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Prophylactic application of nebulized liposomal amphotericin B in hematologic patients with neutropenia
Annette Hullard-Pulstinger1, Ernst Holler, Joachim Hahn
1Abteilung für Hämatologie und Internistische Onkologie, Klinikum der Universität Regensburg, Germany.
Background:
Pulmonary invasive fungal infections (IFI) are well-recognized complications with high morbidity and mortality in patients with hematologic malignancies.
Patients And Methods:
Aerosolized liposomal amphotericin B (lipAmB) was evaluated as an antifungal prophylaxis in patients with an expected neutropenia of more than 10 days due to intensive chemotherapy or stem cell transplantation, in a prospective phase II trial.
Results:
98 treatment episodes were included in the study and compared to 105 historical control patients. Inhalation was performed between 0 and 103 days. No severe side effects of therapy occurred. 40 patients considered inhalations as unpleasant, 2 as very unpleasant, mostly due to bad taste or cough. Few cases of definite or probable IFI were recorded, whereas a large number of patients were treated with systemic antifungal therapy for pneumonia or fever of unknown origin without a significant difference between study patients and controls. In a predefined subgroup analysis of 48 patients with newly diagnosed acute myeloid leukemia (AML), significantly more patients survived for 1 year in the AmB prophylaxis than in the control group (80% vs. 54%, p < 0.01).
Conclusions:
Inhalations of lipAmB are feasible and safe. Results in the subgroup of patients with AML together with data from other trials suggest further evaluation of effectiveness.
Insights
Aerosolized liposomal amphotericin B (lipAmB) is a feasible and safe antifungal prophylaxis for high-risk patients. A subgroup of acute myeloid leukemia (AML) patients showed improved survival with lipAmB.
Area of Science:
- Mycology
- Hematology
- Pharmacology
Background:
- Pulmonary invasive fungal infections (IFI) pose significant risks for patients with hematologic malignancies, leading to high morbidity and mortality.
- Effective prophylactic strategies are crucial for managing IFI in immunocompromised patient populations.
Purpose of the Study:
- To evaluate the safety and feasibility of aerosolized liposomal amphotericin B (lipAmB) as an antifungal prophylaxis.
- To assess the efficacy of lipAmB in preventing IFI in patients undergoing intensive chemotherapy or stem cell transplantation.
Main Methods:
- A prospective phase II clinical trial involving patients with expected neutropenia exceeding 10 days.
- Comparison of 98 treatment episodes with lipAmB inhalation against 105 historical control patients.
- Subgroup analysis focused on 48 patients diagnosed with acute myeloid leukemia (AML).
Main Results:
- Aerosolized lipAmB was found to be feasible and safe, with no severe side effects reported.
- While overall IFI rates did not significantly differ, a subgroup of AML patients receiving lipAmB prophylaxis demonstrated a significant improvement in 1-year survival rates (80% vs. 54%, p < 0.01).
- Patient-reported outcomes indicated that inhalations were generally considered unpleasant by a portion of participants, primarily due to taste or cough.
Conclusions:
- Inhalations of liposomal amphotericin B are a feasible and safe prophylactic option.
- The promising survival data in the AML subgroup warrants further investigation into the effectiveness of aerosolized lipAmB for antifungal prophylaxis in high-risk hematologic malignancy patients.
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