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.

Abstract

CRA506 Background: Sentinel node biopsy (SNB) eliminates the need for axillary dissection (ALND) in patients whose sentinel node (SN) is tumor-free. However, completion ALND remains the gold standard for patients with a tumor-involved sentinel node. ALND achieves regional control, but its effect on survival remains controversial. The main objective of ACOSOG Z0011 was to compare outcomes of patients with hematoxylin and eosin (H&E) detected metastasis in SN managed with or without ALND and no axillary irradiation. Methods: Clinically node-negative patients who underwent SN biopsy and had 1 or 2 SN with metastases detected by H&E were randomized to ALND or no further axillary specific treatment. All patients were treated with lumpectomy and opposing tangential field irradiation. Adjuvant systemic therapy was at the discretion of their physicians. Overall survival (OS), disease-free survival (DFS), and locoregional control were evaluated. Results: 446 patients were randomized to SNB alone and 445 to SNB plus ALND. Patients treated with SNB alone were similar to those treated with SNB + ALND with respect to age, tumor size, Bloom-Richardson score, estrogen receptor status, adjuvant systemic therapy, tumor type, and T stage. Patients randomized to SNB alone had a median of two lymph nodes removed whereas patients randomized to ALND had a median of 17 lymph nodes removed. 17.6% of ALND patients had 3 or more involved nodes compared to 5.0% of SNB patients (p < 0.001). Median follow-up is 6.2 years. 5-year in breast recurrence after ALND was 3.7% compared to 2.1% for SNB (p = 0.16) while 5-year nodal recurrence was 0.6% compared to 1.3% (p = 0.44) respectively. The five-year OS for patients undergoing SNB + ALND is 91.9% compared to 92.5% for SNB alone (p = 0.24), and DFS is 82.2% compared to 83.8% respectively (p = 0.13). Conclusions: Despite the widely held belief that ALND improves survival, no significant difference was recognized by this study of SN node-positive women. Although the study closed early because of low accrual/event rate, it is the largest phase III study of ALND for node-positive women, and it demonstrates no trend toward clinical benefit of ALND for patients with limited nodal disease. [Table: see text]

Factors that determine whether a patient receives completion axillary lymph node dissection after a positive sentinel lymph node biopsy in breast cancer in British Columbia

“…If one could identify this high-risk group after SLNB, the other two-thirds of patients could avoid undergoing a second operation. Our results are in keeping with those recently reported in the Z0011 trial, 5 which did not demonstrate an advantage for ALND in patients with early breast cancer who had 1-2 positive SLNs. In our study, patients who do not receive CALND have 3 or more nodes removed on SLNB, a lower pathologic N stage and less than 50% node positivity.…”

“…4 The American College of Surgeons Oncology Group Z0011 trial, which compared outcomes for patients with positive SLNs with and without ALND, has not shown any difference in recurrence or survival between the 2 groups. 5 Although this trial closed prematurely owing to low accrual, it is the largest trial of its kind and is unlikely to be duplicated. Retrospective outcomes research can provide additional information on current practices in treating women with positive SLNs and thus help guide clinical decisions.…”

Clinical significance of sentinel lymph node isolated tumour cells in breast cancer

“…It would seem rational to rely on systemic adjuvant treatments to perform in the axilla as they do elsewhere. [84,85]. Z-0011 will determine whether removal of axillary nodes, which contain tumour, contributes to survival or whether it is just a staging procedure.…”

Axillary nodal yields: A comparison between primary clearance and completion clearance after sentinel lymph node biopsy in the management of breast cancer

“…The decreasing likelihood of further nodal disease after a positive SLN suggests we should re-evaluate the extent of completion ALND. Indeed recent a ASCO presentation of the Z0011 study has questioned the need for completion ALND in early stage breast cancer [17].…”