A randomised comparison of the novel nucleoside analogue sapacitabine with low-dose cytarabine in older patients with acute myeloid leukaemia
| Autor: | Nicki Panoskaltsis, Nigel H. Russell, Claire Hemmaway, Alan Kenneth Burnett, P Cahalin, Robert Kerrin Hills, Richard E. Clark, Donald Milligan, Asim Khwaja |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Myeloid Sapacitabine Gastroenterology Cytosine chemistry.chemical_compound Internal medicine Antineoplastic Combined Chemotherapy Protocols Humans Medicine Survival rate Aged Neoplasm Staging Aged 80 and over Hematology Nucleoside analogue business.industry Remission Induction Hazard ratio Cytarabine Middle Aged Prognosis medicine.disease Interim analysis Surgery Survival Rate Leukemia Myeloid Acute Leukemia medicine.anatomical_structure Oncology chemistry Female Arabinonucleosides business Follow-Up Studies medicine.drug |
| Zdroj: | Leukemia. 29:1312-1319 |
| ISSN: | 1476-5551 0887-6924 |
| DOI: | 10.1038/leu.2015.38 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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