| Objective(s):Acute promyelocytic leukemia(APL),a special type of acute myeloid leukemia,is characterized by t(15,17)(q22;q21)translocation and PML-RARA fusion gene positive.Both all-trans retinoic acid(ATRA)and arsenite(ATO)for targeted therapy to APL by their different mechanism,they have no cross resistance and can enhance the sensitivity of each other,promoting acute promyelocytic differentiation has the synergistic effects.The mechanism leads to a great breakthrough of the treatment for APL and even can be cured.The combination of ATRA and ATO has been the first line for the treatment of low-to intermediate-risk patients.In order to further reduce myelosuppression caused by chemotherapy and subsequent bleeding,infection and other related risks,recent clinical research at home and abroad also used ATRA and ATO for induction therapy for high-risk patients.The results were not inferior to or even better than ATRA and chemotherapy.The purpose of this study was to investigate the clinical efficacy of ATRA and ATO in the treatment of low,medium and high risk APL.Methods:1.40 patients with APL were selected from Kunming General Hospital of Chengdu military region from February 2008 to July 2016.According to the standard of Sanz classification and the patients’ of white blood cell(WBC)count and platelet(PLT)count.Patients were divided into low risk group,medium risk group and high risk roup.PML-RARA gene was detected in all patients;2.Induction therapy:All patients were given ATRA 25mg/m2/d,divided into 2-3 oral administration after diagnosis,and meanwhile were given ATO 0.15mg/kg/d by administered intravenously until complete remission(CR);3.Consolidation therapy:ATRA 25mg/m2/d,divided into 2-3 oral(dl-d14),4 weeks for 1 cycle,in all 8 cycles;ATO 0.15mg/kg intravenous infusion(dl-d28),8 weeks for 1 cycles,in all 4 cycles;4.According to the clinical manifestations and the results of the test for prophylaxis and treatment of retinoic acid syndrome,central nervous system leukemia prevention and support treatment;5.Observe hematological CR rate,PML-RARA fusion gene negative rate,mortality rate,recurrence rate,adverse reactions during treatment and complication;6.Using SPSS 17.0 statistical software to statistics.The comparison that the CR rate,OS rate and EFS rate of low-intermediate risk group and high risk group was tested by Chi square test,the survival situation was described by the Kaplan-Meier survival and cpmpared by Log-rank test.At the same time draw the survival curve.P<0.05,the difference was statistically significant.Results:1.The study included 40 cases of APL patients finally,38 cases(95%)received hematologic complete remission(CR)after induction therapy,the median time of 28d(10d～30d)is equired for CR;38 cases(95%)acquired PML-RARA gene negative after treatment,the median time is 36d(35d～42d);2.The median time of follow-up was 36 months(1 month to 101 months).3 cases(7.5%)occurred recurrence,and the mortality was 7.5%.The cause of death were intracranial hemorrhage;3.The overall survival rate of 40 patients with APL in this study was 97.5%of 1-year and 4-year OS rate was 92.5%;1-year event free survival was 95%,4-years EFS was 90%.The CR rate of 10 high-risk patients rate was 100%,4-years OS was 90%,4-EFS was 90%;The CR rate of 30 low-to intermediate-risk patients was 93.3%,4-years OS was 93.3%and 4-years EFS was 90%.There was no significant difference in CR rate,overall survival rate and event free survival rate between low-to intermediate-risk and high-risk groups(P>0.05).4.Non hematologic adverse reactions:Edema 13 cases(32.5%),10 cases of chest pain(25%),9 cases with dry skin pruritus(22.5%),6 cases of headache(15%),5 cases of limb pain(12.5%),prolonged Q-T interval in 5 cases(12.5%)and 12 cases of liver injury(30%);III-IV grade hematologic adverse response:leukopenia in 10 cases(27.8%),4 cases of lower hemoglobin(11.1%),thrombocytopenia in 3 cases(8.3%),continuous median time 7d.There were 5 cases of bone marrow suppression,and the median duration was 6d.Among them 4 patients had granulocyte deficiency,the median duration was 5.5d;5.Complications:1 case occurred retinoic acid syndrome,the symptoms were alleviated after hormone,diuretic and other surpotting treatment;6.No case occurred central nervous system leukemia.Conclusion(s):1.The treatment effect of ATRA combined with ATO for high-risk patients is not inferior to,or even higher than the standard treatment program;2.ATRA combined with ATO in the treatment of APL has the advantages of short duration of complete remission,mild bone marrow suppression,less adverse reactions,and toxic side effects can be tolerated;3.The treatment can effectively avoid APL patients with RAS;4.The treatment can effectively avoid APL patients with central nervous system complications. |
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