A retrospective multi-center cohort study investigating safety of sentinel lymph node biopsy for axillary staging in clinical T3-4c breast cancer

Background: Sentinel lymph node biopsy (SLNB) has become a standard procedure for patients with breast cancer (BC) without clinically evident axillary metastasis. However, its role in cT3-4cN0 BC remains underexplored, leading to uncertainty regarding its safety. Methods: This retrospective, multicenter observational study included patients with cT3-4cN0M0 BC who underwent radical surgery between 2006 and 2016. Patients were divided into an SLNB group, which included those who underwent SLNB exclusively and ALND after SLNB, and an ALND group, which included those who underwent ALND exclusively. Inverse probability treatment weighting was applied to balance the patient characteristics, with recurrence-free survival (RFS) as the primary endpoint. Results: The study included 930 patients: 716 in the SLNB group and 214 in the ALND group. The ALND group had a higher proportion of patients diagnosed earlier, more T4 tumors, and more frequent use of neoadjuvant chemotherapy. During a median follow-up period of 89 months, 176 RFS events and 51 loco-regional recurrence events occurred. After adjusting for confounding factors, no significant difference was found in 10-year RFS between the groups (74.2% vs. 79.2%). Adjusted hazard ratios for RFS did not differ between the groups, even when stratified by tumor stage (cT3, cT4) or neoadjuvant chemotherapy. No significant differences were observed between the SLNB and ALND groups in loco-regional recurrence rate (LRR), with 10-year LRR rates of 93.1% and 90.8%, respectively. Conclusions: SLNB was a safe axillary staging method for patients with cT3-4cN0M0 BC and does not impact RFS or LRR negatively when compared with ALND.