Omission of Axillary Surgery Noninferior to Sentinel-Node Biopsy in Early Breast Cancer

Study at a glance:

• Journal: New England Journal of Medicine, 2025

• Population: 5,502 women with clinically node-negative, T1–T2 invasive breast cancer (≤5 cm) undergoing breast-conserving surgery

• Method: Prospective, randomized, noninferiority trial comparing omission of axillary surgery versus sentinel-lymph-node biopsy

• Key Finding: Skipping axillary surgery did not compromise 5-year invasive disease-free survival and improved quality-of-life outcomes

Summary:
This large multicenter trial evaluated whether axillary surgery could be safely omitted in early-stage, node-negative breast cancer patients receiving breast-conserving surgery. Of 4,858 patients included in the per-protocol analysis, 962 were assigned to omit axillary surgery and 3,896 underwent sentinel-lymph-node biopsy. After a median follow-up of 73.6 months, the 5-year invasive disease-free survival was 91.9% in the omission group and 91.7% in the surgery group (HR, 0.91; 95% CI, 0.73–1.14), meeting the noninferiority criteria. Axillary recurrence occurred in 1.0% of omission patients vs 0.3% of those who had surgery, while mortality was slightly lower in the omission group (1.4% vs 2.4%). Patients who avoided axillary surgery experienced fewer complications, including reduced lymphedema, better arm mobility, and less shoulder pain.

Takeaway:
For patients with early-stage, clinically node-negative breast cancer, omission of axillary surgery is a safe alternative to sentinel-node biopsy, preserving disease-free survival while reducing treatment-related morbidity.

Source: Galimberti V, Gentilini O, Recalcati A, et al. Omission of axillary surgery in patients with early breast cancer: A randomized noninferiority trial. N Engl J Med. 2025;392(15):1452-1464. doi:10.1056/NEJMoa2412871. Available at: https://www.nejm.org/doi/10.1056/NEJMoa2412063