Comparison Of Efficacy And Safety Of Decitabine,CAG And HAG Regimens In The Treatment OfHigh-risk Patients With Myelodysplastic Syndromes

Objective:To compare the efficacy and safety of the decitabine single-agent regimen,HAG regimen,and CAG regimen in the treatment of high-risk patients with myelodysplastic syndromes,providing a clinical basis for the selection of clinical treatment options for high-risk patients with myelodysplastic syndromes.Method:A retrospective analysis method was used to collect clinical data from 68 patients with high-risk MDS admitted to the Department of Hematology of the First Affiliated Hospital of Nanchang University from March 01,2013 to March 31,2018.Grouped by treatment regimens,28 cases received decitabine single-agent regimen,19 cases received HAG regimen,21 cases received CAG regimen.Comparing the complete remission rate and the overall response rate of the three treatment options to evaluate the efficacy,and analyze relevant factors that may affect efficacy.The safety of the treatment regimens was evaluated by comparing the occurrence of adverse reactions in each groups.Result:1.Comparison of curative effects in three regimens: In 28 patients that received decitabine single-agent regimen,8(28.6%)cases received(CR),5(17.9%)cases received(PR),1(3.6%)case received(m CR),3(10.7%)cases received(HI),,the overall response rate(ORR)was 60.8%.In 19 patients that received HAG regimen,1(5.3%)cases received(CR),2(10.5%)cases received(PR),1(5.3%)case received(m CR),1(5.3%)cases received(HI),the overall response rate(ORR)was 26.3%.In 21 patients that received CAG regimen,3(14.3%)cases received(CR),2(9.5%)cases received(PR),1(4.3%)case received(mCR),1(4.3%)cases received(HI),the overall response rate(ORR)was 33.3%.The CR rate in three regimens has no statistical difference(P = 0.107).The difference of ORR in three regimens was statistically significant(P =0.038).Subgroup analysis showed,ORR in three regimens has nostatistical difference when patients were stratified by age,sexuality or IPSS-R score.When patients were stratified by disease type,the difference of ORR in three regimens was statistically significant(P =0.035)in the type RAEB-II.When patients were stratified by blutbild,the difference of ORR in three regimens was statistically significant when Hb≥60 g/L(P =0.016)or Plt<20×10^9/L(P=0.025).2.Comparison of survival in three regimens:The median OS of decitabine single-agent regimen,HAG regimen and CAG regimen were 23(4-28)months,12(2-17)months and 14(2-20)months,the difference of OS in three regimen was statistically significant(P = 0.047),The median PFS of decitabine single-agent regimen,HAG regimen and CAG regimen were 13(3-15)months,10(1-15)months and 12(2-19)months,the difference of PFS in three regimen was statistically significant(P = 0.042).Subgroup analysis showed,OS and PFS in three regimens has no statistical difference when patients were stratified by age,disease type or IPSS-R socre.The mortality rate of decitabine single-agent regimen,HAG regimen and CAG regimen were 32.1%,63.2% and 61.9%,the difference of mortality rate in three regimen was statistically significant(P = 0.048).when patients were stratified by IPSS-R score,the difference of mortality rate in three regimens was statistically significant(P =0.030)in the very high risk group.mortality rate in three regimens has no statistical difference when patients were stratified by age,disease type.Treatment-related mortality rate in three regimens has no statistical difference.3.Comparison of the acute leukemia conversion rate in three regimens : The conversion rate to acute leukemia of decitabine single-agent regimen,HAG regimen and CAG regimen were 10.3%,42.7% and 38.1%,the difference of acute leukemia conversion rate in three regimens was statistically significant(P = 0.029).4.Comparison of safety in three regimens:The major adverse reactions of three groups during treatment were hematologic toxicity,infections and gastrointestinal reactions.There were no statistically significant differences among three groups in the incidence of hematologic toxicity.The difference of neutrophenia duration in three regimen was statistically significant(P = 0.018).There were statistically significant differences among three groups in mean red blood cells transfusion(P=0.034)and mean platelet transfusion(P=0.001).The incidences ofinfection has statistically significant differences in three regimens(P=0.026).The incidences of gastrointestinal reactions has statistically significant differences in three regimens(P=0.009).The incidences of other adverse reactions in three regimens has no statistical difference.Conclusion:1.The short-term efficacy of decitabine single-agent regimen in the treatment of high-risk patients with MDS is superior to that of the CAG regimen and the HAG regimen,while long-term effect needs further observation.2.Compared with CAG regimen and HAG regimen,decitabine single-agent regimen has significant advantages in prolonging patient survival,reducing mortality,and reducing transfusion dependency.3.The incidence rates of adverse reactions are similar in the decitabine single-agent regimen,CAG regimen and HAG regimen,but the adverse reactions to the decitabine single-agent regimen were less severe and shorter duration.