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

被引：31

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

来源：

LEUKEMIA | 2015年 / 29卷 / 06期

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 [肿瘤学];

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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