RCT: Omission of axillary dissection noninferior to complete dissection in clinically node-negative breast cancer with sentinel-node metastases – N Engl J Med

Study Design and Population: This noninferiority trial explored the effects of omitting completion axillary-lymph-node dissection in patients with clinically node-negative primary T1 to T3 breast cancer who had one or two sentinel-node macrometastases. A total of 2766 patients were enrolled and randomized 1:1 to either undergo sentinel-node biopsy only or completion dissection. Patients received adjuvant treatment and radiation therapy as per national guidelines, focusing on recurrence-free survival as a secondary end point.

Main Findings: The study reported that the 5-year recurrence-free survival rates were 89.7% in the sentinel-node biopsy-only group and 88.7% in the dissection group, with a country-adjusted hazard ratio for recurrence or death at 0.89 (95% CI, 0.66 to 1.19), significantly below the noninferiority margin (P<0.001). This outcome demonstrates the noninferiority of the less invasive sentinel-node biopsy approach compared to the traditional dissection method in managing sentinel-node macrometastases.

Implications for Practice: The findings suggest that for clinically node-negative breast cancer patients with sentinel-node macrometastases, omitting axillary-lymph-node dissection could be considered a viable treatment option, potentially reducing the surgical burden without compromising recurrence-free survival outcomes. This could lead to adjustments in surgical practice and patient care strategies, emphasizing a less invasive approach while maintaining clinical efficacy.

Reference (link to abstract – $ for full-text):

Boniface, J. et al. (2024). Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases. N Engl J Med, 390(13), 1163-1175. DOI: 10.1056/NEJMoa2313487.