A prospective randomized trial of KRN8602 and cytosine arabinoside vs. daunorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogenous leukemia

A prospective randomized study was conducted to compare the efficacy and to xicity of two anthracyclines for the treatment of patients with acute myelo genous leukemia (AML). Fifty-eight patients were randomized and received in duction therapy consisting of cytosine arabinoside (AraC) 100 mg/m(2)/day f or 7 days combined with either KRN8602 (3'-deamino-3'-morpholino-13-deoxo-1 0-hydroxycarminomycin hydrochloride [KRN]) 15 mg/m(2)/day for 5 days (KRN/A raC group) or daunorubicin (DNR) 40 mg/m(2)/day for 3 days (DNR/AraC group) . Complete remission rate was 78.6%: (22/28) in the KRN/AraC group and 73.1 % (19/26) in the DNR/AraC group. There was a higher incidence of nausea/vom iting and anorexia observed in the KRN/AraC group compared to the DNR/AraC group, while the incidence of other adverse effects (stomatitis, diarrhea, and infectious complications) were similar between both groups. No electroc ardiogram (ECG) abnormalities were observed after treatment in the KRN/AraC group, while in the DNR/AraC group, one patient showed ECG abnormality and three patients exhibited either arrhythmia, heart failure, or tachycardia. Mental disorder was reported in two cases in the KRN/AraC group. These fin dings suggest that KRN/AraC is similar in effectiveness to DNA/AraC but mor e toxic in central nervous system and gastrointestinal symptoms and less to xic regarding cardiac function in patients with previously untreated (C) 19 99 The Japanese Society of Hematology.