| Objective: To estimate the efficacy and safety of Apatinib combined immune checkpoint inhibitors(ICIs)group in the treatment of advanced gastric cancer(AGC)by analyzing and comparing the overall survival(OS)time,progression-free survival(PFS)time and disease remission degree of Apatinib combined ICIs group compared with Apatinib monotherapy group in the treatment of AGC and to provide better later treatment ideas for patients with AGC.Methods: Case data of patients with postoperative recurrence and metastasis of AGC and gastric cancer admitted to Zhejiang Provincial People’s Hospital from January 2018 to September 2022 were retrospectively analyzed.Among them,23 patients were included in Apatinib combined with ICIs group and 23 patients were included in Apatinib monotherapy group.Endpoints were set as overall survival(OS)and progression-free survival(PFS),objective response rate(ORR),disease control rate(DCR),toxic side effects and etc.Version R(4.2.0)was used for data processing and analysis.t test,Wilcoxon rank sum test,or chi-square test were used to determine the clinical characteristics between the two groups,as appropriate.The treatment response of the two groups was compared by Chi-Square test.Kaplan-Meier method was used to construct survival curves,including PFS and OS,and Log-rank test was used to determine analysis of variance.ORR was defined as CR and PR rates for all enrolled patients.DCR was defined as the ratio of CR,PR and stable disease(SD)in all enrolled patients.The prognosis was analyzed by univariate and multivariate Cox proportional hazard regression.P < 0.05 was considered statistically significant.Results: A total of 48 patients were enrolled in this study,including 23 patients in Apatinib combined with ICIs group and 25 patients in apatinib monotherapy group.Median follow-up time was 4.25 months.Kaplan-Meier analysis showed that the median OS was 3 months in the monotherapy group [95%CI 2.5-4.5] and 6 months in the combined treatment group [95%CI 5.0-17.0].PFS were 2 months in the monotherapy group [95%CI 0-3.0] and 3 months in the combination treatment group [95%CI 2.0-4.0].Further subgroup analysis of GC patients showed that the median OS of patients with liver metastasis was 7.5 months,which was significantly longer than those without liver metastasis(4 months)(P=0.036).Meanwhile,the median PFS was 2 months,which had no significant difference compared with patients without liver metastasis(2 months)(P=0.19).Patients with liver metastasis were further divided into Apatinib combined with ICIs group and Apatinib monotherapy group.The median OS of Apatinib combined with ICIs group was longer than Apatinib monotherapy group(P=0.0041)in patients with liver metastasis,however,there was no significant difference in median PFS(P=0.1).In Apatinib combined with ICIs group,ORR and DCR were 4.3% and 78.3%,and CR,PR and SD were achieved in 0 cases(0.0%),1 case(4.3%)and 16 cases(73.9%),respectively.In Apatinib monotherapy group,ORR and DCR were 0% and 60%,and CR,PR and SD were achieved in 0 cases(0.0%),0 cases(0.0%)and 15 cases(60%),respectively.All adverse events occurred in 48 patients with AGC during treatment were analyzed.Indeed,adverse events were acceptable Among the 48 patients,11 patients had Grade III adverse events,including fatigue,severe anemia,granulocytopenia,abnormal liver function,hand-foot syndrome,gastrointestinal bleeding,rash,hypertension and abnormal blood glucose.No IV adverse events were reported.Among all adverse events,the most common adverse events were fatigue,anemia,gastrointestinal reaction and abnormal liver function.Conclusions: Our study suggests that the Apatinib combined ICIs group has longer m OS than Apatinib monotherapy group.ECOG,immune checkpoint inhibitor,liver metastasis,peritoneal metastasis and treatment response are independent factors affecting OS at diagnosis.In addition,for AGC with liver metastasis,immunotherapy significantly prolonged the patients’ m OS. |
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