| ObjectiveTo analyze the clinical efficacy,adverse reactions,and the relevant influencing factors on clinical effect and prognosis of decitabine-based regimens in treatment of relapsed/refractory acute myeloid leukemia(AML)retrospectively.MethodsThe clinical data of eligible relapsed/refractory AML patients incorporated were retrospectively analyzed to assessed the curative efficacy and adverse reactions.The 93 patients who admitted in Qilu Hospital of Shandong University from January 2010 to December 2018 all received 4 courses at least of decitabine-based or traditional regimens.According to the 2007<Criteria for the diagnosis and treatment of hematologic diseases>,all these patients were diagnosed and classified.Risk stratification was performed by<Chinese guidelines for diagnosis and treatment of adult acute myelod leukemia(not APL)(2017)>.The software for statistical analysis was SPSS 22.0.We used chi-square test to analyze the relevant influencing factors on clinical effect,such as gender,age,initial white blood cell count,initial bone marrow cell count,risk stratification,MDS history,disease state.And we chose Kaplan-Meier method for survival analysis,and COX proportional hazards regression model for multivariate analysis.P<0.05 was considered statistically significant.Results1.Among these relapsed/refractory AML patients who received decitabine-based and traditional regimens for 4 courses at least,the distribution of age and sex were as follows:male patients 49(52.7%),and female 44(47.3%).The median age was 54(15-77)years old,and the average age was 50 years old.The refractory acute myeloid leukemia patients were 44(47.3%)cases,and the relapsed were 49(52.7%)cases.Among all the 93 patients,M1 were 4 cases(4.3%),M2 were 3(3.2%)cases,M4 were 22(23.7%)cases,M5 were 56(60.2%)cases,M6 were 8(8.6%)cases.According to the risk stratification of 2017 Chinese guidelines,8(8.6%)cases were low-risk patients,66(71.0%)cases were intermediate-risk patients and 19(20.4%)cases were high-risk patients.Among all the 93 patients,25(26.9%)cases had chromosome abnormalities and the most common abnormality was+mar(7 cases,28%).25(36.2%)cases had molecular genetic abnormalities and the most common abnormality was FLT3-ITD(5 cases,20%).2.Among all the 93 patients,49(52.7%)cases received decitabine-based regimens.35(37.6%)cases received decitabine combined with low-dose CAG regimen,and 14(15.1%)cases received decitabine combined with loe-dose HAG regimen.44(47.3%)cases received traditional regimens.14(15.1%)cases received HAA regimen,17(18.3%)cases received CAG regimen,13(14.0%)cases received HAG regimen.3.In the second course,the overall response rate(ORR)of the relapsed/refractory AML patients of decitabine-based regimens was 57.1%.The complete remission(CR)rate was 40.8%,the partial response(PR)rate 16.3%,and the no remission(NR)rate was 42.9%.The ORR of the patients with traditional-regimen treatments was 45.5%.The CR rate was 36.4%,the PR rate was 9.1%,and the NR rate was 54.5%.In the fourth course,the ORR of the relapsed/refractory AML patients with decitabine-based treatments was 65.3%.The CR rate was 42.9%,the PR rate 22.4%,the NR rate was 30.6%,and 2(4.1%)cases relapsed.The ORR of the patients with traditional-regimen treatments was 61.4%.The CR rate was 36.4%,the PR rate was 25.0%,NR rate was 29.5%,and 4(9.1%)cases relapsed.4.In the second course,the ORR of decitabine-based AML patients whose white blood count were more than 9.5 X 109/L was more than the ORR of decitabine-based AML patients whose white blood count were(3.5-9.5)X 109/L(P=0.021).In the fourth course,the CR rate of old patients(age>60)was more than young patients(age?60)(P=0.041).5.After the median follow-up of 51.2(3.9-95.8)months,84(90.3%)patients had died,9(9.7%)patients were alive,and 6(6.5%)patients recieved stem cell transplantation.The median Overall Survival(OS)time and Progression-Free Survival(PFS)were 10.8(1.3-49.9)months,6.7(0.7-46.2)months respectively.The average time for OS and PFS was 14.2 months,1 1.0 months respectively.The 1-year,2-year OS rates of patients were 46.2%,19.4%and the 1-year,2-year PFS rates were 40.9%,8.6%.6.In the univariate analysis,the curative effect(CR or non-CR)in the second course had relationship with the OS(P=0.000)and the PFS(P=0.000),and other factors such as sex,age,initial white blood count,initial bone marrow count,risk stratification,MDS history,disease state,regimen had no relationship with the OS and the PFS(P>0.05).Multivariate analysis by COX regression showed that the curative effect(CR or non-CR)in the second course had relationship with the OS(P=0.016)and the PFS(P=0.012).The results were the same with univariate analysis.7.The decitabine-based and traditional regimens among all the 93 patients of relapsed/refractory acute myeloid leukemia were well tolerated.During the chemotherapy,the main side effects were myelosuppression,different kinds of infection,gastrointestinal reactions and unspecific clinical manifestations.And myelosuppression and different kinds of infection were more common toxicities in patients with relapsed/refractory AML.The patients with traditional regimens were easier to grade 5 myelosuppression than the patients with decitabine-based regimens(P=0.045).Conclusion1.Decitabine-based and traditional regimens are effective and well-tolerated in treating relapsed/refractory AML patients.2.Initial white blood count and age had statistically relationship with curative effect.The patients whose white blood count were more than 9.5 X 109/L and the old patients(age>60)are better.3.The 1-year OS rates of 93 AML patients were 46.2%and the 1-year PFS rates were 40.9%.The patients whose curative effect achieved CR in the second course were longer than the patients whose curative effect did not achieved CR.4.The decitabine-based and traditional regimens among all the 93 patients of relapsed/refractory AML were well tolerated.Myelosuppression and different kinds of infection were more common toxicities.The patients with traditional regimens were easier to grade 5 myelosuppression than the patients with decitabine-based regimens. |
PDF Full Text Request