| Background The median age at diagnosis of diffuse large B-cell lymphoma(DLBCL)is more than 60 years old.Despite receiving standard first-line chemotherapy,the overall survival rate of elderly patients was still low,which is related to their basic health status,adverse biological characteristics and poor intolerance.Lenalidomide is an immunomodulator drug derived from thalidomide,which can produce direct and indirect antitumor activity through a variety of pathways.It has synergistic effect with rituximab,and is well tolerated,which is expected to improve the prognosis of elderly DLBCL patients.The purpose of this study is to investigate the clinical efficacy of lenalidomide combined with rituximab in the treatment of newly diagnosed DLBCL in the elderly.Methods This study included people aged ≥80 years or ≥70 years old who were newly diagnosed with DLBCL and received R2 regimen(lenalidomide combined with rituximab)from January 1,2018 to December 31,2021.Patients with ECOG(eastern cooperative oncology group)score ≥ 2 points.These patients received rituximab at a dose of 375 mg/m2,once every three weeks,and lenalidomide at a dose of 10-25 mg,orally for 14 consecutive days,with 21 days as a cycle,and patients who reached CR or PR after 8 courses of treatment received lenalidomide amine 10-25 mg monotherapy maintenance therapy for a total of 2 years.These patients were compared with 28 patients treated with R-mini CHOP(the control group)in our hospital from January 1,2017 to December 1,2021.The primary endpoint of the study is the 1-year overall survival(OS)rate,and the secondary endpoints are the overall response rate(ORR)and the 1-year progression-free survival(PFS)rate.Results A total of 53 patients were included,including 25 cases in the R2 group and 28 cases in the control group.The median follow-up time was 18.9 months(range from3.47 to 59.20 months).The 1-year OS rate was 77.6% in the R2 group and 75.8% in the control group.The median OS of the R2 group was 31.6 months,and the median OS of the control group was 28.9 months(HR,0.72;95%CI: 0.29-1.77;P=0.48).Subgroup analysis of OS showed that among patients with Ann Arbor stage III-IV,the median OS was 31.6 months in the R2 group and 17.7 months in the control group(HR,0.41;95%CI: 0.15-1.07;P=0.08).Among patients with ECOG score ≥ 2,the median OS of the R2 group was 31.6 months,and the median OS of the control group was 15.2months(HR,0.38;95%CI: 0.14-1.04;P=0.06).The 1-year PFS in the R2 group and the control group were 52.9% and 58.1% respectively,and the median PFS were 31.0months and 17.7 months(HR,0.90;95%CI: 0.43-1.89;P=0.77).The mid-term assessment ORRs of the R2 group and the control group were 72% and 78.6%(P=0.13);after induction,the ORR was 60% in the R2 group and 64.2% in the control group(P=0.42).The most common adverse reaction in both R2 group and control group was neutropenia,but the incidence rate in R2 group was less than that in the control group.The results of multivariate model analysis showed that no independent prognostic factors affecting OS were found at the P value of 0.05.However,LDH level(HR: 0.35,95%CI: 0.13-0.95)and Ki-67 proliferation index(HR: 0.34,95%CI: 0.12-0.96)were independent prognostic factors for PFS.Conclusion Lenalidomide combined with rituximab is an effective and tolerable choice for elderly patients,especially those who are too old or unfit to be suitable for first-line standard regimen. |
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