title: 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.
abstract: OBJECTIVE
  Sentinel lymph node dissection (SLND) has eliminated the need for axillary dissection (ALND) in patients whose sentinel node (SN) is tumor-free. However, completion ALND for patients with tumor-involved SNs remains the standard to achieve locoregional control. Few studies have examined the outcome of patients who do not undergo ALND for positive SNs. We now report local and regional recurrence information from the American College of Surgeons Oncology Group Z0011 trial.
  
  
  METHODS
  American College of Surgeons Oncology Group Z0011 was a prospective trial examining survival of patients with SN metastases detected by standard H and E, who were randomized to undergo ALND after SLND versus SLND alone without specific axillary treatment. Locoregional recurrence was evaluated.
  
  
  RESULTS
  There were 446 patients randomized to SLND alone and 445 to SLND + ALND. Patients in the 2 groups were similar with respect to age, Bloom-Richardson score, estrogen receptor status, use of adjuvant systemic therapy, tumor type, T stage, and tumor size. Patients randomized to SLND + ALND had a median of 17 axillary nodes removed compared with a median of only 2 SN removed with SLND alone (P < 0.001). ALND also removed more positive lymph nodes (P < 0.001). At a median follow-up time of 6.3 years, there were no statistically significant differences in local recurrence (P = 0.11) or regional recurrence (P = 0.45) between the 2 groups.
  
  
  CONCLUSIONS
  Despite the potential for residual axillary disease after SLND, SLND without ALND can offer excellent regional control and may be reasonable management for selected patients with early-stage breast cancer treated with breast-conserving therapy and adjuvant systemic therapy.
authors.affiliation: John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, CA 90404, USA. giulianoa@jwci.org
authors.forename: Armando E
authors.initials: AE
authors.lastname: Giuliano
authors.forename: Linda
authors.initials: L
authors.lastname: McCall
authors.forename: Peter
authors.initials: P
authors.lastname: Beitsch
authors.forename: Pat W
authors.initials: PW
authors.lastname: Whitworth
authors.forename: Peter
authors.initials: P
authors.lastname: Blumencranz
authors.forename: A Marilyn
authors.initials: AM
authors.lastname: Leitch
authors.forename: Sukamal
authors.initials: S
authors.lastname: Saha
authors.forename: Kelly K
authors.initials: KK
authors.lastname: Hunt
authors.forename: Monica
authors.initials: M
authors.lastname: Morrow
authors.forename: Karla
authors.initials: K
authors.lastname: Ballman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001365:Axilla / Q000601:surgery; D001943:Breast Neoplasms / Q000473:pathology*; D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D008197:Lymph Node Excision; D008207:Lymphatic Metastasis / Q000473:pathology*; D009364:Neoplasm Recurrence, Local; D011379:Prognosis; D011446:Prospective Studies; D021701:Sentinel Lymph Node Biopsy; D015996:Survival Rate