Annals of Surgical Oncology

, Volume 22, Issue 4, pp 1128–1132 | Cite as

Applicability of the ACOSOG Z0011 Criteria in Women with High-Risk Node-Positive Breast Cancer Undergoing Breast Conserving Surgery

  • Alice Chung
  • Alexandra Gangi
  • James Mirocha
  • Armando Giuliano
Breast Oncology



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).


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.


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.


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.


Sentinel Lymph Node Biopsy Axillary Lymph Node Dissection Completion Axillary Lymph Node Dissection Positive SLNs Z0011 Trial 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The authors have no financial or commercial interests to disclose.


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Copyright information

© Society of Surgical Oncology 2014

Authors and Affiliations

  • Alice Chung
    • 1
  • Alexandra Gangi
    • 1
  • James Mirocha
    • 2
  • Armando Giuliano
    • 1
  1. 1.Division of Surgical Oncology, Department of SurgeryCedars-Sinai Medical CenterLos AngelesUSA
  2. 2.Department of BiostatisticsCedars-Sinai Medical CenterLos AngelesUSA

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