Long-term Outcome of Patients Managed With Sentinel Lymph Node Biopsy Alone for Node-Negative Invasive Breast Cancer

Objective: To examine the long-term outcome of patients with early breast cancer with hematoxylin-eosin-negative sentinel lymph nodes (SLNs) who did not undergo completion axillary lymph node dissection. Design, Setting, and Patients: Patients with invasive breast cancer surgically treated between May 1, 1995, and December 31, 2002, with SLN biopsy alone without axillary lymph node dissection who had hematoxylin-eosin-negative SLNs were identified. Main Outcome Measures: Patient and tumor characteristics, adjuvant treatment, disease recurrence, and survival were recorded. A multivariable analysis model was used to identify significant variables associated with disease-free survival and overall survival. Results: A total of 811 patients were included, with a median follow-up of 103.1 months (range, 12.2-182.8 months). The mean patient age was 57.8 years (range, 26-91 years), the mean tumor size was 1.5 cm (range, 0.1-7.5 cm), and the median number of SLNs obtained was 2 (range, 1-8). Seventy-six patients (9.4%) developed disease recurrence; there were 2 patients (0.2%) with isolated axillary recurrences, 40 (4.9%) with local recurrences, 4 (0.5%) with local and regional recurrences, 22 (2.7%) with distant recurrences, and 8 (1.0%) with both local and distant recurrences. The median time to recurrence was 57.2 months (range, 3.1-163.3 months), with 5-year and 10-year disease-free survival rates of 95.1% and 89.9%, respectively. One hundred one patients (12.5%) died; only 15 (1.8%) had distant metastatic disease at the time of death. Patients were significantly more likely to have disease recurrence if they had high-grade tumors (P = . 004). Older age and larger tumor size were significant predictors of worse overall survival on multivariate analysis (P < .001 and P = .01, respectively). Conclusions: This study reports the long-term follow-up of patients with breast cancer and hematoxylin-eosin-negative, tumor-free SLNs, showing a remarkably low axillary recurrence of 0.2% and high disease-free survival. Long-term results of SLN biopsy alone are excellent, and the addition of immunohistochemistry analysis does not contribute to survival. Arch Surg. 2012;147(11):1047-1052. Published online July 16, 2012. doi:10.1001/archsurg.2012.1563