Cornely, Oliver A. ORCID: 0000-0001-9599-3137, Leguay, Thibaut, Maertens, Johan ORCID: 0000-0003-4257-5980, Vehreschild, Maria J. G. T. ORCID: 0000-0003-0446-3224, Anagnostopoulos, Achilles ORCID: 0000-0003-4384-9031, Castagnola, Carlo, Verga, Luisa, Rieger, Christina, Kondakci, Mustafa, Harter, Georg ORCID: 0000-0001-9946-6246, Duarte, Rafael F., Allione, Bernardino, Cordonnier, Catherine, Heussel, Claus Peter ORCID: 0000-0001-5809-5733, Morrissey, C. Orla ORCID: 0000-0002-9970-9575, Agrawal, Samir G., Donnelly, J. Peter ORCID: 0000-0002-8521-335X, Bresnik, Mark, Hawkins, Michael J., Garner, Will ORCID: 0000-0003-0738-8696, Goekbuget, Nicola and Fätkenheuer, Gerd ORCID: 0000-0002-5054-1871 (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 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.UNSPECIFIEDorcid.org/0000-0001-9599-3137UNSPECIFIED
Leguay, ThibautUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maertens, JohanUNSPECIFIEDorcid.org/0000-0003-4257-5980UNSPECIFIED
Vehreschild, Maria J. G. T.UNSPECIFIEDorcid.org/0000-0003-0446-3224UNSPECIFIED
Anagnostopoulos, AchillesUNSPECIFIEDorcid.org/0000-0003-4384-9031UNSPECIFIED
Castagnola, CarloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Verga, LuisaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rieger, ChristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kondakci, MustafaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Harter, GeorgUNSPECIFIEDorcid.org/0000-0001-9946-6246UNSPECIFIED
Duarte, Rafael F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Allione, BernardinoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cordonnier, CatherineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heussel, Claus PeterUNSPECIFIEDorcid.org/0000-0001-5809-5733UNSPECIFIED
Morrissey, C. OrlaUNSPECIFIEDorcid.org/0000-0002-9970-9575UNSPECIFIED
Agrawal, Samir G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Donnelly, J. PeterUNSPECIFIEDorcid.org/0000-0002-8521-335XUNSPECIFIED
Bresnik, MarkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hawkins, Michael J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Garner, WillUNSPECIFIEDorcid.org/0000-0003-0738-8696UNSPECIFIED
Goekbuget, NicolaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fätkenheuer, GerdUNSPECIFIEDorcid.org/0000-0002-5054-1871UNSPECIFIED
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
ISSN: 1460-2091
Language: English
Faculty: Faculty of Medicine
Divisions: Faculty of Medicine > Sonstiges > Zentrum für Versorgungsforschung Köln
Subjects: Medical sciences Medicine
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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