Effect Of TCM Syndrome Type And The Molecular Pathogenetic Characteristics On The Therapeutic Effect Of EGFR-TKI In EGFR Mutation Lung Cancer Patients

ObjectiveThrough the statistical analysis of the TCM syndrome differentiation of EGFR-mutant NSCLC patients and the distribution characteristics of tumor molecular pathological classification,the effect on the efficacy of EGFR-TKI was analyzed.Hope to provide a reference for lung cancer.MethodsIn this study,a prospective and observational study was conducted to collect the results of the Next Generation Sequencing(NGS)gene test in 108 patients with stage ⅢB/Ⅳ NSCLC.Finally,a total of 55 patients with EGFR mutations were included in the study.The 55 patients enrolled in the TCM syndrome according to the five basic TCM syndrome types of lung cancer in the guidelines for the diagnosis and treatment of malignant tumors,and 45 patients who underwent EGFR-TKI targeted therapy were followed up to record the progression-free survival(PFS).The database was established with Epidata3.1,and SPSS18.0 software was used for multi-factor statistical analysis,Person correlation test,Fisher test,Wilcox test,etc.to understand the distribution characteristics of TCM syndrome differentiation and tumor molecular pathological classification,and analyze its EGFR-The effect of TKI efficacy.Results1.From April 2017 to October 2018,55 patients were enrolled in our study,and all of then were classified by TCM syndrome differentiation,including 41 times of Qi deficiency syndrome(74.5%),33 times of phlegm-dampness syndrome(60%),18 times of yin deficiency syndrome(34.5%),15 times of Toxic-heat syndrome(27.3%)and 7 times of blood stasis syndrome(12.7%).2.Baseline NGS test results of tumor tissue in 55 patients:28 cases(50.9%)of EGFR exon 21 missense mutation,18 cases(32.7%)of EGFR exon 19 deletion mutation,other site mutations of EGFR or Amplification of 9 patients(16.4%).3.Forty-six patients who underwent EGFR-TKI treatment in the first line were followed up and one patient refused.As of February 28,2019,the last imaging examination of 19 patients did not suggest tumor progression;imaging examination of 26 patients had indicated tumor progression with an average PFS of 226.4 days.4.The correlation between TCM syndrome differentiation and EGFR-TKI efficacy at baseline in patients enrolled:Among the 26 patients with advanced disease,patients with no toxic syndrome or qi-deficiency syndrome received longer-term PFS with EGFR-TKI first-line targeted therapy.There were statistically significant differences between the groups(P<0.05).There was no significant difference in the effect of yin deficiency syndrome,phlegm-dampness syndrome and blood stasis syndrome on the efficacy of EGFR-TKI.5.Correlation Correlation between molecular pathological typing and EGFR-TKI efficacy:Among the 26 patients with progression,12 were with missense mutation of exon 21 L858R and 13 were with exon 19 deletion mutation,and their effieacy against EGFR-TKI The effect was not statistically significant(P>0.05).Patients with less than 5 mutated genes received longer EGFR treatment with EGFR-TKI,and the effect of TKI-effect was statistically significant(P<0.05).conclution1.Patients with stage ⅢB/Ⅳ EGFR mutations in NSCLC has Qi deficiency syndrome,phlegm dampness syndrome,Yin deficiency syndrome,blood stasis syndrome and heat toxin syndrome.2.Patients with stage ⅢB/Ⅳ EGFR mutations in NSCLC who received EGFR-TKI treatment before TCM syndrome differentiation were better with no heat syndrome or no qi deficiency syndrome.3.Patients with stage ⅢB/Ⅳ EGFR-mutant NSCLC patients with NGS results with<5 mutations have better efficacy with EGFR-TKI as first-line targeted therapy.