Analysis Of The Efficacy And Safety Of Decitabine Monotherapy And Combined With Chemotherapy With Decitabine In The Treatment Of Myelodysplastic Syndromes

Objection:A retrospective analysis of efficacy and adverse reactions of low-dose decitabine(Dac)monotherapy and combined chemotherapy in the treatment of patients with higher-risk Myelodysplastic Syndrome(MDS).Methods:This study mainly collected 81 patients with MDS admitted to the Department of Hematology,Taizhou People’s Hospital from June 2011 to December 2020.Patients can be divided into two groups: monotherapy group(N=40)and combination group(N=41).The clinical characteristics,adverse reactions,curative effect and survival time of the two groups were observed.Results:1.Comparison of clinical features: There was no statistical difference between the two groups in terms of gender,IPSS-R grouping,cytogenetics,pre-treatment hemoglobin and platelet count.At the same time,patients are classified by WHO.MDS-EB-2 is the main type of the combination group,and MDS-EB-1 is the main type of the monotherapy group(P=0.004).The average age and pre-treatment neutrophil count of patients in the combination therapy group were lower than those in the monotherapy group(P=0.006,P=0.022).2.The median treatment time in both the monotherapy group and the combination treatment group was 2 courses.In the monotherapy group,12 patients achieved complete remission/complete bone marrow remission(CR/m CR)(30%),6 patients achieved partial remission(PR)(15%),6 patients achieved hematology improvement(HI)(15%),4 patients with stable remission(SD)(10%),and 12 patients failed to treat(30%).The overall response rate(ORR)is 60%.After treatment,24 patients in the combination group achieved CR/m CR(58.54%),2 patients(4.88%)achieved PR,2patients(4.88%)achieved HI,5 patients(12.2%)achieved stable remission and 6patients did not respond to treatment,the overall response rate is 68.29%.The CR/m CR rate of the combination group was significantly higher than that of the monotherapy group(P=0.034),but the ORR difference between the two groups was not statistically significant(P>0.05).Based on the analysis of the factors that may affect the CR/m CR rate of patients,it was found that low-dose decitabine combined with chemotherapy in patients with higher-risk MDS resulted in a higher CR/m CR rate.3.The follow-up period was up to December 31,2020.The median overall survival(OS)of patients in the combination group was 13[3-66] months,and the median overall survival of patients in the monotherapy group was 18[1-86] months.There was no significant difference in median survival time between the monotherapy group and the combination group(P>0.05).One year later,there was no significant difference in survival between the two groups.After 2 years,the survival rate of the monotherapy group was significantly higher than that of the combination group(35.14% VS 10.53%,P=0.011).At the same time,by analyzing the factors that affect the survival time of patients,it is found that the OS of patients with good cytogenetic prognosis is significantly longer than that of patients with poor cytogenetic prognosis.4.During the treatment,both groups had abnormal reactions,such as bone marrow suppression,infection,gastrointestinal reactions,bleeding,liver and kidney function abnormalities.The adverse reactions such as bone marrow suppression and infection in the combination group were more serious than those in the monotherapy group.But it improved after symptomatic treatment,and there was no significant difference between the two groups.5.As of December 31,2020,15 patients eventually transformed into Acute Myeloid Leukemia(AML),of which 8 were in the monotherapy group(21.05%),and 2patients were in the moderate-risk group(>3.5),4 patients were in the high-risk group,and 2 patients in the very high-risk group.There are 7 patients in the combination group(18.42%).Among them,2 patients were in the high-risk group,and 5 patients in the very high-risk group.There was no significant difference in the conversion to leukemia rate and the median white conversion time between the two groups(P>0.05).Conclusion:1.The short-term efficacy of low-dose decitabine combined with chemotherapy in the treatment of higher-risk MDS patients is better than that of low-dose decitabine alone,and the long-term efficacy remains to be seen.2.Cytogenetics is an independent factor affecting the prognosis of patients with higher-risk MDS.3.The incidence of adverse reactions in high-risk MDS patients of the two regimens is similar,but the incidence of adverse reactions in patients in the monotherapy group is lower and the course of the disease is shorter.4.The combination group has no unique advantages in prolonging the overall survival time of patients with higher-risk MDS and the transformation time to AML.