Clinical Investigation Of Icotinib In The Treatment For Patients With EGFR-mutation Advanced Adenocarcinoma

Object:To retrospectively analysis the efficacy and side effects of icotinib in untreated and previously treated EGFR-mutation positive advanced lung adenocarcinoma patients.Methods:Collect baseline data of 276 previously untreated and treated advanced EGFRmutation positive adenocarcinoma patients,who were admitted to Shanghai Chest Hospital afflicted to Shanghai Jiaotong University and started to receieve icotinib therapy(125mg,3times per day)between Nov,2011 and Jul,2016,until disease progression or intolerable toxicity,collect the efficacy,side effect and survival information.Results:1.Among the 276 EGFR-mutation positive advanced lung adenocarcinoma patients,complete response(CR)was achieved in 7 patients(2.5%),partial response(PR)in 177patients(64.1%),stable disease(SD)in 68 patients(24.6%)and progressive disease(PD)in24 patients(8.7%).The ORR and DCR were 66.7% and 91.3% respectivly.The mPFS was11.6 months(95%CI:10.6~12.6months),mOS was 20.1months(95%CI:18.7~21.5months).In the subgroup analysis,non-somking patients showed better ORR than smoking patient(73.3% vs.56.3%,P=0.005).In patients with different EGFR mutation type,Patients with 19 exon mutation showed better ORR(77.8% vs.54.5%,P=0.000),DCR(92.1% vs.82.9%,P=0.025)and mPFS(12.9months vs.9.8 months,P=0.002)than those with 21 L858 R mutation.First-line icotinib patients demonstrated better mPFS(12.6months vs.9.8months,P=0.007)and mOS(30.3months vs.24.4 months,P=0.008)than previouslytreated patients.Different sexes,ages,number of metastasis sites before therapy,brain assessments and clinical stages showed similar effect over mPFS,mOS,ORR and DCR.The main side effects were rash(44.6%)and diarrhea(26.4%).These side events were generally alleviated after symptomatic treatment.2.Among the 178 first-line icotinib patients,CR were achieved in 6 patients(3.4%),PR in 112 patients(62.9%),SD in 50 patients(28.1%)and PD in 10 patients(6.6%).The ORR was 66.3%(118/178),DCR was 94.4%(157/178).The mPFS was 12.6months(95%CI:11.3~13.8months),mOS was 22.1 months(95%CI:20.3~23.9months).In the subgroup analysis,Patients with 19 exon mutation showed better ORR(75.7%vs.54.7%,P=0.004)and mPFS(13.7months vs.11.1months,P=0.045)than those with 21L858 R mutation.Different sexes,ages,smoking state,number of metastasis sites before therapy,brain assessments and clinical stages show similar effect over mPFS,mOS,ORR and DCR.3.Among the 98 previously treated patients,CR was achieved in 1 patient(1.0%),PR in 66 patients(67.3%),SD in 20 patients(20.4%)and PD in 11 patients(11.2%).The ORR was 68.4%(67/98),DCR was 88.8%(87/98).The mPFS was 9.8 months(95%CI:8.4~12.2months),mOS was 17.0 months(95%CI:15.0~19.1 months).In the subgroup analysis,non-somking patients showed better ORR than smoking patient(76.7% vs.55.3%,P=0.044).Patients with 19 exon mutation showed better ORR(82.0% vs.54.2%,P=0.004),mPFS(11.6months vs.7.7months,P=0.005)and mOS(19.3months vs.14.2months,P=0.005)than those with 21 L858 R mutation.Different sexes,ages,brain assessments and clinical stages showed similar effect over mPFS,mOS,ORR and DCR.Conclusion:1.Among the 276 EGFR-mutation positive advanced lung adenocarcinoma patients,the ORR was 66.7%,DCR was 91.3%.The mPFS was 11.6 months,mOS was 20.1 months.The subgroup analysis showed patients with 19 exon mutation demonstrated better ORR,DCR and mPFS than those with 21 L858 R mutation.Icotinib was effective in treating EGFR-mutation positive advanced adenocarcinoma patients with main side-events of lowgrade rash and diarrhea.2.Among the 178 first-line icotinib patients,the ORR was 66.9%,DCR was 88.2%,mPFS was 12.6 months,mOS was 22.1 months.The subgroup analysis showed patients with 19 exon mutation demonstrated better ORR and mPFS than those with 21 L858 R mutation.3.Among the 98 previously treated patients,the ORR was 68.4%,DCR was 88.8%,mPFS was 9.8 months,mOSwas 17.0 months.The subgroup analysis showed patients with19 exon mutation demonstrated better ORR,mPFS and mOS than those with 21 L858 R mutation.Different sexes,ages,brain assessments and clinical stages showed similar effect over mPFS,mOS,ORR and DCR.4.The ORR and DCR were similar between First-line and previously treated patients.First-line patients showed better mPFS and mOS than previously treated patients.