Clinical Efficacy And Safety Of PD-1 Inhibitors And Its Combination With Other Drugs In Advanced Non-small Cell Lung Cancer: A Real-world Study

Objective: Through retrospective analysis,this study evaluated the clinical efficacy and safety of PD-1 inhibitors and its combination regimens in the treatment of advanced non-small cell lung cancer(NSCLC)in the real world,so as to provide real-world research evidence for clinical medication and adverse reaction management of advanced NSCLC.Methods: Through the electronic medical record system,regular follow-up visits,telephone follow-up,etc.A total of 245 cases of non-small cell lung cancer with unresectable stage IIIB,IIIC and IV who were treated in the Affiliated Hospital of Inner Mongolia Medical University from June 2019 to June 2021.Patients were followed until disease progression,death,or the deadline for follow-up on December 31,2021.The primary endpoint of the study was progression-free survival(PFS)and safety,the secondary endpoints were objective response rate(ORR)and disease control rate(DCR).All data shall be applied with spss 20.0,p<0.05 was statistically significant.Results: Among the 245 patients with evaluable efficacy,ORR 25.3%,DCR 60.4%,and the median PFS was 7.3 months.There were 38 cases in the immune monotherapy group,ORR23.7%,DCR 60.5%,and the median PFS was 6.3 months,172 cases in the immune combined chemotherapy group,ORR 26.7%,DCR 63.4%,and the median PFS was 7.9 months,35 cases in the immune combined anti vascular group,ORR 20.0%,DCR 45.7%,and the median PFS was 5.7 months.There were significant differences between PFS and PD-L1 expression and visceral metastasis(p<0.05),but there was no significant difference with age,gender,smoking history,ECOG score,pathological type,tumor stage,gene mutation,radiotherapy history,number of treatment lines and adverse reactions(p>0.05).Among 245 patients,200(81.6%)had treatment-related adverse events,45(18.4%)had grade ≥3 adverse events,and 120(49.0%)had 2 or more adverse events.Among the 38 cases in the immune monotherapy group,28 cases(73.7%)had treatment-related adverse events,4cases(10.5%)had grade ≥3 treatment-related adverse events.In 172 cases of immune combined chemotherapy group,144 cases(83.7%)had treatment-related adverse events,34cases(19.8%)had grade ≥3 treatment-related adverse events.In the 35 cases of immune combined anti vascular group,28 cases(80%)had treatment-related adverse events,7 cases(20%)had grade ≥3 treatment-related adverse events.30 patients(12.2%)stopped the drug due to adverse events,2 patients died due to serious adverse events,and the remaining adverse events were under control.The correlation between the top five adverse events and PFS was analyzed.The results showed that the occurrence of thyroid dysfunction was related to the prolongation of PFS(p<0.05),but not to skin toxicity,hematological toxicity,gastrointestinal toxicity and hepatotoxicity(p>0.05).Conclusions:(1)In the real world,PD-1 inhibitors and its combination with other drugs have good efficacy in patients with advanced NSCLC.(2)In the real world,most of the adverse events in patients with advanced NSCLC treated with PD-1 inhibitors and combination with other drugs were grade 1-2;Grade 3-4adverse reactions are also mostly within the controllable range.(3)The high expression of PD-L1 and the occurrence of thyroid dysfunction may help to screen the dominant population who benefit from PD-1 inhibitors and combination with other drugs.