Clinical study on Sintilimab combined with recombinant human endostatin in the treatment of advanced non-small cell lung cancer
Objective To study the efficacy of Sintilimab combined with recombinant human endostatin in the treatment of advanced non-small cell lung cancer(NSCLC).Methods This study was a randomized controlled trial.A total of 62 patients with NSCLC admitted to Xianyang First People's Hospital from June 2019 to June 2022 were divided into an observation group and a reference group according to the random number table method,with 31 cases in each group.In the reference group,there were 20 males and 11 females,aged(66.64±9.59)years,16 cases of stage Ⅲ B and 15 cases of stage Ⅳ.In the observation group,there were 19 males and 12 females,aged(65.55±9.16)years,14 cases of stage Ⅲ B and 17 cases of stage Ⅳ.Both groups were given albumin-paclitaxel+carboplatin chemotherapy:intravenous infusion with 100 mg/m2of albumin-paclitaxel was given on day 1 and day 8 of the chemotherapy cycle for 30 min;carboplatin was given intravenously on day 1 of the chemotherapy cycle,with the area under the curve(AUC)of 5 mg/(ml·min)each time,with 21 days as a cycle.The reference group was given 15 mg/m2 of recombinant human endostatin on the basis,added into 500 ml of normal saline,injected intravenously for 3-4 h,once a day,continuous administration for 14 days and then stopped for 7 days.The observation group was given Sintilimab on the basis of the reference group,200 mg/time,diluted with 100 ml of normal saline,intravenous infusion for 30-90 min,and used on day 1 of the chemotherapy cycle.Both groups were treated for 3 consecutive cycles.The clinical efficacy,levels of tumor markers[cytokeratin 19 fragment(CYFRA21-1),carcinoembryonic antigen(CEA),and neuron-specific enolase(NSE)],and safety of the two groups were compared,and the survival of the two groups was recorded during 1-year of follow-up.t test,x2 test,and Log-rank test were used for statistical analysis.Results The objective remission rate and clinical control rate of the observation group were higher than those of the reference group[45.16％(14/31)vs.19.35％(6/31),77.42％(24/31)vs.48.39％(15/31)](both P＜0.05).After treatment,the levels of CEA,CYFRA21-1,and NSE in the observation group were lower than those before treatment and in the reference group(all P＜0.05).There was no statistically significant difference in the incidence of adverse reactions between the observation group and the reference group[19.35％(5/31)vs.22.58％(7/31)](P＞0.05).At 1 year of follow-up,1 and 2 cases were lost and 16 and 10 cases survived in the observation and reference groups,respectively,and the total survival curve of the observation group was better than that of the reference group by Log-rank test(x2=6.987,P=0.010).Conclusion Sintilimab combined with recombinant human endostatin in the treatment of NSCLC is effective,can reduce the levels of tumor markers,has good safety,and can prolong the patients'short-term survival.
Advanced non-small cell lung cancerSintilimabRecombinant human endostatinSurvival rateAdverse reactions
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