Charité, Campus Virchow-Klinikum, Berlin, Germany (J.-W.O.); Medizinische Universitätsklinik, Freiburg, Germany (W.V.K.); Fred Hutchinson Cancer Research Center, Seattle (K.A.M.); Hôpital Saint-Louis, Paris (P.R.); Institut Pasteur, Paris (O.L.); the European Organisation for Research and Treatment of Cancer, Brussels, Belgium (R.S.); Brigham and Women's Hospital, Boston (R.H.R.); the University of Florida College of Medicine, Gainesville (J.R.W.); the University of California at San Diego, San Diego (P.S.); Hôpital du Bocage, Dijon, France (C.D., D.C.); University Hospital Benjamin Franklin, Berlin, Germany (E.T.); Wayne State University School of Medicine, Detroit (P.H.C.); Pfizer Global Research and Development, New York (M.R.H., H.T.S.) and Sandwich, United Kingdom (P.F.T.); and University Medical Center, Nijmegen, the Netherlands (B.P.).

Address reprint requests to Dr. Herbrecht at the Département d'Hématologie et d'Oncologie, Hôpital de Hautepierre, Ave. Molière, 67098 Strasbourg CEDEX, France, or at raoul.herbrecht{at}chru-strasbourg.fr.

Full Text of this Article

Related Letters:

Voriconazole versus Amphotericin B for Invasive Aspergillosis
Blot F., Edé C., Nitenberg G. M., Karthaus M., Herbrecht R., Patterson T. F., Bennett J. E.
Extract | Full Text | PDF  
N Engl J Med 2002; 347:2080-2081, Dec 19, 2002. Correspondence

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