| OBJECTIVE To evaluate the clinical efficacy and safety of decitabine (DAC) and the CAG regimen in the treatment for elderly acute myeloid leukemia.METHODS We collected the clinical data of 37 elderly patients with acute myeloid leukemia (excluding acute early young granulocyte leukemia) who were treated frist in Department of Hematology of Linyi People’s Hospital of Shandong Province from July 2012 to July 2015, All patients were over 60 years old. Patients were randomly divided into two groups:one group were treated with DAC(DAC 25mg/d, intravenous injection, dl-5); the other group were treated with CAG (Ara-C 10-15 mg/m2, hypodermic injection, Q12 h, dl-14; Aclarubicin 10 mg/d, intravenous injection, dl-7; G-CSF 300ug/d, intravenous injection, dl-14). We compared the total efficiency rate (ORR) and one year survival rate (OS) of patients of two groups. We analyzed the relationship between clinical indicators and remission rate. The incidence of adverse reaction of two kinds of treatment was evaluated. We also analyzed the main factors which could influence the prognosis and efficacy of decitabine. The date was statisticed by SPSS 17.0 statistical software. Kaplan Meier was used for survival analysis of two groups of patients, X2 Test (Chi square Test) was used to analyze the differences of efficacy between two groups, P< 0.05 was considered statistically difference.RESULTSThere was no statistically difference of ORR or OS or clinical indicators or adverse reaction between two groups. The ORR of patients treated with DAC was 53.3%(8/15), The ORR of patients treated with CAG was 50%(11/22).There was no statistically difference of the efficacy of two groups (P> 0.05). The follow-up deadline was July 1,2015. The median follow-up time was 9 (1-23) months. There were 15 patients survived,19 patients died, and 3 patients were lost to follow-up. The OS of patients treated with DAC was 40%(6/15), The OS of patients treated with CAG was 40.9%(9/22).There was no statistically difference of the efficacy of two groups (P> 0.05).We discovered that the major factors influencing the efficacy were not the patients’ gender, age, original white blood cells, hemoglobin, platelet count, proportion of bone marrow cell, and fusion gene. There was no statistical difference (P> 0.05).The study found that the major adverse reaction after chemotherapy was infection and bleeding caused by bone marrow suppression.3 patients died of serious lung infection caused by multiple pathogens. The incidence of infection of patients in the observation group (treated with DAC) and the control group (treated with CAG) after two courses of treatment accounted for 46.6%(7/15) and 72.7%(16/22) respectively, There was statistical difference (P<0.05). The average time of agranulocytosis were 15.07 and 16.74 days respectively, the average amount of platelets infusion was 34.4u and 66. 1u respectively, the incidence of bleeding was 20%(3/15),36.3%(8/22) respectively, there was significant statistical difference (P< 0.05). The average amount of red blood cell infusion was 5.8u and 8.9u respectively, there was no statistical difference (P> 0.05).CONCLUSIONS1. It was effective of the therapeutic regimen with DAC or CAG for elderly patients with acute myeloid leukemia. There was no statistically difference of ORR and OS between two groups.2. It was higher obviously of the total efficiency rate between observation group and the control group for elderly AML associated with MDS. There was statistical difference.3. The adverse events of patients treated with DAC were less than the control group. Compared with the CAG regimen, the DAC regimen had higher security, less chemotherapy toxicity, better tolerance, lower incidence of infection and anemia and hemorrhage. |
