title: Applicability of the ACOSOG Z0011 criteria in women with high-risk node-positive breast cancer undergoing breast conserving surgery.
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.
authors.affiliation: Division of Surgical Oncology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA, alice.chung@cshs.org.
authors.forename: Alice
authors.initials: A
authors.lastname: Chung
authors.forename: Alexandra
authors.initials: A
authors.lastname: Gangi
authors.forename: James
authors.initials: J
authors.lastname: Mirocha
authors.forename: Armando
authors.initials: A
authors.lastname: Giuliano
mesh_terms: D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D018275:Carcinoma, Lobular / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008197:Lymph Node Excision; D008198:Lymph Nodes / Q000473:pathology* / Q000601:surgery; D015412:Mastectomy, Segmental; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D017410:Practice Guidelines as Topic; D011379:Prognosis; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D012307:Risk Factors; D021701:Sentinel Lymph Node Biopsy; D015996:Survival Rate; D064726:Triple Negative Breast Neoplasms / Q000401:mortality / Q000473:pathology* / Q000601:surgery
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human