A phase 3, randomized clinical trial enrolled patients with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases from May 1999 to December 2004 at 115 academic and community medical sites. The objective of the study was to establish if the 10-year survival of patients with sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone with no axillary lymph node dissection (ALND) is noninferior to patients treated with axillary dissection. The primary endpoint was overall survival (noninferiority hazard ratio margin of 1.3), and the secondary outcome was disease-free survival.
A total of 856 patients completed the trial, with 446 women in the SLND alone cohort and 445 women in the ALND cohort. The 10-year overall survival was 86.3% in the SLND alone group vs 83.6% in the ALND group at a median follow-up of 9.3 years. The 10-year disease-free survival was 80.2% compared with 78.2%. There was no significant difference in 10-year regional recurrence between either group. It was found that the 10-year overall survival for patients who were treated with sentinel lymph node dissection alone was noninferior to overall survival in those treated with axillary lymph node dissection in this patient population.
Giuliano AE, Ballman KV, McCall L, et al. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017;318(10):918-926. doi:10.1001/jama.2017.11470