Division of Hematology, Jichi Medical University Hospital, Shimotsuke, Japan.
Int J Hematol. 2010 Jul;92(1):111-7. doi: 10.1007/s12185-010-0621-x. Epub 2010 Jun 25.
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 > or =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., > or =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.
尽管伊马替尼已成为慢性髓性白血病（CML）的当前标准治疗方法，但针对日本患者，其疗效和安全性的相关信息有限。因此，我们针对新诊断的慢性期 CML（CP-CML）日本患者开展了一项伊马替尼的前瞻性多中心开放标签研究。共纳入 107 例患者，起始剂量为每日 400mg 伊马替尼治疗。83 例患者完成 3 年研究治疗。3 年时主要细胞遗传学缓解和完全细胞遗传学缓解（CCyR）的累积缓解率分别为 90.9%和 90.2%。安全性特征与 IRIS 研究报告的结果基本相似，尽管 3/4 级中性粒细胞减少症发生率相对较高（31.8% vs. 14.3%）。仅 7 例患者因不良事件而停止研究，4 例患者因疗效不佳而停止研究。3 年总生存率和无进展生存率分别为 93.2%和 91.4%。较高的平均日剂量（即 > 或 =350mg）不仅与更高的 CCyR 率显著相关，而且与 CCyR 的持续时间也更长相关。这些发现证实了伊马替尼在新诊断的 CP-CML 日本患者中的临床应用价值，并提示低平均日剂量对治疗结果有不利影响。
