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.
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.
Morishima
Yasuo
Y
Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan. ymorisim@aichi-cc.jp
Ogura
Michinori
M
Nishimura
Miki
M
Yazaki
Fumiharu
F
Bessho
Masami
M
Mizoguchi
Hideaki
H
Chiba
Shigeru
S
Hirai
Hisamaru
H
Tauchi
Tetsuzo
T
Urabe
Akio
A
Takahashi
Masatomo
M
Ohnishi
Kazunori
K
Yokozawa
Toshiya
T
Emi
Nobuhiko
N
Hirano
Masami
M
Shimazaki
Chihiro
C
Nakao
Shinji
S
Kawai
Yasukazu
Y
Fujimoto
Masahiro
M
Taguchi
Hirokuni
H
Jinnai
Itsuro
I
Ohno
Ryuzo
R
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
D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate