title: Randomized study of induction therapy comparing standard-dose idarubicin with high-dose daunorubicin in adult patients with previously untreated acute myeloid leukemia: the JALSG AML201 Study.
abstract: We conducted a multi-institutional randomized study to determine whether high-dose daunorubicin would be as effective as standard-dose idarubicin in remission-induction therapy for newly diagnosed adult patients younger than 65 years of age with acute myeloid leukemia. Of 1064 patients registered, 1057 were evaluable. They were randomly assigned to receive either daunorubicin (50 mg/m(2) daily for 5 days) or idarubicin (12 mg/m(2) daily for 3 days) in combination with 100 mg/m(2) of cytarabine by continuous infusion daily for 7 days as induction therapy. Complete remission was achieved in 407 (77.5%) of 525 patients in the daunorubicin group and 416 (78.2%) of 532 in the idarubicin group (P = .79). Patients achieving complete remission received intensive postremission therapy that consisted of either 3 courses of high-dose cytarabine or 4 courses of standard-dose therapy. Overall survival rates at 5 years were 48% for the daunorubicin group and 48% for the idarubicin group (P = .54), and relapse-free survival rates at 5 years were 41% and 41% (P = .97), respectively. Thus, high-dose daunorubicin and standard-dose idarubicin were equally effective for the treatment of adult acute myeloid leukemia, achieving a high rate of complete remission and good long-term efficacy. This study is registered at http://www.umin.ac.jp/ctrj/ as C000000157.
authors.affiliation: Department of Clinical Laboratory Science, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan. sohtake@med3.m.kanazawa-u.ac.jp
authors.forename: Shigeki
authors.initials: S
authors.lastname: Ohtake
authors.forename: Shuichi
authors.initials: S
authors.lastname: Miyawaki
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Fujita
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Kiyoi
authors.forename: Katsuji
authors.initials: K
authors.lastname: Shinagawa
authors.forename: Noriko
authors.initials: N
authors.lastname: Usui
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Okumura
authors.forename: Koichi
authors.initials: K
authors.lastname: Miyamura
authors.forename: Chiaki
authors.initials: C
authors.lastname: Nakaseko
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Miyazaki
authors.forename: Atsushi
authors.initials: A
authors.lastname: Fujieda
authors.forename: Tadashi
authors.initials: T
authors.lastname: Nagai
authors.forename: Takahisa
authors.initials: T
authors.lastname: Yamane
authors.forename: Masafumi
authors.initials: M
authors.lastname: Taniwaki
authors.forename: Masatomo
authors.initials: M
authors.lastname: Takahashi
authors.forename: Fumiharu
authors.initials: F
authors.lastname: Yagasaki
authors.forename: Yukihiko
authors.initials: Y
authors.lastname: Kimura
authors.forename: Norio
authors.initials: N
authors.lastname: Asou
authors.forename: Hisashi
authors.initials: H
authors.lastname: Sakamaki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Handa
authors.forename: Sumihisa
authors.initials: S
authors.lastname: Honda
authors.forename: Kazunori
authors.initials: K
authors.lastname: Ohnishi
authors.forename: Tomoki
authors.initials: T
authors.lastname: Naoe
authors.forename: Ryuzo
authors.initials: R
authors.lastname: Ohno
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003561:Cytarabine / Q000008:administration & dosage / Q000627:therapeutic use; D003630:Daunorubicin / Q000008:administration & dosage* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage* / Q000627:therapeutic use; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D008875:Middle Aged; D012074:Remission Induction / Q000379:methods; D016019:Survival Analysis; D055815:Young Adult
chemical_list: D003561:Cytarabine; D015255:Idarubicin; D003630:Daunorubicin