Effectiveness of the Sanyin Formula Plus Chemotherapy on Survival in Women With Triple-Negative Breast Cancer: A Randomized Controlled Trial

Abstract

PurposeTo evaluate the efficacy of the Sanyin formula (SYF) plus conventional standard chemotherapy in operable triple-negative breast cancer (TNBC) patients, a randomized controlled trial was implemented at 5 hospitals and cancer centers in China between May 23, 2016, and October 31, 2019.Materials and MethodsFemale patients aged 18 to 80 years with operable TNBC after definitive surgery were screened and enrolled. The exclusion criteria included metastatic disease, other tumors, or locally advanced disease. Patients were randomly divided into groups SYF plus conventional standard chemotherapy and placebo plus conventional standard chemotherapy at a ratio of 1:1. The primary endpoint of the investigation was disease-free survival (DFS), and secondary endpoints included overall survival (OS) and toxicity.ResultsA total of 252 operable female TNBC patients were randomized to receive SYF plus conventional standard chemotherapy (N = 127) or a placebo plus conventional standard chemotherapy (N = 125). At a median follow-up of 51 months, 5-year DFS time was longer in those assigned to SYF plus conventional standard chemotherapy compared with placebo plus conventional standard chemotherapy (94.2%vs 85.5%, hazard ratio [HR] = 0.40; 95%CI, 0.17-0.97; P = 0.034). The absolute benefit for 5-year DFS was 8.7% in the SYF plus conventional standard chemotherapy group. No statistically significant difference was observed in OS between the two groups (P = 0.23). Patients with negative node status benefited more from SYF plus conventional standard chemotherapy treatment (HR = 0.21, P-interaction = 0.013) in accordance with the exploratory subgroup analyses of DFS.ConclusionsThe results of the present study suggest that the traditional Chinese medicine SYF plus conventional chemotherapy regimens is an effective alternative adjuvant chemotherapy strategy for female operable TNBC patients.Clinical Trial Registrationhttps://www.chictr.org.cn/searchproj.aspx, identifier ChiCTR-IPR-16008590.

Sanyin Formula Enhances the Therapeutic Efficacy of Paclitaxel in Triple-Negative Breast Cancer Metastases through the JAK/STAT3 Pathway in Mice

“…We found that SYF extract significantly inhibited the expression of MMPs in breast cancer cells, suggesting that SYF can effectively inhibit the metastasis of breast cancer. The results of the present study help to explain our previous clinical finding that additional DFS benefits were obtained with SYF plus chemotherapy compared with chemotherapy alone [ 13 ]. Our previous exploratory subgroup analysis showed that the benefit of SYF in patients with node-negative breast cancer was significantly higher than that in patients with node-positive breast cancer, which seemed to be achieved by SYF through the inhibition of MMPs to prevent breast cancer cell metastasis [ 13 ].…”

“…The results of the present study help to explain our previous clinical finding that additional DFS benefits were obtained with SYF plus chemotherapy compared with chemotherapy alone [ 13 ]. Our previous exploratory subgroup analysis showed that the benefit of SYF in patients with node-negative breast cancer was significantly higher than that in patients with node-positive breast cancer, which seemed to be achieved by SYF through the inhibition of MMPs to prevent breast cancer cell metastasis [ 13 ]. This finding further proves the effectiveness of MMP inhibitors in the treatment of breast cancer metastasis.…”

“…We previously found that SYF significantly prolonged DFS in female patients with early-stage TNBC [ 12 , 13 ]. This study aimed to reveal the active components and molecular mechanisms of SYF against TNBC.…”

“…A meta-analysis indicated that traditional Chinese medicine combined with Western medicine has more obvious advantages than Western medicine alone in the treatment of TNBC patients [ 11 ]. Sanyin formula (SYF), a commonly used supplementary traditional Chinese medicinal formula, was found to effectively reduce recurrence and metastasis in TNBC patients [ 12 , 13 ]. Our previous prospective cohort study indicated that SYF significantly increased the 2-year disease-free survival (DFS) rate and reduced the disease-related recurrence and metastasis rate by 11.0% in TNBC patients [ 12 ].…”

“…Our previous prospective cohort study indicated that SYF significantly increased the 2-year disease-free survival (DFS) rate and reduced the disease-related recurrence and metastasis rate by 11.0% in TNBC patients [ 12 ]. In our recent randomized controlled trial, the 5-year DFS time was longer in those who received SYF compared with placebo (94.2% vs. 85.5%, p = 0.034) [ 13 ]. These results indicated that SYF could significantly reduce tumour cell metastasis in TNBC.…”