Efficacy And Safety Of Icotinib Combined With Chemotherapy In The Treatment Of Advanced Adenocarcinoma Of Lung With EGFR Gene Mutation

Purpose:The purpose of this study was to investigate the clinical efficacy and safety of Icotinib combined with platinum-containing chemotherapy in the treatment of advanced lung adenocarcinoma with sensitive mutation of EGFR.Methods:From January 2016 to January 2017,90 patients with advanced lung cancer with EGFR sensitive mutation were hospitalized in Jining first people’s Hospital of Shandong Province and diagnosed by gene detection.A total of 60 patients were included in this study after final screening and follow-up.They were randomly divided into observation group and control group.All patients were aware of the condition and treatment plan before treatment,and voluntarily received treatment and signed informed consent,and the study met the requirements of the Hospital Medical Ethics Committee.The observation group(n=30)were treated with pemetrexed cisplatin and Icotinib(pemetrexed 500 mg/m~2,day 1,intravenous drip),cisplatin 75 mg/m~2,day 1-3,intravenous infusion for more than 2 hours;Icotinib 125mg/d,4-21 days),for a period of one cycle every 21 days,up to 6 cycles,followed every 21days by a single pemetrexed combined with oral administration of Icotinib(medication and dosages the same as before).The control group(n=30)was treated with Icotinib 125 mg/d orally.Patients in both groups were followed up until the patient developed an unbearable adverse reaction or death.The main endpoints wereprogressive survival time(PFS),secondary endpoints were overall remission rate(ORR),disease control rate(DCR)and side effects.Results:The ORR of the observation group was 83.3%and the ORR of the control group was 66.7%.The difference between the two groups was statistically significant(χ~2=7.500).The DCR of the observation group was 96.7%and the DCR of the control group was93.3%.The difference between the two groups was not statistically significant(χ~2=0.351,p>0.05).The mPFS of the observation group was 16.8 months(95%CI:15.0-21.2 month),and the mPFS of the control group was 11.2 months(95%CI:7.0-13.8 month).There was significant difference between the two groups(p<0.001)..The incidence of severe adverse reactions in the observation group was 33.3%and that in the control group was 23.3%.The most common adverse reactions of III-IV degree in the observation group were rash,diarrhea and fatigue.The most common adverse reactions of III-IV degree in the control group were rash,hepatic dysfunction and gastrointestinal reaction,but there was no significant difference between the two groups except diarrhea(p>0.05).Conclusion:Icotinib combined with platinum combined chemotherapy compared with Icotinib alone could significantly prolong PFS,in patients with advanced lung adenocarcinoma with EGFR sensitive mutation and no increase significantly in side effects.