| Objective:To select a better second-line treatment scheme through the clinical observation of the second-line treatment of 40 patients with advanced esophageal squamous cell carcinoma in our hospital.Meanwhile the safety and efficacy of PD-1 inhibitors in the treatment of advanced ESCC were evaluated by Meta analysis to provide the theoretical support for clinical decision-making.Methods:Forty patients with advanced esophageal squamous cell carcinoma who failed to receive first-line treatment in our hospital from September 1,2019 to June 30,2021 were randomly divided into two groups:group A(PD-1 inhibitor+anlotinib)and group B(anlotinib+S-1).The short-term efficacy of the two groups(complete response[CR],partial response[PR],stable disease[SD],progressive disease[PD]),objective response rate(ORR),disease control rate(DCR),mPFS and adverse reactions were observed.The relevant articles published in Pubmed,Embase,Cochrane library and Web of science database from the establishment of the database to November 31,2021 were searched by computer,and the outcome includes OS,PFS,ORR and the incidence of TTRAEs were analyzed by meta.Results:The clinical observation results of 40 patients in our hospital were ORR 30%and DCR 75%in group A,ORR 25%and DCR 70%in group B,respectively.There was no significant difference in ORR and DCR between the two groups(χ2=0.125,p=0.723;χ2=0.125,p=0.723).The median PFS of group A was 4.9months,while that of group B was 4.7months(p=0.673),the difference was not statistically significant.The spectrum of adverse reaction was different between the two groups,but both of them were tolerable.After705studies were selected,9 studies that met the criteria were incl uded.In the first-line treatment,compared with the control group,the OS a nd PFS of the experimental group were significantly prolonged(HR=0.68,[95%CI 0.62],p<0.00001.HR=0.63,95%CI[0.54-0.75],p<0.00001),and O S and PFS were prolonged more significantly in the PD-L1 high expression group(HR=0.58,95%CI[0.49-0.68],p<0.00001.HR=0.59,95%CI[0.52-0.66],p<0.00001).The ORR of the experimental group was significantly high er than that of the control group(OR=1.99,95%CI[1.65-2.39],p<0.00001),and the incidence was high in any grade of TRAEs(OR=2.36,95%CI[1.394.01],p=0.001),but there was no significant difference between the two gro ups in>3 grade TRAEs(OR=1.19,95%CI[0.81-1.74],p=0.37).In the secondline treatment,compared with the control group,PD-1 inhibitor alone signifi cantly prolonged OS in patients with advanced esophageal squamous cell c arcinoma and high expression of PD-L1(HR=0.73,95%CI 0.66-0.81 P<0.00001.HR=0.61,95%CI[0.49-0.76],p<0.00001).There was no significant difference in PFS and ORR between the two groups(HR=0.88,95%CI[0.68-1.14],p=0.33、OR=1.98,95%CI[0.81-4.84],p=0.13).There was no signific ant difference in the incidence of any grade TRAEs between the two groups(OR=0.34,95%CI[0.08-1.52],p=0.16).The incidence of TRAEs≥ grade 3 i n the experimental group was significantly lower than that in the control gr oup(OR=0.24,95%CI[0.13-0.45],p<0.00001).Conclusion:1.There is no significant difference in ORR and DCR between PD-1 inhibitor+anlotinib group and anlotinib+S-1 group.Both regimens may be the choice of second-line treatment for patients with advanced esophageal squamous cell carcinoma.2.First-line PD-1 inhibitors combined with chemotherapy can prolong OS,PFS and increase ORR in advanced esophageal squamous cell carcinoma,and the incidence of severe adverse events related to treatment is lower,and the survival benefit is more obvious in the group with high expression of PD-L1.3.Second-line PD-1 inhibitors alone could prolong OS,PFS in patients with advanced esophageal squamous cell carcinoma without significant improvement,and the incidence of adverse events related to any grade or severe treatment was lower. |