title: A randomized comparison of 4 courses of standard-dose multiagent chemotherapy versus 3 courses of high-dose cytarabine alone in postremission therapy for acute myeloid leukemia in adults: the JALSG AML201 Study.
abstract: We conducted a prospective randomized study to assess the optimal postremission therapy for adult acute myeloid leukemia in patients younger than 65 years in the first complete remission. A total of 781 patients in complete remission were randomly assigned to receive consolidation chemotherapy of either 3 courses of high-dose cytarabine (HiDAC, 2 g/m(2) twice daily for 5 days) alone or 4 courses of conventional standard-dose multiagent chemotherapy (CT) established in the previous JALSG AML97 study. Five-year disease-free survival was 43% for the HiDAC group and 39% for the multiagent CT group (P = .724), and 5-year overall survival was 58% and 56%, respectively (P = .954). Among the favorable cytogenetic risk group (n = 218), 5-year disease-free survival was 57% for HiDAC and 39% for multiagent CT (P = .050), and 5-year overall survival was 75% and 66%, respectively (P = .174). In the HiDAC group, the nadir of leukocyte counts was lower, and the duration of leukocyte less than 1.0 × 10(9)/L longer, and the frequency of documented infections higher. The present study demonstrated that the multiagent CT regimen is as effective as our HiDAC regimen for consolidation. Our HiDAC regimen resulted in a beneficial effect on disease-free survival only in the favorable cytogenetic leukemia group. This trial was registered at www.umin.ac.jp/ctr/ as #C000000157.
authors.affiliation: Leukemia Research Center, Saiseikai Maebashi Hospital, Maebashi, Japan. miyawaki@mail.wind.ne.jp
authors.forename: Shuichi
authors.initials: S
authors.lastname: Miyawaki
authors.forename: Shigeki
authors.initials: S
authors.lastname: Ohtake
authors.forename: Shin
authors.initials: S
authors.lastname: Fujisawa
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: Toru
authors.initials: T
authors.lastname: Sakura
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; D000964:Antimetabolites, Antineoplastic; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D003561:Cytarabine / Q000008:administration & dosage* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D007958:Leukocyte Count; D008875:Middle Aged; D012074:Remission Induction; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000964:Antimetabolites, Antineoplastic; D003561:Cytarabine