Efficacy,Safety And Standardized Management Of A Domestic Imatinib Mesylate In The Treatment Of Newly Diagnosed Chronic Myeloid Leukemia In Chronic Phase

Objective:To investigate the efficacy,safety and standardized management significance of domestic imatinib mesylate in the treatment of chronic myeloid leukemia patients in chronic phase（CML-CP）.Method:Case data were collected from 86 newly diagnosed patients wit h chronic myeloid leukemia in chronic phase（CML-CP）in Wuhan Union Hospital from 2014 to 2017,who were initially treated with domestic imatinib mesylate（Xinwei,manufactured by Jiangsu Hanso h Pharmaceutical Group co.,Ltd.）since diagnosis.Retrospective stat istical analysis of these patients’case data was performed to evaluat e the efficacy and safety of treatment at 3,6,12 and 18 months a nd the significance of standardized management.Results:Among the 86 recruited patients,all of them were treated for at least3 months,80 of them were treated for at least 6 months,75 of them were treated for 12 months or more,63 of them were treated more than 18months.According to the difference of regular follow-up monitoring and treatment adherence,namely,whether or not standardized management was conducted,they were divided into standardized management group and non-standardized management group.At 3 months of treatment,the complete hematologic responses（CHR）rate was 87.1%（27/31）,BCR-ABL^IS≤10%in 32/58 patients（55.2%）,5 of them（5/58,8.6%）achieved major molecular response(MMR,BCR-ABL^IS≤0.1%),the rates of BCR-ABL^IS≤10%in the standardized management group and the non-standardized management group were 75.0%（21/28）and 36.7%（11/30）,respectively,P=0.003.At 6 months of treatment,the CHR rate was 96.4%（27/28）,BCR-ABL^IS≤1%in 26/46 patients（56.5%）,9 of them（9/46,19.6%）achieved MMR,the rates of BCR-ABL^IS≤1%in the standardized management group and the non-standardized management group were 78.3%（18/23）and 34.8%（8/23）,respectively,P=0.003.At12 months of treatment,the CHR rate was 100%（26/26）,26 of the 53patients（49.1%）achieved MMR,the rates of MMR in the standardized management group and the non-standardized management group were59.3%（16/27）and 38.5%（10/26）,respectively,P=0.130.At 18 months of treatment,the CHR rate was 100%（20/20）,24 of the 39 patients（61.5%）achieved MMR,the rates of MMR in the standardized management group and the non-standardized management group were68.4%（13/19）and 55.0%（11/20）,respectively,P=0.389.Among the 36patients who could be evaluated for safety analysis,the hematologic toxicities rates were leukopenia（26.5%）,thrombocytopenia（29.4%）,and anemia（23.5%）respectively,which were usually grade I-II,grade IV hematologic toxicities were observed occasionally,which could be improved after a short withdrawal or reduction of dosage.The common non-hematologic toxicities were edema（66.7%）,abdominal pain and diarrhea（36.1%）,nausea and vomiting（22.2%）,bone pain（11.1%）,rash and itchy skin（11.1%）,decreased appetite（8.3%）,hair loss（2.8%）,muscle cramp（2.8%）and impaired liver function（2.8%）,mostly grade I-II,only 2 cases（5.6%）had grade III bone pain and 1 case（2.8%）had grade III diarrhea,which were improved after a brief adjustment of drug dosage or taking time.No patients experienced grade IV non-hematologic toxicity.No adverse effects related death occurred.Conclusions:The study reveals that domestic imatinib mesylate has excellent efficacy and safety in the treatment of newly diagnosed CML-CP patients,and standardized management of CML-CP patients is conducive to better efficacy and prognosis.