摘要目的 评估国产伊马替尼(格尼可)与原研伊马替尼(格列卫)治疗初诊慢性期慢性髓性白血病(CML-CP)的疗效和安全性.方法 回顾性分析2013年6月至2016年3月期间诊断的323例≥18岁初诊CML-CP患者的临床资料,格列卫组205例,格尼可组118例,起始剂量均为400 mg/d.两组患者基线情况差异无统计学意义.比较两组间细胞遗传学疗效、分子学疗效、不良反应发生率及生存的差异.结果 ①格列卫组与格尼可组中位治疗时间分别为13(0.5~36)个月和11(1~31)个月.②格列卫、格尼可组完全血液学反应率差异无统计学意义[98.0%(201/205)对97.5%(115/118),χ2=0.123,P=0.725].③格列卫、格尼可组3、6、12个月主要细胞遗传学反应率分别为(59.7±3.5)%对(59.1±4.7)%、(79.8±3.1)%对(80.3±4.1)%、(89.2±2.6)%对(87.1±4.3)%,差异无统计学意义(χ2=0.084,P=0.772);格列卫、格尼可组3、6、12个月完全细胞遗传学反应率分别为(32.9±3.4)%对(35.2±4.5)%、(58.3±3.7)%对(64.8±4.8)%、(87.4±3.0)%对(87.3±4.7)%,差异无统计学意义(χ2=0.660,P=0.417).④格列卫、格尼可组伊马替尼治疗后6、12个月主要分子学反应率分别为(24.9±3.3)%对(16.3±4.0)%、(57.0±4.1)%对(55.3±7.7)%,差异无统计学意义(χ2=1.617,P=0.204);格列卫、格尼可组12个月分子学反应MR4.5差异无统计学意义[(14.9±3.2)%对(8.1±2.1)%,χ2=3.628,P=0.057].⑤中位随访12个月时,格列卫、格尼可组的无进展生存率差异无统计学意义[(96.6±1.4)%对(93.3±2.5)%,χ2=2.293,P=0.130],无事件生存率差异亦无统计学意义[(95.6±1.5)%对(93.3±2.4)%,χ2=2.124,P=0.145].⑥格尼可组患者耐受性良好,其不良反应与格列卫组比较差异无统计学意义.结论 国产伊马替尼格尼可与原研伊马替尼格列卫治疗CML-CP的疗效及安全性无明显差异.

abstractsObjective 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). Methods 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. Results 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)vs 97.5%(115/118), χ2=0.123, P=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)%vs(79.8±3.1)%,(89.2±2.6)%vs(59.1±4.7)%,(80.3±4.1)%vs(87.1±4.3)%, respectively, the difference was not statistically significant(χ2=0.084, P=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)%vs(58.3±3.7)%,(87.4±3.0)%vs(35.2±4.5)%,(64.8±4.8)%vs(87.3±4.7)%, respectively, the difference was not statistically significant(χ2=0.660, P=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)% vs(57.0 ± 4.1)%, (16.3 ± 4.0)% vs (55.3 ± 7.7)%, respectively, there was no statistical significance (χ2=1.617, P=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)% vs (8.1 ± 2.1)%(χ2=3.628, P=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)%vs(93.3±2.5)%,χ2=2.293, P=0.130]. The difference of event-free survival(EFS)had no statistical significance, either[(95.6 ± 1.5)%vs(93.3 ± 2.4)%,χ2=2.124, P=0.145].⑥Genike was well tolerated in patients with CML-CP and had no statistically significant difference in adverse events compared with Glevic group. Conclusion There were no statistically significant differences in efficacy and safety between Glevic and Genike treatment in newly diagnosed patients with CML-CP.