国产甲磺酸伊马替尼治疗慢性髓性白血病慢性期早期疗效和安全性的前瞻性、多中心临床研究

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-ABL(IS) was ≤10% in 77/106 patients (72.6%), 11 of them (10.4%) achieved major molecular response (MMR, BCR-ABL(IS) was ≤0.1%). At 6-month, the CHR rate was 100% (54/54); 28/39 patients (71.8%) achieved CCyR; BCR-ABL(IS) 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.