Efficacy And Safety Of Two Asparaginase In Treatment Of Adult Acute Lymphoblastic Leukemia

Objective: To compare the efficacy and safety of pegaspargase and L-asparaginase in adult(≥14 years old)patients with acute lymphoblastic leukemia(ALL).Methods:The clinical data from January 2014 to December 2018 of hospitalized adult patients with acute lymphoblastic leukemia in the Department of Hematology of Fujian Medical University Affiliated Union Hospital were retrospectively analyzed.The induction chemotherapy regimen was VD(C)LP(V: vindesine or vincristine,D: daunorubicin or demethyldaunorubicin,C: cyclophosphamide,L: pegaspargase or L-ASParaginase,P: prednisone or Dexamethasone).According to the dosage types of Asparaginase used in the induction scheme,the test was divided into observation group(PEG-ASP group)and control group(L-ASP group).The baseline data(gender,age),initial disease condition(immune typing,initial white blood cell count,extramedullary infiltration),hospitalization time and cost,short-term and long-term curative effects(complete remission rate,occurrence of CNSL,overall survival time),adverse reactions(anaphylaxis,coagulation dysfunction,liver and kidney dysfunction,pancreatitis,etc.)were compared between the two groups.Based on the different data types,Chi-square test,rank sum test and Evidence-Based Medicine were used accordingly for analysis and comparison.Results:1.This study collected 236 hospitalized cases that met the inclusion criteria,including 126 cases(53.39%,76 males and 50 females)in PEG-ASP group with a median age of 27(18-44)years old;110 cases(46.61%,65 males and 45 females)in L-ASP group with a median age of 27(15-40.5)years old.2.There was no statistical difference in gender,age,immune typing,initial white blood cell count and extramedullary infiltration between PEG-ASP group and L-ASP group(P>0.05)so that the two groups could be proceed.3.the median hospitalization days in PEG-ASP group and L-ASP group were 26(23-30.25)days and 30(27-36)days respectively.the hospitalization time in PEG-ASP group was shorter than that in L-ASP group,and the difference was statistically significant(p < 0.05).The hospitalization expenses of the two groups were 65849(52585-90928)yuan and 62755(45736-88321)yuan respectively,with no statistical difference(P>0.05).4.there was no statistical difference in the CR rate(81.3% and 87.8%)and the occurrence of CNSL(7.1% and 10.0%)between PEG-ASP group and L-ASP group(P>0.05).PEG-ASP was better than L-ASP in prolonging OS of patients,and the difference was statistically significant(P<0.05).5.In this study,some patients were excluded because they were allergic to ASP and did not use enough dose of chemotherapy drugs,so this study cannot compare the allergic reactions of the two kinds of ASP.6.There was no statistical difference between the two groups in APTT extension(54.8% and 43.4%),PT extension(44.4% and 36.8%),FIB reduction(47.6% and 37.3%),hemorrhage(9.5% and 9.1%),thrombosis(3.2% and 0.9%),while PEG-ASP was more prone to coagulation dysfunction than L-ASP(47.6% and 34.0%),and the difference was statistically significant(P<0.05).7.there was no statistical difference between the two groups in liver function abnormality(38.9% and 35.5%),ALB decrease(89.6% and 86.5%)and renal function abnormality(1.6% and 3.6%)(P>0.05).8.There was no statistical difference between PEG-ASP group and L-ASP group in Triglyceride(TG)(30.9% and 26.0%),hemodlastase(1.6% and 2.0%)and pancreatitis(3.2% and 0.9%)(P>0.05).Conclusion:1.PEG-ASP can shorten the hospitalization time of patients;2.The induced remission rate of PEG-ASP is equivalent to that of L-ASP,but it can prolong the OS of patients.3.PEG-ASP is more likely to cause coagulation dysfunction,But there is no difference in hemorrhage and thrombosis;4.The degree of liver and kidney dysfunction and pancreatitis caused by PEG-ASP and L-ASP is equivalent.