ACOSOG Z1071 Trial

The ACOSOG Z1071 trial: 
- Was designed to determine the false negative rate (FNR) of: 
  - Sentinel lymph node (SLN) surgery after chemotherapy:
    -  In women initially presenting with cN1 disease
- It enrolled women from 136 institutions:
  - Who had clinical:
    - T0 through T4
    - N1 through N2
    - M0 breast cancer
  - Who received neoadjuvant chemotherapy
  - Patients enrolled had:
    - Pre-chemotherapy axillary nodal disease confirmed by:
      - Fine-needle aspiration or
      - Core needle biopsy
  - Following chemotherapy:
    - Patients underwent:
      - Both SLN surgery and axillary lymph node dissection
  - - Sentinel lymph node surgery was using both:
      - Blue dye (isosulfan blue or methylene blue) and a radiolabeled colloid mapping agent:
        Was encouraged
  - Rates of detection of at least:
    - One SLN were:
      - 92.9% in patients:
        With cN1 disease and
      - 89.5% in patients:
        With cN2 disease
  - Overall the FNR of SLN:
    - After neoadjuvant chemotherapy was:
      - 12.6%, 90% Bayesian Credible Interval, 9.85%–16.05%
  - Bi-variable analyses found that:
    - The likelihood of a false-negative SLN finding was significantly decreased – when the mapping was performed:
      - With the combination of blue dye and radiolabeled colloid:
        P=.05; FNR:
        10.8% combination vs 20.3% single agent and
        By examination of at least 3 SLNs:
        P=.007; FNR:
        9.1% for ≥3 SLNs vs 21.1% for 2
  - While the study overall did not meet the predetermined acceptability threshold of:
    - Post-neoadjuvant SLN biopsy FNR being 10% or less:
      - The authors concluded that:
        Changes in approach and patient selection:
Resulted in a greater sensitivity that would be necessary to support the use of SLN surgery as an alternative to axillary lymph node dissection in this patient population
References:
- Boughey JC, Suman VJ, Mittendorf EA, et al; Alliance for Clinical Trials in Oncology. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013;310:1455-1461.