Analysis Of The Safety And Effectiveness Of BTK Inhibitor In Treatment Of Chronic Lymphocytic Leukemia In The Real World

Objective:Comparing the efficacy and safety of Bruton tyrosine Kinase inhibitor(Orelabrutinib 、Zanubrutinb versus Ibrutinb)in treatment of Chronic lymphocytic leukemia.Methods:A retrospective analysis was performed on CLL patients who were firstly diagnosed and treated with Bruton tyrosine Kinase(BTK)inhibitor in seven Hospitals from January 2017 to August 2022.According to the inclusion and exclusion criteria,a total of 66 patients were included,including 19 patients in the Ibrutinib group,27 patients in the Zanubrutinib group and 20 patients in the Orelabrutinib group.Patients were followed up by mobile phone、QQ、wechat and other means every 1 month in the first three months,once in 3-6 months and once in 6-24 months.Patients’ baseline data、laboratory data、imaging data、adverse reactions and patient survival were collected and recorded through the hospital inpatient system.Efficacy and safety were evaluated according to the 2022 NCCN CLL/SLL efficacy evaluation criteria and the National Cancer Institute Common Termonilogy Criteria for adverse Events 5.0.To compare the efficacy and adverse reactions of ibrutinib,Zanubrutinib and orelabrutinib,The main outcome measures were progression-free time(PFS)and overall survival(OS),while the secondary outcome measures were adverse reactions and overall remission rate(ORR).Results:1.The median progression-free time(m PFS)and The median survival time(m OS)of Ibrutinib、Zanubrutinib and Orelabrutinib were not reached.2.The 12-month overall response rates of Ibrutinib,Zanubrutinib and Orelabrutinib groups were respectively 52.9% 、 90.0% and 80.0%(P = 0.034).Multi-variate Cox analysis showed that TP53 mutation,no IGHV rearrangement,Rai staging and serum high B2-microglobulinemia were independent prognostic factors of PFS.3.The incidence of adverse reactions of 19 patients in Ibrutinib group was 47.4%,among which grade 3 and above adverse reactions were 15.8%.Common adverse reactions included neutropenia(21.1%)、grade 3 and above infection(15.8%)、diarrhea(10.5%)、rash(10.5%)、hypertension(10.5%)and atrial fibrillation(10.5%).The incidence of adverse reactions of 27 patients in Zanubrutinib group was 44.4%,among which grade 3 and above adverse reactions were 11.1%.Common adverse reactions were neutropenia(29.6%)、 grade 3 and above infection(11.1%)、 rash(3.7%)、diarrhea(3.7%)、atrial flutter/atrial fibrillation(3.7%)and second tumor(3.7%).The incidence of adverse reactions of 20 patients in the Orelabrutinib group was 40.0%,among which the adverse reactions of grade 3 and above were 10.0%.The common adverse reactions were neutropenia(35.0%)、infection of grade 3 and above(10.0%)、diarrhea(10.5%)and rash(5.0%).Conclusion:compared with Ibrutinib,Orelabrutinib and Zanubrutinib can improve ORR in treatment of Chronic lymphocytic leukemia,but The incidence of adverse reactions was similar among the three groups;TP53 mutation 、 IGHV mutation and serum β2-microglobulin remained independent prognostic factors in the era of BTK inhibitor therapy...