Clinical observation on the effect of Chinese medicine-TCM formula intervention on recurrence and metastasis of triple negative breast cancer

Objective: This study used a prospective cohort study to observe the effect of triple-negative breast cancer on the 2-year disease-free survival rate with or without TCM formula. Methods: From November 1 st, 2016, the first patient was enrolled in the cohort study. A total of 356 patients were enrolled on January 30, 2019. Among them, 154 cases were followed up for 2 years. During the follow-up, there were 6 cases of shedding, so 6 cases were affected. A total of 148 cases were included in the analysis, including 73 in the exposed group and 75 in the non-exposed group. The exposed group was given TCM formula on the basis of standardized treatment, and the non-exposed group was treated with simple triple-negative breast cancer. The two groups visited each of the three months. The interview included safety examination (hematology and imaging). The endpoint was the difference in 2-year invasive disease-free survival between the exposed and non-exposed groups and the safety of the TCM formula. Results: There were 6 cases of shedding during the experiment and the shedding rate was 3.9 %. The 2-year rate of invasive disease-free survival in the exposed team was 88.7 % and the non-exposed group was 82.5 %. Logistic multivariate regression analysis predicted that TCM formula could reduce the disease-related recurrence and metastasis rate by 11 % (OR = 0.89, 95 % CI 0.37 - 0.956, P < 0.05). Through K-M survival analysis, TNBC patients with age <= 35 years and regional lymph node stage N1 may be the benefit group of TCM formula(P < 0.05). During the study, the incidence of total adverse events was 8.2 % in the exposed group, mainly manifested as stomach discomfort, diarrhea, and hepatocyte damage. Conclusion: 1. In the exposed group, the two-year rate of invasive disease-free survival increased by 6.2 % compared with the non-exposed group(P > 0.05). 2. According to K-M survival analysis, TNBC patients with age 35 years and regional lymph node metastasis to N1 may be potential beneficiaries of TCM formula. 3. TCM Formula is safe and tolerable to most patients.