Omission of Sentinel Lymph Node Biopsy Safe For Patients With Early Breast Cancer With Negative Ultrasonography of Axillary Lymph Nodes

According to results from the phase 3 SOUND study, omitting sentinel lymph node biopsy is safe for patients with early breast cancer who have negative results on ultrasonography of the axillary lymph node, when the lack of pathological information does not affect the postoperative treatment plan.

“Sentinel lymph node biopsy is the standard of care for axillary node staging of patients with early breast cancer, but its necessity can be questioned since surgery for examination of axillary nodes is not performed with curative intent,” stated Oreste Davide Gentilini, MD, European Institute of Oncology Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy, and coauthors. 

In this prospective, noninferiority study, 1,405 patients with early breast cancer up to 2 cm in diameter who had a negative preoperative axillary ultrasonography of the axillary lymph node were randomized on a 1-to-1 basis to undergo either sentinel lymph node biopsy (n = 708) or no axillary surgery (n = 697). The primary end point was distant disease-free survival (DDFS) at a follow-up of 5 years. Secondary end points included cumulative incidence of distant recurrences and cumulative incidence of axillary recurrences. 

At a median follow-up of 5.7 years, distant DDFS was 97.7% in the surgical arm and 98% in the non-surgical arm (log-rank P = .67; hazard ratio [HR], 0.84; 90% confidence interval [CI], 0.45 to 1.54; noninferiority P = .02). In the surgical arm there were 12 locoregional relapses and 13 deaths. In the non-surgical arm, there were 14 distant metastases and 18 deaths. 

“These results suggest that patients with these features can be safely spared any axillary surgery whenever the lack of pathological information does not affect the postoperative treatment plan,” concluded Dr Gentilini and coauthors. “The incorporation of these data in future guidelines might lead to a substantial decrease in health care costs due to the reduced involvement of human resources and savings in terms of materials and time.” 

Source: 

Gentilini OD, Botteri E, Sangalli C, et al. Sentinel lymph node biopsy vs no axillary surgery in patients with small breast cancer and negative results on ultrasonography of axillary lymph nodes. JAMA Oncol. Published online: September 21, 2023. doi:10.1001/jamaoncol.2023.3759