Analysis Of Clinical Efficacy And Influencing Factors Of Decitabine Alone Or In Combined With Pre-excitation Regimen In Treatment For Patients With Myelodysplastic Syndrome With Excess Blasts

Objective: To evaluate the clinical efficacy and safety of decitabine alone or in combined with pre-excitation regimen in treatment for myelodysplastic syndrome with excess blasts(MDS-EB),and to analyze the influencing factors.Methods: Fifty-eight cases of newly diagnosed MDS-EB admitted in the Department of Hematology of The Second Hospital of Hebei Medical University were selected for retrospective analysis.35 of them treated with single-agent decitabine,23 patients were received the decitabine combined with pre-excitation(CHG,CAG)regimen,and the clinical efficacies and adverse reactions of the two groups were compared.The clinical datas of 58 patients with MDS-EB treated with decitabine alone or decitabine combined with pre-excitation regimen were analyzed by Chi-square test to evaluate the effects of the factors such as gender,age,peripheral blood neutrophil count,peripheral blood hemoglobin count,platelet count doubling after 1 course,marrow blasts,WHO Classification,IPSS-R Risk Category,chromosome karyotype,gene mutations(RUNX1?DNMT3A?TP53?ASXL1?TET2)on the clinical efficacies.Statistically significant factors were selected for Logistic multiple regression analysis,and the Kaplan-Meier method was used to describe the survival curve.Results: 1.Analysis of treatment effect of 58 patients with MDS-EB: The median chemotherapy cycle of 58 patients was 3(1 to 11)cycles.The overall response rate(ORR)of 58 patients was 75.9%(44/58),among them 21 achieved complete remission(CR),20 achieved marrow complete remission(m CR),3 achieved marrow complete remission with hematological improvement(m CR/HI),3 achieved stable disease(SD),treatment failed in 11 cases,including 2 cases with early death.The ORR of decitabine group was 74.3%(26/35),including 9 patients with CR,15 patients with m CR,2 patients with m CR / HI,2 patients with SD,7 patients with treatment failed,including 1 case with early death;The ORR of decitabine combined with pre-excitation regimen group was 78.3%(18/23),including 12 CR,5 m CR,1 m CR / HI,1 SD,and treatment failed in 4 cases,including 1 case with early death.The difference in ORR between two groups was not statistically significant(P>0.05),but there was a statistically significant difference in CR between the two groups(P<0.05).2.Comparison of ORR and CR rate after 2 and 4 cycles of the treatment: The results showed that after 2 cycles of treatment,the ORR of the decitabine group was 45.7%(16/35),of which the CR rate was 5.7%(2/35),the ORR of the decitabine combined with pre-excitation regimen group was 60.9%(14/23),of which the CR rate was 34.8%(8/23).There was no significant difference in ORR between the two groups(P>0.05),and the difference in CR between the two groups was statistically significant(P<0.05).After 4 treatment cycles,the ORR of the decitabine group was 71.4%(25/35),of which the CR rate was 22.9%(8/35),and the ORR of the decitabine combined with pre-excitation regimen group was 73.9%(17/23),of which the CR rate was 47.8 %(11/23);The difference in ORR between the two groups was not statistically significant(P>0.05),but the difference in CR between the two groups was statistically significant(P<0.05).3.Comparison of adverse reactions between the two groups: The most common adverse reactions during the chemotherapy were grade III-IV hematological adverse events and infection.Comparing the adverse reactions of the decitabine group and the decitabine combined with pre-excitation regimen group,all the two groups showed grade III-IV hematological adverse reaction of neutrophile,the incidence of grade III-IV hemoglobin adverse reaction was 94.3% vs 100%(P>0.05),the incidence of grade III-IV platelet adverse reaction was 74.3% vs 82.6%(P>0.05);The infection was mainly caused by pulmonary infection and bloodstream infection,the incidence of pulmonary infection was 71.4% vs 69.6%(P>0.05),and the incidence of bloodstream infection was 45.7% vs 60.9%(P>0.05).Other non-hematological adverse reactions included hepatic dysfunction,respiratory and circulatory failure and arrhythmia.The incidences of hepatic dysfunction in the two groups were2.6% and 26.0%,and the difference in hepatic dysfunction between the groups was statistically significant(P <0.05).All patients had no organ bleeding and severe blood loss during the treatment.4.Analysis of factors affecting the clinical efficacy: In the single-influence factor analysis,platelet count doubling after 1 course treatment,chromosome karyotype and gender were the influencing factors for the efficacy of decitabine alone or decitabine combined with pre-excitation therapy in patients with MDS-EB.Multivariate logistic regression model showed that platelet count doubling after 1 course treatment was the independent prognostic factors for predicting the CR after the treatment of decitabine alone or decitabine combined with pre-excitation regimen,there was no independent factors was found to predict the ORR of patients with MDS-EB after the treatment.5.Survival analysis of the two groups: The median follow-up time of 58 patients was 12(1 to 32)months.The median OS time of the decitabine group was 12(1 to 32)months,and the median PFS time was 9(1 to 32)months,among them 10 patients progressed to AML and 26 cases died.The median OS time was 11(2 to 26)months and the median PFS time was 9(2 to 26)months in the decitabine combined with pre-excitation regimen group,of which 5 patients progressed to AML and 16 cases died.There was no statistically significant difference in OS and PFS between the two groups(P=0.899 P=0.370).Conclusions: 1.The clinical efficacies of decitabine alone or decitabine combined with pre-excitation regimen in patients with myelodysplastic syndrome with excess blasts are positive.Decitabine combined with pre-excitation regimen achieves complete remission more easier and earlier.The most common adverse reactions during chemotherapy are grade III-IV hematological adverse events and infection,which can be tolerated by active symptomatic support treatment.2.The platelet count doubling after 1 course,moderate/good karyotype and female patients with MDS-EB are more likely to achieve clinical remission after the treatment of decitabine alone or decitabine combined with pre-excitation regimen.The platelet count doubling after 1 course is the independent factor affecting CR rate in patients with MDS-EB after the treatment of decitabine alone or decitabine combined with pre-excitation regimen.