Universität zu Köln

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:	Creators Email ORCID ORCID Put Code Cornely, Oliver A. UNSPECIFIED orcid.org/0000-0001-9599-3137 UNSPECIFIED Leguay, Thibaut UNSPECIFIED UNSPECIFIED UNSPECIFIED Maertens, Johan UNSPECIFIED orcid.org/0000-0003-4257-5980 UNSPECIFIED Vehreschild, Maria J. G. T. UNSPECIFIED orcid.org/0000-0003-0446-3224 UNSPECIFIED Anagnostopoulos, Achilles UNSPECIFIED orcid.org/0000-0003-4384-9031 UNSPECIFIED Castagnola, Carlo UNSPECIFIED UNSPECIFIED UNSPECIFIED Verga, Luisa UNSPECIFIED UNSPECIFIED UNSPECIFIED Rieger, Christina UNSPECIFIED UNSPECIFIED UNSPECIFIED Kondakci, Mustafa UNSPECIFIED UNSPECIFIED UNSPECIFIED Harter, Georg UNSPECIFIED orcid.org/0000-0001-9946-6246 UNSPECIFIED Duarte, Rafael F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Allione, Bernardino UNSPECIFIED UNSPECIFIED UNSPECIFIED Cordonnier, Catherine UNSPECIFIED UNSPECIFIED UNSPECIFIED Heussel, Claus Peter UNSPECIFIED orcid.org/0000-0001-5809-5733 UNSPECIFIED Morrissey, C. Orla UNSPECIFIED orcid.org/0000-0002-9970-9575 UNSPECIFIED Agrawal, Samir G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Donnelly, J. Peter UNSPECIFIED orcid.org/0000-0002-8521-335X UNSPECIFIED Bresnik, Mark UNSPECIFIED UNSPECIFIED UNSPECIFIED Hawkins, Michael J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Garner, Will UNSPECIFIED orcid.org/0000-0003-0738-8696 UNSPECIFIED Goekbuget, Nicola UNSPECIFIED UNSPECIFIED UNSPECIFIED Fätkenheuer, Gerd UNSPECIFIED orcid.org/0000-0002-5054-1871 UNSPECIFIED
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:	Keywords Language DISEASES WORKING PARTY; FUNGAL-INFECTIONS; GERMAN SOCIETY; PROPHYLAXIS; AMBISOME; PHARMACOKINETICS; FLUCONAZOLE; SAFETY; FORMULATION; HEMATOLOGY Multiple languages Infectious Diseases; Microbiology; Pharmacology & Pharmacy Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/22411