Local and Regional Control in Breast Cancer After Sentinel Node Biopsy without Axillary Lymph Node Dissection: Results from a Randomized Trial
Armando E Giuliano, MD1, *Linda McCall, MS2, *Peter Beitsch, MD3, *Pat W Whitworth, MD4, *Peter Blumencranz, MD5, *Marilyn Leitch, MD6, *Sukamal Saha, MD7, Kelly K Hunt, MD8, Monica Morrow, MD9, *Karla Ballman, PhD10
1John Wayne Cancer Institute, Santa Monica, CA, 2American College of Surgeons Oncology Group, 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, 7McLaren Regional Medical Center, Michigan State University, Flint, MI, 8MD Anderson Cancer Center, Houston, TX, 9Memorial Sloan-Kettering Cancer Center, New York City, NY, 10Mayo Clinic, Rochester, MN
OBJECTIVE: Sentinel node biopsy (SNB) revolutionized the management of breast cancer by eliminating the need for axillary dissection (ALND) in patients whose sentinel node (SN) is tumor-free. Completion ALND for patients with tumor-involved SN remains the standard to achieve loco-regional control. Few studies have examined the outcome of patients who do not undergo ALND for positive SN. We now report local and regional recurrence in H&E-node-positive women after SNB alone compared to those treated with ALND.
METHODS: ACOSOG Z0011 is a prospective randomized trial examining survival of patients with SN metastases detected by standard H&E and treated with and without ALND or axillary radiation. Local and regional recurrence was evaluated.
RESULTS: 446 patients were randomized to SNB alone and 445 to SNB + ALND. Patients with SNB alone were similar to those with SNB + ALND with respect to age, Bloom-Richardson score, estrogen receptor status, the use of adjuvant systemic therapy, tumor type, T stage, and tumor size . Patients randomized to SNB + ALND had a median of 17 axillary nodes removed compared to a median of only 2 SN removed with SNB only (p < .001). ALND also removed more involved nodes (p <.001). Median follow-up was 5.9 years. Neither differences in local recurrence (p <.169) nor regional recurrence (p <.443) were statistically significant between the two groups.
CONCLUSION: Despite the potential of residual disease in the axilla, SNB alone can offer excellent regional control and may be reasonable management for selected patients with breast cancer.