Efficacy
A phase III, international, multicenter, randomised, controlled, parallel-group trial with AZA treatment for high risk myelodysplasia was re-analysed for patients with > 20% BM or peripheral blasts (ie. with FAB-defined RAEB-t and WHO-defined AML).r AZA was compared to current conventional care (CCR), which included; best supportive care, low dose cytarabine (LDAC) and intensive chemotherapy (IC). This study group of 113 patients had an average age of 70 years (range 50-83 years). After a median follow-up time of 20.1 months survival was significantly longer in the AZA group compared with CCR; median survival 24.5 cf 16.0 months . No significant difference was observed for AZA compared with LDAC; median survival of 24.5 cf 17.0 months. Median survival was not reached for AZA cf 14.2 months for IC. The 2-year OS rate was 50% in the AZA group versus 16% in the CCR group. The survival benefit obtained with AZA, despite a low CR rate (18%), suggests that AZA can prolong survival in the absence of a CR.r AZA-treated patients had fewer hospital admissions compared with CCR treated patients. Patients in the AZA group had a lower rate of fever requiring intravenous antibiotics compared with the CCR group.r
A multicentre, randomized, open-label, international phase 3 trial evaluated Azacitidine efficacy and safety vs conventional care regimens (CCR – standard induction therapy, low dose cytarabine or supportive care only) in 488 patients, age =65 years with newly diagnosed acute myeloid leukaemia (AML) with >30% bone marrow blasts. Patients were assigned 1:1.r
Azacitidine increased median overall survival by 3.8 months vs current commonly used AML treatments (10.5 months vs 6.5 months, p=0.1009. One year survival rates with Azacitidine and CCR with 46.5% and 34.2% respectively.r
© J Clin Oncol 2010