| Objective:Older patients with acute myeloid leukemia(AML)and myelodysplastic syndromes(MDS)unfit for intensive chemotherapy are emergent for suitable treatment strategies.Hypomethylating agents and low-dose cytarabine have generated relevant benefits in the hematological malignancies over recent decades.We evaluated the efficacy and safety of the novel treatment regimen consisted of granulocyte colony-stimulating factor(G-CSF)combined with ultra-low-dose of decitabine and low-dose cytarabine in this population of patients.Methods:Between January 2017 and December 2020,patients aged more than 60 years with newly diagnosed AML(non M3)/MDS in the Third Affiliated Hospital of Soochow University were enrolled to receive therapy combined of G-CSF 300ug subcutaneously per day for priming,decitabine 10mg(5.15～7.62 mg/m2/d)intravenously and cytarabine 15 mg/m2/d twice a day subcutaneously for consecutive 10 days every 28 days.The treatment group enrolled 28 patients unfit for standard intensive chemotherapy.The mean age of patients was 68.96(±5.706)years and 20(71.4%)patients harbored AML.Retrospective analysis of 22 patients with newly diagnosed AML(non M3)/MDS interfered with DAC plus CAG or IAG was conducted in our hospital during the same time.The clinical characteristics,overall response rate(ORR),adverse events and overall survival(OS)were evaluated.Methods of t test,χ2 test and Mann-Whitney U test were applied.Survival analysis and survival curve were estimated according to method of Kaplan-Meier.Log Rank test was applied to distinguish OS between two groups.Results:ORR,including CR+CRi+PR in AML and CR+mCR+PR in MDS,was 57.1%after the first treatment course in treatment arm.Responses of HI(hematologic improvement)were achieved in 18 of 28(64.3%)patients.ORR and HI in the control arm were 42.9%and 52.4%respectively,showing no significantly difference with that in treatment arm(P>0.05).Overall,this novel ultra-low-dose treatment regimen was well tolerated,with the 0%of both 4-and 8-week mortality occurrence.The control group had 2 patients occur early mortality.Occurrence of febrile fever in treatment arm was significantly less than that in control arm(P=0.014).Overall survival time of treatment arm and control arm were 12.2(0.0-30.0)months and 13.2(0.0-29.4)months respectively,showing no significantly difference(P>0.05).Conclusion:Untreated elderly with AML/MDS were well tolerated and benefited from this novel ultra-low-dose treatment regimen.Further studies are warranted to evaluate the significance of this treatment regimen consisting of G-CSF combined with ultra-low-dose decitabine and low-dose cytarabine. |
