Oncologic safety and patient-reported outcomes of sentinel lymph node biopsy omission in early breast cancer: A meta-analysis of randomized controlled trials.

Abstract

e12618 Background: Sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection for axillary staging in clinically node-negative early breast cancer (BC) as randomized controlled trials (RCTs) suggest that omission of SLNB may result in non-inferior oncologic outcomes in selected low-risk patients. However, the impact of SLNB omission on recurrence and patient-reported outcomes (PROs) remains incompletely defined. This meta-analysis aims to evaluate the oncologic safety of omitting SLNB and its effects on PROs in early BC. Methods: RCTs comparing surgical omission versus standard SLNB in clinically and sonographically node-negative early BC patients undergoing breast-conserving therapy (BCT) were identified through searches of PubMed, Embase, and Cochrane. Outcomes of interest included disease-free survival (DFS), distant recurrence, axillary recurrence, overall mortality, breast cancer-specific mortality, and PROs including global health status and functional domains. Random-effects models were used, reporting hazard or odds ratios with 95% confidence intervals; heterogeneity was assessed using I². When individual patient data were unavailable, quantitative data were extracted from graphical representations using PlotDigitizer. All analyses were performed using RevMan version 5.4. Results: Four RCTs met inclusion criteria, encompassing 6,329 patients randomized to SLNB omission (4,636) versus standard SLNB (1,693). Omission of SLNB resulted in non-inferior DFS (HR 0.90, 95% CI 0.73–1.11, I² = 0%), with no significant differences in distant recurrence (OR 0.97, 95% CI 0.66–1.41, I² = 0%), overall mortality (OR 0.59, 95% CI 0.15–2.30, I² = 86%) and BC-specific mortality (OR 1.55, 95% CI 0.49–4.90, I² = 0%) between groups. Notably, axillary recurrence was significantly lower in the SLNB omission group (OR 0.35, 95% CI 0.17–0.73, p = 0.005, I² = 0%). Patient-reported outcomes at 6 months revealed no significant differences in global health status (MD −0.49, 95% CI −2.08 to 1.10) or physical functioning (MD −0.22, 95% CI −2.16 to 1.73) between groups. However, role functioning at 6 months was significantly better in the SLNB omission group (MD 1.96, 95% CI 0.17 to 3.76), though this difference was not sustained at 12 months (MD −1.37, 95% CI −3.02 to 0.27). Conclusions: In patients with clinically and sonographically node-negative early BC undergoing BCT, omission of SLNB was associated with non-inferior oncologic outcomes compared with standard SLNB. SLNB omission was associated with a modest improvement in role functioning at 6 months, without differences in global health or physical functioning. These findings support axillary de-escalation in low-risk patients, although longer follow-up is needed to confirm durability and refine patient selection.