%0 Journal Article
%A Cornely, Oliver A
%A Leguay, Thibaut
%A Maertens, Johan
%A Vehreschild, Maria J G T
%A Anagnostopoulos, Achilles
%A Castagnola, Carlo
%A Verga, Luisa
%A Rieger, Christina
%A Kondakci, Mustafa
%A Härter, Georg
%A Duarte, Rafael F
%A Allione, Bernardino
%A Cordonnier, Catherine
%A Heussel, Claus Peter
%A Morrissey, C Orla
%A Agrawal, Samir G
%A Donnelly, J Peter
%A Bresnik, Mark
%A Hawkins, Michael J
%A Garner, Will
%A Gökbuget, Nicola
%A AmBiGuard Study Group
%T Randomized comparison of liposomal amphotericin B versus placebo to prevent invasive mycoses in acute lymphoblastic leukaemia.
%D 2017
%U https://hdl.handle.net/10668/26496
%X To prevent invasive fungal disease (IFD) in adult patients undergoing remission-induction chemotherapy for newly diagnosed acute lymphoblastic leukaemia (ALL). 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. 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. The IFD rate among adult patients undergoing remission-induction chemotherapy for newly diagnosed ALL was 11.7% in the placebo group, and was 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.
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