International Breast Cancer Study Group (IBCSG) 23-01 — Comparison of ALND versus No ALND in Cases of Micrometastases (≤ 2 mm)

Rodrigo Arrangoiz MS, MD, FACS, FSSO
  • Design:
    • Phase III, randomized, non-inferiority trial: 
      • Micrometastatic (≤ 2 mm) SLN, tumor ≤ 5 cm, clinically node-negative (cN0); no extracapsular extension
    • Randomized:
      • ALND vs no ALND
    • Primary endpoint: 
      • DFS:
      • NI margin HR 1.25
    • Population:
      • N = 934 randomized:
        • ALND 465
        • No-ALND 469
      • Median age ≈ 55
      • Most patietns had:
        • Breast-conserving surgery (~ 91%)
        • Tumors < 3 cm (~ 92%)
        • Received adjuvant systemic therapy (~ 96%)
        • Mastectomy (~ 9%)
    • 5-year results (primary publication, Lancet Oncology 2013):
      • 5-yr DFS: 
        • 87.8% (No-ALND) vs 84.4% (ALND):
          • HR 0.78 (95% CI 0.55–1.11):
            • Non-inferior (p for NI = 0.0042)
      • Axillary / regional recurrences (early report): 
        • Very low and similar:
          • Reported counts: 
            • 1 ALND vs 5 No-ALND over early follow-up -absolute numbers small
      • Toxicity: 
        • Grade 3 to 4 surgical morbidities (neuropathy / lymphedema) occurred almost exclusively in the ALND arm
      • Conclusion: 
        • In SLN micro metastases:
          • Omitting ALND did not compromise DFS and reduced morbidity
    • 10-year update (Lancet Oncology 2018):
      • Median follow-up 9.7 y (IQR 7.8–12.7).
      • 10-yr DFS: 
        • 76.8% (No-ALND) vs 74.9% (ALND):
          • HR 0.85 (95% CI 0.65–1.11); log-rank p = 0.24:
            • Non-inferiority maintained (p for NI = 0.0024)
      • Long-term morbidity: 
        • Lymphedema (any grade):
          • 4% No-ALND vs 13% ALND
        • Sensory neuropathy 
          • 13% No-ALND vs 19% ALND
        • Motor neuropathy:
          • 3% No-ALND vs 9% ALND
    • Interpretation: 
      • 10-year outcomes corroborate 5-year findings and align with Z0011:
        • ALND can be omitted when SLN tumor burden is minimal
    • Practice take-home:
      • In cT1 to cT2, cN0 patients with SLN micrometastases ≤ 2 mm, skip ALND: 
        • Non-inferior DFS to 10 years and meaningfully less arm morbidity
      • Fits the broader de-escalation arc alongside ACOSOG Z0011 (1 to 2 macrometastases-positive SLNs in BCT + WBRT → omit ALND) and AMAROS (if nodal control needed, axillary RT ≈ ALND with less lymphedema)
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Published by Rodrigo Arrangoiz MS, MD, FACS, FSSO

My name is Rodrigo Arrangoiz I am a breast surgeon/ thyroid surgeon / parathyroid surgeon / head and neck surgeon / surgical oncologist that works at Center for Advanced Surgical Oncology in Miami, Florida. I was trained as a surgeon at Michigan State University from (2005 to 2010) where I was a chief resident in 2010. My surgical oncology and head and neck training was performed at the Fox Chase Cancer Center in Philadelphia from 2010 to 2012. At the same time I underwent a masters in science (Clinical research for health professionals) at the University of Drexel. Through the International Federation of Head and Neck Societies / Memorial Sloan Kettering Cancer Center I performed a two year head and neck surgery and oncology / endocrine fellowship that ended in 2016. Mi nombre es Rodrigo Arrangoiz, soy cirujano oncólogo / cirujano de tumores de cabeza y cuello / cirujano endocrino que trabaja Center for Advanced Surgical Oncology en Miami, Florida. Fui entrenado como cirujano en Michigan State University (2005 a 2010 ) donde fui jefe de residentes en 2010. Mi formación en oncología quirúrgica y e n tumores de cabeza y cuello se realizó en el Fox Chase Cancer Center en Filadelfia de 2010 a 2012. Al mismo tiempo, me sometí a una maestría en ciencias (investigación clínica para profesionales de la salud) en la Universidad de Drexel. A través de la Federación Internacional de Sociedades de Cabeza y Cuello / Memorial Sloan Kettering Cancer Center realicé una sub especialidad en cirugía de cabeza y cuello / cirugia endocrina de dos años que terminó en 2016.

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