甲磺酸伊马替尼治疗120例成人慢性粒细胞白血病的临床研究

[A clinical study of treating 120 cases of adult chronic myelocytic leukemia with imatinib mesylate].

作者信息

Chen Zhi-Chao, You Yong, Zhu Xiao-Ming, Li Qiu-Bai, Li Wei-Ming, Zou Ping

机构信息

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

出版信息

Zhonghua Nei Ke Za Zhi. 2007 Dec;46(12):1003-6.

PMID:18478917

Abstract

OBJECTIVE

To analyze and evaluate the clinical efficacy and safety of imatinib mesylate (IM) as a tyrosine kinase inhibitor on Ph-positive or BCR/ABL positive chronic myelogenous leukemia (CML).

METHODS

120 patients diagnosed as CML with positive Ph chromosome were treated with IM 400 mg/d for CML in chronic phase (CP) (n = 90) or 600 mg/d for CML in accelerated or blastic phase (AP or BP) (n = 30) once daily. Hematological, cytogenetic and molecular effects of IM on the disease process of these patients were evaluated with blood and marrow cells morphology examination, G-band conventional cytogenetics analysis for Ph chromosome and PCR assay for BCR/ABL gene. The treatment efficacy and safety were retrospectively studied.

RESULTS

(1) In CML-CP patients, after a follow-up of 9 ( range 3-42) months, cumulative complete hematological response (CHR), complete cytogenetic response (CCyR) and complete molecular response (CMR) rates were 73.3%, 66.7% and 54.4%, which was not influenced by prior treatment of interferon. CMR was better when time from diagnosis to treatment with IM was < or = 6 months (P < 0.05). The effect was not related with sex or age (P < 0.05). It is significant that the time to first CHR and time to first CCyR were related with the time to first CCyR and the time to first negative BCR/ ABL, respectively (both P < 0.05), while there was no relation between the time to first CHR and the time to first negative BCR/ABL (P > 0.05). (2) CHR, CCyR and CMR rates of the patients with progressive course (AP and BP) were 43.3%, 25.9% and 25.0%, respectively. The total mortality rate was 30.0%. (3) The mortality rate of the patients with age < or = 25 was higher than those >25 (P < 0.05). (4) Grade 3 leukocytopenia occurred in 16.0% of the patients and grade 3 thrombocytopenia in 18.0% of the patients and they 12 (5-20) weeks and 9 (3-16) weeks after the treatment, respectively. Nonhematological toxicities were common and tolerable.

CONCLUSION

IM can lead to considerable hematological, cytogenetic and molecular response rates in CML, especially CML-CP patients, with minor tolerable side effects.

摘要

目的

分析和评估甲磺酸伊马替尼（IM）作为酪氨酸激酶抑制剂对Ph阳性或BCR/ABL阳性慢性髓性白血病（CML）的临床疗效及安全性。

方法

120例确诊为Ph染色体阳性的CML患者，慢性期（CP）患者90例，接受IM 400mg/d治疗；加速期或急变期（AP或BP）患者30例，接受IM 600mg/d治疗，均为每日1次。通过血液和骨髓细胞形态学检查、Ph染色体G带常规细胞遗传学分析及BCR/ABL基因PCR检测，评估IM对这些患者疾病进程的血液学、细胞遗传学及分子学效应。对治疗疗效及安全性进行回顾性研究。

结果

（1）CML-CP患者，随访9（3 - 42）个月，累积完全血液学缓解（CHR）率、完全细胞遗传学缓解（CCyR）率及完全分子学缓解（CMR）率分别为73.3%、66.7%和54.4%，不受干扰素既往治疗影响。从诊断至IM治疗时间≤6个月时CMR更佳（P<0.05）。疗效与性别及年龄无关（P>0.05）。首次CHR时间及首次CCyR时间分别与首次CCyR时间及首次BCR/ABL阴性时间相关（均P<0.05），而首次CHR时间与首次BCR/ABL阴性时间无关（P>0.05）。（2）病程进展（AP和BP）患者的CHR、CCyR及CMR率分别为43.3%、25.9%和25.0%。总死亡率为30.0%。（3）年龄≤25岁患者的死亡率高于>25岁患者（P<0.05）。（4）16.0%的患者出现3级白细胞减少，18.0%的患者出现3级血小板减少，分别在治疗后12（5 - 20）周和9（3 - 16）周出现。非血液学毒性常见且可耐受。