Clinical Observation Of Domestic Imatinib In Patients With Chronic Myeloid Leukemia And Detection And Clinical Analysis Of ABL Kinase Region Mutation In Patients With Chronic Myeloid Leukemia

Objective:To observe therapeutic efficacy and safety of generic Imatinib mesylate tablet in the treatment of chronic myeloid leukemia(CML).And provide some evidence for clinical medication.Methods:Retrospective analysis 87 newly diagnosis and treatment of chronic-phase CML patients.Then we evaluated hematology,cytogenetics,molecular biology and security of patients after imatinib mesylate treatment at the time of the third,sixth,and twelfth month.Results: After 3-month intervention,the completely hematology reaction(CHR)rate was95.4%,the number of patients whose completely cytogenetic reaction(CCy R)rate was 31.0% and the major cytogenetic reaction(MCy R)rate was 63.2%.The BCR-ABL/ABL value was equal to or less than 10% was 50.6%,BCR-ABL/ABL value was equal to or less than 0.1% was 4.6%.At 6-month,the completely CHR rate was 97.7%,the number of patients whose completely cytogenetic reaction(CCy R)rate was 42.5% and the major cytogenetic reaction(MCy R)rate was 67.8%.The BCR-ABL/ABL value was equal to or less than 1% was 44.8%,BCR-ABL/ABL value was equal to or less than 0.1% was 14.9%.At 12-month,the completely CHR rate was 92.0%,the number of patients whose completely cytogenetic reaction(CCy R)rate was 64.4% and the major cytogenetic reaction(MCy R)rate was 75.9%.The BCR-ABL/ABL value was equal to or less than 0.1% was 35.6%.All of the patients were included in the observation of adverse reactions.The hemotology adverse reactions were leukocytes,hemoglobin and platelets reduced.The most of hemotology adverse reaction was grade I–II hemocytopenia.The common non-hemotology adverse reactions were edema,muscular and joints soreness,nausea and vomiting and diarrhea.The most of patients didn't have severe adverse reactions.Conclusion : The clinical efficacy of CML patients with the generic imatinib treatment is sure.CML patients with the generic imatinib treatment are well-tolerated and safe.It is worth widely using in clinic treatment.Objective Explore the BCR-ABL tyrosine kinase domain mutations in imatinib treated chronic myeloid leukemia(CML)patients in order to provide the basis for clinical treatment.Methods Totally 50 bone/ peripheral blood samples from 50 CML patients were included in this study.All samples were reversely transcribed,amplified by nested reverse transcription polymerase chain reaction(RT-PCR)and sequenced by using next generation sequencing.The occurrence of BCR-ABL tyrosine kinase domain point mutations was analysed and its relationship with imatinib resistance was analyzed.Results In the 50 patients,mutations in BCR-ABL kinase domain were detected in 11patients(22%).The mutation rate of patients with CML in the stage of the chronic phase was 5.9%(2/34)and accelerated phase/ blast phase(AP/BP)were 57.1%(4/7)and 55.6%(5/9),respectively.There was significant difference in the mutation rate between three phase(P=0.000<0.05).Eight types of mutations were detected,including E255K/V in three patients,Y253 H in three patients,G250 E and M3517 in one patient,M351 T in one patient,T315 I in one patient,M244 V in one patient and Y253 F in one patient.The ABL tyrosine kinase domain mutation is one of main reasons of the imatinib resistance.Timely detection of BCR-ABL tyrosine kinase domain mutation is helpful in diagnosing IM resistant patients,guiding clinical treatment and improving the clinical efficacy.