国产伊马替尼治疗慢性髓细胞白血病有效性和安全性分析

Efficacy and safety of domestic imatinib used on patients with chronic myeloid leukemia

目的:观察国产伊马替尼治疗慢性髓细胞白血病(CML)的有效性与安全性。方法:来自三所医院30例CML慢性期(CP)患者给予国产伊马替尼治疗,观察其血液学、细胞遗传学、分子学反应以及不良反应、总生存和无病生存情况。结果:随访至2015年4月,可评价患者28例,2例失访。CML-CP患者3月总完全血液学缓解率92.9%(26/28),微小细胞遗传学反应75.0%(21/28),6月部分遗传学反应53.6%(15/28),微小遗传学反应32.1%(9/28),12月完全遗传学反应71.4%(20/28),其中主要分子学反应5例,完全分子学反应3例。3例患者进展至CML-AP,加量治疗后回至CML-CP,达到部分遗传学反应。28例患者疾病进展死亡2例,总生存92.9%,无进展生存为75.0%。无Ⅴ级血液学不良事件,Ⅲ-Ⅳ级中性粒细胞减少21.4%(6/28),血小板减少25.0%(7/28),贫血10.7%(3/28);无Ⅲ-Ⅳ级非血液学不良事件。结论:国产伊马替尼治疗CML-CP患者,有较高的完全血液学缓解率和细胞遗传学缓解率,发生Ⅲ-Ⅳ级血液学及非血液学毒性少,患者有较好的药物耐受性。

Objective：To observe the efficacy and safety of domestic imatinib used on patients with chronic myeloid leukemia（CML）. Methods：30 CML patients were treated with domestic imatinib. The responses in hematology, cytogenetics, molecules as well as overall survival and disease-free survival were observed. Results：Followed up until April 2015,28 patients were evaluable, but two cases were lost. CML-CP patients with total complete hematologic remission （CHR} were 92.9% （26/28）, minor cytogenetic response （CyR） 75.0% （21/28） in 3 months;partial cytogenetic response （PCyR） was 53.6% （15/28） ,and minor CyR 32.1% （9/28） after 6 months. CCyR reached 71.4% （20/28） after 12 months. 3 patients progressed to CML-AP. After added treatment they went back to CML-CP and reached PCyR. Among the 28 patients,2 patients died of disease progression. Overall survival was 92.9% and progression- free survival was 75.0 %. No grade V hematologic adverse events occurred. Grades m-IV neutropenia was 21.4% （6/28） , thrombocy- topenia was 25.0% （7/28} ,anemia 10.7% （3/28） ;no grade Ⅲ-Ⅳ non-haematological adverse events occurred. Conclusion： CMLCP patients have a higher rate of complete hematologic remission and cytogenetic response rates when treated in domestic imatinib therapy. Less grades Ⅲ-Ⅳ hematologic and non-hematologic toxicity occurred. The patients have a better drug tolerance.