甲磺酸伊马替尼治疗慢性粒细胞白血病的临床研究

Effect of glivec on chronic myelogenous leukemia: preliminary experience of 54 cases

目的 评价酪氨酸激酶抑制剂甲磺酸伊马替尼 (STI5 71,商品名格列卫 )治疗慢性粒细胞白血病(CML)的临床近期疗效。方法 2 0 0 1年 10月～ 2 0 0 2年 11月间CML患者 5 4例 ,其中慢性期 18例 ,进展期 3 6例 (加速期 13例 ,急变期 2 3例 )。根据骨髓象和外周血常规情况给予不同剂量STI5 71口服治疗 ,每周复查血常规 ,每 3个月进行骨髓象及细胞遗传学检查。结果 开始治疗至首次血液学完全缓解 (CHR)的中位时间为 5周( 1～ 2 6周 )。中止随访时存活的患者占 87% ( 4 7/5 4例 ) ,其中 2 2例处于CHR。采用Kaplan Meier方法估计生存时间 ,从投药开始 5 2周的总生存率为 84% ,其中慢性期为 10 0 % ,加速期 64 % ,急变期 75 %。完全停药的 2 6例中 ,仅 5例 ( 19% )缘于药物不良反应。结论 大多数CML患者对口服STI5 71具有良好的耐受性 ,开始治疗时的病程、疾病阶段及投药总剂量对于治疗效果有一定影响 。

Objective To evaluate the therapeutic efficacy and side effects of Glivec (STI571), a selective tyrosine kinase inhibitor, on chronic myelogenous leukemia(CML). Methods 54 patients with CML (chronic phase 18, accelerate D phase 13 and blast crisis 23) received Glivec at the dosage of 400～600 mg once daily. Toxic effects with hematological, biochemical, and cytogenetic measurements were assessed during the 59 weeks of follow up. Results At the last visit, 47 patients were still alive and 22 patients were still continuously in complete hematological remission (CHR). The probability of survival was made with the method of Kaplan Meier, from the date of therapy visit to the last visit or to the relevant event. The overall 52 week survival was 84% including 100% in chronic phase (CP), 64% in accelerated phase (AP) and 75% in blastic crisis (BC). Of the 26 patients who discontinued STI571, only 5 patients (19%, 5/26) were due to adverse effects. Conclusion Adverse effects of STI571 are minimal and a dosage lower than 600 mg is well tolerated. We find that duration of the courses, different disease stages and the dosage impact on the effect of the drug STI571, have significant influence on the antileukemic activity in patients with CML in chronic phase.