Clinical Observation Of Feiji Recipe Combined With Afatinib In The Intervention Of Advanced Non-small Cell Lung Cancer With EGFR Positive Mutation (Qi Deficiency And Phlegm Dampness Syndrome)

Purpose: We evaluated the clinical efficacy and safety of Feiji Formula combined with afatinib in the treatment of EGFR-positive mutation advanced non-small cell lung cancer with Qi deficiency and phlegm dampness syndrome,and provide theoretical basis and clinical research experience for the application of traditional Chinese medicine in the treatment of EGFR-positive mutation non-small cell lung cancer.Methods: In this study,on the basis of random grouping,60 NSCLC patients with IV stage who comformed the inclusion criteria were randomly divided into observation group and control group.The control group received oral targeted therapy with afatinib,40 mg daily for 8 weeks.The observation group was treated with Feiji Fang,one dose per day,morning and evening,for 8 weeks.The short-term efficacy(including the size of solid tumor,objective response rate,disease control rate),TCM clinical syndrome score,Karnofsky score,serum tumor markers and drug-related adverse reactions were recorded and compared between the two groups before and after treatment,and statistical software was used for data processing and analysis to comprehensively evaluate the clinical efficacy and safety of Feiji Fang combined with afatinib.Results:(1)Short-term efficacy: The ORR(56.7%)and DCR(93.3%)of the observation group were superior than those of the control group(53.3%)and DCR(90.0%).The combination therapy showed a trend of benefit,but the difference between the two groups was not statistically significant(P>0.05).(2)TCM syndrome score: The effective rate of the observation group was 73.3%,and that of the control group was 46.7%,the difference was statistically significant(P<0.05).(3)Kamofsky performance score: The improvement rate of Kamofsky performance status(KPS)score in the observation group was 96.7%,higher than that in the control group(76.7%),and the difference between two group was statistically significant(P<0.05).(4)Serum tumor markers: After treatment,the values of CEA,CA125 and CA19-9in the observation group and the control group were observably lower than those before treatment.(P<0.05).Although the decrease of CEA,CA125 and CA19-9 in the observation group was greater than that in the control group before and after treatment,the difference was not statistically significant(P>0.05).(5)Comparison of adverse reactions:Comparison of adverse reactions: the incidence of skin reaction and diarrhea in the observation group was 40.0% and 23.3% respectively,which was significantly lower than that in the control group(skin reaction: 80.0%;diarrhea: 73.3%),and the difference was statistically significant(P<0.01).The incidence of drug-induced liver injury in the observation group was 3.3%,slenderly lower than that in the control group(6.7%),but the difference was not statistically significant(P>0.05).Conclusion: In the treatment of advanced non-small cell lung cancer with EGFR positive mutation,Feiji Formula combined with afatinib can improve the clinical symptoms of patients,improve the living standards of patients,and reduce the occurrence of adverse drug reactions.It provides clinical medical ideas for the combination of traditional Chinese and Western medicine to reduce the adverse reactions caused by tumor targeted therapy,which is deserved of popularization and application.