Size of Extranodal Extension on Sentinel Lymph Node Dissection in the American College of Surgeons Oncology Group Z0011 Trial Era.

IMPORTANCE: Based on the American College of Surgeons Oncology Group Z0011 trial exclusion criteria, patients with T1N0 or T2N0 breast cancer with 1 or 2 positive sentinel lymph nodes (SLNs) are recommended to undergo axillary lymph node dissection if extranodal extension (ENE) is present.

OBJECTIVE: To determine the effect of ENE size on residual axillary nodal burden, disease recurrence, and survival in patients meeting Z0011 criteria.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study between January 1, 2000, and December 31, 2012, at a single tertiary cancer center. Patients had T1 or T2 breast cancer with 1 or 2 positive SLNs. The ENE was classified as 2 mm or smaller or as larger than 2 mm.

MAIN OUTCOMES AND MEASURES: Nodal burden, disease recurrence, and overall survival.

RESULTS: Of 208 patients, 149 (71.6%) had no ENE, 21 (10.1%) had ENE 2 mm or smaller, and 38 (18.3%) had ENE larger than 2 mm on SLN dissection. The median follow-up time was 60 months (range, 1-158 months). The mean (SD) total number of positive lymph nodes differed significantly for the group with no ENE (1.72 [1.39]) vs the group with ENE 2 mm or smaller (3.22 [2.09]; P < .001) and vs the group with ENE larger than 2 mm (4.26 [5.01]; P < .001). Similar patterns were observed for mean (SD) nonsentinel lymph node metastases: 0.48 (1.30) for no ENE vs 1.91 (2.07) with ENE 2 mm or smaller (P = .02) and vs 2.95 (4.95) with ENE larger than 2 mm (P < .001). For the group without ENE vs the group with ENE 2 mm or smaller, there were no significant differences in recurrence (distant recurrence, 4 patients [2.7%] vs 1 patient [4.8%], respectively; P = .62) or in mortality (18 patients [12.1%] vs 4 patients [19.1%], respectively; P = .48). For the group without ENE vs the group with ENE larger than 2 mm, there were no significant differences in recurrence (distant recurrence, 4 patients [2.7%] vs 4 patients [10.5%], respectively; P = .19) or in mortality (18 patients [12.1%] vs 9 patients [23.7%], respectively; P = .07).

CONCLUSIONS AND RELEVANCE: Presence of ENE on SLN dissection is associated with N2 disease. Despite increased nodal burden, patients with 1 or 2 positive SLNs and ENE 2 mm or smaller demonstrated recurrence and survival rates similar to those of patients without ENE. Reporting of ENE size should be standardized and required.