Alternating Icotinib And Chemotherapy For Advanced Non-small Cell Lung Cancer With EGFR Mutation

Background and ObjectiveLung cancer is the most malignant tumor with the highest morbidity and mortality in the world.It is classified into non-small cell lung cancer(NSCLC)and small cell lung cancer(SCLC),of which 85% are non-small cell lung cancer.Epidemiological survey shows that 50% of patients are in advanced stage at the time of diagnosis.Alternating Icotinib and chemotherapy for advanced Non-small Cell Lung Cancer with EGFR mutation(NCT02737774)was initiated to explore and analyze the efficacy and safety of this treatment model,so that we can provide new treatment ideas for patients with advanced lung adenocarcinoma.MethodsThis study was a single-center(The Affiliated Cancer Hospital of Zhengzhou University),one-arm phase II study(NCT02737774).All 50 patients who met the criteria of this clinical trial were treated with Icotinib(125 mg,three times a day).After 18 weeks,the patients who had progressed disease would be out of the group.After a two-week washout period,four cycles of standard chemotherapy are given,and then,oral Icotinib was continued until the disease is progressed.All patients were diagnosed as lung adenocarcinoma in pathology and all had measurable lesions.The efficacy was evaluated according to RECIST 1.1.A total of 50 patients in the study from November 2016 to December 12,2018 were enrolled to analyze PFS,ORR,safety and underlying mechanisms.Statistical analysis was performed using SPSS20.0 software.The categorical variable rate was compared by chi-square test or Fisher’s exact probability method.The survival curve was drawn by Kaplan-Meier method,and the Log-rank test was performed.P <0.05 was considered statistically significant.ResultsThere were 28 cases(59.57%)of disease progression.For all of the 47 patients,the median PFS was 11.7 months(4.300 months-29.370 months).The mPFS of 19 del group and 21l858 r group was 11.230 months(4.330 months-29.370 months),12.215 months(4.300 months-24.130 months),there was no significant difference in the PFS between patients with 19 del and 21L858R(P>0.05).The median PFS between the high and low abundance of the overall patient was 10.10 months(4.300 months-29.370 months),20.000 months(4.900 months-26.370 months),there was no significant difference(P>0.05).COX regression analysis showed that there was no statistically significant difference of all patients and the 23 patients with low abundance sensitive mutation about gender,age,smoking history,gene mutation site,bone metastasis,brain metastasis,liver metastasis,pleural metastasis,bilateral lung metastasis and the best efficacy during the period at the time of initial diagnosis.All adverse reactions could be alleviated after symptomatic support.1.The median PFS of patients with EGFR gene-sensitive mutations is not inferior to previous related studies,and the ORR is high.2.The main cause of resistance is the T790 M mutation in exon 20 of the EGFR gene when genetic test is performed again in the case of progression.3.All adverse reactions could be alleviated after symptomatic support.Conclusions1.The median PFS of patients with EGFR gene-sensitive mutations is not inferior to previous related studies,and the ORR is high.2.The main cause of resistance is the T790 M mutation in exon 20 of the EGFR gene when genetic test is performed again in the case of progression.3.All adverse reactions could be alleviated after symptomatic support.