| Objective: To analyze factors influencing the efficacy,safety and prognosis of three or more lines of anlotinib hydrochloride therapy for advanced NSCLC patients.Methods: The medical records and follow-up data of 114 patients with advanced NSCLC who were treated with three or more lines of anlotinib hydrochloride at the Department of Respiratory Oncology,Affiliated Cancer Hospital,Guangxi Medical University between June 2018 and August 2020 were collected for a retrospective analysis on relevant factors influencing the efficacy,safety and prognosis.Survival curves were derived using the Kaplan–Meier method.Logistic regression model was used to analyze the influencing factors of the efficacy.The prognostic factors were analyzed by Cox regression analysis model.The factors with statistical differences in univariate analysis were then analyzed by multivariate analysis.Results: The overall median progression-free survival(m PFS)was 2.95 months(95%CI: 2.567~3.567,median overall survival(m OS)7.47 months(95%CI :6.167~9.567);objective response rate(ORR)15.8%,and the disease control rate(DCR)78.9%.In a subgroup analysis,for m PFS,there were differences for ECOG score(P < 0.0001)and therapy lines(P=0.012).The higher the ECOG score or the more the therapy lines,the shorter the m PFS,and for m OS,there were statistically significant differences for ECOG score(P < 0.0001)and pathological type(P=0.019).The higher the ECOG score,the shorter the m OS.The patients with squamous cell carcinoma had the longest m OS,while the patients with adenosquamous cell carcinoma had the shortest m OS.The adverse reactions with an incidence rate more than 10% included hypertension(30.7%),fatigue(27.2%),loss of appetite(21.1%),oral mucositis(17.5%),elevated triglyceride(16.7%),hypothyroidism(15.8%),hand-foot reaction(14.9%),nausea(14.0%),urinary protein(12.3%),abdominal pain(12.3%),and rash(10.5%).The incidence rate of Grades 3-4 adverse reactions was 41.2%.The dose was reduced in 25 cases(21.9%)and discontinued in 8 cases(7%).In both univariate and multivariate analyses,the results showed that the factors influencing the efficacy of anlotinib for advanced NSCLC treatment were ECOG score(OR=7.4,95%CI : 2.49~22.01,P=0.0003)and the number of therapy lines(OR=3.74,95%CI :1.3~10.74,P=0.0144).The efficacy in patients with ECOG score 2-3 was lower than in those with ECOG score 1,and the efficacy for 4 lines of therapy was lower than for 3 lines of therapy.The factor influencing prognosis of advanced NSCLC patients treated with anlotinib was ECOG score(HR=8.63,95%CI: 5.18~214.38,P < 0.0001).The prognosis for ECOG score 2-3 was worse than that for ECOG score 1.As for the influence of adverse reactions on the prognosis,a relevant analysis showed that the risk of progression decreased for hypertension(HR=0.63,95%CI =0.42-0.95,P=0.0289),hypothyroidism(HR=0.55,95%CI: 0.33~0.93,P=0.0261),hand-foot reaction(HR=0.44,95%CI: 0.26~0.74,P=0.0021),while the risk of death increased if nausea occurred after treatment(HR=2.25,95%CI: 1.27~3.99,P=0.0057).The results of analysis based on the Cox regression model showed that hand-foot reaction(HR=0.49,95%CI: 0.29~0.85,P= 0.0109)was an independent protective factor for prognosis.Conclusion: The anlotinib hydrochloride is effective in three or more lines of therapy for advanced NSCLC.In the advanced NSCLC treatment,the efficacy of anlotinib is correlated to ECOG score and the number of therapy lines,and the adverse reactions are tolerable.High ECOG score is an important factor for poor prognosis of advanced NSCLC treated with anlotinib.The hand-foot reaction after treatment was an independent protective factor for the prognosis of advanced NSCLC treated with anlotinib. |