Abstract
Background
The relevance of the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial in patients with high-risk breast cancer has been questioned. We hypothesize that Z0011 applies to women with HER2-positive disease (HER2+), triple-negative breast cancer (TNBC), and/or age <50 years at diagnosis (YA).
Methods
Women with node-positive HER2+, TNBC, or YA were identified from a prospectively maintained database. Patients were grouped based on Z0011 trial eligibility criteria into those meeting criteria (eligible) and those who did not (ineligible). Patient and tumor characteristics were compared; survival of those meeting Z0011 criteria was determined.
Results
We identified 186 node-positive women undergoing lumpectomy/radiation for high-risk breast cancer: 57 of 186 (31 %) HER2+, 55 of 186 (30 %) TNBC, 74 of 186 (40 %) YA. Overall, 125 of 186 (67 %) met Z0011 criteria. HER2-positivity was associated with the lowest rate of ineligibility compared with TNBC and YA (16 vs. 53 and 31 %, respectively, p < 0.01). Larger tumor size, high grade, extranodal extension, and high Ki67 were associated with Z0011 ineligibility. Among those who were eligible, 105 of 125 (84 %) had ALND and 48 of 125 (38 %) had involvement of nonsentinel nodes (NSLN); median number of NSLNs involved was one (range 1–3). With median follow-up of 5.5 years, there was no difference in survival between those who had ALND and those who did not. After patients with clinically palpable nodes were excluded, 125 of 149 (84 %) met criteria.
Conclusions
The Z0011 trial eligibility requirements apply to a significant proportion of patients with HER2+, TNBC, and YA. ALND can be avoided in 67 % node-positive cases and in 84 % of those with clinically negative nodes.
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References
Giuliano AE, McCall L, Beitsch P, et al. 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. Ann Surg. 2010;252:426–32; discussion 432–3.
Giuliano AE, Hunt KK, Ballman KV, et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011;305:569–75.
Lyman GH, Temin S, Edge SB, et al. Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2014;32(13):1365–85.
Network NCC. Practice guidelines in oncology: breast, version 1.2012. Fort Washington: NCCN 2012.
Giuliano AE, Morrow M, Duggal S, Julian TB. Should ACOSOG Z0011 change practice with respect to axillary lymph node dissection for a positive sentinel lymph node biopsy in breast cancer? Clin Exp Metastasis. 2012;29:687–92.
Shah-Khan M, Boughey JC. Evolution of axillary nodal staging in breast cancer: clinical implications of the ACOSOG Z0011 trial. Cancer Control. 2012;19:267–76.
Guth U, Myrick ME, Viehl CT, et al. The post ACOSOG Z0011 era: does our new understanding of breast cancer really change clinical practice? Eur J Surg Oncol. 2012;38:645–50.
Gatzemeier W, Mann GB. Which sentinel lymph-node (SLN) positive breast cancer patient needs an axillary lymph-node dissection (ALND)–ACOSOG Z0011 results and beyond. Breast. 2013;22:211–6.
Anderson BO, Gralow JR. Axillary vs. sentinel lymph node dissection for invasive breast cancer. JAMA. 2011;305:2290; author reply 2290–1.
Fayda M, Chen R. Axillary vs. sentinel lymph node dissection for invasive breast cancer. JAMA. 2011;305:2289; author reply 2290–1.
Vuthaluru S, Srivastava A. Axillary vs. sentinel lymph node dissection for invasive breast cancer. JAMA. 2011;305:2290; author reply 2290–1.
Krishnan MS, Recht A, Bellon JR, Punglia RS. Trade-offs associated with axillary lymph node dissection with breast irradiation versus breast irradiation alone in patients with a positive sentinel node in relation to the risk of non-sentinel node involvement: implications of ACOSOG Z0011. Breast Cancer Res Treat. 2013;138:205–13.
Chen JJ, Wu J. Management strategy of early-stage breast cancer patients with a positive sentinel lymph node: With or without axillary lymph node dissection. Crit Rev Oncol Hematol. 2011;79:293–301.
Barry JM, Weber WP, Sacchini V. The evolving role of axillary lymph node dissection in the modern era of breast cancer management. Surg Oncol. 2012; 21: 143–145.
Yi M, Kuerer HM, Mittendorf EA, et al. Impact of the American College of Surgeons Oncology Group Z0011 criteria applied to a contemporary patient population. J Am Coll Surg. 2013;216:105–13.
Dengel LT, Van Zee KJ, King TA, et al. Axillary dissection can be avoided in the majority of clinically node-negative patients undergoing breast-conserving therapy. Ann Surg Oncol. 2014;21:22–7.
Van Zee KJ, Manasseh DM, Bevilacqua JL, et al. A nomogram for predicting the likelihood of additional nodal metastases in breast cancer patients with a positive sentinel node biopsy. Ann Surg Oncol. 2003;10:1140–51.
Hwang RF, Krishnamurthy S, Hunt KK, et al. Clinicopathologic factors predicting involvement of nonsentinel axillary nodes in women with breast cancer. Ann Surg Oncol. 2003;10:248–54.
Barranger E, Coutant C, Flahault A, et al. An axilla scoring system to predict non-sentinel lymph node status in breast cancer patients with sentinel lymph node involvement. Breast Cancer Res Treat. 2005;91:113–9.
Pal A, Provenzano E, Duffy SW, et al. A model for predicting non-sentinel lymph node metastatic disease when the sentinel lymph node is positive. Br J Surg. 2008;95:302–9.
Kohrt HE, Olshen RA, Bermas HR, et al. New models and online calculator for predicting non-sentinel lymph node status in sentinel lymph node positive breast cancer patients. BMC Cancer. 2008;8:66.
Gill G. Sentinel-lymph-node-based management or routine axillary clearance? One-year outcomes of sentinel node biopsy versus axillary clearance (SNAC): a randomized controlled surgical trial. Ann Surg Oncol. 2009;16:266–75.
Veronesi U, Paganelli G, Viale G, et al. Sentinel lymph node biopsy and axillary dissection in breast cancer: results in a large series. J Natl Cancer Inst. 1999;91:368–73.
Krag DN, Anderson SJ, Julian TB, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol. 2010;11:927–33.
Canavese G, Catturich A, Vecchio C, et al. Sentinel node biopsy compared with complete axillary dissection for staging early breast cancer with clinically negative lymph nodes: results of randomized trial. Ann Oncol. 2009;20:1001–7.
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Chung, A., Gangi, A., Mirocha, J. et al. Applicability of the ACOSOG Z0011 Criteria in Women with High-Risk Node-Positive Breast Cancer Undergoing Breast Conserving Surgery. Ann Surg Oncol 22, 1128–1132 (2015). https://doi.org/10.1245/s10434-014-4090-y
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DOI: https://doi.org/10.1245/s10434-014-4090-y