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A randomised comparison of the novel nucleoside analogue sapacitabine with low-dose cytarabine in older patients with acute myeloid leukaemia
被引:29
作者:

Burnett, A. K.
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h-index: 0
机构:
Cardiff Univ, Sch Med, Dept Haematol, Cardiff CF4 14XN, S Glam, Wales Cardiff Univ, Sch Med, Dept Haematol, Cardiff CF4 14XN, S Glam, Wales

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Hills, R. K.
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h-index: 0
机构:
Cardiff Univ, Sch Med, Dept Haematol, Cardiff CF4 14XN, S Glam, Wales Cardiff Univ, Sch Med, Dept Haematol, Cardiff CF4 14XN, S Glam, Wales

Panoskaltsis, N.
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机构:
Northwick Pk Hosp & Clin Res Ctr, Harrow HA1 3UJ, Middx, England Cardiff Univ, Sch Med, Dept Haematol, Cardiff CF4 14XN, S Glam, Wales

Khwaja, A.
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Univ Coll London Hosp, London, ON, Canada Cardiff Univ, Sch Med, Dept Haematol, Cardiff CF4 14XN, S Glam, Wales

Hemmaway, C.
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Queens Hosp, Romford, Essex, England Cardiff Univ, Sch Med, Dept Haematol, Cardiff CF4 14XN, S Glam, Wales

Cahalin, P.
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h-index: 0
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Blackpool Victoria Hosp, Blackpool, England Cardiff Univ, Sch Med, Dept Haematol, Cardiff CF4 14XN, S Glam, Wales

Clark, R. E.
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h-index: 0
机构:
Royal Liverpool Univ Hosp, Dept Haematol, Liverpool, Merseyside, England Cardiff Univ, Sch Med, Dept Haematol, Cardiff CF4 14XN, S Glam, Wales

Milligan, D.
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h-index: 0
机构:
Birmingham Heartlands Hosp, Dept Haematol, Birmingham B9 5ST, W Midlands, England Cardiff Univ, Sch Med, Dept Haematol, Cardiff CF4 14XN, S Glam, Wales
机构:
[1] Cardiff Univ, Sch Med, Dept Haematol, Cardiff CF4 14XN, S Glam, Wales
[2] Nottingham Univ Hosp NHS Trust, Dept Haematol, Nottingham, England
[3] Northwick Pk Hosp & Clin Res Ctr, Harrow HA1 3UJ, Middx, England
[4] Univ Coll London Hosp, London, ON, Canada
[5] Queens Hosp, Romford, Essex, England
[6] Blackpool Victoria Hosp, Blackpool, England
[7] Royal Liverpool Univ Hosp, Dept Haematol, Liverpool, Merseyside, England
[8] Birmingham Heartlands Hosp, Dept Haematol, Birmingham B9 5ST, W Midlands, England
来源:
关键词:
RISK MYELODYSPLASTIC SYNDROME;
ACUTE NONLYMPHOCYTIC LEUKEMIA;
CONVENTIONAL CARE REGIMENS;
INTENSIVE CHEMOTHERAPY;
ELDERLY-PATIENTS;
ORAL SAPACITABINE;
OPEN-LABEL;
SURVIVAL;
AML;
REMISSION;
D O I:
10.1038/leu.2015.38
中图分类号:
R73 [肿瘤学];
学科分类号:
100214 ;
摘要:
The development of new treatments for older patients with acute myeloid leukaemia (AML) is an active area, but has met with limited success. Sapacitabine is a novel orally administered nucleoside analogue that has shown encouraging activity in unrandomised early-stage trials. We randomised 143 untreated patients with AML or with high-risk myelodysplastic syndrome (>10% marrow blasts) between sapacitibine and low-dose ara-C (LDAC) in our 'Pick a Winner' trial design. At the planned interim analysis there was no difference between LDAC and sapacitibine in terms of remission rate (CR/CRi, 27% vs 16% hazard ratio (HR) 1.98(0.90-4.39) P = 0.09), relapse-free survival (10% vs 14% at 2 years, HR 0.73(0.33-1.61) P = 0.4) or overall survival (OS; 12% vs 11% at 2 years, HR 1.24(0.86-1.78) P = 0.2). Sapacitibine was well tolerated, apart from more grade 3/4 diarrhoea. On the basis of these findings sapacitibine did not show sufficient evidence of benefit over LDAC for the trial to be continued.
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页码:1312 / 1319
页数:8
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