Efficacy Analysis Of Lenalidomide Maintenance Therapy For Medium-high Risk Diffuse Large B Cell Lymphoma

Objective To explore the efficacy and safety of lenalidomide monotherapy maintenance therapy for diffuse large B-cell lymphoma(DLBCL)with medium-high risk and high risk,as well as the effect of the immune system and the risk factors influencing the efficacy of maintenance therapy.Methods Ninety patients with DLBCL from February 2014 to April 2021 were retrospectively analyzed,of which 45 received lenalidomide monotherapy as the observation group and 45 did not receive maintenance therapy as the control group.Collection included age,gender,time of first diagnosis,clinical staging,grade,IPI/aa-IPI,B symptoms,Eastern Cooperative Oncology Group(ECOG)score,treatment plan,extranodal involved sites,pre-medication status(PR/CR),drug maintenance dose and other medical records.The data of blood routine,lactate dehydrogenase(LDH),lymphocyte subsets,immunoglobulin,cytokines and other laboratory tests were evaluated.Kaplan Meier method was used to draw the survival curve,and log-rank t test was used for survival analysis.Cox proportional hazards model was used to analyze the related factors affecting the prognosis of maintenance treatment.The analysis of drug safety was mainly conducted by descriptive analysis,and the effects of drugs on immune function were analyzed by means of paired sample T test.Non-parametric test was used to analyze the data that did not conform to normal distribution.P<0.05 was considered statistically significant.Results There were 45 patients in the observation group and 45 patients in the control group.There were no statistical differences in age,gender,clinical staging,grade,IPI score,B symptoms,extranodal involved sites,pre-medication status(PR/CR)and other clinical characteristics between the two groups.Adverse reactions such as decreased blood picture,rash,and peripheral nerve numbness occurred in the patients during drug administration,but no serious adverse reactions above grade Ⅲ(CTCAE V5.0)occurred.Effectiveness analysis: The total PFS of the observation group and the control group were80% and 46.7%,respectively,with statistical significance(P=0.002).The OS were 97.8%and 84.4%,respectively,with no significant difference(P=0.066).The 1-year PFS rate were 79.4% and 50%,respectively,with statistical significance(P=0.005).The 1-year OS rates were 100% and 97.6%,respectively,with no significant difference(P=0.941).Laboratory examination of patients in the observation group showed: NLR and PLR decreased significantly 3 months after treatment,the differences were statistically significant(P=0.001,P<0.001).The lymphocyte subsets of 11 patients showed that the count of NK cells increased after 3-6 months of treatment,the difference was statistically significant(P=0.033).There were no significant differences in CD3+CD4 count and CD3+CD8+ count before and after treatment(P=0.374,0.062).Ig G of 15 patients,Ig M of14 patients and Ig A of 12 patients increased significantly 3 months after treatment compared with before,the difference was statistically significant(P = 0.011,0.046,0.003).There was no significant difference in C3 and C4 in 11 patients before and after treatment(P = 0.859,0.182);There was no significant difference in IL-2,IL-10,IFN-γ,IL-6,IL-12 and TNF-α of 5 patients 3-6 months after treatment compared with before(P=0.225,0.080,0.345,0.500,0.465,0.345).Kaplan-meier univariate analysis of the effects of age,gender,clinical staging,grade,IPI score,B symptoms,extranodal involved sites,pre-medication status(PR/CR),LDH,bone marrow on prognosis showed that bone marrow involvement and pre-medication status(PR/CR)had significant effects on PFS of lenalidomide maintenance treatment patients(P=0.002,0.012).Cox regression multivariate analysis showed that bone marrow involvement was independent risk factor for PFS in lenalidomide maintenance therapy patients(P = 0.021).Conclusion Lenalidomide maintenance therapy has good efficacy and high safety for DLBCL patients with medium-high risk and high risk.Lenalidomide may regulate immunity by decreasing NLR and PLR,increasing NK cells and immunoglobulin,thus achieving the effect of maintenance therapy.Bone marrow was independent factor affecting the effectiveness of lenalidomide maintenance therapy.