| Objective: To observe the outcome and analyze the prognosis of childhood acute lymphoblastic leukemia treated with Guangdong Acute Lymphoblastic Leukemia 2008(GD-ALL 2008)protocol and South China Childhood Leukemia Group Acute Lymphoblastic Leukemia 2016(SCCLG-ALL 2016)protocol.We also compare the treatment effects of these two protocols in order to provide reference for appropriate protocol and further optimizing the treatment regimen for ALL children.Methods: Children ranging from 0 to 18 years old were diagnosed ALL by Department of Hematology and Oncology at Shenzhen Children’s Hospital from August1,2008 to August 30,2019 and treated with GD-ALL 2008(protocol A)and SCCLGALL 2016(protocol B).We retrospectively analyzed the clinical characteristics,remission rate,recurrence rate,5-year survival rate and event-free survival rate.The last follow-up date was December 31,2022.SPSS 26.0 was used for statistical analysis.Results: During the follow-up period,a total of 509 children with ALL were enrolled,of which 273 received protocol A and 236 received protocol B.There was no statistical difference in the clinical data of the children treated with the two protocols at the initial diagnosis(P>0.05).Ninty-one point six percent of children treated with protocol A were sensitive to prednisone at the early stage of treatment,and 85.3% of them achieved M1 remission in bone marrow morphology on the d33 after induction.The 5-year overall survival(OS)of children treated with protocol A was 88.9% ± 3.9%,and the 5-year event free survival(EFS)was 76.0% ± 5.1%;89.8% of the children treated with B regimen were sensitive to prednisone,and 97.5% of the bone marrow morphology reached M1 on d33.The 5-year OS of the children treated with protocol B was 95.9% ± 2.5%,and the 5-year EFS was 91.7% ± 3.7%.There were significant statistical differences between OS and EFS groups treated with these two protocols(P<0.01).The recurrence rate of children in these two groups was 10.4%.After treatment with GD-ALL 2008 and SCCLG-ALL 2016,there were 41 cases(15.0%)and 12 cases(5.0%)children with recurrence,respectively.The recurrence rate of these two protocols was statistically significant(P<0.05).The recurrence sites of the two protocol were mainly isolated bone marrow recurrence,and the recurrence time was mainly early recurrence(18-36 months after initial diagnosis).The 5-year cumulative incidence rate(CIR)of children treated with protocol A was 16.2% ± 4.5%,and those treated with B was 5.8%±3.1%.There was a statistically significant difference in the 5-year CIR between the two groups(P<0.05).The 5-year OS of children with ALL after relapse was 49.0% ± 14.5%.Thirtythree patients(80.5%)continued to receive treatment after the recurrence of protocol A,of which 25 patients(61.0%)chose simple recurrence chemotherapy,6 patients(14.6%) received hematopoietic stem cell transplantation(HSCT)after chemotherapy,and the remaining 2 patients(4.9%)received chimeric antigen ceceptor T-Cell(CAR-T)therapy. Eight cases(19.5%)of the recurrent children treated with protocol A abondoned or lost follow-up due to various reasons.Up to the follow-up date,10 recurrent children(24.4%)survived and 23(56.1%)died.After the recurrence of protocol B,9 patients(83.3%)continued to receive treatment,of which 2 patients(16.7%)chose the recurrence regimen for chemotherapy,3 patients(25%)were treated with HSCT after chemotherapy,5 patients(41.7%)were treated with CAR-T,and 2 patients(16.7%) abandoned or lost follow-up due to various reasons after recurrence.Up to the followup daate,8 recurrent children(66.7%)survived and 2(16.7%)died.There was statistically significant difference between the survival rate and mortality rate of children treated with two groups(P<0.01).Twenty-eight children(10.2%)died within 5 years of treatment with protocol A,and 7(3.0%)children died with protocol B.There was a statistically significant difference in mortality between the two protocols after 5 years of treatment(P=0.03).In protocol A,23 cases(82.0%)mainly died of recurrence or severe infection and multiple organ dysfunction Syndrome(MODS),while in protocol B,2 cases(28.6%)died of recurrence,and 3 cases(42.3%)died of severe infection and MODS.The rates of abandoning or dropping out of protocol A and protocol B were 8.0%and 6.3% respectively,and there was no statistically significant difference between the two groups(P>0.05).Risk stratification,age,immunophenotype,WBC count at the initial diagnosis,bone marrow remission status after induction remission treatment,chromosome structural abnormality,BCR/ABL fusion gene positive and recurrence were the factors that affect the prognosis in two groups by univariate analysis. Multivariate analysis showed that ageover 10 years,T-ALL,relapse after treatment,and non-remission at d33 were independent risk factors affecting prognosis.Conclusion: The treatment effect of SCCLG-ALL 2016 protocol was better than that of GD-ALL 2008 protocol and the recurrence rate and mortality rate of SCCLG-ALL2016 protocol are significantly lower than that of GD-ALL 2008 protocol.Recurrence was a particularly important cause of treatment failure.The recurrence location of the two protocols were isolated bone marrow recurrence,and the recurrence time was mainly very early recurrence and early recurrence.Age over 10 years,T-ALL,relapse after treatment and non-remission at d33 were independent risk factors leading to poor prognosis. |
PDF Full Text Request