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Randomized comparison of liposomal amphotericin B versus placebo to prevent invasive mycoses in acute lymphoblastic leukaemia

Authors :
Cornely, O.A.
Leguay, T.
Maertens, J.
Vehreschild, M.
Anagnostopoulos, A.
Castagnola, C.
Verga, L.
Rieger, C.
Kondakci, M.
Harter, G.
Duarte, R.F.
Allione, B.
Cordonnier, C.
Heussel, C.P.
Morrissey, C.O.
Agrawal, S.G.
Donnelly, J.P.
Bresnik, M.
Hawkins, M.J.
Garner, W.
Gokbuget, N.
Cornely, O.A.
Leguay, T.
Maertens, J.
Vehreschild, M.
Anagnostopoulos, A.
Castagnola, C.
Verga, L.
Rieger, C.
Kondakci, M.
Harter, G.
Duarte, R.F.
Allione, B.
Cordonnier, C.
Heussel, C.P.
Morrissey, C.O.
Agrawal, S.G.
Donnelly, J.P.
Bresnik, M.
Hawkins, M.J.
Garner, W.
Gokbuget, N.
Source :
Journal of Antimicrobial Chemotherapy; 2359; 2367; 0305-7453; 8; 72; ~Journal of Antimicrobial Chemotherapy~2359~2367~~~0305-7453~8~72~~
Publication Year :
2017

Abstract

Item does not contain fulltext<br />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, 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.

Details

Database :
OAIster
Journal :
Journal of Antimicrobial Chemotherapy; 2359; 2367; 0305-7453; 8; 72; ~Journal of Antimicrobial Chemotherapy~2359~2367~~~0305-7453~8~72~~
Publication Type :
Electronic Resource
Accession number :
edsoai.on1284032695
Document Type :
Electronic Resource