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Locoregional Recurrence After Sentinel Lymph Node Dissection With or Without Axillary Dissection in Patients With Sentinel Lymph Node Metastases: The American College of Surgeons Oncology Group Z0011 Randomized Trial

Giuliano, Armando E. MD*; McCall, Linda MS; Beitsch, Peter MD; Whitworth, Pat W. MD§; Blumencranz, Peter MD; Leitch, A. Marilyn MD; Saha, Sukamal MD**; Hunt, Kelly K. MD††; Morrow, Monica MD‡‡; Ballman, Karla PhD§§

doi: 10.1097/SLA.0b013e3181f08f32
Original Articles

Background and Objective: Sentinel lymph node dissection (SLND) has eliminated the need for axillary dissection (ALND) in patients whose sentinel node (SN) is tumor-free. However, completion ALND for patients with tumor-involved SNs remains the standard to achieve locoregional control. Few studies have examined the outcome of patients who do not undergo ALND for positive SNs. We now report local and regional recurrence information from the American College of Surgeons Oncology Group Z0011 trial.

Methods: American College of Surgeons Oncology Group Z0011 was a prospective trial examining survival of patients with SN metastases detected by standard H and E, who were randomized to undergo ALND after SLND versus SLND alone without specific axillary treatment. Locoregional recurrence was evaluated.

Results: There were 446 patients randomized to SLND alone and 445 to SLND + ALND. Patients in the 2 groups were similar with respect to age, Bloom-Richardson score, estrogen receptor status, use of adjuvant systemic therapy, tumor type, T stage, and tumor size. Patients randomized to SLND + ALND had a median of 17 axillary nodes removed compared with a median of only 2 SN removed with SLND alone (P < 0.001). ALND also removed more positive lymph nodes (P < 0.001). At a median follow-up time of 6.3 years, there were no statistically significant differences in local recurrence (P = 0.11) or regional recurrence (P = 0.45) between the 2 groups.

Conclusions: Despite the potential for residual axillary disease after SLND, SLND without ALND can offer excellent regional control and may be reasonable management for selected patients with early-stage breast cancer treated with breast-conserving therapy and adjuvant systemic therapy.

This prospective randomized controlled study compares sentinel lymph node dissection (SLND) alone with SLND followed by completion axillary lymph node dissection in women with tumor-involved sentinel nodes. There was no difference in locoregional control by omission of axillary lymph node dissection after SLND.

From the *John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, CA; †American College of Surgeons Oncology Group, Durham, NC; ‡Dallas Surgical Group, Dallas, TX; §Nashville Breast Center, Nashville, TN; ¶Morton Plant Hospital, Clear Water, FL; ∥University of Texas Southwestern Medical Center, Dallas, TX; **McLaren Regional Medical Center, Michigan State University, Flint, MI; ††M.D. Anderson Cancer Center, Houston, TX; ‡‡Memorial Sloan Kettering Cancer Center, New York City, NY; and §§Mayo Clinic, Rochester, MN.

Supported by federal funds from the National Institutes of Health, under the Grant entitled “American College of Surgeons Oncology Group.”

This study has been registered at ClinicalTrials.gov and carries the identifier NCT00003855.

The content is solely the responsibility of the authors and does not necessarily represent the official view of the National Institutes of Health.

Reprints: Armando E. Giuliano, MD, John Wayne Cancer Institute, 2200 Santa Monica Blvd, Santa Monica, CA 90404. E-mail: giulianoa@jwci.org.

© 2010 Lippincott Williams & Wilkins, Inc.