A Real-world Study Of The Effects Of Prior Use Or Non-use Of Anti-angiogenic Agents On The Efficacy And Safety Of Late-line Therapy With Anlotinib In Patients With Advanced Non-small Cell Lung Cancer

Objective: Anlotinib is a commonly used late-line drug for advanced lung cancer,however,its efficacy in patients previously treated with anti-angiogenic drugs is still unclear.The purpose of this study was to investigate the impact of prior treatment with or without antivascular agents on the efficacy and safety of anlotinib in patients with advanced non-small cell lung cancer(NSCLC),and to explore the predictors that might affect the efficacy of anlotinib.Methods: Forty-five patients with advanced NSCLC treated with anlotinib who attended Shengjing Hospital of China Medical University and Anshan Cancer Hospital between May 2018 and January 2020 were retrospectively collected as study subjects.The endpoints observed in the study included progression-free survival(PFS),objective response rate(ORR),disease control rate(DCR),and treatment-related adverse events(TRAEs).The study groups were divided into study group 1(treated with anti-angiogenic therapy group)and group 2(untreated with anti-angiogenic therapy group)based on previous use or non-use of anti-angiogenic targeted drugs.The occurrence of PFS,ORR,DCR and TRAEs were compared between the two groups.The efficacy was evaluated using RECIST 1.1 criteria and TRAEs were evaluated using CTCAE 5.0 criteria.Univariate analysis and Cox multivariate regression analysis were performed on the factors associated with the effect of PFS.Results: Of the 45 patients in the group,the ORR was 22.2% and DCR was 73.3%,including 10 cases of PR(22.2%),23 cases of SD(51.11%)and 12 cases of PD(26.7%).The ORR(14.3% vs 35.3%)and DCR(64.3% vs 88.2%)of study group 1 were lower than those of study group 2,but the difference was not statistically significant(P>0.05).The median PFS between study group 1 and study group 2 was 3.0 months(95% CI:2.145-3.855)and 4.0 months(95% CI: 3.33-4.663),respectively,P=0.036.Univariate regression analysis of PFS showed that ECOG PS and fibrinogen content were the influencing factors of PFS(all P<0.05).Cox multivariate regression analysis showed that ECOG PS(P=0.044)and fibrinogen content(P=0.019)were independent factors affecting the prognosis of PFS.The most common(>10%)TRAEs of anlotinib were hypertension(25.0%)in study group 1 and hypertension(17.6%)and rash(10.7%)in study group 2.There was no significant difference between the two groups(P>0.05).Conclusion: Anlotinib has shown good efficacy and safety in patients with advanced NSCLC,regardless of whether they have received prior anti-angiogenic targeted therapy.Anlotinib demonstrated better response rates and PFS especially in patients who had not received prior anti-angiogenic therapy.