SOUND and INSEMA Trials for Omitting Sentinel Lymph Node Biopsy in Breast Cancer

Rodrigo Arrangoiz MS, MD, FACS, FSSO
  • Recent high-quality randomized trials have provided strong evidence supporting the:
    • Omission of sentinel lymph node biopsy (SLNB) in select patients with:
      • Early-stage, clinically node-negative breast cancer
  • The SOUND and INSEMA trials both demonstrated that:
    • In patients with small tumors (≤ 2 cm in SOUND; ≤ 5 cm in INSEMA) and negative axillary imaging:
      • Omission of SLNB is noninferior to SLNB in terms of:
        • Invasive disease-free survival (INSEMA) and distant disease-free survival (SOUND):
          • With very low rates of axillary recurrence and improved quality of life due to fewer surgical complications such as lymphedema and reduced arm mobility
  • Guidelines from the American Society of Clinical Oncology (ASCO) and Ontario Health (Cancer Care Ontario):
    • Now recommend omitting SLNB in women aged 70 or older with:
      • Clinically node-negative, hormone receptor–positive, HER2-negative tumors who will receive endocrine therapy:
        • As supported by the Society of Surgical Oncology Choosing Wisely campaign
    • For younger or higher-risk patients:
      • SLNB remains standard unless ongoing or future trials further expand the eligible population
  • According to a study published in JAMA Oncology, the following conclusion was reached:
    • In this randomized clinical trial, omission of axillary surgery was noninferior to SLNB in patients with small breast cancer (BC) and a negative result on ultrasonography of the axillary lymph nodes
    • These results suggest that patients with these features can be safely spared any axillary surgery whenever the lack of pathological information does not affect the postoperative treatment plan
  • In summary:
    • Omission of SLNB is now supported for older women with low-risk, node-negative breast cancer and for select patients with small tumors and negative axillary imaging, provided that the lack of nodal pathological information does not alter adjuvant therapy decisions
    • Ongoing trials:
      • BOOG 2013-08, NAUTILUS:
        • Will further clarify the boundaries of safe omission
  • References:
    • Axillary Surgery in Breast Cancer — Primary Results of the INSEMA Trial. Reimer T, Stachs A, Veselinovic K, et al. The New England Journal of Medicine. 2024;. doi:10.1056/NEJMoa2412063.
    • Sentinel Lymph Node Biopsy vs No Axillary Surgery in Patients With Small Breast Cancer and Negative Results on Ultrasonography of Axillary Lymph Nodes: The SOUND Randomized Clinical Trial. Gentilini OD, Botteri E, Sangalli C, et al. JAMA Oncology. 2023;9(11):1557-1564. doi:10.1001/jamaoncol.2023.3759.
    • Management of the Axilla in Early-Stage Breast Cancer: Ontario Health (Cancer Care Ontario) and ASCO Guideline. Brackstone M, Baldassarre FG, Perera FE, et al. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology. 2021;39(27):3056-3082. doi:10.1200/JCO.21.00934.
    • Omitting Axillary Staging in Selected Patients: Rationale of Choosing Wisely in Breast Cancer Treatment. Grossi S, Le J, Armani A. Surgery. 2023;174(2):413-415. doi:10.1016/j.surg.2023.03.023.
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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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