Shugan Yishen Recipe Combined With Exemestane In The Treatment Of Advanced Breast Cancer With CtDNA Endocrine Resistance Gene Mutation

Objective:Research purposes:in order to exist in the ctDNA endocrine therapy resistance related gene(ESR1,PIK3CA,PTEN,EGFR,one of CDK4/6,mTOR)mutations in HR(+)/its ehrs(-)advanced breast cancer as the research object,using a single set of clinical research method,the results of experiment design to explore the traditional chinese medicine shuganyishen joint exemestane curative effect and ctDAN endocrine resistance related gene mutations in the relationship,observe whether length of PFS,quality of life level is improving,drug safety,clear its beneficiaries,will provide new options for accurate treatment of advanced breast cancer,to improve the present status of the advanced breast cancer treatment,promote the formation of solution,which can be promoted research will produce a foundation of long-term social and economic benefits.Methods:This research uses a single set of clinical trial design,select the HR(+)/HER-2(-)Advanced breast cancer Who has ctDNA endocrine resistance in breast cancer related gene(ESR1,PIK3CA,PTEN,EGFR,one of CDK4/6,mTOR)mutations in patients with positive,by selected after screening,fill in baseline survey,regular use the traditional chinese medicine shuganyishen,daily dose,cooperate with endocrine treatment during exemestane(25mg,Qd,Po),until the toxicity of the resistance of tumor progression,or cancelled automatically informed consent.Every 8 weeks(2 months)we Regular follow-up.After the evaluation of efficacy,the medication could be continued according to the patient's symptoms.Results:(1)progression free survival:the median PFS was 8 months after the treatment of the traditional chinese medicine shuganyishen joint exemestane.The median PFS was 10 months in patients with pleural thoracic mammary gland metastasis.The median PFS was 10 months in patients with bone metastasis.The median PFS was 8 months in patients with lymphatic metastasis.The median PFS was 6 months in patients with visceral metastasis.(2)the correlation of PFS and age,ECOG score,quality of life rating scale,the site of recurrence and metastasis:independent risk factors that affect the patients PFS are the site of recurrence and metastasis and quality of life.The site of recurrence and metastasis's RR value is 2.003,shows that patients with visceral metastasis have shorter PFS and poor prognosis.The RR for the quality of life scale score was 0.303,indicating that with the increase of the score of life quality scale,the longer the PFS,the better the prognosis.Age and ECOG scores were not independent risk factors for PFS.(3)the influence on quality of life by the traditional chinese medicine shuganyishen joint exemestane:Karnofsky perform status and quality of life scale(including five parts of them)before and after the treatment's comparison was significant(P<0.05),and seven indexes about the quality of life scores were increased after the treatment.ECOG comparison was statistically significant before and after treatment(P<0.05).And ECOG scores declined after treatment.Therefore,the quality of life of patients with advanced breast cancer with endocrine resistant gene mutation can be improved by the treatment of the traditional chinese medicine shuganyishen joint exemestane.(4)There was some difference between the two indexes(CA153,CEA)in the patients after treatment(P<0.05).(5)impact on security metrics with Traditional chinese medicine shuganyishen joint exemestane:Before and after the treatment,the relevant index to the safety in the treatment of patients with liver and kidney function(ALS,AST,BUN,Cr to compare the four index differences were statistically significant(P<0.05),and ALT,Cr,BUN,AST were decreased after the treatment.The blood routine comparison between the before and after treatment was statistically significant(P<0.05),and the hemoglobin level increased after treatment.There was no statistically significant difference between the three other indicators(RBC,platelet,leukocyte).In conclusion,there is no obvious liver and kidney function damage and bone marrow suppression in this treatment regimen.Conclusions:(1)The median PFS was 8 months after the treatment of the traditional chinese medicine shuganyishen joint exemestane.independent risk factors that affect the patients PFS are the site of recurrence and metastasis and quality of life.The site of recurrence and metastasis's RR value is 2.003,shows that patients with visceral metastasis have shorter PFS and poor prognosis.The RR for the quality of life scale score was 0.303,indicating that with the increase of the score of life quality scale,the longer the PFS,the better the prognosis.Age and ECOG scores were not independent risk factors for PFS.(2)the quality of life of patients with advanced breast cancer with endocrine resistant gene mutation can be improved by the treatment of the traditional chinese medicine shuganyishen joint exemestane.(3)The treatment of the traditional chinese medicine shuganyishen joint exemestane has some effect on the changes of tumor markers,it can reduce the expression.(4)There is no obvious liver and kidney function damage and bone marrow suppression in this treatment regimen.