Aerosol amphotericin B inhalations for prevention of invasive pulmonary aspergillosis in neutropenic cancer patients

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...

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Bibliographic Details
Published in:	Annals of hematology Vol. 71; no. 6; pp. 287 - 291
Main Authors:	BEHRE, G. F, SCHWARTZ, S, TREDER, W, SIEGERT, W, HIDDEMANN, W, BEYER, J, LENZ, K, LUDWIG, W.-D, WANDT, H, SCHILLING, E, HEINEMANN, V, LINK, H, TRITTIN, A, BOENISCH, O
Format:	Journal Article
Language:	English
Published:	Berlin Springer 01-12-1995
Subjects:	Administration, Inhalation Adolescent Adult Aged Aged, 80 and over Amphotericin B - administration & dosage Amphotericin B - therapeutic use Antifungal Agents - administration & dosage Antifungal Agents - therapeutic use Antineoplastic Agents - adverse effects Aspergillosis - etiology Aspergillosis - prevention & control Biological and medical sciences Drug toxicity and drugs side effects treatment Female Humans Leukemia - complications Leukemia - drug therapy Lung Diseases, Fungal - etiology Lung Diseases, Fungal - prevention & control Lymphoma - complications Lymphoma - drug therapy Male Medical sciences Middle Aged Neutropenia - chemically induced Neutropenia - complications Pharmacology. Drug treatments Toxicity: blood Antineoplastic agent Chemoprophylaxis Mycosis Toxicity Lung Hemopathy Antifungal agent Lymphoproliferative syndrome Complication Acute lymphocytic leukemia Neutropenia Human Lung disease Leukopenia Respiratory disease Acute Malignant hemopathy Malignant tumor Non Hodgkin lymphoma Inhalation Infection Antibiotic Chemotherapy Treatment Polyenic compound Aspergillosis Acute myelocytic leukemia
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Summary:	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, probably, 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.
ISSN:	0939-5555 1432-0584
DOI:	10.1007/BF01697981