| Objective To explore the clinical effects and adverse reactions of children with acute promyelocytic leukemia(APL)by application of children with APL-2010 protocol in single center.Method Fourty seven children with newly diagnosed APL in Children’s Hospital of Suzhou University from October 2010 to September 2015 were selected,of which 46 cases were treated by adopting children APL–2010 protocol(one child left hospital automatically and had no treatment).Their clinical features and therapeutic prognosis were analyzed retrospectively in low,intermediate and high risk groups.Five-year event-free survival(EFS)rate and overall survival(OS)rate of each group were analyzed with Kaplan Meier curve method.Results(1)Pediatric patients included 30 boys and 17 girls.Their median age was seven years old(from 1 year and two months~14 years old).Three groups included 11 children in the low-risk group,20 patients in the intermediate-risk group and 16 children in the high-risk group.The clinical features in three groups were mainly anemia,hemorrhage and fever.The differences in gender,age and hemoglobin value had no statistical significance in different groups,but the fibrinogen and lactate dehydrogenase(LDH)were statistically significant in the high-risk group(P=0.008、P=0.039).(2)The expression of CD13、CD33and MPO was high,and the expression of HLA-DR was negative.(3)The peak difference of the peripheral blood leukocytes among three groups during induction chemotherapy was statistically significant(F=7.61,P=0.002).The platelet’s minimum value in the low-risk group was statistically significant in different groups(P=0.049 、P=0.019).The occurrence rate of disseminated intravascular coagulation(DIC)was 68.8%,and the tate in the high-risk group was much higher than those other two groups(P=0.016).(4)Side effects of ATO included electrocardiographic abnormality(manifestation),hepatic dysfunction and anaphylactic reaction,but they can restore the original condition after supportive therapy.(5)The rate of Hematologic response(HCR)was 93.7% in the high-risk group.The average time of HCR was(39.3±2.68)days and the time of molecular complete remission(MCR)was(71.0±9.7)days.HCR rate was 95.0% in the intermediate-risk group,HCR’s time(44.6±3.1)days and MCR’s time(80.0±8.2)days.HCR rate was 100% in the low-risk group,HCR’s time(32.4±2.3)days and MCR’s time(71.5± 12.0)days.The time of HCR between low-risk group and high-risk group was statistical significance(P=0.010),the rates of HCR among three groups had no statistical significance(P=0.736).The time of MCR among three groups had no statistical significance(P=0.729).5-year overall survival(OS)rate and event-free survival(EFS)rate were(93.8±6.1)% and(87.5±8.3)% respectively in the high-risk group.Meanwhile,5-year OS rate and EFS rate were 100% other two groups.Conclusions(1)Fibrinogen was low and LDH was high in the high-risk group at dignosis.(2)The peak value of peripheral blood leukocytes during induction therapy and the occurrence rate of DIC in the high-risk group were significantly higher than those other two groups.(3)In our center,children APL-2010 protocol according to the risk-stratification was applied to children with APL.The adverse reactions were low.5-year EFS rate in the low group,the intermediate-risk group and the high-risk group were 100%,100% and87.5%. |
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