| Part I Clinical effect of DCAG regimen in elderly patients aged over 80 years with newly diagnosed acute myeloid leukemiaObjective:To investigate the effectiveness and safety of dicitabine combined with low dose CAG(DCAG)regimen in elderly patients aged over 80 years with newly diagnosed acute myeloid leukemia(AML).Methods:A total of 25 previously untreated AML patients were enrolled.Twelve patients were male,and 13 were female,with ages ranging from 80 to 87(median:82)years.Cytogenetic analysis was performed in 24 patients.Ten patients with ECOG performance status Ⅰ to Ⅱ at diagnosis,and 15 with Ⅲ to Ⅳ.The DCAG regimen contained decitabine(15 mg/(m·d),dl-5),and aclacinomycin(10 mg/d,d3-6),cytarabine(10 mg/m2,ql2h,d3-9),and granulocyte colony-stimulating factor(G-CSF,300 pg/d,qd,d0-d9).Results:After one course of induction therapy,the complete remission(CR)rate was 71%,partial remission(PR)rate was 9.5%.The CR rate for patients with intermediate and unfavorable prognostic karyotypes was 81.8%and 62.5%,respectively.The median overall survival(OS)was 10 months.The disease-free survival(DFS)was 14 months.The median time to neutrophil>0.5×109/L and platelet>20×109/L was 14 d and 12 d after chemotherapy.However,13 patients interrupted chemotherapy after one or two cycles.Myelosuppression and infection due to neutropenia were the most frequent adverse effects,and the early death rate was 12.5%.Conclusion:DCAG induction therapy results in a 81%response rate in elderly patients aged over 80 years with acceptable toxicity.Part Ⅱ Comparison of clinical efficacy between DCAG regimen and CAG regimen alone in elderly patients with acute myeloid leukemiaObjective:To compare the clinical efficacy and safety of elderly patients with AML treated by DCAG(decitabine combined with low dose CAG)regimen with standard CAG regimen at our single center.Methods:Totally 67 elderly patients with AML were divided into two groups:Treated with DCAG regimen(decitabine 15 mg/(m2·d)dl-5,aclacinomycin 10 mg qd d3-6,cytarabine 10 mg/m2 q12h d3-9,G-CSF 300 μg/d qd d0-d9)and CAG(aclacinomycin 10 mg qd dl-8,cytarabine 10 mg/m2 q12h dl-14,G-CSF 300 μg/d qd d0-d14).The complete remission(CR)rate,overall survival(OS),disease-free survival(DFS)and safety of the two groups were observed.Results:CR rate in the two groups were 81.1%and 63.3%respectively,with no statistically significant difference(P>0.05).We further divided the 2 groups of patients into different subgroups according to different clinical characters including age and cytogenetics and compared the CR rates between these subgroups.There was no statistically significant difference in these CR rates.The median OS was 25 months for the DCAG group and 13 months for the CAG group.The median DFS was 13 months in the group of DCAG chemothrapy and 11.9 months in the group of CAG chemotherapy.Intrestingly,the median OS(18 months)of the elderly patients aged over 70 years receiving DCAG regimen had significantly longer than that(11 months)of those receiving CAG regimen.The adverse events of infection and bleeding were mainly caused by bone marrow suppression.The two groups showed similar incidence of adverse reaction,83.8%and 83.3%respectively,the difference is statistically insignificant.Conclusion:The DC AG regimen and CAG regimen are effective and safe as remission induction for elderly patients with AML.Interestingly,the median OS and DFS of patients in the DCAG group was found to be significantly longer than the CAG group,but the adverse events in the two groups were similar.Future studies need to identify the subset of older patients with AML who are more likely to benefit from DCAG regiment.Part Ⅲ Clinical efficacy of DCAG combined with HLA-mismatched stem-cell micro-transplantation regimen in elderly patients with acute myeloid leukemiaObjective:To evaluate the curative effect and toxicity of decitabine priming,low dose aclarubicin and cytarabine(DCAG)combined with human leukocyte antigen(HLA)mismatched stem-cell micro-transplantation(SC-MST)infusions without graft-versus-host disease(GVHD)prophylaxis.Methods:We conducted a prospective study of 23 patients(median age,68 years;range,60-87 years)with AML in elderly patients to observe the curative effect and toxicity of DCAG combined with HLA mismatched SC-MST infusions without GVHD prophylaxis.All patients received induction chemotherapy with DCAG regimen[decitabine of 15 mg/m2 intravenously over 4h for 5 consecutive days(day 1-5)and granulocyte colony stimulating factor(G-CSF)of 300 μg/day(day 0-9)for priming combined with cytarabine of 10 mg/m2 ql2h for 7 days(day 3-9),aclarubicin of 10 mg/d for 4 days(day 3-6)],followed by intravenous infusion of HLA-mismatched G-CSF mobilized donor peripheral blood stem cells(GPBSCs)24 h without graft-versus-host disease(GVHD)prophylaxis after each completed cycle of DCAG therapy.Mandatory bone marrow aspiration was performed on day 28 or at the time of hematopoietic recovery after the treatment.Treatment was continued until relapse or progressive disease,death,or unacceptable toxicity occurred,or patients/physicians requested the discontinuity.All patients received antimicrobials,supportive care,and transfusions of blood products according to the institutional guidelines.Results:After the first cycle,the overall response rate(ORR)and complete remission(CR)rate were 86.4%,81.8%respectively.CR was achieved in 90.9%(10 Of 11)for patients with a normal karyotype,and 83.3%in patients with complex karyotypes at baseline.The median overall survival(OS)and disease-free survival(DFS)were 17 months and 13 months respectively,with a 2-years OS probability of 34.8%.The median OS of the patients receiving ≥ 3 cycles of SC-MST had significantly longer than that of those receiving 1-2 cycles.The regimen was well tolerated with 4-week mortality rates of 4.3%,and no GVHD were observed.The most common adverse events were hematologic toxicities.Conclusion:Decitabine prior to CAG combined with SC-MST may provide an effective,feasible and safe treatment for elderly patients with AML. |
PDF Full Text Request