| Objective: Endostar(Recombinant human endostatin,Endostar,YH.16)is an anti-angiogenic drug widely used in patients with advanced non-small cell lung cancer(NSCLC).The purpose of this study was to retrospectively analyze the safety and efficacy of Endostar plus Chemotherapy regimen in the first-line treatment of advanced NSCLC,and to compare it with chemotherapy regimen.Methods: The data of patients with stage IV NSCLC who were treated in our center from January 1,2012 to June 1,2020 with Endostar plus chemotherapy or chemotherapy alone were collected and followed up.The observation group was given continuous intravenous infusion(CIV)of Endostar plus chemotherapy,and the control group was given chemotherapy;the efficacy evaluation was based on the RECIST 1.1 standard,and the adverse reactions were evaluated by the WHO anticancer drug adverse reaction grade.The primary endpoints of this study were median progression-free survival(m PFS),median overall survival(m OS),and secondary endpoints were objective response rate(ORR),disease control rate(DCR),and safety.Results: Finally,216 patients with advanced NSLCC were included in the analysis.There were 117 patients in the Endostar plus chemotherapy group,including 45 patients with squamous cell carcinoma and 72 patients with adenocarcinoma.There were 99 patients in the chemotherapy group,46 patients with squamous cell carcinoma,and 53 patients with adenocarcinoma.(1)Overall m PFS and m OS:The m PFS of the two groups was 6.1 months vs 4.2 months(P<0.05),and m OS data of the observation group and the control group were 12.8 months and 8.8 months(P<0.05)respectively.COX regression show that Endostar plus chemotherapy(HR=0.621,95%CI,0.457-0.844),Chest radiotherapy(HR=0.642,95% CI,0.433-0.951),and squamous cell carcinoma(HR=0.520,95% CI,0.357-0.758)were the risk factors for independent prognosis of m PFS,while Endostar plus chemotherapy(HR=0.514,95%CI,0.377-0.702),and Chest radiotherapy(HR=0.469,95%CI,0.314-0.700),male(HR=1.947,95%CI,1.190-3.184),squamous-carcinoma(HR=0.668,95%CI,0.461-0.967),surgery(HR=0.515,95%CI,0.278-0.956)were independent prognostic risk factors affecting m OS.(2)Subgroup m PFS and m OS: Squamous carcinoma subgroup: 6.8 months vs 4.6 months for m PFS(P<0.05)and 12.8 months vs 9.4 months for m OS(P<0.05)for two groups.Adenocarcinoma subgroup:4.6 months vs 4.1 months(P<0.05)for m PFS and 12.2 months vs 7.5 months(P<0.05 months)for m OS bewteen observation and control groups.(3)Overall short-term efficacy: The ORR were 34.2% vs 15.2%(P<0.05);DCR were82.8% vs 46.5%(P<0.05)respectively.The results of Logistic regression show that Endostar combined chemotherapy(OR=0.247,95% CI,0.104-0.585),chest radiotherapy(OR=0.086,95% CI,0.034-0.218),squamous cell carcinoma(OR=0.290,95% CI,0.117-0.717),and male(HR=0.1.336,95% CI,1.093-2.258)were independent prognostic factors for ORR.In the subgroup analysis,the observation group and the control group of squamous cell carcinoma ORR and DCR were 37.8% vs 17.4%(P<0.05)and 77.8% vs52.2%(P<0.05)respectively,and ORR and DCR in the adenocarcinoma subgroup were31.9% vs 13.2%(P<0.05),84.7% vs 41.5%(P<0.05)respectively.(4)Adverse reactions and safety: Endostar CIV plus chemotherapy did not significantly increase the incidence of adverse reactions in myelosuppression,elevated transaminases,and gastrointestinal reactions compared with Chemotherapy,and the incidence of cardiotoxicity was 5.9%,can be tolerated and relieved spontaneously;the incidence of hypertension was 3.4%,and the incidence of proteinuria was 1.7%,with well safety and has no intolerable serious adverse reactions.Conclusions: Compared with chemotherapy alone,Endostar combined chemotherapy has a good effect in the first-line treatment of stage IV NSCLC,which can significantly prolong m PFS and m OS in patients in the subgroups of squamous cell carcinoma and adenocarcinoma,and improved the short-term efficacy.Prognostic analysis found that subvariates such as chest radiotherapy and squamous cell carcinoma may be related to better prognosis;the incidence of adverse reactions in combination chemotherapy of Endostar plus chemotherapy not significantly increased,and the safety was reliable;Continuous intravenous infusion(CIV)of Endostar could be a safe and effective endurance administration method. |
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