Efficacy And Safety Analysis Of PD-1 Monoclonal Antibody In Advanced Primary Liver Cancer

Objective: This study mainly investigated the clinical efficacy and safety of Programmed Cell Death Protein 1 combined with Lenvatinib mesylate compared with sorafenib besylate monotherapy in first-line application of advanced liver cancer.To provide more real world clinical reference for the treatment of advanced liver cancer.Methods:Patients with advanced liver cancer who visited Qinghai university affiliated hospital from September 2019 to December 2021 were included according to the inclusion and exclusion criteria,and all of them were diagnosed pathologically or clinically.Eligible patients with advanced liver cancer were divided into 2groups.A total of 26 patients were included in the combination therapy group,in which patients were treated with PD-1 mab(including Sintilimab 200mg/time or Toripalimab 240mg/time or Tislelizumab 200mg/time or Camrelizumab 200mg/time,once every 3 weeks).combined with Lenvatinib(8mg/d(<60kg),12mg/d(≥60kg));A total of 28 patients were included in the control group,who received Sorafenib besylate(400mg/time,bid).Results:1.In terms of the main endpoint,the m PFS in the PD-1 monoclonal antibody combined treatment group was 7.3 months,which was longer than 4.6months in the control group.The combined treatment group had some advantages in prolonging the PFS time,which was statistically significant(P=0.010);In addition,according to m RECIST,the ORR and DCR in the combined treatment group were34.6% and 76.9%;The ORR and DCR of the control group were 21.4% and 57.1%respectively.In terms of secondary end points,the ORR and DCR of the combined group were higher than control group,but there was no statistical significance.Univariate and multivariate Cox regression analysis revealed that the presence or absence of combination therapy had a statistically significant effect on PFS time(P=0.006),and in addition,BCLC stage C patients had a statistically significant effect on PFS time relative to BCLC stage B patients(P=0.020).2.The grade 3 and 4 adverse reactions caused by PD-1 monoclonal antibody combined with Lenvatinib mainly included hand-foot syndrome in 2 cases(2/26,7.7%),hypothyroidism in 2 cases(2/26,7.7%),loss of appetite in 2 cases(2/26,7.7%)and capillary proliferation in 1 case(1/26,3.8%).Other adverse reactions included hypertension,proteinuria,fatigue,diarrhea and rash,all of which were grade1-2 Hypothyroidism and capillary proliferation were seen in PD-1 monoclonal antibody combination therapy group.Analysis using chi-square test showed that the remaining adverse events in both groups were not statistically significant.Conclusion:PD-1 monoclonal antibody combined with Lenvatinib showed good efficacy in first-line treatment of advanced primary liver cancer,and the m PFS was prolonged in the control group,with statistical significance(P=0.010).Although the DCR and ORR results were higher than those of Sorafenib besylate regimen,they did not achieve statistical significance(P>0.05).In addition,the adverse reactions were few,safe and controllable,with good clinical efficacy.