Imatinib for newly diagnosed chronic-phase chronic myeloid leukemia: results of a prospective study in Japan

被引:0
作者
Tadashi Nagai
Jin Takeuchi
Nobuaki Dobashi
Yuzuru Kanakura
Shuichi Taniguchi
Koji Ezaki
Chiaki Nakaseko
Akira Hiraoka
Masaya Okada
Yasushi Miyazaki
Toshiko Motoji
Masaaki Higashihara
Norifumi Tsukamoto
Hitoshi Kiyoi
Shinji Nakao
Katsuji Shinagawa
Ryuzo Ohno
Tomoki Naoe
Kazunori Ohnishi
Noriko Usui
机构
[1] Jichi Medical University Hospital,Division of Hematology
[2] Nihon University Itabashi Hospital,undefined
[3] Jikei University Hospital,undefined
[4] Osaka University Hospital,undefined
[5] Toranomon Hospital,undefined
[6] Fujita Health University Hospital,undefined
[7] Chiba University Hospital,undefined
[8] Osaka Medical Center for Cancer and Cardiovascular Diseases,undefined
[9] The Hospital of Hyogo College of Medicine,undefined
[10] Nagasaki University Hospital,undefined
[11] Tokyo Women’s Medical University,undefined
[12] Kitasato University Hospital,undefined
[13] Gunma University Hospital,undefined
[14] Nagoya University Hospital,undefined
[15] Kanazawa University Hospital,undefined
[16] Okayama University Hospital,undefined
[17] Aichi Cancer Center,undefined
[18] Hamamatsu University School of Medicine,undefined
来源
International Journal of Hematology | 2010年 / 92卷
关键词
Chronic myeloid leukemia; Chronic phase; Newly diagnosed; Imatinib;
D O I
暂无
中图分类号
学科分类号
摘要
Although imatinib has become the current standard treatment for chronic myeloid leukemia (CML), there is limited information regarding its efficacy and safety among Japanese patients. We therefore conducted a prospective multi-center open-label study of imatinib for Japanese patients with newly diagnosed chronic-phase CML (CP-CML). A total of 107 patients were enrolled and treated with imatinib at an initial daily dose of 400 mg. Eighty-three patients completed 3 years of study treatment. The cumulative rates of major cytogenetic response and complete cytogenetic response (CCyR) were 90.9 and 90.2% at 3 years, respectively. The safety profile was not very different from that reported in the IRIS study, although grade ≥3 neutropenia occurred relatively frequently (31.8 vs. 14.3%). Only seven patients discontinued the study due to adverse events, as did four patients due to insufficient efficacy. The 3-year probabilities of overall survival and progression-free survival were 93.2 and 91.4%, respectively. Higher average daily doses (i.e., ≥350 mg) were significantly associated not only with higher rates of achieving CCyR, but also with longer duration of CCyR. These findings confirm the clinical utility of imatinib in Japanese patients with newly diagnosed CP-CML, and suggest detrimental effect of low average daily dose on treatment results.
引用
收藏
页码:111 / 117
页数:6
相关论文
共 93 条
[1]  
Druker BJ(1996)Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells Nat Med 2 561-566
[2]  
Tamura S(2001)Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia N Eng J Med 344 1031-1037
[3]  
Buchdunger E(2003)Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia N Eng J Med 348 994-1004
[4]  
Ohno S(2002)Hematologic and cytogenetic responses to imatinib mesylate in chronic myelogenous leukemia N Eng J Med 346 645-652
[5]  
Segal GM(2008)Imatinib for newly diagnosed patients with chronic myeloid leukemia: incidence of sustained responses in an intention-to-treat analysis J Clin Oncol 26 3358-3363
[6]  
Fanning S(2002)Imatinib induces durable hematologic and cytogenetic responses in patients with accelerated phase chronic myeloid leukemia: results of a phase 2 study Blood 99 1928-1937
[7]  
Druker BJ(2002)Imatinib induces hematologic and cytogenetic responses in patients with chronic myelogenous leukemia in myeloid blast crisis: results of a phase II study Blood 99 3530-3539
[8]  
Talpaz M(2004)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 Int J Hematol 80 261-266
[9]  
Resta DJ(2006)Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia N Eng J Med 355 2408-2417
[10]  
Peng B(2007)Imatinib provides durable molecular and cytogenetic responses in a practical setting for both newly diagnosed and previously treated chronic myelogenous leukemia: a study in Nagasaki prefecture, Japan Int J Hematol 85 132-139