A Comparative Study Of The Postoperative Efficacy Of Icotinib Combined With Chemotherapy And Monotherapy In The Treatment Of Stage Ⅱ-ⅢA EGFR Mutation-Positive Lung Adenocarcinoma

Objective:To compare the efficacy and safety of Icotinib combined with chemotherapy with Icotinib monotherapy in the treatment of stageⅡ-ⅢA EGFR-mutation-positive lung adenocarcinoma after radical resection,and provide a reference for adjuvant targeted therapy with EGFR-TKI for postoperative non-small cell lung cancer.Methods:160 patients with stageⅡ-ⅢA lung adenocarcinoma with EGFR mutation positive admitted to the First Affiliated Hospital of Hebei North University from December 2017 to December 2019 after radical surgery were collected.20 patients with incomplete data or those who did not meet the inclusion criteria were excluded.Finally,a total of 140patients met the inclusion conditions.According to the previous treatment regimen,140 patients were divided into:Icotinib monotherapy(referred to as monotherapy group,70 cases)and Icotinib combined with pemetrexel+cisplatin(referred to as combination group,70 cases).The Monotherapy group was given Icotinib 125mg/time,3 times/day.The combination group received Icotinib combined with Pemetrexed+Cisplatin.On the first day,Pemetrexed 500mg/m~2mixed with 100ml sodium chloride was given intravenously,and the injection time was longer than 10mins.On the second day,cisplatin 75mg/m~2mixed with500ml sodium chloride was administered intravenously for more than 2h.In order to reduce the side effects of chemotherapy,folic acid(400μg,qd,oral)and vitamin B12(1000μg,ONCE)were orally injected 7 days before chemotherapy.Dexamethasone tablets with a dose of 4mg were orally injected 1 day before chemotherapy,bid,three days in a row.Icotinib was taken orally on days 3 to 19(125mg/time,3 times/day).Chemotherapy was performed for four cycles with an interval of 21 days.Icotinib was continued after completion of chemotherapy.Before receiving treatment,patients in the two groups were required to undergo chest CT review to determine whether there was a recurrence.Meanwhile,blood routine,liver,kidney function and other tests were performed.Patients with obvious abnormal indicators who could not take drugs 1month after surgery were not included in the group.A 21-day treatment cycle was used in both groups.After four cycles of treatment,blood routine,liver and kidney function,tumor markers and other laboratory tests were tested again in both groups,and side effects of drugs were recorded.CEA,CA125,NLR and PLR values were recorded in both groups before and after four cycles of treatment.t-test was used to compare whether there was statistical significance between the two groups before and after treatment.Chi-square test was used to analyze whether there were significant differences in ADR between the two groups.According to the NCCN guidelines for follow-up after radical lung cancer surgery,patients are recommended to be reviewed regularly(every 3 months for 2 years,and thereafter every 6 months for 3 years).The patients were followed up regularly,and their disease-free survival and overall survival were counted.Kaplan-Meierfen survival analysis was used to calculate the median disease-free survival and median overall survival of the two groups,and Log Rank test was used to compare the difference in survival time between the two groups.Patients with disease progression or recurrence were given the same treatment regimen:paclitaxel(albumin-binding)plus carboplatin combined with bevarizumab.According to the NCCN guidelines for follow-up after radical lung cancer surgery,patients are recommended to be reviewed regularly(every 3 months for 2 years,and thereafter every 6 months for 3years).The patients were followed up regularly,and their disease-free survival and overall survival were counted.Kaplan-Meierfen survival analysis was used to calculate the median disease-free survival and median overall survival of the two groups,and Log Rank test was used to compare the difference in survival time between the two groups.The influence of baseline data on DFS and OS was evaluated by COX univariate and multivariate analysis.Results:There were significant differences in CEA,CA125,NLR and PLR between the two groups before and after treatment(P<0.05).After treatment,CEA,CA125,NLR and PLR in the combination group were significantly lower than those in the single drug group(P<0.05).The DFS and OS of the single drug group and the combination group were compared.The median DFS of the single drug group was 24 months,and the combination group was 30 months.The DFS of the combination group was significantly higher than that of the single drug group(χ~2=4.725,P<0.05).The median OS of the single drug group was 37 months,and the median OS of the combination group was 45 months.The OS of the combination group was significantly higher than that of the single drug group(χ~2=6.089,P<0.05).By COX regression analysis of the factors affecting DFS and OS,combined administration,stageⅡpatients and EGFR 19 exon mutation could make patients obtain better clinical benefit(P<0.05).In addition,inflammatory factors NLR and PLR are independent prognostic factors for DFS and OS.Adverse reactions occurred in both groups after treatment.The adverse reactions in the single drug group were mainly concentrated in non-hematological toxicity,while the adverse reactions in the combination group occurred in hematological toxicity,systemic symptoms,liver and kidney function damage.The incidence of adverse reactions in the combination group was significantly higher than that in the single drug group,and the difference was statistically significant(P<0.05).Conclusion:For patients with EGFR mutation-positive lung adenocarcinoma after radical surgery at stageⅡ-ⅢA,Icotinib combined with pemetrexed plus cisplatin has more advantages in disease-free survival and overall survival.