Abstract: Objective To investigate the risk factors of prognosis, recurrence and metastasis of breast cancer patients with non⁃pathologic complete response (non⁃pCR)  after neoadjuvant chemotherapy. Methods The clinical characteristics of 500 patients with breast cancer diagnosed and treated with neoadjuvant chemotherapy, in the Breast Surgery Department of Guangxi Medical University Cancer Hospital from January 2016 to December 2020 and the First Affiliated Hospital of Hainan Medical University from  January 2020 to December 2022, were retrospectively analyzed. Compare the disease⁃free survival (DFS) and overall survival (OS) of pathologic complete response (pCR) and non⁃pCR patients, respectively. Cox regression analysis was used to screen independent risk factors for recurrence and metastasis of non⁃pCR patients after neoadjuvant chemotherapy. Results The median follow⁃up time was 38 months (range: 6-81 months) in the study cohort, and the median DFS and OS were not reached. The pCR rate after neoadjuvant chemotherapy was 19.4% (97/500). The 5⁃year DFS of pCR and non⁃pCR patients were 91.9 % and 81.2%, respectively (P=0.003), and their 5⁃year OS were 96.1% and 81.6%, respectively (P=0.007). A total of 71 patients experienced recurrence and metastasis after neoadjuvant chemotherapy, including 4 patients with pCR and 67 patients with non⁃pCR. Cox regression analysis showed that age > 35 years (HR=0.393, 95%CI: 0.220-0.701) was the protective factor for recurrence and metastasis in non⁃pCR patients, while the histological grade 3 (HR=3.568, 95%CI: 2.050-6.210), high Ki⁃67 index (HR=2.742, 95%CI: 1.528-4.921), elevated postoperative Ki⁃67 index (HR=5.349, 95%CI: 2.470-11.586) and high pN stage (HR=6.716, 95%CI: 2.922-15.436) were independent risk factors for recurrence and metastasis in non⁃pCR patients. Conclusions Achieving pCR after neoadjuvant chemotherapy can improve the DFS and OS of the patients. Age≤35 years, histological grade 3, Ki⁃67>30%, elevated postoperative Ki⁃67 index and high pN stage are independent risk factors of recurrence and metastasis in non⁃pCR patients. 

Key words: Breast cancer')">Breast cancer, Neoadjuvant chemotherapy, Non?pCR, Prognosis, Recurrence, Metastasis