Jiang H, Zhi L T, Hou M, Wang J X, Wu D P, Huang X J
The Institute of Hematology, People's Hospital of Peking University, Beijing 100044, China.
The First Affiliated Hospital of Suzhou University, Jiangsu Institute of Hemayology, Suzhou 215006, China.
Zhonghua Xue Ye Xue Za Zhi. 2017 Jul 14;38(7):566-571. doi: 10.3760/cma.j.issn.0253-2727.2017.07.003.
To evaluate the efficacy and safety of generic imatinib (Genike, Chiatai Tianqing Pharmaceutical Group Co., Ltd.) and imatinib (Glevic, Novartis, Switzerland) in newly diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP) . A retrospective study of 323 CML-CP patients (205 in Glivec treatment group and 118 in Genike group) who were ≥ 18 years old receiving imatinib monotherapy over the period of June 2013 to March 2016 was done to compare the differences of cytogenetics, molecular curative effect, survival, and adverse reactions between the two groups. The beginning dosage of imatinib was 400mg per day. There was no statistically difference between the two groups of patients on baseline. ①The median duration of imatinib treatment was 13 (0.5-36) months in Glevic group and 11 (1-31) months in Genike group. ②The rate of complete hematological remission (CHR) had no statistically difference between Glivec and Genike treatment groups[98% (201/205) 97.5% (115/118) , (2)=0.123, =0.725]. ③Cumulative rates of major cytogenetic responses (MCyR) at 3, 6 and 12 months after imatinib treatment in Gleevec and Genike groups were (59.7±3.5) % (79.8±3.1) %, (89.2±2.6) % (59.1±4.7) %, (80.3±4.1) % (87.1±4.3) %, respectively, the difference was not statistically significant ((2)=0.084, =0.772) . Cumulative rates of complete cytogenetic response (CCyR) at 3, 6 and 12 months after imatinib treatment in Gleevec and Genike groups were (32.9±3.4) % (58.3±3.7) %, (87.4±3.0) % (35.2±4.5) %, (64.8±4.8) % (87.3±4.7) %, respectively, the difference was not statistically significant ((2)=0.660, =0.417) . ④Cumulative rates of major molecular responses at 6, 12 months after imatinib treatment in Glevic and Genike groups were (24.9±3.3) % (57.0±4.1) %, (16.3±4.0) % (55.3±7.7) %, respectively, there was no statistical significance ((2)=1.617, =0.204) . Cumulative rates of molecular response 4.5 (MR4.5) at 12 months after imatinib treatment in Glevic and Genike groups were (14.9±3.2) % (8.1±2.1) % ((2)=3.628, =0.057) , respectively. ⑤At a median follow-up of 12 months, the difference of progression-free survival (PFS) in Glevic and Genike groups had no statistical significance[ (96.6±1.4) % (93.3±2.5) %, (2)=2.293, =0.130]. The difference of event-free survival (EFS) had no statistical significance, either[ (95.6±1.5) % (93.3±2.4) %, (2)=2.124, =0.145]. ⑥Genike was well tolerated in patients with CML-CP and had no statistically significant difference in adverse events compared with Glevic group. There were no statistically significant differences in efficacy and safety between Glevic and Genike treatment in newly diagnosed patients with CML-CP.
评估国产伊马替尼（格列卫，正大天晴药业集团股份有限公司）与伊马替尼（格列卫，瑞士诺华公司）治疗新诊断慢性期慢性髓性白血病（CML-CP）患者的疗效和安全性。对2013年6月至2016年3月期间接受伊马替尼单药治疗的323例年龄≥18岁的CML-CP患者进行回顾性研究（格列卫治疗组205例，格列卫组118例），比较两组患者细胞遗传学、分子疗效、生存率及不良反应的差异。伊马替尼起始剂量为每日400mg。两组患者基线时无统计学差异。①格列卫组伊马替尼治疗的中位持续时间为13（0.5 - 36）个月，格列卫组为11（1 - 31）个月。②完全血液学缓解（CHR）率在格列卫组和格列卫组之间无统计学差异[98%（201/205）对97.5%（115/118），(2)=0.123，=0.725]。③格列卫组和格列卫组伊马替尼治疗后3、6和12个月的主要细胞遗传学反应（MCyR）累积率分别为（59.7±3.5）%对（79.8±3.1）%、（89.2±2.6）%对（59.1±4.7）%、（80.3±4.1）%对（87.1±4.3）%，差异无统计学意义（(2)=0.084，=0.772）。格列卫组和格列卫组伊马替尼治疗后3、6和12个月的完全细胞遗传学反应（CCyR）累积率分别为（32.9±3.4）%对（58.3±3.7）%、（87.4±3.0）%对（35.2±4.5）%、（64.8±4.8）%对（87.3±4.7）%，差异无统计学意义（(2)=0.660，=0.417）。④格列卫组和格列卫组伊马替尼治疗后6、12个月主要分子反应的累积率分别为（24.9±3.3）%对（57.0±4.1）%、（16.3±4.0）%对（55.3±7.7）%，无统计学意义（(2)=1.617，=0.204）。格列卫组和格列卫组伊马替尼治疗12个月时分子反应4.5（MR4.5）的累积率分别为（14.9±3.2）%对（8.1±2.1）%（(2)=3.628，=0.057）。⑤中位随访12个月时，格列卫组和格列卫组的无进展生存期（PFS）差异无统计学意义[（96.6±1.4）%对（93.3±2.5）%，(2)=2.293，=0.130]。无事件生存期（EFS）差异也无统计学意义[（95.6±1.5）%对（93.3±2.4）%，(2)=2.124，=0.145]。⑥格列卫在CML-CP患者中耐受性良好，与格列卫组相比不良事件无统计学差异。格列卫组和格列卫组治疗新诊断CML-CP患者的疗效和安全性无统计学差异。
