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Factors Associated with Local-Regional Recurrence Following a Negative Sentinel Node Biopsy: Results of the ACOSOG Z0010 Trial
Kelly K Hunt1, Linda M. McCall*2, Karla V. Ballman*3, Judy C. Boughey*3, Elizabeth A. Mittendorf*1, Charles Cox*4, Pat W. Whitworth*5, A. Marilyn Leitch*6, Peter D. Beitsch*7, Armando E. Giuliano8
1The University of Texas MD Anderson Cancer Center, Houston, TX;2American College of Surgeons Oncology Group, Durham, NC;3The Mayo Clinic, Rochester, MN;4Moffitt Cancer Center, Tampa, FL;5Nashville Breast Center, Nashville, TN;6UT Southwestern, Dallas, TX;7Dallas Surgical Group, Dallas, TX;8Cedars Sinai Medical Center, Los Angeles, CA

OBJECTIVE(S): ACOSOG Z0010 was a prospective study to determine the significance of metastases detected by immunohistochemistry (IHC) on survival and local-regional recurrence (LRR) in patients with negative sentinel lymph nodes (SLNs) by hematoxylin and eosin (H&E) staining. We report here factors associated with LRR in patients with H&E-negative SLNs.
METHODS: Women with clinical T1-2,N0,M0 disease underwent lumpectomy and SLN biopsy. There was no axillary specific treatment for H&E-negative SLNs and clinicians were blinded to IHC results. Systemic therapy was based on primary tumor factors. Univariable and multivariable analyses were performed to determine clinicopathologic factors associated with LRR.
RESULTS: Of 5119 patients, 3904 (76.3%) had H&E-negative SLNs (of which 10% had occult metastases by IHC). Median age was 56 years (range 23-95), median follow-up was 8.4 years. There were 127 (3.2%) local, 20 (0.5%) regional, and 134 (3.4%) distant recurrences.
Clinicopathologic factors associated with regional recurrence in H&E-negative SLNs were PR-negative disease (p=0.006) and presence of lymphovascular invasion (LVI) (p=0.0002). When local and regional recurrence were included in the model, age >50, T2 disease and local recurrence were associated with reduced overall survival, ER-positive disease and no LVI were associated with improved overall survival.
CONCLUSIONS: Regional recurrence is rare in patients after H&E-negative SLN biopsy and is associated with LVI and PR-negative disease. Regional recurrence after negative SLN biopsy is not associated with reduced overall survival.

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