Academic Journal
Liposomal amphotericin B retrospective multicentre study on mycosis prophylaxis (L-AmB_RUSCO): tolerability and safety of extended-dosing primary antifungal prophylaxis in children with newly diagnosed acute myeloid leukaemia.
| Τίτλος: | Liposomal amphotericin B retrospective multicentre study on mycosis prophylaxis (L-AmB_RUSCO): tolerability and safety of extended-dosing primary antifungal prophylaxis in children with newly diagnosed acute myeloid leukaemia. |
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| Συγγραφείς: | Ricci E; Infectious Disease Unit, Department of Paediatrics, IRCCS Istituto Giannina Gaslini, Genoa, Italy., Mesini A; Infectious Disease Unit, Department of Paediatrics, IRCCS Istituto Giannina Gaslini, Genoa, Italy., Mariani M; Infectious Disease Unit, Department of Paediatrics, IRCCS Istituto Giannina Gaslini, Genoa, Italy., Aloj G; Department of Oncology, Hematology and Cellular Therapies-A.O.R.N. Santobono-Pausilipon, Naples, Italy., Macri B; Department of Translational Medical Sciences, Pediatric Section, University of Naples Federico II, Naples, Italy., Mendoza-Palomar NA; Paediatric Infectious Diseases and Immunodeficiencies Unit, Children's Hospital, Vall D'Hebron Barcelona Hospital Campus, Barcelona, Spain.; Infection and Immunity in Children Research Group-Vall D'Hebron Research Institute, Barcelona, Spain., Espinosa-López B; Pediatric Oncology and Hematology Department- Children's Hospital, Vall D'Hebron Barcelona Hospital Campus, Barcelona, Spain.; Childhood Cancer and Blood Disorders Research Group, Vall D'Hebron Institut de Recerca, Barcelona, Catalonia, Spain., Buntrock K; Department of Pediatrics Division of Hematology, Oncology and Hemostaseology; Goethe University Frankfurt, Frankfurt am Main, Germany., Gordon K; Infectious Disease Research Program, Center for Bone Marrow Transplantation and Department of Pediatric Hematology/Oncology, University Children's Hospital Münster, Münster, Germany., De Leonardis F; Division of Paediatric Haematology and Oncology-Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari, Italy., Koronica R; Division of Paediatric Haematology and Oncology-Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari, Italy., Ferreras-Antolin L; Centre for Neonatal and Paediatric Infection, City St. George's, University of London, London, UK.; Paediatric Infectious Diseases Department, Great Ormond Street Hospital, NHS Foundation Trust, London, UK.; Medical Research Council Centre for Medical Mycology, Department of Biosciences, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK., Mahjoob H; Paediatric Infectious Diseases Unit, St.George's University Hospital, London, UK., Warris A; Paediatric Infectious Diseases Department, Great Ormond Street Hospital, NHS Foundation Trust, London, UK.; Medical Research Council Centre for Medical Mycology, Department of Biosciences, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK., Lehrnbecher T; Department of Pediatrics Division of Hematology, Oncology and Hemostaseology; Goethe University Frankfurt, Frankfurt am Main, Germany., Groll AH; Infectious Disease Research Program, Center for Bone Marrow Transplantation and Department of Pediatric Hematology/Oncology, University Children's Hospital Münster, Münster, Germany., Castagnola E; Infectious Disease Unit, Department of Paediatrics, IRCCS Istituto Giannina Gaslini, Genoa, Italy. |
| Πηγή: | The Journal of antimicrobial chemotherapy [J Antimicrob Chemother] 2026 Aug 04; Vol. 81 (9). |
| Τύπος έκδοσης: | Journal Article; Multicenter Study; Observational Study |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Oxford University Press Country of Publication: England NLM ID: 7513617 Publication Model: Print Cited Medium: Internet ISSN: 1460-2091 (Electronic) Linking ISSN: 03057453 NLM ISO Abbreviation: J Antimicrob Chemother Subsets: MEDLINE |
| Imprint Name(s): | Publication: 1997- : London : Oxford University Press Original Publication: London, New York, Academic Press. |
| Ιατρικοί όροι (MeSH): | Antifungal Agents*/administration & dosage , Antifungal Agents*/adverse effects , Antifungal Agents*/therapeutic use , Amphotericin B*/administration & dosage , Amphotericin B*/adverse effects , Amphotericin B*/therapeutic use , Leukemia, Myeloid, Acute*/drug therapy , Leukemia, Myeloid, Acute*/complications , Invasive Fungal Infections*/prevention & control , Mycoses*/prevention & control, Humans ; Retrospective Studies ; Female ; Male ; Child ; Child, Preschool ; Adolescent |
| Περίληψη: | Objectives: To evaluate the tolerability and safety of extended-dosing liposomal amphotericin B (LAmB) as primary antifungal prophylaxis against invasive fungal disease (IFD) in children receiving chemotherapy for newly diagnosed acute myeloid leukaemia (AML); breakthrough proven or probable IFD was assessed as an exploratory secondary endpoint. Methods: This retrospective, multinational, multicentre observational study included children treated for newly diagnosed AML between January 2019 and December 2023. LAmB was administered according to local protocols at 1 mg/kg three times weekly, 2.5 mg/kg twice weekly or 5 mg/kg once weekly. Clinical and laboratory adverse events (AEs) were assessed to evaluate tolerability and safety. Breakthrough proven or probable IFD, defined according to EORTC/MSG criteria, was recorded as an exploratory secondary outcome. Results: Eighty-six courses of extended-dosing LAmB were analysed. The median age at first LAmB administration was 91 months (IQR 26-156). The median treatment duration was 13 weeks (IQR 3-21) at a median dose of 2.7 mg/kg per infusion, with a median estimated cumulative dose of 77.6 mg/kg (IQR 21.3-110.1). Clinical AEs occurred in 21% of courses, predominantly skin rash and lumbosacral pain. Laboratory AEs were mainly hypokalaemia (48%) and hepatotoxicity (19%), both dose related. Treatment discontinuation due to toxicity occurred in 15% of courses. Breakthrough proven or probable IFD occurred in 3% of cases. Conclusions: Extended-dosing LAmB represents a reasonably well-tolerated mould-active option for primary antifungal prophylaxis in children with newly diagnosed AML, particularly when triazoles are contraindicated or daily intravenous echinocandin administration is impractical; the low observed rate of breakthrough IFD should be interpreted cautiously given the absence of a comparator group. (© The Author(s) 2026. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.) |
| Substance Nomenclature: | 0 (Antifungal Agents) 7XU7A7DROE (Amphotericin B) 0 (liposomal amphotericin B) |
| Entry Date(s): | Date Created: 20260817 Date Completed: 20260817 Latest Revision: 20260902 |
| Update Code: | 20260902 |
| DOI: | 10.1093/jac/dkag289 |
| PMID: | 42606142 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1460-2091 |
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| DOI: | 10.1093/jac/dkag289 |