Omitting Surgical Axillary Staging Prior to Breast-Conserving Therapy Does Not Negatively Impact Survival for Patients With Node-Negative Breast Cancer
According to results from the INSEMA trial, omitting surgical axillary staging with sentinel lymph node biopsy prior to breast-conserving therapy does not negatively impact survival outcomes among patients with stage T1 or T2 node-negative breast cancer.
In this study, 4858 patients were assigned to undergo treatment either without axillary surgery (n = 962) or with sentinel lymph node biopsy (n = 3896). The primary end point was 5-year invasive disease-free survival (iDFS). A key secondary end point was safety.
At a median follow-up of 73.6 months, the estimated 5-year iDFS was 91.9% in the surgery omission arm (95% confidence interval [CI], 89.9 to 93.5) and 91.7% in the surgical arm (hazard ratio [HR], 0.91; 95% CI, 90.8 to 92.6). The occurrence or recurrence of axillary invasive disease was 1.0% in the surgery omission arm and 0.3% in the surgery arm. The incidence of death from any cause was 1.4% in the surgery omission arm and 2.4% in the surgery arm.
Patients who underwent treatment without axillary surgery experienced lower incidences of lymphedema, greater arm mobility, and less pain with movement of the arm or shoulder compared to patients who underwent treatment with sentinel lymph node biopsy.
“In this trial involving patients with clinically node-negative, T1 or T2 invasive breast cancer (90% with clinical T1 cancer and 79% with pathological T1 cancer), omission of surgical axillary staging was noninferior to sentinel-lymph-node biopsy after a median follow-up of 6 years,” concluded Dr Reimer et al.
Source:
Reimer T, Stachs A, Veselinovic K, et al. Axillary surgery in breast cancer — Primary results of the INSEMA trial. N Engl J Med. Published Online: December 12, 2024. doi: 10.1056/NEJMoa2412063
