A Randomized Controlled Clinical Study Of Yangyin Jiedu Granule Combined With Gefitinib In The Treatment Of Patients With Advanced Lung Adenocarcinoma Of EGFR Mutation

Purpose:To observe the clinical efficacy and progression-free survival(PFS)of Chinese medicine Yangyin Jiedu Granule combined with targeted drug gefitinib in the treatment of patients with advanced lung adenocarcinoma of EGFR-sensitive mutation,and to explore the characteristics and advantages of traditional Chinese medicine(TCM)in the treatment of lung malignant tumors.To explore the advantages of Chinese medicine in the treatment of lung cancer,and to provide data support for the combination of Chinese medicine and targeted drug in treatment of lung cancer.Methods:A randomized controlled clinical study was conducted in this study.A total of 69 patients with yin deficiency type,stage IIIa-IV or postoperative recurrence of non-small cell lung cancer who were relapsed from the department of oncology and thoracic surgery at Longhua hospital were randomly assigned to the treatment group(n=35)and the control group(n=34).The control group was treated with gefitinib,and the treatment group was given the Chinese medicine Yangyin Jiedu Granule on the basis of the control group.Objective response rate,duration of response,disease control rate,and progression-free survival of patients were evaluated for tumor efficacy.Changes of tumor markers(CEA,CA125,CA199),immune function(NK,CD3+,CD4+,CD8+),the quality of life,TCM syndrome symptoms and the safety during treatment were assessed.Results:(1)The objective response rate was significantly higher in the treatment group than that in the control group at the 3rd,6th,and 8th month,and the difference was statistically significant(P<0.05).The average duration of response in the treatment group was longer than that in the control group(P<0.05).The disease control rate of the treatment group was higher than that in the control group from the 8th month to the end of the follow-up.The difference was statistically significant(P<0.05).(2)The progression-free survival of the treatment group and the control group was 12.70 months and 8.58 months respectively.The median progression-free survival of the progression-free survival in the treatment group and the control group was 12.40 months and 8.20 months respectively.The difference was statistically significant(P<0.05).(3)The tumor marker CEA in the treatment group decreased significantly at the 3rd,6th,and 9th months,and the difference was statistically significant(P<0.05).During follow-up,tumor markers CA125 and CA199 in both groups after treatment were lower than those before treatment,but there was no difference between the two groups.(4)There was no statistically significant difference in the levels of immunological function NK,CD3+,CD4+ and CD8+ between the two groups before and after treatment.(5)In terms of symptoms of TCM syndrome,the improvement rate of the treatment group was better than that of the control group for the symptoms of cough,blood in the sputum,spontaneous sweating,night sweating,and five upset fever.(6)In terms of quality of life,the improvement rate of KPS scores in the treatment group was better than that in the control group at 3rd,6th and 9th months after treatment.The difference was statistically significant(P<0.05),and the physiological status and functional status were also superior to the control group.(7)The incidence of adverse events in the treatment group was lower than that in the control group.Conclusion:Yangyin Jiedu Granule can improve the efficacy of gefitinib in the treatment of advanced lung adenocarcinoma with EGFR-sensitive mutation,and prolong the progression-free survival of patients;Yangyin Jiedu Granule can reduce serum tumor markers CEA.Yangyin Jiedu Granule can alleviate the clinical symptoms of patients with yin deficiency type lung cancer and improve the quality of life of patients.