Clinical Study Of Decitabine Based Therapy In The Treatment Ofpatients With Myeloid Malignancies

Part1Clinical study of efficacy and safety of decitabine combinedtraditional chemotherapy in the treatment of AML【Objective】To investigate and analysis the efficacy and safety of combination of decitabine withtraditional chemotherapy regimens in the treatment of patients with acute myeloidleukemia, and to identity on relative factors affecting curative effect.【Methods】From Jan2012to March2014,57patients with acute myeloid leukemia inHematology Department of The No.2Affiliated Hospital of Soochow University wereenrolled to this study. A total of21patients with AML were received decitabine basedchemotherapy (such as DA, HAA, CAG) and the patients were randomized to1of3decitabine schedules, the total dose of decitabine was75~100mg/m2. The administrationof traditional chemotherapy in two groups in the light of " Chinese guidelines for thediagnosis and treatment of acute myeloid leukemia (2011Edition)", The effectivenessand OS were analyzed by SPSS17.0software.【Results】66.7%of the patients with decitabine group was be seen to improve disease, including47.6%complete response, compared with traditional chemotherapy group (OR47.2%, CR36.4%).1-year OS in decitabine group was57.1%, while the control group was41.7%.The21patients in the decitabine group were divided into three groups according tochromosomal factors:3patients in low risk group,12in intermediate risk group and6in high-risk group, The treatment efficiency were66.7%,66.7%,66.7%.25patients intraditional chemotherapy group were feasible to evaluation chromosome,3in low-riskgroup,19were intermediate risk,3were high-risk, the treatment efficiency were33.3%,52.6%,66.7%. Curative effect of decitabine for low-risk patients was similar to patients athigh risk group.Patients who were treated with decitabine were randomized to receive decitabine at adose of25mg/d given intravenously over1hour for5days or20mg/(m2·d) givenintravenously over1hour for5days or20mg/(m2·d) given intravenously over1hour for3days and repeated every4weeks, Efficiency analysis shows that different dosing regimensof decitabine does not affect the efficacy.The adverse reactions in decitabine group was similar to traditional programs.【Conclusions】There were no difference between decitanime group and control group. Decitabineadministration did not affect the treatment effect; The adverse drug reactions of thetreatment group was not significantly different from each others. Part II Clinical study of efficacy and safety of decitabine in thetreatment of patients with myelodysplastic syndrome【Objective】Observation and analysis efficacy and safety of decitabine vs. best supportive care inpatients with myelodysplastic syndrome.【Methods】From Jan2012to Mar2014,42patients with myelodysplastic syndrome inHematology Department of The No.2Hospital Affiliated to Suzhou University wereenrolled to this study.11patients with MDS were randomized to DAC group or bestsupport care group. Decitabine treatment group were25mg/d intravenously daily for5 days, every28days a cycle. BSC group treatment with testosterone undecanoate,cyclosporine, transfusion of blood and low-dose pre-excitation. The effectiveness and OSwere analyzed by SPSS17.0software.【Results】11patients of decitabine group completed a total of35cycles of chemotherapy, theOR rate was81.8%, including27.3%CR,27.3%mCR (two cases mCR with HI, one casesmCR without HI),18.2%HI. While the OR rate was48.4%in patients with BSC group,including6.5%CR,6.5%mCR (two cases mCR without HI),35.5%HI. Two treatmentprograms had no significant effect on efficiency. There were3people of pancytopenia inDAC group,3two-line hypocytomsis,2monosystem hypocytomsis,2normal. the OR ratewere50%,66.7%,100%,100%. The OR rate in BSC group were47.1%,90%,100%,100%. The median follow-up time in decitabine group was15months,1-year survival ratewas81.8%. Supportive care group median was11months and25.8%. Survival betweenthe two groups of patients was statistically significant. The mainly adverse reactions indecitabine group was myelosuppression, most patients can tolerate and completedchemotherapy.【Conclusions】The overall response rate and remission rates in DAC group of myelodysplasticsyndrome were higher than supportive therapy group, The survival time was longer indecitabine group, and had a low incidence of adverse events. Showed that decitabine waseffective and safe in the of treatment of MDS.