Efficacy And Safety Evaluation Of Domestic Azacitidine In The Treatment Of Myelodysplastic Syndromes

Objective:Azacytidine has been widely used in the treatment of myelodysplastic syndrome abroad,but it has just been approved for clinical application in China.In order to investigate the efficacy and safety of domestic azacytidine in the treatment of middle and high risk myelodysplastic syndromes,the clinical efficacy and adverse reactions of domestic azacytidine in the treatment of myelodysplastic syndrome were observed.Methods:Analysis of 20 cases,from January 2014 to December 2015 in the Department of Hematology of the Affiliated Hospital of Qingdao University,the patients diagnosed with medium and high-risk myelodysplastic syndromes.The patients were treated with standard dose of azacytidine,75mg/m~2/day,and subcutaneous injection treatment,continuous use for 7 days,every 28 days is 1 course of treatment.The effective rate(ORR),median survival time,adverse reactions and tolerance of domestic azacytidine treatment.Data were analyzed using SPSS 24.0 software.The qualitative data were analyzed by chi-square and Fisher Probability test,P<0.05 is used for test criterion.Results:20 patients with middle and high-risk myelodysplastic syndromes were treated with standard-dose domestic azacitidine treatment,11 patients achieved remission,the total effective rate(ORR)was 55%.There were CR 1 cases(5%),mCR 8 cases(40%),including 7 cases of mCR with HI,and HI 2 cases(10%).20 patients received a total of104 treatment courses,of which 3 patients had received less than 3 courses of treatment due to disease progression,and the remaining 17 patients had a median of 6(3-11)courses of treatment.After the first course of treatment,the effective rate was 5%,the effective rate was 35%after the third course,and the effective rate was 45%after the sixth course.Followed up to November 1,2018,the median survival time was 11 months.Among the 20 patients,there were 14 patients with intermediate risk-2,1case with CR,5cases with mCR(including 4cases with mCR and HI),and 1 cases HI alone,with a total effective rate of 50%(7/14)and median survival was 10.5 months.There were 6 high-risk patients,3 cases were mCR(all with HI),and 1 case was HI alone.The total effective rate was 67%(4/6),and the median survival time of the high-risk patients was 7 months.There were 13 patients with abnormal karyotype.There 1case was CR,4 cases were mCR(3cases were mCR with HI),1case was HI alone,the total effective rate was 46%(6/13),and the median survival time was 11.5 months.There were 7 patients with normal karyotype.There 4 cases of the normal karyotype patients were mCR(4 cases were all mCR with HI),1case was HI alone,the total effective rate was 71%(5/7),and the median survival time was 9.5 months.There were 12 male patients and 5 cases were mCR(including 4cases were mCR with HI),the total effective rate was 42%(5/12),and the median survival time was 10.5 months.There were 8 female patients,and 1case was CR,3cases were mCR(all with HI),and 2cases were HI.The total response rate was 75%(6/8),and the median survival time was 21 months.In addition,of the 20 patients,8patients had significantly fewer blood transfusions after treatment,and 2 patients even got rid of blood transfusion dependence.The main adverse events of treatment are myelosuppression,blood cell reduction and gastrointestinal reactions.During the treatment of domestic azacitidine,20 patients had grade III to IV hematological adverse reactions during the treatment.After they are supplemented with symptomatic supportive treatment,the patient can tolerate it.There were 13 patients with fever and 8 patients had symptoms of infection.After they applied antimicrobial therapy,the patient got better.15patients had gastrointestinal reactions such as nausea and vomiting.3 patients developed abnormal liver function.2 patients developed redness and pain at the injection site.After giving treatment,their condition improved and did not affect the treatment.There was no damage to heart and kidney function.Conclusion:1.Domestic azacitidine has a good effect on the treatment of patients with middle-and high-risk myelodysplastic syndrome,which can prolong the survival time.2.The domestic azacitidine treatment of MDS has at least 3 courses or more to have a significant effect.3.For MDS patients with chromosomal abnormalities caused by gene mutations,domestic azazctidine can prolong their survival time.4.After application of domestic azartidine,the patients can reduce the number of blood transfusions and improve their quality of life.5.Adverse reactions that can occur after treatment with domestic azacitidine include:myelosuppression,gastrointestinal reaction,fever infection,liver dysfunction,injection site redness,but can be tolerated after timely supplemented with symptomatic support treatment,and the safety is good.