| ObjectiveTo evaluate the efficacy and tolerability of rituximab combined with lenalidomine in patients with previously untreated or relapsed/refractory B-NHL.MethodsA retrospective analysis of 52 cases of previously untreated or relapsed/refractory B-NHL treated by rituximab combined with lenalidomide(R~2)from August2016 to December 2020 in the Department of Hematology,Affiliated Cancer Hospital of Zhengzhou University.Induction period:all types of B-NHL received rituximab375 mg/m~2 on day 1 of each cycle,plus lenalidomide 10～25mg per day for six to eight 21-day cycles.Maintenance period:aggressive B-NHL recieved lenalidomide monotherapy(10～20 mg/d)/without therapy;indolent B-NHL recieved R~2 regimens(rituximab 375 mg/m~2 on day 1 of each cycle,combined with lenalidomide 10～20mg/d for every 3 months)/lenalidomide/without treatment.Maintenance lasted for 2years.During treatment period,blood routine,blood biochemical and urine routine were monitored,and dose reductions and interruptions of drugs were adjusted according to WBC level,platelet level and renal function.Patients with bone marrow invasion would take bone marrow cell morphology and flow cytometry after finishing6～8 cycles,to detect minimal residual disease(MRD).Patients were restaged by ultra-B and/or systemic enhanced CT,MRI,PET-CT every 2～3 cycles to evaluate the tumor lesion.Observe the efficacy and adverse events.Results1.Overall response:52 previously untreated or relapsed/refractory B-NHL patients finally received R~2 regimens.The overall response rate(ORR)was 84.6%(44/52);the complete remission(CR)rate was 59.6%(31/52);the partial response(PR)rate was 25.0%(13/52).With a median follow-up of 17.0(7.7～55.4)months,the median duration of response(DOR)was 11.0(0～38.5)months,and the median progression-free survival(PFS)and overall survival(OS)were not reached.The3-year PFS and OS rates were 73.9%and 76.1%,respectively.2.Comparison of efficacy between the untreated group and the relapsed/refractory group:The ORR of the untreated group and the relapsed/refractory group were 92.3%(24/26)and 76.9%(20/26),respectively,and there was no significant difference(P=0.248);the CR rates were 73.1%and 46.2%,respectively;the PR rates were 19.2%and 30.8%,respectively.The 3-year PFS of the untreated group was higher than the relapsed/refractory group(87.8%vs 62.7%,P=0.004);the 3-year OS was similar in the two groups(93.8%vs 53.5%,P=0.152).3.Analysis of B-NHL subtypes:The ORR of diffuse large B cell lymphoma(DLBCL),follicular lymphoma(FL),marginal zone lymphoma(MZL),mantle cell lymphoma(MCL),chronic lymphocytic leukemia/small cell lymphoma(CLL/SLL)were100%(2/2),94.1%(32/34),71.4%(5/7),50.0%(2/4),33.3%(1/3).FL was the bestest,followed by MZL among indolent NHL.4.FL:The ORR of 34 patients who were diagnosed FL was 94.1%(32/34);the CR and PR rate was 61.8%(21/34)and 32.4%(11/34),respectively.With a median follow-up of 17.0(7.7-55.4)months,the median DOR was 11.6(0-38.0)months,and the median PFS and OS were not reached;the 3-year PFS and OS rates were 78.0%and 78.9%,respectively.R~2 regimens,lenalidomide monotherapy,or without theraphy during maintenance probably had effects on the PFS and OS who were FL,but the difference was not statistically significant(all P values≥0.05).There was no significant difference in ORR,3-year PFS,and 3-year OS between the untreated group and the relapsed/refractory group(P≥0.05).5.Safety:The most common grade 3～4 adverse events included neutropenia(34.6%)and thrombocytopenia(13.5%),which can be tolerated after drug dose adjustment and symptomatic treatment.34.6%of patients han lenalidomide dose reductions and interruptions due to adverse events.There were no treatment-related deaths.Conclusion1.The R~2 regimen is effective in patients with previously untreated or relapsed/refractory B-NHL.The effecacy of R~2regimen in the first-line for B-NHL treated with R~2 regimen is higher than that of second-line and above.2.The adverse events of R~2 regimen in patients with previously untreated or relapsed/refractory B-NHL are well tolerated. |
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