| ObjectiveTo analyze the clinical features and prognostic factors of 284 patients with Chronic Lymphoytic Leukemia(CLL)in our center,and analyze the difference in the efficacy of different small molecule inhibitors and immunochemotherapy strategies in the untreat and relapsed/refractory(R/R)patients,and provide reference for the selection of treatment options for patients with CLL.Methods1.Collect all in March 2012 to August 2020 in zhengzhou university affiliated tumor hospital 284 cases of CLL with clinical and laboratory data.The therapeutic effects of different treatment regimens were compared between the untreat group and the R/R group.The treatment regimens include: ibrutinib monotherapy,and other small molecular inhibitors(second-generation BTK inhibitors,Bcl-2 inhibitors,PI3 K inhibitors)and immunochemotherapy,etc.We classified ibrutinib and other small molecule inhibitors as targeted therapy group,and other chemotherapy regimens as routine therapy group.2.CLL patients who were treated with ibrutinib monotherapy,according to the number of ibrutinib treatment lines,they were divided into first,second,third and above lines.To compare the efficacy of ibrutinib in the untreat group and R/R group,and to compare the differences in the efficacy of different treatment lines.Results1.A total of 284 patients with CLL were collected.Among them,126 cases in the untreat group,the median age was 61(36～87)years old,the male: female ratio was 1.42:1,and the Rai stage 0～II 76 cases(60.3%),III/IV stage 50 cases(39.7%);Benit stage A and B 83 cases(65.9%),stage C 43 cases(34.1%).158 cases in the R/R group,the median age was 61(32～90)years old,the male: female ratio was 1.68:1,and the Rai stage 0～II 53 cases(34.5%),Rai III/IV 105 cases(66.5%),Benit stage A and B 76 cases(48.1%),stage C 82 cases(51.9%).2.The ratio of β2-M and LDH increased in the R/R group was higher than that in the untreat group(P=0.035 and P=0.002).FISH test showed that the positive rate of 13q-was the highest in both the untreat and R/R group(38.0% in the untreat group,38.9% in the R/R group).The detection rate of 17p-was 22.2% in the R/R group,which was significantly higher than that in the untreat group 6.8%,and the difference was statistically significant(P=0.006).The detection rate of 11q-in the R/R group was 26.6% higher than that in the untreat group 12.7%,and the difference was statistically significant(P=0.029).The complex karyotype of chromosome in R/R group(17.1%)was higher than that in untreat group(7.9%).The rate of unmutated IGHV status in the R/R group was(63.2%)higher than that in the untreat group(45.5%),but the difference were not statistically significant.3.Total 99 patients reached the treatment indication in the untreat group.The median PFS of targeted therapy(not reached)longer than conventional therapy(48months),but no statistically significant difference(P=0.139).The median OS of targeted therapy(not reached)was better than that in the conventional treatment group(85 months),and the difference was statistically significant(P=0.017).Total128 cases in the R/R group reached the treatment indication.The median PFS(30months)and the median OS(not reached)of targeted therapy was significantly longer than that of conventional therapy(15 months and 82 months),the differences were statistically significant(P values were P=0.017 and P<0.001,respectively).The median PFS of patients with TP53 gene abnormalities(17p-and TP53 mutations)in the untreat group(not reached)was better than that of R/R patients(11 months),the difference was statistically significant(P=0.038).However,the median OS between the two groups was not statistically significant.The median PFS(not reached)and the median OS(not reached)with targeted therapy were better than that of conventional therapy(15 months and not reached)in R/R group patients with 11q-,the differences were statistically significant(P values were P=0.003 and P=0.025,respectively).4.A total of 55 patients received ibrutinib monotherapy,including 23 patients in untreat group and 32 patients in R/R group.The median PFS(not reached)in the untreat group was significantly higher than in R/R group(19 months),the difference was statistically significant(P=0.004).The median OS was not reached in both groups,and the difference was not statistically significant.The median PFS of first-line treatment(not reached)was significantly higher than that of second-line(48months)(P=0.042)and third-line and above(13 months)(P<0.001).Conclusion1.In the R/R group,the proportion of poor prognosis such as the increase ofβ2-M and LDH,the detection rate of 17p-and 11q-,the complex karyotype of chromosome,and the unmutated IGHV status in the R/R group was higher than that in the untreat group.2.The efficacy of targeted therapy in patients with R/R and untreated CLL is better than that of conventional therapy,especially for high-risk patients.Small molecular inhibitors completely overcome the poor prognosis of 11q-.The efficacy of first-line and second-line ibrutinib treatment was better than that of third-line and above. |
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