Objective:To systematically evaluate the efficacy and safety of zanubrutinib monotherapy in the treatment of B-cell lymphoma(BCM).Methods:A comprehensive literature search was conducted from database inception to August 2023 in PubMed,Embase,Cochrane Library,Web of Science,CNKI,Wanfang,VIP,and CBM databases.Study quality was assessed using the Cochrane risk of bias tool for randomized controlled trials(RCTs)and the MINORS checklist for observational studies.A Meta-analysis was performed on RCTs and single-arm clinical trials.Data were analyzed using both random and fixed-effects models.Results:A total of 11 studies were included,comprising 3 RCTs and 8 single-arm clinical trials,involving a total of 1,869 patients.The Meta-analysis showed:(1)RCTs:Compared with the control group,the differences in overall response rate(ORR)and progression-free survival(PFS)were statistically significant(all P<0.05),while there were no statistically significant differences in complete response(CR),overall survival(OS),or the incidence of overall adverse events(AEs)(all P>0.05).(2)Single-arm clinical trials:The ORR for zanubrutinib treatment was 0.73(95%CI 0.59-0.86),the CR was 0.24(95%CI 0.03-0.45),and the 1-,2-,and 3-year PFS were 0.57(95%CI 0.08-1.06),0.66(95%CI 0.49-0.82),and 0.60(95%CI 0.40-0.79),respectively.The 1-,2-,and 3-year OS were 0.81(95%CI 0.57-1.05),0.85(95%CI 0.77-0.92),and 0.84(95%CI 0.77-0.90),respectively.The overall incidence of AEs was 0.99(95%CI 0.91-1.08).Conclusion:Zanubrutinib significantly prolongs PFS and improves ORR in patients with BCM.Although the overall incidence of AEs is high,the rates of severe(≥grade 3)hypertension,bleeding,and infection are not elevated.Close monitoring of adverse events is necessary in clinical practice to enhance patient safety.
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