ASH Clinical News June 2015 | Page 22

CLINICAL NEWS Written in Blood randomized, open-label, phase III trial, investigators evaluated the safety and efficacy of azacitidine versus conventional care regimens (CCR) in 488 patients 65 years old or older with newly diagnosed AML and >30 percent of bone marrow blasts who were not considered eligible for hematopoietic stem cell transplantation. Before randomization, one CCR approach (consisting of standard, “7+3” induction chemotherapy, low-dose cytarabine, or supportive care only) was selected by doctors for each patient; patients were then assigned 1:1 to azacitidine (n=241) or CCR (n=247). Azacitidine (75 mg/m2) was administered once-daily subcutaneously for seven consecutive days per 28-day treatment cycle for at least six cycles. In the CCR arm, 45 patients were assigned to best supportive care, 158 to cytarabine, and 44 to induction chemotherapy. Baseline demographic and disease characteristics were generally balanced between the treatment arms, with more than half of all pat