| Object: Icotinib is a selective epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI),a large number of previous studies have demonstrated that icotinib is a safe and efficacious targeted therapy in patients with advanced non-small cell lung cancer(NSCLC)for whom platinum-based chemotherapy had failed,which improve patients' quality of life and prolonged their survival.The aim of this study is to evaluate the efficacy and safety of icotinib for the treatment of advanced NSCLC.Methods: 326 patients with advanced NSCLC,received oral icotinib(125mg,three times per day)until disease progression or unacceptable toxicity.Results: 1.For 326 patients,Complete response was seen in 5 patients,partial response was obtained in 136 patients.93 patients achieved stable disease for at least 8 weeks.Progressive disease was seen in 92 patients.The response rate(RR)and disease control rate(DCR)of the 326 patients were 43.3%(141/326)and 71.8%(234/326),respectively.The median progression-free survival(PFS)was 8.4 months(95%CI: 7.5-9.3 months),the median overall survival(OS)was 16.9 months(95%CI: 15.5-18.3 months).The RR and DCR were significantly higher in women,adenocarcinoma,nonsmoking,ECOG PS?1 and EGFR mutation patients(P<0.05).The women,patients with adenocarcinoma,non-smoking,EGFR mutation and lower PS had a longer PFS than men,non-adenocarcinoma,smoking,EGFR wild type and higher PS,respectively(P<0.05).Treatments were generally well tolerated.The main adverse reactions included rash(42.6%)and diarrhea(27.3%).2.111 untreated patients with advanced NSCLC received icotinib.Complete response was seen in 3 patients(2.7%),partial response was seen in 61 patients(55.0%).26 patients(23.4%)achieved stable disease.Progressive disease was seen in 21 patients(18.9%).The RR and DCR of the 111 patients were 57.6% and 81.8%,respectively.The RR was significantly higher in women,adenocarcinoma,ECOG PS?1,nonsmoking,EGFR mutation patients(P<0.05)and DCR was significantly higher in patients of ECOG PS?1 and EGFR mutation(P<0.05).The median progression-free survival(PFS)was 11.7 months(95%CI: 9.7-13.7 months),the median overall survival(OS)was 19.3 months(95%CI: 17.2-21.4 months).The women,non-smoking,EGFR mutation and lower PS patients had a longer PFS than men,smoking,EGFR wild type and higher PS,respectively(P<0.05).3.215 re-treated NSCLC patients treated with icotinib.Complete response was seen in 2 patients(0.9%),partial response was seen in 75 patients(34.9%).67 patients(31.2%)achieved stable disease.Progressive disease was seen in 71 patients(33.0%).The RR and DCR of the 215 re-treated patients were 35.8% and 67.0%,respectively.The RR was significantly higher in women,adenocarcinoma,ECOG PS?1,non-smoking,EGFR mutation patients(P<0.05)and DCR was significantly higher in patients of women,ECOG PS?1 and non-smoking(P<0.05).The median progression-free survival(PFS)was 6.8 months(95%CI: 5.9-7.7 months),the median overall survival(OS)was 15.5 months(95%CI: 14.0-16.9 months).The women,adenocarcinoma,non-smoking,EGFR mutation and lower PS patients had a longer PFS than men,non-adenocarcinoma,smoking,EGFR wild type and higher PS,respectively(P<0.05).4.There were 84 EGFR mutation-positive patients.The RR and DCR of the 84 patients were 71.4% and 86.9%,respectively.The median progression-free survival(PFS)was 12.1 months(95%CI: 10.0-14.3months),the median overall survival(OS)was 20.3 months(95%CI: 18.4-22.3 months).There were 44 untreated patients with EGFR mutation-positive received icotinib.The RR and DCR of the 84 patients were 75.0% and 93.2%,respectively.The median progression-free survival(PFS)was 14.2 months(95%CI: 10.8-17.6months).For 40 re-treated EGFR mutation-positive patients,The RR and DCR were 67.5% and 80.0%,respectively.The median progression-free survival(PFS)was 10.5 months(95%CI: 7.8-13.1months).The RR,DCR and median progression-free survival had no statistic difference between the two groups(P>0.05).Conclusions: 1.For 326 patients with advanced NSCLC,The response rate(RR)and disease control rate(DCR)of the 326 patients were 43.3%(141/326)and 71.8%(234/326),respectively.The median progression-free survival(PFS)was 8.4 months(95%CI: 7.5-9.3 months),the median overall survival(OS)was 16.9 months(95%CI: 15.5-18.3 months).Treatments were generally well tolerated.The main adverse reactions included rash(42.6%)and diarrhea(27.3%).2.111 untreated patients with advanced NSCLC received icotinib.The RR and DCR of the 111 patients were 57.6% and 81.8%,respectively.The median progression-free survival(PFS)was 11.7 months(95%CI: 9.7-13.7 months),the median overall survival(OS)was 19.3 months(95%CI: 17.2-21.4 months).3.215 re-treated NSCLC patients treated with icotinib.The RR and DCR of the 215 retreated patients were 35.8% and 67.0%,respectively.The median progression-free survival(PFS)was 6.8 months(95%CI: 5.9-7.7 months),the median overall survival(OS)was 15.5 months(95%CI: 14.0-16.9 months).4.The RR and DCR of the 84 EGFR mutation-positive patients were 71.4% and 86.9%,respectively.The median progression-free survival(PFS)was 12.1 months(95%CI: 10.0-14.3months),the median overall survival(OS)was 20.3 months(95%CI: 18.4-22.3 months).The RR,DCR and median progression-free survival had no statistic difference between the untreated and re-treated groups(P>0.05).Icotinib had a substantial effect for patients with untreated advanced NSCLC,especially for adenocarcinoma patients with EGFR mutation.The toxicity profile was favorable. |
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