title: Efficacy and safety of imatinib mesylate for patients in the first chronic phase of chronic myeloid leukemia: results of a Japanese phase II clinical study.
abstract: Imatinib mesylate is a relatively new drug that targets the BCR-ABL chimeric protein, the molecular basis of chronic myeloid leukemia (CML). A phase II clinical trial in 39 Japanese patients in the first chronic phase of CML was conducted with imatinib mesylate at a dose of 400 mg/day. Hematologic complete response was obtained in 92.3% of the patients, complete cytogenetic response (CR) was obtained in 43.6%, and major partial CR was obtained in 20.5% of the patients. Although 29 of 39 patients required an adjustment of dosing because of grade 3 or 4 adverse events, most of the events were reversible, and 25 of the 29 patients were able to resume therapy. Between day 15 and day 35, grade 3 or 4 neutropenia and/or leukocytopenia occurred in 13 patients, and grade 3 thrombocytopenia occurred in 5 patients. Overall, nonhematologic grade 3 adverse events occurred in 28.2% of the patients. These data support the use of imatinib mesylate as the treatment of choice for chronic-phase CML patients.
authors.affiliation: Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan. ymorisim@aichi-cc.jp
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Morishima
authors.forename: Michinori
authors.initials: M
authors.lastname: Ogura
authors.forename: Miki
authors.initials: M
authors.lastname: Nishimura
authors.forename: Fumiharu
authors.initials: F
authors.lastname: Yazaki
authors.forename: Masami
authors.initials: M
authors.lastname: Bessho
authors.forename: Hideaki
authors.initials: H
authors.lastname: Mizoguchi
authors.forename: Shigeru
authors.initials: S
authors.lastname: Chiba
authors.forename: Hisamaru
authors.initials: H
authors.lastname: Hirai
authors.forename: Tetsuzo
authors.initials: T
authors.lastname: Tauchi
authors.forename: Akio
authors.initials: A
authors.lastname: Urabe
authors.forename: Masatomo
authors.initials: M
authors.lastname: Takahashi
authors.forename: Kazunori
authors.initials: K
authors.lastname: Ohnishi
authors.forename: Toshiya
authors.initials: T
authors.lastname: Yokozawa
authors.forename: Nobuhiko
authors.initials: N
authors.lastname: Emi
authors.forename: Masami
authors.initials: M
authors.lastname: Hirano
authors.forename: Chihiro
authors.initials: C
authors.lastname: Shimazaki
authors.forename: Shinji
authors.initials: S
authors.lastname: Nakao
authors.forename: Yasukazu
authors.initials: Y
authors.lastname: Kawai
authors.forename: Masahiro
authors.initials: M
authors.lastname: Fujimoto
authors.forename: Hirokuni
authors.initials: H
authors.lastname: Taguchi
authors.forename: Itsuro
authors.initials: I
authors.lastname: Jinnai
authors.forename: Ryuzo
authors.initials: R
authors.lastname: Ohno
mesh_terms: D000328:Adult; D000368:Aged; D001549:Benzamides; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate; D007564:Japan; D015466:Leukemia, Myeloid, Chronic-Phase / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage* / Q000633:toxicity; D011743:Pyrimidines / Q000008:administration & dosage* / Q000633:toxicity; D012074:Remission Induction; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate