title: Cytarabine plus idarubicin or daunorubicin as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia.
abstract: The purpose of this study was to determine the relative merits of idarubicin and daunorubicin in acute myeloid leukemia (AML) therapy. Thirty-two sites provided 214 previously untreated adults with AML aged 15 years or more who were randomized to receive for induction therapy cytarabine 100 mg/m2/d as a continuous 7-day infusion plus either daunorubicin 45 mg/m2/d (A + D) or idarubicin 13 mg/m2/d (A + I), daily on the first three days of treatment. Postremission therapy consisted of two courses of the induction regimen at the same daily doses, with the anthracycline administered for 2 days and cytarabine for 5. The complete response (CR) rates for evaluable patients were 70% (A + I) and 59% (A + D) (P = .08). The difference in CR rates was significant in patients aged 18 to 50 years (88% for A + I, 70% for A + D, P = .035). Resistant disease was a significantly more frequent cause of induction therapy failure with A + D than with A + I. Hyperleukocytosis (white blood cell count greater than 50,000/microL) unfavorably affected the attainment of CR with A + D but not with A + I. CR duration was significantly greater after A + I. CR duration was significantly greater after A + I treatment, and the survival of all randomized patients treated with A + I was significantly better than that observed after A + D treatment (median 12.9 months v 8.7 months, respectively, P = .038). Toxicity of the two treatments was similar, although A + I patients experienced more prolonged myelosuppression during consolidation therapy, and a greater incidence of mild chemical hepatitis was observed in the A + I group. It is concluded that, at the doses and schedule used in this study, A + I is superior to A + D for induction therapy of AML in adults.
authors.affiliation: Albert Einstein Cancer Center, Montefiore Medical Center, Bronx, NY 10467.
authors.forename: P H
authors.initials: PH
authors.lastname: Wiernik
authors.forename: P L
authors.initials: PL
authors.lastname: Banks
authors.forename: D C
authors.initials: DC
authors.lastname: Case
authors.forename: Z A
authors.initials: ZA
authors.lastname: Arlin
authors.forename: P O
authors.initials: PO
authors.lastname: Periman
authors.forename: M B
authors.initials: MB
authors.lastname: Todd
authors.forename: P S
authors.initials: PS
authors.lastname: Ritch
authors.forename: R E
authors.initials: RE
authors.lastname: Enck
authors.forename: A B
authors.initials: AB
authors.lastname: Weitberg
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage* / Q000009:adverse effects; D003630:Daunorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage* / Q000009:adverse effects; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000473:pathology; D007964:Leukocytosis; D008297:Male; D008875:Middle Aged; D012074:Remission Induction
chemical_list: D003561:Cytarabine; D015255:Idarubicin; D003630:Daunorubicin