| Objective: Summarize and evaluate the curative effect and outcome of the Hematology Oncology Center of Children’s Hospital Affiliated to Chongqing Medical University using CCCG-ALL-2015 in the treatment of T-ALL patients,and provide a basis for the improvement of the follow-up T-ALL diagnosis and treatment plan and clinical guidance.Methods: Collect clinical data of T-ALL patients diagnosed in our center from January 2015 to December 2019 and treated by CCCG-ALL-2015 protocol.Follow-up treatment response and treatment effect and carry out statistical analysis.MRD was monitored by flow cytometry on the 19 th and 46 th days of treatment;ETP status was determined by a special immunophenotype.The chi-square test was used to compare categorical variables;the Kaplan-Meier method was used for survival analysis,and the log-rank test was used for univariate analysis;the Cox proportional hazard model was used for multivariate analysis.Results: A total of 96 patients were included in this study for analysis.The median age of patients at diagnosis was 8.8 years(1-15.2 years);73 cases(76%)were male,23 cases were female(24%),male : female was3.2:1;median peripheral blood white blood cell count was 56.15 x109/L(0.97-648.94x109/L),there were 38 patients(40%)with white blood cell≥100x109/L.2 patients(3%)had testicular infiltration;5 patients(5%)had central nervous system leukemia.78 patients have complete immunoomics data for analysis,of which 12(15%)can be diagnosed as ETP-ALL.94 patients underwent karyotype analysis at the time of diagnosis.7 cases had no mitotic figures,9 cases’ chromosome number were abnormal,14 cases’ chromosome structure were abnormal,and the remaining 64 cases had no abnormal chromosomal karyotype.SIL/TAL1 rearrangement was found to be positive in 24 patients(25%).62 patients(65%)achieved complete remission on the 46 th day of induction therapy;11 patients(11%)were partial remission;23 patients(24%)failed induction therapy.The median follow-up time was 32 months(1-74 months).The 5-year EFS rate of patients was 63.9±5.2%,the 5-year OS rate was 67.8±5.9%,and the5-year CIR is 24.1%.There were 20 patients relapsed,of which 11 were bone marrow relapse;6 were CNS relapse;1 was bone marrow + CNS relapse;2 were relapsed in other parts.The median time with relapse was8.5 months after diagnosis.26 cases died,of which 15 case died after relapse;3 cases died due to hemorrhagic shock;3 cases died after hematopoietic stem cell transplantation;4 cases died due to the progression of the primary disease;1 case died due to severe infection.The prognosis of patients with chromosomal abnormalities is worse than that of patients with normal karyotypes(5-year EFS rates were 47.4±11.5%;69.9±6%,p=0.042).In the late stage of induction therapy(day 46),MRD≥1% is an independent risk factor for poor prognosis(the 5-year EFS rate of patients with MRD≥1% and <1% on day 46 is 70.6±5.5,40.0±15.5,p=0.007,respectively;The 5-year OS rate was 75.9±6.2%,46.7±16.6%,p=0.023).ETP-ALL patients have poor response to early treatment,but the long-term prognosis is not significantly different from that of non-ETP T-ALL patients.Conclusion: The CCCG-ALL-2015 protocol is effective in treating T-ALL patients,and its prognosis is similar to that reported by other centers in China,but there is a certain gap with developed countries.The5-year CIR results are slightly higher than other studies,and the outcomes for relapsed patients is significantly worse than that of developed countries in Europe and America.The mortality of patients due to primary disease progression or treatment-related mortality is also higher than other studies reported.In the future,we should consider adding nelarabine to treat T-ALL patients;encourage relapsed patients to actively accept chemotherapy;try to add nelarabine,bortezomib to the chemotherapy protocol for relapsed patients for further hematopoietic stem cell transplantation treatment.Improve patient management to reduce infections and bleeding deaths.The detection rate of CNS2 is low,and the cerebrospinal fluid detection method should be improved to better evaluate the influence of CNS status on the prognosis of patients.MRD≥1% on the46 th day is an indicator of poor prognosis.The chemotherapy regimen of this group of patients should be strengthened or the treatment method should be changed;this study failed to find the MRD measurement value and time point related to the very good prognosis,and consider the MRD measurement.The earlier time is related,and the MRD measurement time should be extended for further research.The ETP-ALL subtype is determined as the T-ALL subtype with poor response to early treatment,which can strengthen or improve the early treatment plan.Other risk factors,such as central nervous system leukemia,early treatment response to glucocorticoids,chromosomal abnormalities and molecular biological prognostic indicators on the prognostic efficiency of T-ALL,require further researches. |
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