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.
#Arrangoiz #CancerSurgeon #BreastSurgeon #SurgicalOncologist #Miami #MSMC #MountSinaiMedicalCenter #Mexico

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