Aerosol amphotericin B inhalations for prevention of invasive pulmonary aspergillosis in neutropenic cancer patients |
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| Authors: | G F Behre S Schwartz K Lenz W -D Ludwig H Wandt E Schilling V Heinemann H Link A Trittin O Boenisch W Treder W Siegert W Hiddemann J Beyer |
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| Institution: | (1) Department of Hematology/Oncology, University Hospital Göttingen, Robert-Koch-Strasse 40, D-37075 Göttingen, Germany;(2) Present address: Department of Medicine, Division of Geographic Medicine and Infectious Diseases, Tufts University School of Medicine and New England Medical Center, 750 Washington St., Box 68, 02111 Boston, MA, USA;(3) Department of Hematology/Oncology, University Hospital Benjamin-Franklin, Hindenburgdamm 30, D-12200 Berlin, Germany;(4) Department of Hematology/Oncology, University Hospital Rudolf-Virchow, Spandauer Damm 130, D-14050 Berlin, Germany;(5) Department of Hematology/Oncology, Robert Rössle Clinic, University Hospital Rudolf-Virchow, Lindenburger Weg 80, D-13122 Berlin, Germany;(6) Department of Hematology/Oncology, Community Hospital Nuremberg, Flurstrasse 17, D-90340 Nuremberg, Germany;(7) Department of Hematology/Oncology, Community Hospital Neukölln, Rudower Strasse 48, D-12313 Berlin, Germany;(8) Department of Hematology/Oncology, University Hospital Großhadern, Marchioninistrasse 15, D-81366 Munich, Germany;(9) Department of Hematology/Oncology, Hannover Medical School, Konstanty Gutschow Strasse 8, D-30623 Hannover, Germany;(10) Department of Hematology/Oncology, University Hospital Charité, Schumannstrasse 20-21, D-10117 Berlin, Germany |
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| Abstract: | To determine the value of aerosol amphotericin B inhalations for prevention of invasive pulmonary aspergillosis (IPA), we initiated a prospective randomized multicenter trial. The scheduled intent-to-treat interim analysis included 115 patients (30%) with prolonged neutropenia after chemotherapy for acute myeloid leukemia, acute lymphoblastic leukemia/high-grade non-Hodgkin's lymphoma, or solid tumors undergoing autologous stem cell transplantation. Sixty-five patients had been randomized to receive prophylactic aerosol amphotericin B inhalations at a dose of 10 mg twice daily (group A); for the remaining 50 patients no aerosol amphotericin B prophylaxis was used (group B). No serious side effects from amphotericin B inhalations occurred, but coughing (54%), bad taste (51%), and nausea (37%) caused early cessation of aerosol amphotericin B prophylaxis in 23% (15/65) of courses. In group A, the incidence of proven, probable, or possible IPA was 5% (3/65) as compared with 12% (6/50) in group B (p>0.05). Microbiologically documented bacterial pneumonias were observed in 5/65 (8%) patients in group A and in 1/50 (2%) patients in group B (p>0.05). Thus, no reduction in incidence of IPA from use of prophylactic aerosol amphotericin B inhalations was found in this interim analysis. As there were no serious side effects from aerosol amphotericin B prophylaxis, accrual in the study will continue for a total of 380 patients. |
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| Keywords: | Aspergillosis Amphotericin B Inhalation Neutropenia Prophylaxis |
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