| Background:Breast cancer is still the leading cause of cancer death for women worldwide.Triple-negative breast cancer(TNBC)is a special molecular subtype of breast cancer,accounting for about 15%to 20%of breast cancer.TNBC has the characteristics of strong invasion,early onset age,high histological grade and early recurrence and metastasis.TNBC has relatively poor prognosis.The prognosis of TNBC patients is affected by a number of factors,including age,family history,menstrual condition,tumor size,lymph node status,tumor stages,surgical methods,radiotherapy,chemotherapy,tumor infiltrating lymphocytes,biomarkers,and so on.Due to the lack of endocrine and targeted therapy targets,TNBC’s treatment is still mainly chemotherapy and treatments are relatively limited.Especially when postoperative TNBC patients complete chemotherapy and radiation,domestic and international guidelines have no follow-up treatment recommendations,but mainly observation,resulting in patients facing the awkward situation of waiting for relapse.Therefore,the search for new methods to reduce recurrence and metastasis in TNBC patients and improve survival rates in advanced TNBC patients is particularly critical.Phlegm-reducing and masses-resolving therapy is one of the most important methods of TNBC.Louci Nodule-dissipating Decoction based on Phlegm-reducing and masses-resolving therapy,and previous studies have found that Louci Nodule-dissipating Decoction can extend the disease-free survival of TNBC patients,but has not yet been compared with Western medicine observation groups.Method:This study is a retrospective cohort study,using the electronic medical record system of the China-Japan Friendship Hospital and the team’s homemade database of breast cancer patients to find the medical records of TNBC patients who underwent surgery from January 1,2015 to December 30,2017 and then used Excel to record the patient’s name,case number,contact information,gender,age,family history,site of the tumor,pathological type,tumor size,lymph node metastasis,TNM staging,Ki-67,surgical methods,adjuvant chemotherapy,neoadjuvant chemotherapy,adjuvant radiotherapy,etc.This study divided patients into LCSJ and Non-LCSJ cohorts based on whether to take Louci Nodule-dissipating Decoction,and obtained disease-free survival,overall survival and other information by telephone follow-up.It balanced two sets of baselines by using propensity score matching(PSM)to count the median disease-free survival,1,2,3 years disease free survival,median survival time,1,2,3 years survival rate,local recurrence rate and distant metastasis rate,as well as changes in life quality,anxiety-depression,sleep quality,and fatigue conditions in patients in the two cohorts.Univariate analysis and multivariate analysis were used to explore the prognostic factors for the disease-free survival of patients in the LCSJ cohort.Result:A total of 196 TNBC patients were included in this study,including 108 cases in the LCSJ group and 88 cases in the Non-LCSJ group,and 124 cases were finally included after PSM treatment,and 62 cases in each group.The age of onset of the two groups of patients was mainly concentrated in 35-45 years old and 45-55 years old,the tumor size was concentrated in T1 and T2,and the pathological type was mainly invasive ductal carcinoma,which was basically consistent with the literature reports.A total of 9 cases of recurrence and metastasis occurred in the LCSJ cohort,and 36 cases of recurrence and metastasis in the Non-LCSJ cohort,the difference was statistically significant(P<0.00).The three common sites of recurrence and metastasis in the LCSJ cohort were lung in 3 cases(33.33%),contralateral mammary gland in 2 cases(22.22%),and mediastinal and/or hilar lymph nodes in 2 cases(22.22%).The three common sites of recurrence and metastasis in the Non-LCSJ cohort were 15 regional lymph nodes(41.67%),12 lungs(33.33%),and 12 bones(33.33%).The 1-year,2-year,and 3-year DFS of the LCSJ cohort were 96.77%,90.32%,and 85.48%,respectively.The median DFS was not followed.The non-LCSJ cohort’s 1-year,2-year,and 3-year DFS were 80.66%,53.23%,41.24%,with a median DFS of 27 months,the difference was statistically significant(P<0.00).The 1-year,2-year,and 3-year overall survival rates of the LCSJ cohort were 100.00%,100.00%,and 98.31%,and the 1-year,2-year,and 3-year overall survival rates of the Non-LCSJ cohort were 100.00%,95.16%,and 90.05%.The LCSJ cohort was better than the Non-LCSJ cohort and the difference was statistically significant(P<0.00),but neither cohort was followed up to a median OS.The 1-year,2-year,and 3-year local recurrence rates of the LCSJ cohort were 1.64%,3.31%,and 5.07%,and the Non-LCSJ cohort’s 1-year,2-year,and 3-year local recurrence rates were 14.91%,29.83%,and 44.52%,respectively.The local recurrence rate of the LCSJ cohort was significantly lower than that of the Non-LCSJ cohort,and the difference was statistically significant(P<0.00).The 1-year,2-year,and 3-year distant transfer rates in the LCSJ cohort were 1.61%,6.59%,and 9.96%,and the 1-year,2-year,and 3-year remote transfer rates in the Non-LCSJ cohort were 8.58%,25.55%,and 34.87%,respectively.The distant metastasis rate of LCSJ cohort was significantly lower than that of Non-LCSJ cohort,the difference was statistically significant(P<0.00).In terms of subgroup analysis,the 3-year disease-free survival rate of the LCSJ cohort was significantly higher than that of theNon-LCSJ cohort at the age of 45-55 years(94.74%vs 27.27%,P<0.00).The 3-year disease-free survival rate of the LCSJ cohort in Ki-67 high expression population(30%)was significantly higher than that of the Non-LCSJ cohort(86.79%vs 39.82%,P<0.00).The 3-year disease-free survival rate of the LCSJ cohort in both T1 and T2 subgroups was higher than that of the Non-LCSJ cohort(78.26%vs 54.47%,P=0.03;89.65%vs 34.48%,P<0.00).The 3-year disease-free survival rate of the LCSJ cohort in the NO and N3 subgroups was significantly higher than that of the Non-LCSJ cohort(97.22%vs 48.14%,P<0.00;50.00%vs 0%,P=0.04).The 3-year disease-free survival rates of LCSJ cohort in the I,II,and III subgroups were 93.33%,83.87%,and 66.67%,and Non-LCSJ cohort were 43.42%,41.38%,and 25.00%,respectively.The differences were statistically significant(P<0.00;P<0.00;P=0.04).In the subgroups receiving modified radical mastectomy,breast conserving surgery,neoadjuvant chemotherapy,and adjuvant chemotherapy,the 3-year disease-free survival rate of the LCSJ cohort was higher than that of the Non-LCSJ cohort(P<0.05).Univariate analysis of the LCSJ cohort found that the 3-year disease-free survival rate of the regional lymph node negative group was higher than that of the regional lymph node positive group,which was a prognostic factor.However,age,family history,Ki-67 expression,tumor size,clinical stage,surgical method,radiotherapy and chemotherapy had no significant effect on the 3-year disease-free survival rate of the LCSJ cohort(P>0.05).The quality of life,anxiety-depression,quality of sleep,and fatigue of the LCSJ cohort after 1 and 2 years of intervention were significantly improved compared with before intervention(P>0.05).Conclusion:Compared with the Western Medicine Observation(Non-LCSJ)cohort,LCSJ can improve the disease-free survival rate and overall survival time of 1,2,and 3 years.Regional lymph node negative is a prognostic factor for 3-year disease-free survival.Louci Nodule-dissipating Decoction can improve the quality of life of TNBC patients,reduce anxiety and depression,improve sleep quality,and relieve fatigue.In view of the fact that this study is a retrospective study and some data is missing,it still needs to be prospective randomized controlled trials or systematic reviews based on randomized controlled trials for verification. |
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