AEROSOL AMPHOTERICIN-B INHALATIONS FOR PREVENTION OF INVASIVE PULMONARY ASPERGILLOSIS IN NEUTROPENIC CANCER-PATIENTS

To determine the value of aerosol amphotericin B inhalations for preve ntion of invasive pulmonary aspergillosis (IPA), we initiated a prospe ctive randomized multicenter trial. The scheduled intent-to-treat inte rim analysis included 115 patients (30%) with prolonged neutropenia af ter chemotherapy for acute myeloid leukemia, acute lymphoblastic leuke mia/high-grade non-Hodgkin's lymphoma, or solid tumors undergoing auto logous stem cell transplantation. Sixty-five patients had been randomi zed to receive prophylactic aerosol amphotericin B inhalations at a do se of 10 mg twice daily (group A); for the remaining 50 patients no ae rosol amphotericin B prophylaxis was used (group B), No serious side e ffects from amphotericin B inhalations occurred, but coughing (54%), b ad taste (51%), and nausea (37%) caused early cessation of aerosol amp hotericin B prophylaxis in 23% (15/65) of courses. In group A, the inc idence of proven, probable, or possible IPA was 5% (3/65) as compared with 12% (6/50) in group B (p > 0.05). Microbiologically documented ba cterial 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 inc idence of IPA from use of prophylactic aerosol amphotericin B inhalati ons 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.