Imatinib for newly diagnosed chronic-phase chronic myeloid leukemia: results of a prospective study in Japan
Imatinib for newly diagnosed chronic-phase chronic myeloid leukemia: results of a prospective study in Japan
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DOI：
10.1007/s12185-010-0621-x
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发表时间：
2010-06
影响因子：
2.1
通讯作者：
T. Nagai;J. Takeuchi;N. Dobashi;Y. Kanakura;S. Taniguchi;K. Ezaki;C. Nakaseko;A. Hiraoka;M. Okada;Y. Miyazaki;T. Motoji;M. Higashihara;N. Tsukamoto;H. Kiyoi;S. Nakao;K. Shinagawa;R. Ohno;T. Naoe;K. Ohnishi;N. Usui
中科院分区：
文献类型：
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作者：
T. Nagai;J. Takeuchi;N. Dobashi;Y. Kanakura;S. Taniguchi;K. Ezaki;C. Nakaseko;A. Hiraoka;M. Okada;Y. Miyazaki;T. Motoji;M. Higashihara;N. Tsukamoto;H. Kiyoi;S. Nakao;K. Shinagawa;R. Ohno;T. Naoe;K. Ohnishi;N. Usui
尽管伊马替尼已成为当前慢性粒细胞白血病（CML）的标准治疗方法，但有关其在日本患者中的疗效和安全性的信息有限。因此，我们针对日本新诊断的慢性期 CML（CP-CML）患者开展了一项伊马替尼前瞻性多中心开放标签研究。共有 107 名患者入组并接受伊马替尼治疗，初始每日剂量为 400 毫克。 83 名患者完成了 3 年的研究治疗。 3 年时主要细胞遗传学反应和完全细胞遗传学反应 (CCyR) 的累积率分别为 90.9% 和 90.2%。尽管≥3级中性粒细胞减少症发生的频率相对较高（31.8% vs. 14.3%），但安全性与 IRIS 研究中报告的并无太大差异。只有七名患者因不良事件而终止研究，四名患者因疗效不足而终止研究。 3 年总生存率和无进展生存率分别为 93.2% 和 91.4%。较高的平均每日剂量（即≥350 mg）不仅与较高的 CCyR 实现率显着相关，而且与较长的 CCyR 持续时间显着相关。这些发现证实了伊马替尼在日本新诊断的 CP-CML 患者中的临床效用，并表明低平均每日剂量对治疗结果产生不利影响。
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.