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Locoregional Recurrence After Sentinel Lymph Node Dissection With Or Without Axillary Dissection In Patients With Sentinel Lymph Node Metastases: Long-Term Follow-Up From The American College Of Surgeons Oncology Group (Alliance) Z0011 Randomized Trial
Armando E Giuliano1, Linda McCall*2, Peter beitsch*3, Pat W Whitworth*4, Peter Blumencranz*5, A. Merilyn Leitch*6, Sukamal Saha*7, Kelly K Hunt*8, Monica Morrow*9, Karla Ballman*10
1CEDARS SINAI MEDICAL CENTER, WEST HOLLYWOOD, CA;2Alliance for Clinical Trials in Oncology, Durham, NC;3Dallas Surgical Group, Dallas, TX;4Nashville Breast Center, Nashville, TN;5Morton Plant Hospital, Clear Water, FL;6University of Texas Southwestern Medical Center Surgery, Dallas, TX;77. McLaren Regional Medical Center, Michigan State University, Flint, MI;8M.D. Anderson Cancer Center, Houston, TX;9Memorial Sloan-Kettering Cancer Center, New York, NY;10Alliance for Clinical Trials in Oncology, New York, NY

Background and Objective: The American College of Surgeons Oncology Group (ACOSOG) Z0011 trial demonstrated no difference in locoregional recurrence for patients with positive sentinel nodes (SLN) randomized either to axillary lymph node dissection (ALND) or SLN dissection (SLND) alone. We now report long-term locoregional recurrence results of the trial.
Methods: ACOSOG Z0011 prospectively examined overall survival of patients with SLN metastases undergoing breast conserving therapy randomized to undergo ALND after SLND or no further axillary specific treatment. Locoregional recurrence was evaluated and compared.
Results: Four hundred forty six patients were randomized to SLND alone and 445 to completion ALND. The two groups were similar with respect to age, Bloom-Richardson score, ER status, adjuvant systemic therapy, histology, and tumor size. Patients randomized to ALND had a median of 17 axillary nodes removed compared to a median of only 2 SLNs removed with SLND alone (P < 0.001). ALND also removed more positive lymph nodes (P < 0.001). At a median follow-up of 9.25 years, there was no statistically significant difference in locoregional recurrence (P=0.13). There were only two nodal recurrences in the ALND arm (0.5%) and only five in the SLND alone arm (P=0.27). Ten year local and regional recurrence free survival was 93.2% for the ALND arm and 94.1% for the SLND alone arm (P=0.36).
Conclusion: Despite the potential for residual axillary disease after SLND, SLND without ALND offers excellent regional control for selected patients with early metastatic breast cancer treated with breast-conserving therapy and adjuvant systemic therapy.


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