| Objective:To compare the differences in short-term efficacy and long-term survival,as well as changes in immune function and infection in patients with DLBCL treated by R-CHOP±thymosinα1(Tα1).Evaluate the benefits of thymosinα1 in improving efficacy and immune function,reducing infection in DLBCL patients.Methods:Analyzing the clinical data of newly diagnosed DLBCL patients receiving R-CHOP+Tα1 regimen in Shanxi Province Cancer Hospital from January 2014 to December 2018retrospectively.DLBCL patients who were diagnosed at the same time and treated by R-CHOP only were included as controls.Finally,109 cases were included in each group.General clinical characteristics,including age,gender,clinical staging(Ann Arbor staging system),IPI(international prognostic index)score,and clinical symptoms,were collected and analyzed.The efficacy of all patients were evaluated according to Lugano evaluation standard.The results were classified into CR,PR,SD,PD.Overall response rate(ORR)was defined as the sum of CR and PR.Follow-up started from the time of pathological diagnosis to January 31,2022.Overall Survival(OS)was defined as the interval between the beginning of follow-up to death due to any cause or the last follow-up.Progression Free Survival(PFS)was defined as the time interval from the beginning of follow-up to progression or recurrence,or to the last follow-up in patients without recurrence.Analyzing the difference of ORR,OS and PFS between two groups.Recording the changes of T cell subsets(CD3~+,CD4~+,CD8~+,CD4~+/CD8~+),NK cells,cytokines(IL-2,IFN-γ)in peripheral blood of 2 groups and comparing the differences of immune function between two groups before and after chemotherapy.Recording the infection of each patient during chemotherapy and comparing the differences in infection events between the two groups.Results:218 subjects were included,with 109 in the each group.There were 64 males and 45females in the observation group with an average age of(57.63±4.58)years,16 patients at stage I,38 at stage II,42 at stage III and 13 I at stage IV.IPI scores were 0-1 in 75 cases,2 in 18 cases,3 in 14 cases,4 to 5 in 2 cases.46 cases had B symptoms.In the control group,there were 68 males and 41 females with an average age of(59.93±7.15)years,15in stage I,39 in stage II,41 in stage III and 14 in stage IV.IPI scores were 0-1 in 77 cases,2 in 16 cases,3 in 13 cases,4-5 in 3 cases and 49 cases had B symptoms.There was no statistical difference in general data between the two groups(P>0.05).The short-term efficacy assessment was conducted after chemotherapy.92 patients in the observation group achieved CR,9 patients achieved PR.ORR was 92.67%.88 patients in the control group achieved CR,7 patients achieved PR,and ORR was 87.15%.There was no statistical difference between the two groups(P>0.05).After a median follow-up of 31.4months,the median OS and PFS were both not achieved.The 3-year PFS were 70.7%and 67.5%respectively,without statistical difference(P>0.05).3-year OS were 77.2%and 68.5%respectively,with statistical difference(P<0.05).There were no statistically significant differences in various indexes of immune function between the two groups before treatment(P>0.05).The levels of CD4~+,NK,CD4~+/CD8~+and IFN-γin the observation group were higher than those before chemotherapy and higher than those in control group after chemotherapy(P<0.05).While the ratios of CD4~+,NK and CD4~+/CD8~+in the control group were lower than those before chemotherapy(P<0.05).There were 40 patients in the observation group who were infected during chemotherapy(36.70%),and 68 patients in the control group(62.39%).The incidence of infection events in R-CHOP+Tα1 group was lower than that in R-CHOP group(P<0.05).Conclusion:Thymosin Tα1 can significantly improve the immune function and long-term survival,reduce the risk of infection in DLBCL patients treated by R-CHOP.But Tα1 has no obvious advantage in improving short-term efficacy. |
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