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.
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.
Ohtake
Shigeki
S
Department of Clinical Laboratory Science, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan. sohtake@med3.m.kanazawa-u.ac.jp
Miyawaki
Shuichi
S
Fujita
Hiroyuki
H
Kiyoi
Hitoshi
H
Shinagawa
Katsuji
K
Usui
Noriko
N
Okumura
Hirokazu
H
Miyamura
Koichi
K
Nakaseko
Chiaki
C
Miyazaki
Yasushi
Y
Fujieda
Atsushi
A
Nagai
Tadashi
T
Yamane
Takahisa
T
Taniwaki
Masafumi
M
Takahashi
Masatomo
M
Yagasaki
Fumiharu
F
Kimura
Yukihiko
Y
Asou
Norio
N
Sakamaki
Hisashi
H
Handa
Hiroshi
H
Honda
Sumihisa
S
Ohnishi
Kazunori
K
Naoe
Tomoki
T
Ohno
Ryuzo
R
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
D003561:Cytarabine; D015255:Idarubicin; D003630:Daunorubicin