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.