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Sentinel lymph node dissection (SLND) has eliminated the need for axillary lymph node dissection (ALND) in patients whose SLNs are tumor free. Completion ALND for patients who have tumor-involved SLNs is considered standard practice; however, whether ALND affects survival when SLNs contain metastases is unknown. Now, in a randomized, prospective noninferiority trial (Z0011) conducted at 115 sites by the American College of Surgeons Oncology Group, overall and disease-free survival were assessed among women with metastases detected at SLND who were randomized to undergo ALND (445 patients) versus no axillary treatment (446 patients). Eligible women had invasive breast tumors <5 cm and one or two positive SLNs. All patients received whole-breast radiotherapy following breast-conserving surgery and SLND; 96% received adjuvant systemic therapy.
A median of 17 versus 2 axillary nodes were removed in patients who underwent SLND plus ALND versus SLND alone (P<0.001). Among patients in the ALND group, 27.4% were found to have additional positive nodes. Neither overall nor disease-free survival was substantially affected by receipt of axillary dissection: At median follow-up of 6.3 years, 5-year overall survival was 91.8% with ALND and 92.5% with SLND alone, and 5-year disease-free survival was 82.2% with ALND and 83.9% with SLND alone.
Giuliano AE et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: A randomized clinical trial. JAMA 2011 Feb 9; 305:569.
Carlson GW and Wood WC. Management of axillary lymph node metastasis in breast cancer: Making progress. JAMA 2011 Feb 9; 305:606.
Comment
These practice-changing results show that — despite the potential for residual axillary disease after sentinel lymph node dissection alone — omission of axillary lymph node dissection does not affect overall survival or disease-free survival. The high overall survival rates in this population of node-positive breast cancer patients suggest a relatively low tumor burden as well as effective use of systemic and local therapies. Most patients with positive SLNs in the SLND-alone group would not be expected to have additional nodal metastases, underscoring the growing realization that ALND in such women is unnecessary (and can lead to lymphedema, pain syndromes, and shoulder dysfunction). Accordingly, many U.S. multidisciplinary teams (including those at M.D. Anderson Cancer Center) have begun to eliminate ALND among patients with positive SLNs who will be treated with subsequent adjuvant systemic therapies and whole-breast radiotherapy. However, these results do not apply to women who have palpable nodal disease at presentation, who have received preoperative chemotherapy, who undergo mastectomies, or who do not receive postoperative radiotherapy or partial-breast radiotherapy.