| Background:Breast cancer is the most prevalent cancer worldwide and the leading cause of cancer death in women.Triple-negative breast cancer(TNBC)is a special type of breast cancer,accounting for 15%-20%of all breast cancers.Compared with other types,TNBC has the characteristics of early age of onset,high malignancy,large tumor burden,invasiveness,easy recurrence and metastasis,and poor prognosis.At present,the treatment of TNBC is still based on chemotherapy,and anthracyclines and taxanes are recommended at home and abroad.However,patients still have a higher risk of recurrence within 2-3 years after standardized treatment,affecting the survival of patients.With the in-depth study of TNBC gene expression profile,although many drugs targeting molecular targets have emerged,such as PARP inhibitors,Anti-VEGF,Anti-EGFR,Anti-AR and other drugs,as well as PD-1/PD-L1 and other immunotherapeutic drugs,most of these clinical studies focus on advanced TNBC,and the medication regimen for the prevention and treatment of recurrence and metastasis of early TNBC is still being explored.In recent years,capecitabine,cyclophosphamide,methotrexate and other drugs have been used to prevent the recurrence and metastasis of TNBC.Although it can improve the survival of patients to a certain extent,the adverse reactions caused by oral chemotherapy drugs,treatment costs,etc.reduce the compliance of patients and affect the survival of patients.Therefore,it is necessary to find new treatment methods to reduce the risk of recurrence and metastasis of patients.Our team's previous study found that Lou Ci San Jie Fang(LCSJ)could improve the disease-free survival rate of TNBC patients,but the sample size in the previous study was relatively small.and at the same time,due to various factors such as region and economy under realistic conditions,the medication time of TNBC patients was different,so this study further expanded the sample size and explored the effect of different intervention time on the survival of patients,providing an evidence-based basis for the length of TNBC patients taking LCSJ after surgery,so as to further improve patient compliance and improve patient survival.Methods:This study was a retrospective study.The medical records of TNBC patients who underwent surgery on October 31,2017 were searched through the electronic medical record system in the medical record room of China-Japan Friendship Hospital and the self-made breast cancer patient database of our team.The name,medical record number,contact information,gender,age,family history,tumor location,pathological type,tumor size,lymph node metastasis,TNM stage,Ki-67 expression,surgical methods,neoadjuvant/adjuvant chemotherapy,adjuvant radiotherapy,LCSJ dose,LCSJ start time,etc.of the patients were recorded in Excel table.The disease-free survival,overall survival.adverse reactions and other data were obtained by telephone and other follow-up methods.Results:A total of 475 patients with early TNBC were included in this study.The population was mainly concentrated in the age groups of 35?45 years and 45?55 years.The pathological type of the tumor was mainly invasive ductal carcinoma.The tumor size was mainly concentrated in T1 and T2.The lymph node status was mainly NO.The clinical stage was mainly stage ? and ?.A total of 26 of 475 patients experienced recurrence and metastasis,and 7 patients experienced death.The 1-year,2-year,and 3-year DFS of the total population were 99.16%,99.50%,and 92.34%,respectively,and compared with the literature on metronomic capecitabine chemotherapy after standardized treatment of TNBC,the 3-year DFS%of the LCSJ formula was better than that of capecitabine.The patients were divided into low exposure group and high exposure group according to the median average annual LCSJ intake.There were 253 patients in the low exposure group and 222 patients in the high exposure group.There was no statistical difference in age,tumor location,tumor size,lymph node status,TNM clinical stage,pathological type and histological grade between the two groups.During the follow-up period,19 patients in the low exposure group had recurrence and metastasis,and 9 patients in the high exposure group had recurrence and metastasis.The difference between the two groups was statistically significant(P=0.037).Six patients in the low exposure group died,and 1 patient in the high exposure group died.The difference between the two groups was not statistically significant(P=0.083).The 1-year,2-year and 3-year DFS were 98.81%,94.61%and 89.97%in the low exposure group and 99.10%.98.17%and 95.27%in the high exposure group,respectively.The median disease-free survival between the two groups was not statistically significantin both groups.The disease-free survival rate of patients in the high exposure group was better than that of patients in the low exposure group,and the difference had statistical significance(P=0.025).The 1-year,2-year and 3-year overall survival rates were 99.60%,97.85%and 97.16%in the low exposure group and 100.00%,100.00%and 99.49%in the high exposure group,respectively.Median overall survival was not followed up in both groups.There was no significant difference in the overall survival rate between the two groups(P>0.05).In terms of analysis,the 3-year DFS was better in the high-exposure group with Ki-67?30%than in the low-exposure group(94.21%vs 89.36%,P=0.044).In terms of safety,a total of 19 of 475 patients had diarrhea,2 patients had mildly abnormal liver function,29 patients had stomach discomfort,and 4 patients had dry mouth when taking LCSJ for the first time.Conclusion:Lou Ci San Jie Fang can improve the disease-free survival rate of patients,and has better safety.Taking Lou Ci San Jie Fang for more than 3 months per year can improve the 1-year,2-year,and 3-year disease-free survival rates,and patients with high Ki-67 expression can have better survival when taken longer than 3 months per year.Although there was no statistically significant difference in overall survival between the high-exposure and low-exposure groups at present,a trend toward a survival benefit was seen. |
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