Clinical Efficacy Analysis Of Decitabine In Patients With Intermediate Or High-Risk Myelodysplastic Syndrome And Combined With CAG Regimen In Patients With Elderly And Refractory Or Relapsed Acute Myeloid Leukemia

Part One Reduced-Dose Decitabine Versus Traditional Chemotherapy Regimen in Patients with Intermediate-or High-Risk Myelodysplastic SyndromeObjective : This study was purposed to compare the clinical efficacy and relevant adverse reactions of homebred decitabine and traditional chemotherapy regimen in patients with intermediate-or high-risk myelodysplastic syndrome(MDS).Methods: 48 patients suffered from newly diagnosed intermediate-or high-risk MDS from December 2011 to December 2016 were analyzed retrospectively.28 patients were treated by traditional chemotherapy regimen,19 patients were treated by homebred decitabine regimen(15 mg/(m2.d),ivgtt,d1-5).The clinical efficacy and relevant adverse reactions of two groups were observed.Results: After 1 cycle of treatment,the overall response rate(ORR)of decitabine treatment group and traditional chemotherapy treatment group was 15.8%,20.6%,respectively.the difference was not statistically significant(χ2=0.062,P>0.05).After2 cycles of treatment,the ORR of decitabine group was 78.9%(15 cases),among the patients,5 achieved complete remission(CR),5 achieved partial remission(PR),5achieved hematological improvement(HI).The ORR of traditional chemotherapy treatment group was 65.9%(16 cases),including 6 CR、5 PR、8 HI,the ORR and remission rate(PR+CR)difference with decitabine versus traditional chemotherapy were not statistically significant(χ2=0.458,P>0.05;χ2=0.499,P>0.05).After 4cycles of treatment,the ORR in decitabine group was 84.2%(16 cases),including 5CR、9 PR、2 HI.The ORR in traditional chemotherapy group was 68.9%(20cases),including 6 CR、5 PR、9 HI.The ORR difference with decitabine versus traditional chemotherapy was not statistically significant(χ2=0.726,P>0.05),but the remission rate difference was statistically significant(χ2=4.534,P<0.05).The median overall survival(OS)of traditional chemotherapy group was 18(14-26)mouths,the median progression-free survival(PFS)was 11(9-19)mouths.In the all patients,5 patients were turned to acute myeloid leukemia(AML),19 patients were dead.The median OS and PFS in decitabine group were not reached,The overall survival and progression-free survival prolongation with decitabine versus traditional chemotherapy were statistically significant(P=0.034;P=0.003).The rates of Ⅲ-Ⅳ grades adverse reactions of hemoglobin,platelet and neutrophile in patients treated with decitabine and traditional chemotherapy were 52.6%: 79.3%(P > 0.05),57.9%: 86.2%(P > 0.05),84.2%:96.6%(P>0.05),respectively.And the rates of infection were 26.3%: 79.3%(P<0.05),respectively.Conclusion: Decitabine can effectively treat intermediate to High-Risk MDS,It can be also well tolerated.So,It is worth to apply in clinic.Part Two Clinical Efficacy Analysis of Decitabine Combined with CAG Regimen on Elderly and Refractory or Relapsed Acute Myeloid LeukemiaObjective : To investigate the therapeutic effectiveness and side effect of homebred decitabine combined with CAG regimen on elderly and relapse or refractory patients with acute myeloid leukemia(AML).Methods: 22 patients suffered from elderly or relapsed or refractory acute myeloid leukemia(AML)from January 2015 to August 2016 treated with homebred decitabin combined with CAG regimen[decitabine 15 mg/(m2.d),d1-5,aclarubicin 10 mg/d,d3-6,Ara-C 10 mg/m2,q12 h,d3-9,G-CSF,300 mg/d,d0-9),the therapeutic effectiveness and adverse reactions were observed.Results: Of eight newly diagnosed elderly patients,four achieved complete remission(CR),two achieved partial remission(PR),the overall response rate(ORR)was 75.0%.In the fourteen refractory or relapsed patients,three cases achieved CR,six cases achieved PR,and the ORR was 64.3%.The median overall survival(OS)time was 12months(1-17 months).The median progression-free survival(PFS)time was 9months(0-15 months).The 6-month OS was 57.3%,the 12-month OS was 31.8%.The hematologic toxicity rate was 100 % and the severe bleeding rate was 4.5%,the incidence rate of infection was 63.6%.Neither liver and kidney injury,nor nausea and vomiting,at the degree of grade 3 or 4,was observed.Conclusion: Homebred decitabine combined with CAG regiment can effectively treat elderly and refractory or relapsed AML,but the rate of hematologic toxicity and infections is severe,it is necessary to give appropriate monitoring and supportive treatment.