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. [1 ]
Russell, N. [2 ]
Hills, R. K. [1 ]
Panoskaltsis, N. [3 ]
Khwaja, A. [4 ]
Hemmaway, C. [5 ]
Cahalin, P. [6 ]
Clark, R. E. [7 ]
Milligan, D. [8 ]
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
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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收藏
页码:1312 / 1319
页数:8
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