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Blood, Vol. 93 No. 11 (June 1), 1999:
pp. 3654-3661
Aerosolized Amphotericin B Inhalations as Prophylaxis of Invasive
Aspergillus Infections During Prolonged Neutropenia: Results of a
Prospective Randomized Multicenter Trial
S. Schwartz,
G. Behre,
V. Heinemann,
H. Wandt,
E. Schilling,
M. Arning,
A. Trittin,
W.V. Kern,
O. Boenisch,
D. Bosse,
K. Lenz,
W.D. Ludwig,
W. Hiddemann,
W. Siegert, and
J. Beyer
From the Department of Hematology and Oncology,
Universitätsklinikum Benjamin Franklin, Berlin, Germany; the
Department of Hematology and Oncology, Universitätsklinikum
Göttingen, Göttingen, Germany; the Department of Hematology
and Oncology, Klinikum Gro hadern der Universität
München, München, Germany; the Department of Hematology and
Oncology, Klinikum der Stadt Nürnberg, Nürnberg, Germany;
the Department of Hematology and Oncology, Städtisches Klinikum
Neukölln, Berlin, Germany; the Department of Hematology and
Oncology, Universitätsklinikum Düsseldorf,
Düsseldorf, Germany; the Department of Hematology and Oncology,
Universitätsklinikum Charité, Campus Charité, Berlin,
Germany; the Department of Hematology and Oncology,
Universitätsklinikum Ulm, Ulm, Germany; the Department of
Hematology and Oncology, Universitätsklinikum Charité,
Campus Virchow, Berlin, Germany; and the Department of Hematology and
Oncology, Universitätsklinikum Charité, Campus Buch,
Berlin, Germany.
We performed a prospective, randomized, multicenter trial to
evaluate the effectiveness of prophylactic inhalations with aerosolized amphotericin B (aeroAmB) to reduce the incidence of invasive
aspergillus (IA) infections in patients after chemotherapy or
autologous bone marrow transplantation and an expected duration of
neutropenia of at least 10 days. From March 1993 until April 1996, 382 patients with leukemias, relapsed high-grade non-Hodgkin lymphomas, or solid tumors were randomized with a 13:10 ratio to receive either prophylactic aeroAmB inhalations at a dose of 10 mg twice daily or no
inhalation prophylaxis in an unblinded fashion. The incidence of
proven, probable, or possible IA infections was 10 of 227 (4%) in
patients who received prophylactic aeroAmB. This did not differ significantly from the 11 of 155 (7%) incidence in patients who received no inhalation prophylaxis (P = .37). Moreover, no
differences in the overall mortality (13% v 10%; P
= .37) or in the infection-related mortality (8% v 7%;
P = .79) were found. In contrast to other nonrandomized
trials, we observed no benefit from prophylactic aeroAmB inhalations,
but the overall incidence of IA infections was low.
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