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

Chunyu Wu; Chenping Sun; Guangyu Liu; Yuenong Qin; Xiaohong Xue; Xueqing Wu; Qun Wang; Jin Liu; Zhen Ye; Qiong Li; Wenchao Qu; Yi Wang; Shuai Zhang; Zhiming Shao; Sheng Liu

doi:10.3389/fonc.2022.850155

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

Front Oncol. 2022 May 26:12:850155. doi: 10.3389/fonc.2022.850155. eCollection 2022.

Authors

Chunyu Wu¹, Chenping Sun¹, Guangyu Liu^{2

3}, Yuenong Qin¹, Xiaohong Xue⁴, Xueqing Wu⁵, Qun Wang⁶, Jin Liu⁶, Zhen Ye^{1

7}, Qiong Li⁴, Wenchao Qu⁵, Yi Wang^{1

7}, Shuai Zhang¹, Zhiming Shao^{2

3

8}, Sheng Liu⁹

Affiliations

¹ Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
² Department of Breast Surgery, Key Laboratory of Breast Cancer in Shanghai, Fudan University Shanghai Cancer Center, Shanghai, China.
³ Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
⁴ Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
⁵ Department of Breast, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
⁶ Department of Surgery (Thyroid and Breast Surgery), Shanghai Traditional Chinese Medicine Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
⁷ School of Longhua Clinical Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
⁸ Shanghai Cancer Center and Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai, China.
⁹ Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Abstract

Purpose: To 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 methods: Female 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.

Results: A 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.

Conclusions: The 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 registration: https://www.chictr.org.cn/searchproj.aspx, identifier ChiCTR-IPR-16008590.

Keywords: Sanyin formula; a randomized controlled trial; survival; traditional Chinese medicine; triple-negative breast cancer.