Ten-year survival results of ACOSOG Z0011: A randomized trial of axillary node dissection in women with clinical T1-2 N0 M0 breast cancer who have a positive sentinel node (Alliance).

Abstract

1007Background: The early results of ACOSOG Z0011 showed that selected sentinel node (SN)-positive patients (pts) treated with sentinel node biopsy (SNB), whole breast irradiation, and adjuvant systemic therapy experienced overall survival (OS) and disease-free survival (DFS) not inferior to those treated with axillary lymph node dissection (ALND). There were concerns that the follow-up was inadequate to assure non-inferiority. The 10-year survival results of Z0011 are reported here. Methods: Clinically node-negative pts with 1 or 2 SNs with H&E-detected metastases were randomized to ALND or no further axillary specific treatment. All pts were to receive whole breast irradiation and systemic therapy. OS and DFS were evaluated. Results: 446 pts were randomized to SNB alone and 445 to SNB + ALND. Pts in both arms were similar with respect to age, tumor size, Bloom-Richardson score, estrogen receptor status, adjuvant systemic therapy, tumor type, and stage. Pts randomized to SNB alone had a median of two lym...