Objective: To evaluate the early hematologic, cytogenetic and molecular responses in newly diagnosed patients with chronic myelogenous leukemia in chronic phase（CML-CP）and initially treated with a generic imatinib（Xinwei）, manufactured by Jiansu Hansoh Pharmaceutical Group Co., Ltd.
Methods: 107 newly diagnosed patients of CML-CP, whose ages were above 18- year- old and who had never received any tyrosine kinase inhibitor（TKI）were treated with Xinwei 400 mg QD. The hematologic, cytogenetic and molecular responses were assessed at 3- and 6-month, and adverse effects were evaluated throughout the study.
Results: 107 patients were treated with Xinwei for at least 3 months, 54 of them were treated for 6 months or more. At 3- month, the complete hematologic responses（CHR）rate were 98.1%（105/107）; 47/57（82.5%） patients achieved major cytogenetic response（MCyR）, and 20/57 （35.1%） patients complete cytogenetic response（CCyR）; BCR- ABLIS was ≤10% in 77/106 patients （72.6%）, 11 of them（10.4%）achieved major molecular response（MMR, BCR-ABLIS was ≤0.1%）. At 6-month, the CHR rate was 100%（54/54）; 28/39 patients（71.8%）achieved CCyR; BCR-ABLIS was ≤1% in 37/54 patients （68.5% ）, 18 of them （33.3% ） achieved MMR. The grade Ⅲ leukopenia, thrombocytopenia and anemia rates were 19.5%, 23.0% and 13.8%, respectively. No grade Ⅳ hematologic toxicity occurred. The common non- hematologic toxicities were edema（74.7%）, nausea（48.3%）, bone pain（42.5%）, rash（36.8%）, diarrhea（34.5%）, fever（23.0%）, cramp（11.5%）and impaired liver function （3.4%）. No patient experienced grade Ⅳ non- hematologic toxicity. No adverse effects related death occurred.
Conclusion: Our results revealed the excellent early haematology, cytogenetic and molecular responses and safety of Xinwei in treating patients with CML-CP.
目的: 评价国产甲磺酸伊马替尼(商品名昕维，江苏豪森药业股份有限公司产品)治疗新诊断慢性髓性白血病慢性期(CML-CP)患者的早期血液学、细胞遗传学、分子学反应和安全性。
方法: 107例年龄≥18岁、初次确诊、除羟基脲外未接受其他任何抗CML治疗的CML-CP患者，给予国产甲磺酸伊马替尼400 mg每日1次治疗，评价3、6个月时的血液学、细胞遗传学和分子学反应及安全性。
结果: 107例患者均治疗≥3个月，其中54例患者治疗≥6个月。治疗3个月时，完全血液学反应(CHR)率为98.1%(105/107)；57例进行了细胞遗传学检测的患者中47例(82.5%)获得主要细胞遗传学反应(MCyR)，其中20例(35.1%)获得完全细胞遗传学反应(CCyR)；106例进行了分子学检测的患者中77例(72.6%)国际标准化BCR-ABL转录本水平(BCR-ABLIS)≤10%，其中11例(10.4%) BCR-ABLIS≤0.1 %。治疗6个月时，CHR率为100%(54/54)；CCyR率为71.8%(28/39)；37例(68.5%) BCR-ABLIS≤1%，其中18例(33.3%)BCR-ABLIS≤0.1%。Ⅲ级白细胞减少、血小板减少和贫血发生率分别为19.5%、23.0％和13.8%，无Ⅳ级血液学不良反应发生。最常见的非血液学不良反应依次为水肿(74.7%)、恶心(48.3%)、骨关节痛(42.5%)、皮疹(36.8%)、腹泻(34.5%)、发热(23.0%)、肌肉痉挛(11.5%)和肝功能损害(3.4%)。无一例患者出现Ⅳ级非血液学不良反应。无药物毒性相关性死亡。
结论: 国产甲磺酸伊马替尼初始治疗新诊断CML-CP的早期血液学、细胞遗传学和分子学反应优异，安全性良好。