Observation Of Efficacy And Safety Of Brand Name Imatinib And Domestic Imatinib In Chronic Myeloid Leukemia

Objective: Tyrosine kinase inhibitors are the molecular targeted drugs for the treatment of chronic myeloid leukemia, imatinib(gleevec) is the first generation of tyrosine kinase inhibitors, significantly improved the long-term prognosis and survive of patients with chronic myeloid leukemia, but most of the patients with chronic myeloid leukemia of developing countries.Since unbearable the expensive cost. Since 2013, domestic imatinib listed, provides more choices for clinicians and patients with chronic myelogenous leukemia, but domestic imatinib lack of clinical research of efficacy and safety, this study aims to observe efficacy and safety of Domestic imatinib and brand name imatinib in Chronic myeloid leukemia.Methords: From January 2012 to December 2015, 78 patients diagnosed chronic phase of chronic myeloid leukemia(CML- CP) in our hospital, was divided into two groups(41 cases received brand name imatinib, 37 cases received domestic imatinib at a dose of 400 mg once daily). All patients diagnosed with chronic myeloid leukemia chronic phase after the examination such as MICM in our hospital. Before TKI treatment, patients did not receive other drugs for the treatment of chronic myelogenous leukemia in addition to receiving hydroxyurea and interferon treatment. Hematology response,Molecular response and cytogenetic response was assessedand at 3 months, 6 months,12 month and the adversereactions were recorded in the process of treatments of two groups of patients for analysis of efficacy and safety.Results: The rates of complete hematologic response at 3 months were 98% for patients receiving brand name imatinib, 97% for those receiving domestic imatinib. The rates of complete hematologic response of two groups of patients at 6 months and 12 months were 100%. The rates of major molecular response at 3 months were 3% for patients receiving brand name imatinib, 8% for those receiving domestic imatinib. The rates of major molecular response at 6 months were 33% for patients receiving brand name imatinib, 37% for those receiving domestic imatinib. The rates of major molecular response of two groups of patients at 12 months were 63%. The rates of getting the optimal effect namely the BCR/ABL1 IS < 1% at 6 months were 73%, 58% respectively. The rates of Complete cytogenetic response of two groups at 3 months were 34%, 39% respectively. The rates of Complete cytogenetic response of two groups at 6 months were 78%, 63% respectivel. The rates of Complete cytogenetic response of two groups at12 months were 82%, 79% respectively. The distribution of adverse events of two groups was similar in the process of treatment, there was no significant difference, but have their own characteristics.Conclusion: The rates of complete hematologic response?major molecular response?Complete cytogenetic response of two groups of patients at 3 months?6 months and 12 months were similar. The rate of BCR-ABL1IS?10% at 3 months for those receiving domestic imatinib was not less than the rate for those receiving brand name imatinib. The long term efficacy of domestic imatinib in the treatment of CML after brand name imatinib therapy and getting major molecular response is still to be observed.The spectrum of adverse response of two groups are similar, but each have characteristics.