Efficacy and safety of orelabrutinib-based regimens in 28 cases of newly diagnosed diffuse large B-cell lymphoma
Objective:To investigate the efficacy and safety of orelabrutinib-based regimens in newly diagnosed diffuse large B-cell lymphoma(DLBCL).Methods:The clinical data of 28 newly diagnosed patients with DLBCL,who were treated with orelabrutinib-based regimens between September 2020 and October 2024 in the Institute of Hematology in Union Hospital of Tongji Medical College of Huazhong University of Science and Technology,were collected and retrospectively analyzed.Results:A total of 28 patients with a median age of 61.5 years(range 36-83 years)were included.Fourteen patients had double-expression lymphoma(DEL)and 15 patients were 60 years old and above.Of all the patients,20 cases received orelabrutinib in combination with R-CHOP/CDOP(OR-CHOP/CDOP)regimens,4 cases received orelabrutinib in combination with R-miniCDOP(OR-miniCDOP)regi-mens,and 4 cases received ORL regimens.PET/CT was used for the evaluation of the treatment response.The objective response rate(ORR)and complete remission(CR)rate of all the patients were 85.7％and 67.9％,and the progressive disease(PD)rate was 14.3％.The ORR,CR rate and PD rate of the DEL patients were 78.6％,64.3％and 21.4％,respectively.The ORR,CR rate and PD rate of the elderly patients(＞60 years)were 86.7％,66.7％and 13.3％,respectively.The ORR,CR rate and PD rate were 85.0％,75.0％and 15.0％in the OR-CHOP/CDOP regimens;the ORR,CR rate and PD rate were 75.0％,50.0％and 25.0％in the OR-miniCDOP regimens;the ORR and CR rate were 100.0％and 50.0％in the ORL regimens.With a median fol-low-up of 14.5 months,the estimated 3-year overall survival(OS)and progression-free survival(PFS)rate were 84.9％and 70.6％for all the patients,100.0％and 70.9％for the DEL patients,and 71.4％and 65.5％for the elderly patients.There was no statistical difference in ORR,CR rate,3-year OS and PFS between the DEL and non-DEL patients.There was no statistical difference in ORR,CR rate,3-year OS and PFS between the elderly and young patients,neither.The most common adverse events were anemia(76.9％of grade 1-2,19.2％of grade 3-4),neutropenia(46.2％of grade 1-2,38.5％of grade 3-4)and thrombocytopenia(34.6％of grade 1-2,15.4％of grade 3-4).The most common non hematological adverse events were pulmonary infection(17.9％),loss of appetite(10.7％),nausea(10.7％)and vomiting(10.7％).Conclusion:Orelabrutinib-based regimens show prom-ising efficacy and tolerable safety in newly diagnosed DLBCL,with a promising improvement of the efficacy and survival in the DEL and old patients,which deserves further study.
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