Omission of axillary surgery in early breast cancer with negative lymph nodes: a systematic review and meta-analysis of randomized clinical trials

TL;DR

Skipping axillary surgery for early breast cancer with no lymph node involvement does not harm survival but slightly increases the risk of recurrence in the armpit area.

Contribution

This study provides a comprehensive meta-analysis of randomized trials on axillary surgery omission in early breast cancer.

Findings

No significant difference in overall survival between groups with or without axillary surgery.

Disease-free survival was similar, with a borderline non-significant trend.

Axillary recurrence was significantly higher in patients who skipped axillary surgery.

Abstract

To evaluate whether the omission of axillary surgery impacts clinical outcomes in patients with early-stage breast cancer and clinically negative lymph nodes.

We conducted a systematic review and meta-analysis of randomized clinical trials (RCTs) comparing no axillary surgery with standard axillary interventions (sentinel lymph node biopsy [SLNB] or axillary dissection [AD]). This study followed PRISMA guidelines and was registered in PROSPERO (CRD420250653779). Searches were conducted in PubMed, Web of Science, and Embase through June 2025. Outcomes assessed included overall survival (OS), disease-free survival (DFS), and axillary recurrence (AR). Meta-analyses were performed using RevMan 5.4. Risk of bias was assessed using the RoB 2 tool.

Out of 853 records, seven RCTs including 8806 patients met the inclusion criteria. Among them, 2,915 patients underwent no axillary surgery, while 5891 received surgical axillary treatment. Two trials compared no surgery with SLNB, and five compared no surgery with AD. No significant differences were found in OS (OR = 1.02; 95% CI, 0.86–1.20; p = 0.84; I2 = 36%) or DFS (OR = 0.80; 95% CI, 0.63–1.00; p = 0.05; I2 = 63%). AR was significantly lower in the axillary surgery group (OR = 0.18; 95% CI, 0.10–0.31; p < 0.01; I2 = 39%).

The omission of axillary surgery in early-stage breast cancer with clinically negative lymph nodes does not negatively impact overall or disease-free survival. However, it is associated with a higher—though still low—risk of axillary recurrence.

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