Randomized trial of response-oriented individualized versus   fixed-schedule induction chemotherapy with idarubicin   and cytarabine in adult acute myeloid leukemia:   the JALSG AML95 study.
A multicenter, prospective, randomized study was conducted to compare a response-oriented individualized remission induction therapy with a standard fixed-schedule induction therapy, using idarubicin (IDR) and cytarabine (Ara-C), in adult patients with acute myeloid leukemia (AML). Newly diagnosed patients with AML of age less than 65 were randomly assigned to receive either of the two schedules. Both groups received IDR (12 mg/m2) for 3 days and Ara-C (100 mg/m2) for 7 days. In the individualized group, if the bone marrow on day 8 did not become hypocellular with less than 15% blasts, patients received additional IDR for one more day and Ara-C for 2 or 3 more days. Patients achieving complete remission (CR) received the same post-remission therapy. The CR rate was 79.4% for the individualized group (n = 209) and 81.9% for the fixed group (n = 221) (p = 0.598). At a median follow-up of 81 months, 7-year predicted overall survival was 37% for the individualized group and 39% for the fixed group (p = 0.496), and 7-year predicted event-free survival was 22% for the individualized group and 23% for the fixed group (p = 0.546). Thus, the present study could not demonstrate any advantage of a response-oriented individualized induction therapy over a fixed-schedule induction therapy in this protocol setting.
Ohtake
Shigeki
S
Department of Hematology, Kanazawa University Graduate School of Medical Science, 13-1 Takara-machi, Kanazawa 920-8641, Japan. sohtake@med3.m.kanazawa-u.ac.jp
Miyawaki
Shuichi
S
Kiyoi
Hitoshi
H
Miyazaki
Yasushi
Y
Okumura
Hirokazu
H
Matsuda
Shin
S
Nagai
Tadashi
T
Kishimoto
Yuji
Y
Okada
Masaya
M
Takahashi
Masatomo
M
Handa
Hiroshi
H
Takeuchi
Jin
J
Kageyama
Shinichi
S
Asou
Norio
N
Yagasaki
Fumiharu
F
Maeda
Yasuhiro
Y
Ohnishi
Kazunori
K
Naoe
Tomoki
T
Ohno
Ryuzo
R
D000293:Adolescent; D000328:Adult; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D003561:Cytarabine / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D008875:Middle Aged; D057285:Precision Medicine; D011379:Prognosis; D012074:Remission Induction; D016896:Treatment Outcome; D055815:Young Adult
D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D003561:Cytarabine; D015255:Idarubicin