| Objective:To explore the relationship between the efficacy of immune checkpoint inhibitors in the treatment of primary liver cancer or the adverse reaction and the application of antibiotics.Methods:A collection of 40 patients with primary liver cancer who underwent PD-1antibody combined with lenvatinib or sorafenib in the Second Affiliated Hospital of Nanchang University from September 2018 to June 2020.Patients were divided into two groups according to whether they used antibiotics within 60 days before and after immunotherapy.There were 18 cases in the antibiotic group and22 cases in the non-antibiotic group.According to the RESIST1.1 standard,the efficacy of the antibiotic group and the non-antibiotic group was evaluated,and the treatment-related adverse events of the two groups were evaluated according to the CTCAE-5.0 standard.The primary endpoints of this study are Progression Free Survival(PFS)and Overall Survival OS(Overall Survival OS),and the secondary endpoints are ORR、DCR and treatment-related adverse reactions.Results:1.Short-term efficacy evaluation results show in the antibiotic group,there were 0 cases of CR,4 cases of PR(22.2%),4cases of SD(22.2%),10 cases of PD(55.6%),22.2% of ORR(4/18),and 44.4% of DCR(8/18);In non-antibiotic the group,there were 1cases of CR(4.5%),8 cases of PR(36.4%),10 cases of SD(45.5%),3 cases of PD(13.6%),40.9% of ORR(9/22),and 86.4% of DCR;There was no statistically significant difference in ORR between the two groups(p=0.209),while DCR in the non-antibiotic group was significantly higher than that in the antibiotic group,and there was statistical difference(p=0.005).2.Long-term efficacy evaluation results that among 40 patients,The overall median progression free survival(m PFS)was 7.4 months and the median overall survival(m OS)was 14.3 months.The PFS of the antibiotic group was 6.7months,and the non-antibiotic group was 8.9 months,p=0.038,with statistically significant difference.The OS antibiotic group was 13.2 months,and the non-antibiotic was16.3 months,p=0.025,with statistically significant difference.The COX risk model was used to conduct a multivariate regression analysis on various factors that may affect the prognosis,and it was found that the BCLC staging and the use of antibiotics may affect the patient’s PFS,and the use of antibiotics is an independent factor affecting OS.3.In terms of adverse reaction,in the antibiotic group mainly include hypothyroidism(33.3%),diarrhea(33.3%),decrease appetite(38.9%),fatigue(38.9%).I-II level in the non-antibiotic group,there were mainly include hypothyroidism(27.3%),decrease appetite(27.3%),fatigue(27.3%).The above I-II levels of adverse reaction are the most common,but there is no statistical significance in the two groups(p>0.05).There was no statistically significant difference in adverse reactions of grade III and above between the two groups(p>0.05).When corresponding toxic and adverse reactions occur,based on the symptomatic treatment,they can be alleviated,and there is no death due to drugs and toxics adverse reactions.Conclusions:1.Compared with the non-antibiotic group,the use of antibiotics may reduce the DCR,m PFS and m OS of immune checkpoint inhibitors in the treatment of primary liver cancer,but the mechanism is unknown.2.There is no obvious correlation between the use of antibiotics and the adverse reaction related to treatment. |
