Axillary dissection versus axillary observation for low risk, clinically node-negative invasive breast cancer: a...

1. To systematically analyse studies comparing survival outcomes between axillary lymph-node dissection (ALND) and axilla observation (Obs), in women with low-risk, clinically node-negative breast cancer. 2. To consider results in the context of current axillary surgery de-escalation trials and studies.

9 eligible studies were identified, 6 RCTs and 3 non-randomized studies (4236 women in total). Outcomes assessed: overall survival (OS) and disease-free survival (DFS). The logged (ln) hazard ratio (HR) was calculated and used as the statistic of interest. Data was grouped by follow-up.

Meta-analyses found no significant difference in OS at 5, 10 and 25-years follow-up (5-year ln HR = 0.08, 95% CI - 0.09, 0.25, 10-year ln HR =  0.33, 95% CI - 0.07, 0.72, 25-year ln HR = 0.00, 95% CI - 0.18, 0.19). ALND caused improvement in DFS at 5-years follow-up (ln HR = 0.16, 95% CI 0.03, 0.29), this was not demonstrated at 10 and 25-years follow-up (10-year ln HR = 0.07, 95% CI - 0.09, 0.23, 25-year ln HR = - 0.03, 95% CI - 0.21, 0.16). Studies supporting ALND for DFS at 5-years follow-up had greater relative chemotherapy use in the ALND cohort.

ALND does not cause a significant improvement in OS in women with clinically node-negative breast cancer. ALND may improve DFS in the short term by tailoring a proportion of patients towards chemotherapy. Our evidence suggests that when the administration of systemic therapy is balanced between the two arms, axillary de-escalation studies will likely find no difference in OS or DFS.