Morishima Yasuo, Ogura Michinori, Nishimura Miki, Yazaki Fumiharu, Bessho Masami, Mizoguchi Hideaki, Chiba Shigeru, Hirai Hisamaru, Tauchi Tetsuzo, Urabe Akio, Takahashi Masatomo, Ohnishi Kazunori, Yokozawa Toshiya, Emi Nobuhiko, Hirano Masami, Shimazaki Chihiro, Nakao Shinji, Kawai Yasukazu, Fujimoto Masahiro, Taguchi Hirokuni, Jinnai Itsuro, Ohno Ryuzo
Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan.
Int J Hematol. 2004 Oct;80(3):261-6. doi: 10.1532/ijh97.04074.
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.
甲磺酸伊马替尼是一种相对较新的药物，它作用于慢性粒细胞白血病（CML）的分子基础——BCR-ABL嵌合蛋白。针对39例处于CML慢性期的日本患者开展了一项II期临床试验，使用剂量为每日400 mg的甲磺酸伊马替尼。92.3%的患者获得血液学完全缓解，43.6%的患者获得完全细胞遗传学缓解（CR），20.5%的患者获得主要部分缓解。尽管39例患者中有29例因3级或4级不良事件需要调整剂量，但大多数事件是可逆的，29例患者中有25例能够恢复治疗。在第15天至第35天之间，13例患者出现3级或4级中性粒细胞减少和/或白细胞减少，5例患者出现3级血小板减少。总体而言，28.2%的患者出现非血液学3级不良事件。这些数据支持将甲磺酸伊马替尼作为慢性期CML患者的首选治疗药物。
