Analysis On Clinical Efficacy And The Related Influencing Factors Of Decitabine-based Regimens In Patients With Myelodysplastic Syndrome

ObjectiveWe aimed to analyze the clinical date of decitabine-based regimens in patients with myelodysplastic syndrome retrospectively,as well as the clinical efficacy,side effects of decitabine,and the differences of relevant influencing factors on curative effect and prognosis.MethodsThe clinical data of 85 patients with myelodysplastic syndromes who received 2 or more courses of decitabine-based regimens were analyzed retrospectively to evaluate the clinical efficacy and toxicity.All these patients were admitted in Qilu Hospital of Shandong University from March 2010 to September 2016.And all patients were diagnosed and classified by 2008 WHO revised myeloid dysplasia syndrome classification criteria.Risk stratification was performed by the 2012 revised international prognostic score system.We chose SPSS 19.0 software for statistical analysis,and chi-square test for the analysis of gender,age,IPSS-R staging,IPSS-R cytogenetic groups,WHO classification,medication regimens,medication days,courses of treatment,complications,blood cell status,original or imitated products and other factors on the efficiency and prognosis.Kaplan-Meier method was used for survival analysis.COX proportional hazards regression model was used for multivariate analysis.And P<0.05 was considered statistically significant.Results1.Among all the 85 patients with myelodysplastic syndromes who received decitabine-based regimens for 2 or more cycles,the distribution of age and sex were as follows:male patients 52,and female 33,and the median age was 54(16-78)years old.According to the classification of 2008 WHO,1 case was refractory anemia(RA),2 cases were refractory anemia with ring sideroblasts(RAS),12 cases were refractory cytopenia with multiple system abnormalities(RCMD),23 cases were refractory anemia with excess blasts-1(RAEB-1),38 cases were refractory anemia with excess blasts-2(RAEB-2),8 cases were MDS/MPN(Including CMML),another one was MDS with chronic lymphocytic leukemia(CLL).In the IPSS-R group,2 cases were in low-risk group,11 in middle-risk group,37 in high-risk group and 35 in higher-risk group.2.The overall response rate of the 85 MDS patients with decitabine treatments was 52.9%.The complete remission(CR)rate was 17.6%,partial response(PR)rate 2.3%,bone marrow complete remission(mCR)rate 10.6%,and the hematological improvement(HI)rate 22.3%,respectively.Among the 85 patients,6(7.06%)patients died and 6(7.06%)patients transformed into acute leukemia.It was about 3.5(3-4)cycles which could achieve the best efficiencies.After the median follow-up of13(1-68)months,the median overall survival(OS)time and Progression-Free Survival(PFS)were 13 months and 11 months respectively.The average time for OS anf PFS was 15.8 months and 14.1 months respectively.The 1-year overall survival(OS)rates of patients were 85.1%,and the 1-year Progression-Free Survival(PFS)rates were 74.6%.3.Among the influencing factors for efficacy of decitabine,the risk stratification of IPSS-R which revised by MDS prognosis working group in 2012 was statistically significant.The high-risk and higher-risk groups were more beneficial form decitabine.4.In the univariate analysis,the factors such as sex,age,IPSS-R stage,IPSS-R cytogenetic groups,WHO classification,medication regimens,medication days,complications,and original or imitated products had no relationship with the efficacy(P>0.05).CR,PR,mCR or HI response(P=0.019 vs P=0.009)and ranulocytopenia at onset(P=0.02 vs P=0.009)were prognostic factors for OS,which were same with factors for PFS(P<0.05).Multivariate analysis by COX regression results were the same with univariate analysis.5.Myelosuppression and lung infection were the most common toxicity of decitabine in patients with MDS.Other infection including gingivitis/stomatitis,skin and soft tissue,urinary tract,perianal and intestinal infection.Some others may suffer abnormal liver function,gastrointestinal reactions,lack of grain with fever,dizziness,headache,rash,chest tightness,edema,any part of the paresthesia and cerebral hemorrhage.Conclusion1.Decitabine is an effective and well-tolerated drug in the treatment of myelodysplastic syndrome.2.The cytogenetic characteristics of MDS are highly heterogeneous.Decitabine is more efficient for middle-risk cytogenetic groups.3.Revised International scoring system(IPSS-R)was the most important factor influencing the efficacy of decitabine.And high-risk group will get more benifits from decitabine.4.The 1-year progression free survival(PFS)rate was 74.6%,while the 1-year cumulative survival rates(OS)of MDS were 85.1%.Granulocytopenia at onset and the response for decitabine were prognostic factors for OS and PFS.5.Bone marrow suppression and infection are the main side effects for decitabine.Prophylactic use of anti-infective drugs can significantly reduce infection-related adverse events.