Axillary Management in Patients with Isolated Tumor Cells (ITCs) and Micrometastatic Disease

• It is clear that patients with pathologically negative sentinel lymph nodes:
  • Do not require completion ALND:
    • But the management of patients with ITCs and micrometastatic disease in sentinel lymph nodes:
      • Has extensively been debated
• Micrometastatic disease is defined as:
  • Tumor deposits spanning:
    • 0.2 mm to 2.0 mm:
      • Within lymph nodes
• ITCs are:
  • Groupings of cells not greater than 0.2 mm or 200 cells:
    • In a single lymph node cross section
• According to the American Joint Committee on Cancer (AJCC) staging guidelines:
  • Patients with ITCs are N0(i+)
  • Patients with micrometastases in one to three axillary lymph nodes are N1mi
• ACOSOG Z0010:
  • Is one of the largest trials to prospectively evaluate the significance of small metastases in sentinel nodes
  • Hematoxylin and eosin (H&E) tumor-free sentinel nodes:
    • From patients with early breast cancer were evaluated in a central laboratory with:
      • Immunohistochemistry (IHC)
  • Micrometastatic or ITC disease:
    • Was found in 11% of 3,326 sentinel lymph nodes
  • With a median follow-up of 6.3 years:
    • Occult sentinel lymph node metastases:
      • Were not associated with differences in overall survival, disease-free survival, or recurrence:
        • When compared with patients with IHC-negative lymph nodes
• A subset analysis of NSABP-32:
  • Looked retrospectively at patients with occult metastatic disease:
    • Including patients with micrometastatic or isolated tumor cells
  • In patients who were sentinel node negative:
    • 16% had occult metastases detected on further evaluation:
      • 11% of occult metastases were isolated tumor-cell clusters, 4% were micrometastases, and less than 1% of patients had macrometastatic deposits seen on additional sectioning of the lymph node
  • Log-rank tests indicated that patients with occult metastasis:
    • Had worse overall survival (95% versus 96%), disease-free survival (87% versus 89%), and distant disease-free interval (90% versus 93%):
      • When compared with patients without occult metastases
    • Although statistically significant:
      • These differences were not felt to be clinically relevant
  • There was no improvement in overall or disease-free survival:
    • When patients with occult metastasis underwent completion ALND

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