国产与原研伊马替尼治疗初诊慢性期慢性髓性白血病的疗效和安全性比较——多中心回顾性临床研究

OBJECTIVE: 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), χ(2)=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 (χ(2)=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 (χ(2)=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 (χ(2)=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) % (χ(2)=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) %, χ(2)=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) %, χ(2)=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.