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December 12, 2024New England Journal of Medicine296 citations

Axillary Surgery in Breast Cancer — Primary Results of the INSEMA Trial

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TRToralf ReimerASAngrit StachsKVKristina Veselinovic

Key Points

  • To determine whether omitting surgical axillary staging is noninferior to sentinel-lymph-node biopsy in patients with clinically node-negative early invasive breast cancer.
  • Interventional randomized trial (INSEMA, NCT02466737) involving patients with clinically node-negative, T1 or T2 invasive breast cancer (90% clinical T1, 79% pathological T1).
  • Compared omission of surgical axillary staging against sentinel-lymph-node biopsy with a median follow-up of 6 years.
  • Omission of surgical axillary staging was noninferior to sentinel-lymph-node biopsy after a median follow-up duration of 6 years.

Abstract

In this trial involving patients with clinically node-negative, T1 or T2 invasive breast cancer (90% with clinical T1 cancer and 79% with pathological T1 cancer), omission of surgical axillary staging was noninferior to sentinel-lymph-node biopsy after a median follow-up of 6 years. (Funded by the German Cancer Aid; INSEMA ClinicalTrials.gov number, NCT02466737.).

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Cite This Study

Reimer et al. (2024) studied this question.

synapsesocial.com/papers/69d83f2b5c3030ff03d19929https://doi.org/10.1056/nejmoa2412063
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