Abstract |
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.
|
Authors | A K Burnett, N Russell, R K Hills, N Panoskaltsis, A Khwaja, C Hemmaway, P Cahalin, R E Clark, D Milligan |
Journal | Leukemia
(Leukemia)
Vol. 29
Issue 6
Pg. 1312-9
(Jun 2015)
ISSN: 1476-5551 [Electronic] England |
PMID | 25676423
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
|
Chemical References |
- Arabinonucleosides
- Cytarabine
- Cytosine
- sapacitabine
|
Topics |
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Arabinonucleosides
(administration & dosage)
- Cytarabine
(administration & dosage)
- Cytosine
(administration & dosage, analogs & derivatives)
- Female
- Follow-Up Studies
- Humans
- Leukemia, Myeloid, Acute
(drug therapy, mortality, pathology)
- Male
- Middle Aged
- Neoplasm Staging
- Prognosis
- Remission Induction
- Survival Rate
|