Predicting Axillary Response in Hormone Receptor-Positive Breast Cancer after Neoadjuvant Chemotherapy Using Real-World Data

Abstract

Purpose. To develop a scoring system for hormone receptor-positive (HR+) breast cancer patients who are expected to achieve axillary pathological complete response (pCR) after neoadjuvant chemotherapy (NAC). To confirm the correlation between axillary status and survival rate in HR+ breast cancer after NAC. Methods. Women from the Shanghai Jiao Tong University Breast Cancer Database (SJTU-BCDB) who underwent NAC for cT1-4N1-3M0 primary HR+ breast cancer between 2009 and 2018 were included in the study. In this case, patient follow up was performed until 2022 for those with complete data before and after NAC. The main outcome measures were the axillary pCR rate, overall survival (OS), and disease-free survival (DFS). The patients were randomly assigned to a test set (n = 175) and a validation set (n = 68) in a 7 : 3 ratio. A prediction risk score was then developed based on the odds ratios from the multivariate analysis of the test set (n = 175) before being validated in the validation set (n = 68). Finally, the Kaplan–Meier curves were used to explore the survival on this score system. Results. From the database, 243 women were included, and the median follow-up period was 47.5 months (95% confidence interval: 41.9–53.1). The axillary pCR rate was 18.9% (46 of 243), with the independent predictors of residual positive axillary lymph nodes (LNs) being lymphovascular invasion (LVI), breast conserving surgery (BCS), Ki67 < 14%, HER2 negativity, positive lymph nodes in ultrasound (US) before surgery, and stage III histological grade (All, $P<0.05$ ). Using the above predictors of the model, the receiver operating characteristic (ROC) curve was used for calibration and inspection, with values for the test and validation sets being 0.847 ( $P<0.001$ ; 95% CI: 0.769, 0.925) and 0.813 ( $P<0.001$ ; 95% CI: 0.741, 0.885), respectively. The total risk score ranged from 0 to 6 for the multivariate analysis, and from this range, a risk score of 0–2 was defined as a low-risk group, while scores of 3–6 were defined as the high-risk one. By constructing the survival curve, it was found that the 5-year OS rates for the low-risk and high-risk groups were 89.0% and 84.2% (P = 0.236). Similarly, the 5-year DFS rates for the low-risk and high-risk groups were 80% and 68.5% (P = 0.048), respectively. In addition, axillary pathological stages were significantly correlated with the overall survival (OS) and disease-free survival (DFS) (All, $P<0.05$ ). Conclusion. The prediction model showed good performance for HR + breast cancer. LVI, BCS, low Ki-67, HER2 negativity, suspected positive LNs before surgery, and stage III histological grade were all risk factors for residual positive axillary LNs. However, unlike pathological stages, achieving pCR in the axillary LNs does not affect the survival status.