Efficacy And Safety Of Decitabine Combined With CAG For Patients With Intermediate Or High Risk Myelodysplastic Syndrome And Acute Myeloid Leukemia:a Meta-analysis

【Objectives】To systematically review the efficacy and safety of DCAG regimen in intermediate or high risk MDS and AML.【Methods】Pub Med,EMbase,The Cochrane Library,Wan Fang Data and CNKI databases were searched to collect randomized controlled trials(RCTs)of decitabine combined with CAG regimen for intermediate or high risk MDS and AML from inception to February,2019.The quality of each RCT was evaluated by the Cochrane collaboration’s tool for assessing the risk of bias.Then,data were analyzed by using Rev Man 5.3.【Results】Twenty-seven RCTs were included in the meta-analysis,containing 1763 patients with intermediate or high-risk MDS and AML,of whom 594 were AML patients and 650 were MDS patients.The DCAG group treated with the DCAG protocol,and the control group treated with single-agent decitabine or CAG regimen.The results of metaanalysis showed that:1、Compared with other therapies,the complete remission rate of DCAG regimen in patients with intermediate or high-risk MDS and AML is 50%,95% CI:43%-57%,higher than that of other groups(RR=1.61,95% CI:1.44-1.81,P=0.0002),and the overall response rate is 76%,95% CI:70%-81%,also higher than that of other groups(RR=1.42,95% CI:1.33-1.53,P<0.00001).2、The complete remission rate of DCAG regimen in patients with elderly AML is 61%(95% CI:56%-66%),the overall response rate is 83%(95% CI:76%-91%),the overall response rate of DCAG regimen in patients with intermediate or high-risk MDS is 44%(95% CI:32%-57%),the overall response rate is 72%(95% CI:61%-83%).There was no significant difference in the CRR and ORR between elderly AML and intermediate or high-risk MDS(P>0.05).3、Subgroup analysis results showed that DCAG regimen was better than CAG regimen in the complete remission rate(RR=1.67,95% CI:1.46-1.91,P<0.00001),and better than single-agent decitabine group(RR=1.48,95% CI : 1.19-1.84,P=0.000 5).Meanwhile,DCAG regimen was also better than CAG regimen in the overall response rate(RR=1.41,95% CI:1.29-1.53,P<0.00001),and better than singleagent decitabine group(RR=1.47,95% CI:1.28-1.67,P<0.00001).4、In terms of adverse reactions,there was no statistically significant difference in the rates of pulmonary infection(RR=0.93,95% CI : 0.62-1.40,P=0.73),myelosuppression,gastrointestinal reactions(RR=0.78,95% CI:0.50-1.21,P=0.27),myelosuppression(RR=1.02,95% CI:0.82-1.26,P=0.87)and bleeding events(RR=0.88,95% CI:0.62-1.26,P=0.49)between the two groups(P>0.05).【Results】1、DCAG regimen has significant efficacy in the treatment of intermediate or highrisk MDS and AML,and is superior to CAG regimen and single-agent decitabine regimen.2、Between elderly AML and intermediate or high-risk MDS,the therapeutic effects were similar in CRR and ORR.3、DCAG regimen has good safety in the treatment of intermediate or high-risk MDS and AML.Due to limited quantity and quality of the included studies,more high quality studies are needed to verify above conclusion.