Cornely, Oliver A., Leguay, Thibaut, Maertens, Johan, Vehreschild, Maria J. G. T., Anagnostopoulos, Achilles ORCID: 0000-0003-4384-9031, Castagnola, Carlo, Verga, Luisa, Rieger, Christina, Kondakci, Mustafa, Haerter, Georg, Duarte, Rafael F., Allione, Bernardino, Cordonnier, Catherine, Heussel, Claus Peter, Morrissey, C. Orla, Agrawal, Samir G., Donnelly, J. Peter, Bresnik, Mark, Hawkins, Michael J., Garner, Will and Goekbuget, Nicola (2017). Randomized comparison of liposomal amphotericin B versus placebo to prevent invasive mycoses in acute lymphoblastic leukaemia. J. Antimicrob. Chemother., 72 (8). S. 2359 - 2368. OXFORD: OXFORD UNIV PRESS. ISSN 1460-2091

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Abstract

Objectives: To prevent invasive fungal disease (IFD) in adult patients undergoing remission-induction chemotherapy for newly diagnosed acute lymphoblastic leukaemia (ALL). Patients and methods: In a double-blind multicentre Phase 3 study, patients received prophylactic liposomal amphotericin B (L-AMB) at 5 mg/kg intravenously or placebo twice weekly in a 2: 1 random allocation during remission-induction treatment. The primary endpoint was the development of proven or probable IFD. Secondary endpoints included those focused on the safety and tolerability of prophylactic L-AMB. Results: Three hundred and fifty-five patients from 86 centres in Europe and South America received at least one dose of L-AMB (n = 237) or placebo (n = 118). Rates of proven and probable IFD assessed independently were 7.9%(18/228) in the L-AMB group and 11.7%(13/111) in the placebo group (P = 0.24). Rates of possible IFD were 4.8% (11/228) in the L-AMB and 5.4% (6/111) in the placebo group (P = 0.82). The remission-induction phase was a median of 22 days for both groups. Overall mortality was similar between the groups: 7.2% (17/237) for L-AMB and 6.8% (8/118) for placebo (P = 1.00). Hypokalaemia and creatinine increase were significantly more frequent with L-AMB. Conclusions: The IFD rate among adult patients undergoing remission-induction chemotherapy for newly diagnosed ALL was 11.7% in the placebo group, andwas not significantly different in patients receiving L-AMB, suggesting that the L-AMB regimen studied is not effective as prophylaxis against IFD. The IFD rate appears higher than previously reported, warranting further investigation. Tolerability of L-AMB was what might be expected. Further studies are needed to determine the optimal antifungal strategy during remission-induction chemotherapy of ALL.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Cornely, Oliver A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Leguay, ThibautUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maertens, JohanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vehreschild, Maria J. G. T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Anagnostopoulos, AchillesUNSPECIFIEDorcid.org/0000-0003-4384-9031UNSPECIFIED
Castagnola, CarloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Verga, LuisaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rieger, ChristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kondakci, MustafaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haerter, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Duarte, Rafael F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Allione, BernardinoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cordonnier, CatherineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heussel, Claus PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Morrissey, C. OrlaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Agrawal, Samir G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Donnelly, J. PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bresnik, MarkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hawkins, Michael J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Garner, WillUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goekbuget, NicolaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-224110
DOI: 10.1093/jac/dkx133
Journal or Publication Title: J. Antimicrob. Chemother.
Volume: 72
Number: 8
Page Range: S. 2359 - 2368
Date: 2017
Publisher: OXFORD UNIV PRESS
Place of Publication: OXFORD
ISSN: 1460-2091
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
DISEASES WORKING PARTY; FUNGAL-INFECTIONS; GERMAN SOCIETY; PROPHYLAXIS; AMBISOME; PHARMACOKINETICS; FLUCONAZOLE; SAFETY; FORMULATION; HEMATOLOGYMultiple languages
Infectious Diseases; Microbiology; Pharmacology & PharmacyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/22411

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