Abstract | 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.
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Authors | Qian Jiang, Donglu Zhao, Jie Jin, Depei Wu, Fanyi Meng, Jianda Hu, Bingcheng Liu, Xin DU, Ting Liu, Yan Li, Ming Hou, Xiaopin Han, Zhixiang Shen, Jun Ma |
Journal | Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi
(Zhonghua Xue Ye Xue Za Zhi)
Vol. 36
Issue 8
Pg. 651-5
(Aug 2015)
ISSN: 0253-2727 [Print] China |
PMID | 26462633
(Publication Type: Clinical Trial, Journal Article, Multicenter Study)
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Chemical References |
- Drugs, Generic
- Protein Kinase Inhibitors
- Imatinib Mesylate
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Topics |
- Anemia
- Antineoplastic Combined Chemotherapy Protocols
- Cytogenetics
- Drugs, Generic
- Humans
- Imatinib Mesylate
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Prospective Studies
- Protein Kinase Inhibitors
- Remission Induction
- Thrombocytopenia
- Treatment Outcome
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