Support for Omitting SLNB in Some Early Breast Cancers

Rodrigo Arrangoiz MS, MD, FACS, FSSO
  • Sentinel Lymph Node Biopsy Omission in Early Breast Cancer:
    • Insights from the INSEMA Trial
  • Recent findings from the INSEMA trial offer robust evidence supporting the omission of sentinel lymph node biopsy (SLNB) in select patients with low-risk, early-stage invasive breast cancer undergoing breast-conserving surgery (BCS).
  • Presented by Toralf Reimer, PhD, at the 2024 San Antonio Breast Cancer Symposium (SABCS) and published in the New England Journal of Medicine, the trial demonstrates no significant compromise in survival outcomes when SLNB is omitted in these patients.
  • Among clinically node-negative women with stage T1 or T2 breast cancer, the 5-year invasive disease-free survival (DFS) rates were comparable:
    • 91.9% in patients omitting SLNB and 91.7% in those who underwent SLNB (HR: 0.91; 95% CI: 0.73–1.14).
  • Overall survival (OS) rates were also similar, estimated at 98.2% without SLNB and 96.9% with SLNB.
  • Trial Design and Key Results:
    • The INSEMA trial enrolled 5,502 patients with clinically node-negative, hormone receptor-positive, HER2-negative invasive breast cancer (T1 / T2, tumor size ≤ 5 cm). Following BCS and whole-breast irradiation, patients were randomized to SLNB or no axillary surgery.
      • Median follow-up: 73.6 months
      • Axillary recurrence:
      • Slightly higher in the no-SLNB group (1.0% vs. 0.3%):
        • Though the absolute numbers were low
      • Distant relapse rates:
        • Identical at 2.7% in both groups
      • Morbidity:
        • Omitting SLNB significantly reduced rates of lymphedema (5.7% vs. 1.8%), arm mobility restrictions (3.5% vs.
          and pain with arm or shoulder movement (4.2% vs. 2.0%).
          • Context Within Ongoing De-Escalation Trials
            • The INSEMA trial is one of four ongoing studies exploring the omission of axillary surgery in select patients with early-stage breast cancer. These include:
              • SOUND trial: Published results demonstrated no difference in 5-year DFS or OS between patients undergoing or omitting axillary surgery for small (≤ 2 cm) breast tumors.
              • BOOG 2013-08 and NAUTILUS trials: Expected to further validate and refine patient selection criteria for omitting axillary surgery.
            • Clinical Implications
            • The INSEMA trial strengthens the case for omitting SLNB in carefully selected patients, particularly for tumors ≤ 2 cm. However, the continued role of SLNB as a staging tool in certain patients and the need for shared decision-making with multidisciplinary teams.
            • This trial represents a key milestone in an ongoing paradigm shift, aligning with earlier data (e.g., Danish Breast Cancer Cooperative Group studies from the 1980s) that suggested no survival benefit from extensive axillary node removal.
            • Conclusion:
              • The findings from the INSEMA trial provide compelling evidence supporting deescalation of axillary surgery in early-stage breast cancer, with a significant reduction in morbidity and no compromise in survival outcomes.
              • Further results from ongoing trials such as BOOG 2013-08 and NAUTILUS will likely cement this strategy as standard practice for patients with low axillary disease burden.






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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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