title: Axillary Management of Stage II/III Breast Cancer in Patients Treated with Neoadjuvant Systemic Therapy: Results of CALGB 40601 (HER2-Positive) and CALGB 40603 (Triple-Negative).
abstract: BACKGROUND
  Management of the axilla in stage II/III breast cancer undergoing neoadjuvant systemic therapy (NST) is controversial. To understand current patterns of care, we collected axillary data from 2 NST trials: HER2-positive (Cancer and Leukemia Group B [CALGB] 40601) and triple-negative (CALGB 40603).
  
  
  METHODS
  Axillary evaluation pre- and post-NST was per the treating surgeon and could include sentinel node biopsy. Post-NST, node-positive patients were recommended to undergo axillary lymph node dissection (ALND). We report pre-NST histopathologic nodal evaluation and post-NST axillary surgical procedures with correlation to clinical and pathologic nodal status.
  
  
  RESULTS
  Seven hundred and forty-two patients were treated, 704 had complete nodal data pre-NST and post-NST. Pre-NST, 422 (60%) of 704 patients underwent at least 1 procedure for axillary node evaluation (total of 468 procedures): fine needle aspiration (n = 234; 74% positive), core needle biopsy (n = 138; 72% positive), and sentinel node biopsy (n = 96; 33% positive). Pre-NST, 304 patients were considered node-positive. Post-NST, 304 of 704 patients (43%) underwent sentinel node biopsy; 44 were positive and 259 were negative (29 and 36 patients, respectively, had subsequent ALND). Three hundred and ninety-one (56%) patients went directly to post-NST ALND and 9 (1%) pre-NST node-positive patients had no post-NST axillary procedure. Post-NST, 170 (24%) of the 704 patients had residual axillary disease. Agreement between post-NST clinical and radiologic staging and post-NST histologic staging was strongest for node-negative (81%) and weaker for node-positive (N1 31%, N2 29%), with more than half of the clinically node-positive patients found to be pathologic negative (p < 0.001).
  
  
  CONCLUSIONS
  Our results suggest there is no widely accepted standard for axillary nodal evaluation pre-NST. Post-NST staging was highly concordant in patients with N0 disease, but poorly so in node-positive disease. Accurate methods are needed to identify post-NST patients without residual axillary disease to potentially spare ALND.
authors.affiliation: Department of Surgery, University of North Carolina, at Chapel Hill, Chapel Hill, NC. Electronic address: david_ollila@med.unc.edu.
authors.forename: David W
authors.initials: DW
authors.lastname: Ollila
authors.affiliation: Alliance Statistics and Data Center, Duke University Medical Center, Durham, NC.
authors.forename: Constance T
authors.initials: CT
authors.lastname: Cirrincione
authors.affiliation: Alliance Statistics and Data Center, MD Anderson Cancer Center, Houston, TX.
authors.forename: Donald A
authors.initials: DA
authors.lastname: Berry
authors.affiliation: Department of Medical Oncology, University of North Carolina, at Chapel Hill, Chapel Hill, NC.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Carey
authors.affiliation: Program in Women's Oncology, Women and Infants Hospital of Rhode Island, Providence, RI; Alpert Medical School of Brown University, Providence, RI.
authors.forename: William M
authors.initials: WM
authors.lastname: Sikov
authors.affiliation: Department of Medical Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY.
authors.forename: Clifford A
authors.initials: CA
authors.lastname: Hudis
authors.affiliation: Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA.
authors.forename: Eric P
authors.initials: EP
authors.lastname: Winer
authors.affiliation: Department of Surgery, Brigham and Women's Hospital, Boston, MA.
authors.forename: Mehra
authors.initials: M
authors.lastname: Golshan
mesh_terms: D000328:Adult; D000368:Aged; D001365:Axilla; D001706:Biopsy / Q000379:methods / Q000706:statistics & numerical data; D001943:Breast Neoplasms / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D018270:Carcinoma, Ductal, Breast / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D018275:Carcinoma, Lobular / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D005260:Female; D006801:Humans; D008197:Lymph Node Excision / Q000706:statistics & numerical data*; D008198:Lymph Nodes / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D008207:Lymphatic Metastasis; D008408:Mastectomy; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D021701:Sentinel Lymph Node Biopsy / Q000706:statistics & numerical data; D064726:Triple Negative Breast Neoplasms / Q000473:pathology / Q000628:therapy; D014481:United States
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human