Efficacy Analysis Of Arsenic Trioxide Combined With Decitabine As The Main Regimen In The Treatment Of High-risk MDS

PurposeTo evaluate the clinical efficacy,adverse reactions and survival of arsenous acid injection combined with decitabine in the treatment of WPSS score high-risk myelodysplastic syndromes,MDS),and to provide clinical basis for the treatment of high-risk MDS.MethodsThe clinical data of 10 patients with WPSS score high-risk MDS and 1 patient with chronic myelomonocytic leukemia(CMML)who were hospitalized in Guangdong Provincial Hospital of Traditional Chinese Medicine from September 2015 to January 2020 were retrospectively analyzed and treated with arsenic trioxide injection combined with decitabine as the main regimen for 2 or more courses of treatment.According to the "Guiding Principles for Clinical Research of New Chinese Medicines"(Trial)issued by the Drug Administration of the Ministry of Health of the People’ s Republic of China in 2002,the efficacy of traditional Chinese medicine is determined.The efficacy is evaluated according to the MDS International Working Group(IWG)2006 revised efficacy standard and MDS/MPN efficacy standard published in 2015 "Blood" to evaluate the synergistic effect of arsenous acid injection.According to the World Health Organization(WHO)classification criteria for acute and subacute adverse drug reactions of anticancer drugs,the adverse reactions and safety of the scheme were evaluated.Follow-up until January 31,2020,progression-free survival(PFS)and total survival(OS)were calculated and the survival of patients was analyzed.ResultsOf the 11 patients,8 were male(72.7%)and 3 were female(27.3%).The age ranged from 20 to 71 years old,and the median age was 58 years old.The course of disease is 0.3～60 months,and the median course of disease is 3 months.The course of treatment is 2～4 courses and the median course of treatment is 3 courses.2.Evaluation of curative effect:according to the criteria for judging the curative effect of traditional Chinese medicine,after 2 courses of treatment,4 cases showed marked effect and 4 cases were effective,with an overall improvement rate of 72.8%.Symptoms such as mental fatigue,pale complexion or sallow complexion can be improved(P<0.05).According to the evaluation of western medicine efficacy standards,11 patients had complete remission(CR)in 4 cases(36.4%),complete remission of bone marrow(mCR)in 1 case(9.1%),complete remission of bone marrow with hematological progress(MCR with HI)in 2 cases(18.2%),stable(SD)in 1 case(9.1%),and progressive(PD)in 3 cases(27.3%).The overall improvement rate(CR+PR+mCR+mCR with HI)was 63.6%,the total effective rate(ORR=CR+PR+MCR+HI)was 72.7%,and the better response rate(PR above)was 36.4%.3.Adverse reactions:The main adverse reactions include bone marrow suppression,infection,cardiovascular adverse reactions,digestive system adverse reactions,water and sodium retention,liver function damage,renal insufficiency and electrolyte disturbance.Grade Ⅳ myelosuppression in 11 cases(100%);Infection:pulmonary infection in 5 cases(45.5%),sepsis in 1 case(9.1%),oral infection in 1 case(9.1%),perianal infection in 1 case(9.1%);Adverse cardiovascular reactions:paroxysmal atrial fibrillation in 2 cases(18.2%),supraventricular tachycardia in 1 case(9.1%),QT interval prolongation in 1 case(9.1%),heart failure in 2 cases(18.2%);Gastrointestinal adverse reactions occurred in 10 cases(90.9%);Water and sodium retention occurred in 7 cases(63.6%):peripheral edema in 4 cases(36.4%),pleural effusion in 1 case(9.1%),peripheral edema with pleural effusion in 2 cases(18.2%);Liver function damage occurred in 4 cases(36.4%):transaminase increased in 2 cases(18.2%),bilirubin increased in 2 cases(18.2%);2 cases(18.2%)of prerenal renal insufficiency;Electrolyte disorders were found in 7 cases(63.6%):hypokalemia in 3 cases(27.3%),hyponatremia in 1 case(9.1%),hypokalemia in 3 cases(27.3%).Skin GVHD1 was found in 1 case(9.1%).The above adverse reactions can be improved after symptomatic treatment.4.Survival:Follow-up to January 31,2020,median follow-up time was 24 months(2~43 months),3 cases(27.3%),4 cases(36.4%)died,and 4 cases(36.4%)survived.The progression-free survival(PFS)was 3～44 months,and the median PFS was 12 months.The overall survival time(OS)was from May to 49 months,and the median OS was 12 months.PFS and OS of patients in the effective group after 2 courses of treatment have no significant difference from those in the ineffective group after 2 courses of treatment.ConclusionArsenic trioxide injection combined with decitabine as the main regimen has satisfactory short-term efficacy and tolerable adverse reactions in the treatment of high-risk MDS.The scheme provides a feasible treatment method for high-risk MDS.Survival:Follow-up until January 31,2010,3 cases(27.3%)were lost,4 cases(36.4%)died,and 4 cases(36.4%)survived.The progression-free survival(PFS)was3~40,and the median progression-free survival(PFS)was 12 months.The overall survival time(OS)was 9～40 months,and the median overall survival time(OS)was 18 months.PFS and OS of patients in the effective group after 2 courses of treatment have no significant difference from those in the ineffective group after 2 courses of treatment.ConclusionArsenic trioxide injection combined with decitabine as the main regimen has satisfactory short-term efficacy in the treatment of high-risk MDS,which can effectively improve the clinical symptoms of patients in traditional Chinese medicine,such as mental fatigue,pale complexion and other symptoms,and the adverse reactions can be tolerated.The scheme provides a feasible treatment method for high-risk MDS.