Clinical Efficacy Of Ibrutinib Monotherapy And R-CHOP In The Treatment Of Chronic Lymphocytic Leukemia

Objective:To observe the clinical efficacy and safety of ibrutinib monotherapy and R-CHOP in the therapy of patients newly diagnosed with Chronic lymphocytic leukemia(CLL),and to analyze the influence of cytogenetical,molecular biological and other factors on the efficacy and survival of patients.Methods:Retrospective analysis was performed on 63 newly diagnosed patients with chronic lymphocytic leukemia,all of whom were treated in the Hematology Department of the Affiliated Hospital of Qingdao University and Qingdao Commercial Workers Hospital from March 2014 to December 2020,and with relatively complete clinical data.According to different treatment regimens,they were divided into ibrutinib group(35cases)and R-CHOP group(28 cases),taking 28 days as a treatment course.The efficacy was evaluated every 4 courses of therapy,and the clinical efficacy,adverse reactions and survival time of the two groups were compared.SPSS25.0 software was used to statistically analyze their clinical characteristics,efficacy,progression-free survival,adverse reactions,etc,and P<0.05 was considered statistically significant.Results:1.A total of 63 patients,primarily diagnosed with chronic lymphocytic leukemia,were included in this study,including 35 in the ibrutinib group and 28 in the R-CHOP group.There was no statistical difference in the basic clinical data between 2groups(P>0.05).2.The results showed that the overall response rate(0RR)in ibrutinib group was higher than that in R-CHOP group(85.71%(30/35)VS 50%(14/28),P=0.020).The incomplete remission(CRi)and partial remission(PR)of the two groups were 17.14%(6/35)VS 10.71%(3/28)and 48.57%(17/35)VS 39.29%(11/28),respectively,and there was no significant difference between the two groups(P>0.05).3.In this study,the median follow-up time was 18 months(4-25 months).A total of 3 patients died of disease progression or severe complications,including 1 in the ibrutinib group and 2 in the R-CHOP group;PFS comparison showed that median progression-free survival in ibrutinib group was significantly higher than that in R-CHOP group(16months vs 8 months,P<0.001).Univariate analysis showed that patients with combined IGHV mutation and/or TP53 free mutation had longer progression-free survival,and the difference was statistically significant(P<0.05)Age、gender、Del(17P)and Del(11q)had no statistical significant influence on progression-free survival.4.Common adverse reactions during treatment mainly include bleeding,infection,etc.;The incidence of grade 1-2 bleeding,grade 1-2 infection,and digestive tract reactions in ibrutinib group was lower than those in R-CHOP group,and the difference was statistically significant.Adverse reactions in the treatment process were mostly at grade1-2,and the incidence of adverse reactions became lower and lower with the extension of treatment time.Conclusion:1.Compared with R-CHOP,ibrutinib regimen can improve the remission rate and overall response rate in primary diagnosed patients with chronic lymphocytic leukemia.2.IGHV and TP53 mutation status were important factors affecting the prognosis of patients,and there was no statistical difference in the effect of age,gender、Del(17P)and Del(11q)on the progression-free survival of ibatinib group.3.Both ibrutinib and R-CHOP have different degrees of adverse reactions during treatment.The incidence of adverse reactions in the ibrutinib group was relatively low,most of which were grade 1-2,and can be tolerated by patients.With the extension of the treatment course,the incidence of adverse reactions gradually decreased,and patients could tolerate long-term application.