| Objective: This study used retrospective method to investigate and analyze the efficacy and safety of intermediate-dose cytarabine(ID-Ara-C)and high-dose cytarabine(HD-Ara-C)in the consolidation treatment of patients with acute myeloid leukemia(AML).To provide the basis for exploring the optimal consolidation treatment for AML patients.Methods: From January 2011 to October 2016,searching for the patients with AML who admitted to the Department of Hematology,total 49 patients,randomly divided into three groups(A,B,C),according to the dose of cytarabine,ID-Ara-C(Group A:1.0g/m2 once every 12 hours,iv,d1,d3,d5,Group B: 2.0 g/m2 once every 12 hours,iv,d1,d3,d5)or HD-Ara-C(Group C:3.0 g/m2 once every 12 hours,iv,d1,d3,d5)were used alone or in combination with any of darubicin,daunorubicin,etoposide,mitoxantrone and other chemotherapy drugs to consolidate the intensive treatment.The use of cytarabine was once every 12 hours,d1,d3,d5,ID-Ara-C group were completed for 6 consecutive cycles,the combination drug of the two groups are the same,HD-AraC group for single use Cytarabine,a total of three consecutive cycles.The patients were followed up every 3 months and lasted for 3 to 5 years.The clinical data were collected and the incidence of disease adverse events,disease recurrence rate,5-year disease-free survival rate(DFS)and 5 year's overall survival rate(OS)were observed and compared.The efficacy and safety statistics were analyzed by SPSS19.0.Results: A total of 44 patients who underwent HD-Ara-C for 3 cycles,ID-Ara-C for 6 cycles were selected and the efficacy were evaluated.Among them,23 males and21 females(male: female = 1.09:1),median age was 53 years old(13 years old to 66 years old),group A: 58 years old(15-66 years);group B: 54 years old(21-64 years old);group C: 26 years old(13-38 years old).11 patients in A group and B group were older than 60 years old(25.0%),all patients in C group were less than 40 years old,there was no ECOG scores more than one,three groups of patients with age distribution are not all the same,there were statistical significantly differences between group A and C,group B and group C(p < 0.05),no difference between A and B group(p > 0.05).Efficacy:Group A: 20 cases,CR rate was 80%,PR rate was 20%,5 cases of recurrence(25.0%),death in 6 cases(30.0%),4 cases died after recurrence(20.0%),1 case of nonrecurrence death.In group B,the CR rate was 85.7%,the PR rate was 14.3%,the relapse was 5 cases(35.7%)and the death in 5 cases(35.7%).Among them,4 cases died after relapse(28.6%),1 case of death was due to pulmonary infection during chemotherapy.Group C: All patients received CR,relapse in 3 cases(30.0%),1 case of recurrence ended in death(10.0%),1 case relapsed then applicated other chemotherapy to obtain relief and disease-free survival.There was no significant difference in the relapse rate between the three groups(A vs.B,P = 0.12;B vs.C,P = 0.45;A vs.C,P =0.53).Three groups did not reach the median OS,DFS.Group A: the estimated 3-year OS rate was 66.2%,the 3-year DFS rate was 65.5%,the 5-year OS rate was 53.1%,and the 5-year DFS rate was 52.0%.Group B: estimated 3-year and 5-year OS rate were62.1%,3-year and 5-years DFS rate all were 56.3%.Group C: the estimated 3-year and5-year OS rate were 90.0%,3-year and 5-year DFS rate were 58.2%.There were no statistically significant differences in OS rate between the three groups(A vs.B,P =0.64;B vs.C,P = 0.16;A vs.C,P = 0.31).There was no significant difference in DFS among the three groups(A vs.B,P = 0.66;B vs.C,P = 0.55;A vs.C,P = 0.8).Adverse reactions: All groups of patients showed ? degree myelosuppression,no significant difference.The median time of myelosuppression was 9-11 days.Three groups of patients were infected in varying degrees,infection rate of group A was 50.5%,B group67.9%,1 case died due to infection in group B.The infection rate of group C was 80.0%.The overall infection rate of group C was higher than that of group A(B vs.A,P = 0;C vs.A,P = 0.006).There was no difference in infection rate between group B and group C(P = 0.34).The incidence of liver injury was higher in group C than that in group A(P = 0.026).The incidence of gastrointestinal reaction was higher than that of the other two groups(A vs.C,P = 0.0;B vs.C,P = 0.014).The incidence of non-infected adverse reactions in A group and B group were similar(P > 0.05).There was no significant heart,liver,kidney and nervous system dysfunction in the three groups.Conclusion: In this study,although high-dose cytarabine chemotherapy regimen gained better efficacy in AML patients(? 40 years old),there were great toxic side effects.Therefore application was limited and needs further improvement.The median dose of cytarabine can be applied to some patients older than 60 years old,in which the toxicity is relatively low,and has the same efficacy as high-dose cytarabine.Further exploration and improvement need to be done.At the same time,this study indicated the significant difference of the efficacy between cytarabine 1 g/m2 and 2 g/m2.It was found that the 5-year survival rate of indicated AML patients was high,no significantly differences with 1 g/m2 regimen in adverse effects.We preliminarily considerate that the2g/m2 regimen has better treatment efficacy.It is the reason why we still need to expand the number of cases to further optimize the dose of cytarabine in AML treatment regimens,which could improve the current treatment regimens and reduce the toxicity of cytarabine.To study age,prognosis,fusion genes and disease status in AML patients helps to develop better treatment regimens individually,to find new effective and less toxic drugs,and finally to improve the treatment efficacy and extend the survival duration. |
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