| Objective:The efficacy and safety of Nivolumab in the treatment of various relapsing or refractory(R/R)lymphoproliferative diseases were systematically evaluated by Metaanalysis,to provide an objective basis for the clinical application of Nivolumab in the treatment of lymphoproliferative diseases.Methods:Pubmed,Medline,Embase,Cochrane Library,Web of science,US Clinical Trials Registry,China Clinical Trials Registry,China Knowledge Network,Wanfang,and China Biomedical Literature were searched for prospective clinical trials that evaluate Nivolumab in treating relapsed or refractory malignant lymphoproliferative disease from the time of database construction until September 2021.Objective response rate(ORR),complete remission rate(CRR),partial remission rate(PRR),overall survival(OS)and adverse events(AEs)of grade 3 + were used as outcome indicators,and the incidence was summarized by Meta-analysis.Results:A total of 1082 papers were retrieved after screening,11 papers and 19 studies with 646 patients meeting the inclusion criteria.1.The ORR was 40% in the nineteen studies,CRR was 9%,and PRR was 25%.The ORR in the B-cell tumor group was 8%,CRR was 2%,and PRR was 4%.The ORR in the T and Natural Killer(NK/T)cell tumor group was 18%,CRR was 2%,and PRR was 13%.The ORR in the Hodgkin’s lymphoma(HL)group was 72%,the CRR was 18%,and the PRR in the HL group was 50%.2.In the HL group,the ORR for patients with median prior treatmen<4 was 70%,CRR was 29%,and PRR was 40%.The ORR for median prior treatment≥4 was 74%,CRR was 17%,and PRR was 56%.3.In the HL group,the ORR for dosing regimen 1 was 90%,CRR was 16%,and PRR was 16%,while the results for regimen 2 showed an ORR of 68%,CRR of 17%,and PRR of 49%.(Dosing regimen 1: Nivolumab 3mg/kg IV at week 1 and 4 and then every 2 weeks for up to 2 years.Dosing regimen 2: Nivolumab 3mg/kg IV every 2weeks).4.In the HL group,the ORR for patients with previously treated BV was 69%,CRR was 24%,and PRR was 38%.In contrast,the ORR in the previously treated BV+ASCT group was 73%,CRR was 11%,and PRR was 60%.5.In the HL group,patients aged<35 years had an ORR of 66%,CRR of 23%,and PRR of 38%,while patients aged≥35 years had an ORR of 77%,CRR of 16% and PRR of 62%.6.In the seven studies that gave 6-month PFS rates the overall PFS rate was 41%and the PFS rate in the NHL group was 12%,the PFS rate in the HL group was 85%.7.Among the eight studies that gave OS rates,the 6-month OS rate of the NHL group was 57% and the 1-year OS rate of the HL group was 94%.8.In the 9 studies that gave the number of people with grade 3+ AEs,the overall incidence was 26%.The incidence of grade 3+ AEs was 22% for dosing regimen 1 and25% for regimen 2.The incidence of grade 3+ AEs was 17% in patients with median prior treatmen≥4 and 25% in patients with median prior treatment<4.The incidence of grade 3+ AEs was 31% in patients aged ≤ 63 years and 26% in patients aged>63years.Conclusion1.Nivolumab had the best efficiency and survival rates for HL,followed by the T and NK cell tumor groups,and the worst for B cell tumors.2.Compared to dosing regimen 2,dosing regimen 1 showed more remarkable tumor-eliminating activity in HL patients and a lower overall incidence of AEs than regimen 2.(Dosing regimen 1: Nivolumab 3mg/kg IV at week 1 and 4 and then every2 weeks for up to 2 years.Dosing regimen 2: Nivolumab 3mg/kg IV every 2 weeks).3.In the HL group,Nivolumab seems to have a more significant efficacy in patients with more prior treatment compared to those with less prior treatment.And overall,the incidence of AEs was less in patients with more prior treatment than in those with less prior treatment,but the CRR was higher in those with less prior treatment.4.Among HL patients,Nivolumab is more likely to achieve CR in patients previously treated for BV than in BV+ASCT. |
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