ACOSOG Z0011, AMAROS, ACOSOG Z0010 Trial

  • Data from the ACOSOG Z0011 trial:
    • Suggest completion axillary dissection can be avoided in patients with:
      • cT1 / T2 N0 breast cancer with sentinel lymph node (SLN) metastasis:
        • Provided that systemic therapy and whole-breast irradiation (WBI):
          • Are incorporated into the treatment strategy for early-stage breast cancer following breast-conserving surgery (BCS)
    • This trial enrolled:
      • Clinically node-negative patients with:
        • Tumors less than 5 cm in size and with 1 to 2 positive SLNs by hematoxylin and eosin staining who were treated with BCS and planned WBI
    • Patients were randomized to:
      • SLN biopsy alone vs. axillary lymph node dissection (ALND)
    • The 10-year:
      • Overall survival was similar in the SLNB only group compared to the ALND group:
        • 86.3% vs. 83.6%, p = 0.72
      • Disease-free survival was similar in the SLNB only group compared to the ALND group:
        • 80.2% and 78.2%
      • In patients treated with ALND:
        • 27% had additional non-SLN disease found at the time of ALND:
          • Suggesting that patients treated with SLNB alone would have a similar disease burden:
            • Yet, nodal recurrence rates were similar between the SLNB and ALND groups at 10 years:
              • 1.5% vs. 0.5%, p = 0.13
            • Suggesting that systemic therapy and radiation therapy:
              • Provide adequate local control in patients with limited disease burden in the axilla
  • The AMAROS trial:
    • Is a phase III non-inferiority study:
      • Comparing ALND with axillary radiation therapy in patients with:
        • Clinical T1 / T2 N0 breast cancer with a positive sentinel node
    • The trial showed low 5-year rates of regional recurrence:
      • In the ALND and axillary radiation therapy groups:
        • 0.43% vs 1.19%, respectively
      • But the risk of patient perceived (subjective) or measured (objective) lymphedema:
        • Was twice as high in the ALND arm compared to the radiation arm:
          • Subjective
            • 23% vs. 11% after 5 years of follow-up
          • Objective:
            • 13% vs. 5% after 5 years of follow-up
  • The ACOSOG Z0010 trial:
    • Evaluates the incidence and impact of SLN and bone marrow micro-metastases on patients with early-stage breast cancer treated with BCS and radiation
    • It demonstrated that:
      • Identification of occult disease in the SNs with immunohistochemistry was not associated with survival
  • References:
    • Giuliano AE, McCall L, Beitsch P, Whitworth PW, Blumencranz P, Leitch AM, et al. 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. Ann Surg. 2010;252(3):426-432.
    • Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, et al. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002;347(16):1227-1232.
    • Rutgers EJ, Donker M, Straver ME. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer patients: final analysis of the EORTC AMAROS trial (10981/22023). J Clin Oncol. 2013;31 (suppl; abstr LBA1001). Available at: http://meetinglibrary.asco.org/content/109779-132. Accessed November 7, 2013.
    • Straver ME, Meijnen P, van Tienhoven G, et al. Sentinel node identification rate and nodal involvement in the EORTC 10981-22023 AMAROS trial. Ann Surg Oncol. 2010;17:1854-1861.
    • Hunt KK, Ballman KV, McCall LM, et al. Factors associated with local-regional recurrence after a negative sentinel node dissection: results of the ACOSOG Z0010 trial. Ann Surg. 2012;256:428-436.

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