10 YEAR RESULTS OF AXILLARY SLNB

As reported in JAMA by Giuliano et al, 10-year overall survival in the ACOSOG Z0011 (Alliance) trial with sentinel lymph node dissection (SLND) alone was noninferior to that with axillary lymph node dissection (ALND) in women with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and one or two positive sentinel lymph nodes.

Study Details

In the trial, 891 women were randomized between May 1999 and December 2004 to undergo SLND alone (n = 446) or ALND (n = 445). All patients had planned lumpectomy, planned tangential whole-breast irradiation, and adjuvant systemic therapy; third-field radiation was prohibited. The primary outcome was overall survival with a noninferiority hazard ratio (HR) margin of 1.3.

Overall Survival

At a median follow-up of 9.3 years, 10-year overall survival was 86.3% in the SLND-alone group vs 83.6% in the ALND group (HR = 0.85, 1-sided 95% confidence interval [CI] = 0–1.16; noninferiority P = .02). Ten-year disease-free survival was 80.2% vs 78.2% (HR = 0.85, 95% CI = 0.62–1.17, P = .32). Between year 5 and year 10, regional recurrence occurred in one patient in the SLND-alone group vs none in the ALND group. Ten-year locoregional relapse–free survival was 83.0% vs 81.2% (HR = 0.87, P = .41).

The investigators concluded: “Among women with T1 or T2 invasive primary breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases, 10-year overall survival for patients treated with sentinel lymph node dissection alone was noninferior to overall survival for those treated with axillary lymph node dissection. These findings do not support routine use of axillary lymph node dissection in this patient population based on 10-year outcomes.”

The study was supported by grants from the National Cancer Institute

Armando E. Giuliano, MD, of Cedars-Sinai Medical Center, Los Angeles, is the corresponding author of the JAMA article.