EORTC Amaros Trial

  • The EORTC AMAROS trial:
    • Was a randomized controlled trial comparing completion axillary lymph node dissection (ALND) versus axillary radiotherapy (ART):
      • In women with clinical T1 to T2, N0 who were found to have a positive sentinel lymph node upon undergoing sentinel lymph node biopsy
    • Axillary RT was to levels I to III and SCV fossa:
      • To 50 Gy / 25 fractions
    • The primary endpoint was:
    • Non-inferiority of 5-year axillary recurrence
  • The 5-year axillary lymph node recurrence rate:
    • As 0.43% in the ALND group and 1.19% in the ART group (p=non-significant), with authors concluding that ALND and ART offer excellent and comparable axillary control in this set of patients
  • Of note, non-randomized patients with a negative sentinel lymph node biopsy had a similar axillary recurrence rate of 0.8%
  • Disease-free and overall survival were similar between the two arms
  • Lymphedema:
    • Was increased in those receiving ALND (23% vs. 11%, p<0.001 with clinical signs; 13% vs. 5%, p=0.0009 with arm circumference > 10%)
  • This result echoes findings of the ACOSOG Z0011 trial with low rates of axillary recurrence while omitting ALND
  • Those offering their expert opinion have agreed that results from these two randomized trials support the omission of ALND in patients with a clinically node negative axilla and a low burden of node positive disease found upon sentinel lymph node dissection
  • References
    • Donker M, Van Teinhoven G, Straver M, et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014;15(12):1303-1310.
    • Giuliano AE, McCall L, Beitsch P, 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.
    • Mahmoud O, Haffty B. Regional nodal management in the light of the AMAROS trial. Ann Transl Med. 2015; 3(7):88.

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