title: Randomized trial of response-oriented individualized versus   fixed-schedule induction chemotherapy with idarubicin   and cytarabine in adult acute myeloid leukemia:   the JALSG AML95 study.
abstract: 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.
authors.affiliation: 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
authors.forename: Shigeki
authors.initials: S
authors.lastname: Ohtake
authors.forename: Shuichi
authors.initials: S
authors.lastname: Miyawaki
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Kiyoi
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Miyazaki
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Okumura
authors.forename: Shin
authors.initials: S
authors.lastname: Matsuda
authors.forename: Tadashi
authors.initials: T
authors.lastname: Nagai
authors.forename: Yuji
authors.initials: Y
authors.lastname: Kishimoto
authors.forename: Masaya
authors.initials: M
authors.lastname: Okada
authors.forename: Masatomo
authors.initials: M
authors.lastname: Takahashi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Handa
authors.forename: Jin
authors.initials: J
authors.lastname: Takeuchi
authors.forename: Shinichi
authors.initials: S
authors.lastname: Kageyama
authors.forename: Norio
authors.initials: N
authors.lastname: Asou
authors.forename: Fumiharu
authors.initials: F
authors.lastname: Yagasaki
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Maeda
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; 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
chemical_list: D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D003561:Cytarabine; D015255:Idarubicin