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Axillary surgery in patients with sentinel node macrometastases: secondary results of the randomized INSEMA trial

The sub-study of the INSEMA trial (randomization-2) compares completion axillary lymph node dissection (cALND) with sentinel lymph node biopsy (SLNB) alone in cN0 patients with T1/T2 invasive breast cancer and one to three sentinel node macrometastases undergoing upfront breast-conserving surgery. T...

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Main Authors: Reimer, Toralf (Author) , Stachs, Angrit (Author) , Veselinovic, Kristina (Author) , Kuehn, Thorsten (Author) , Heil, Jörg (Author) , Polata, Silke (Author) , Marmé, Frederik (Author) , Trapp, Elisabeth (Author) , Hildebrandt, Guido (Author) , Krug, David (Author) , Ataseven, Beyhan (Author) , Reitsamer, Roland (Author) , Ruth, Sylvia (Author) , Denkert, Carsten (Author) , Bekes, Inga (Author) , Stahl, Nicole (Author) , Thill, Marc (Author) , Strittmatter, Hans-Joachim (Author) , Mueller, Thomas (Author) , Golatta, Michael (Author) , Zahm, Dirk-Michael (Author) , Holtschmidt, Johannes (Author) , Knauer, Michael (Author) , Nekljudova, Valentina (Author) , Loibl, Sibylle (Author) , Gerber, Bernd (Author)
Format: Article (Journal)
Language:English
Published: 27 January 2026
In: npj Breast cancer
Year: 2026, Volume: 12, Pages: 1-9
ISSN:2374-4677
DOI:10.1038/s41523-026-00902-7
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1038/s41523-026-00902-7
Verlag, kostenfrei, Volltext: https://www.nature.com/articles/s41523-026-00902-7
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Author Notes:Toralf Reimer, Angrit Stachs, Kristina Veselinovic, Thorsten Kuehn, Joerg Heil, Silke Polata, Frederik Marme, Elisabeth Trapp, Guido Hildebrandt, David Krug, Beyhan Ataseven, Roland Reitsamer, Sylvia Ruth, Carsten Denkert, Inga Bekes, Nicole Stahl, Marc Thill, Hans-Joachim Strittmatter, Thomas Mueller, Michael Golatta, Dirk-Michael Zahm, Johannes Holtschmidt, Michael Knauer, Valentina Nekljudova, Sibylle Loibl & Bernd Gerber
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Summary:The sub-study of the INSEMA trial (randomization-2) compares completion axillary lymph node dissection (cALND) with sentinel lymph node biopsy (SLNB) alone in cN0 patients with T1/T2 invasive breast cancer and one to three sentinel node macrometastases undergoing upfront breast-conserving surgery. The key secondary objective is to assess whether the SLNB-alone arm is non-inferior to cALND in terms of invasive disease-free survival (iDFS). Finally, 485 patients were recruited, and 386 patients (cALND: N = 169, SLNB alone: N = 217) were included in the per-protocol set. The median follow-up is 74.2 months. The 5-year iDFS analysis in the per-protocol set demonstrates a non-significant difference between study arms, with a hazard ratio (HR) of 1.69 (95% CI: 0.98-2.94) for SLNB alone compared to cALND. The 5-year iDFS rates are 86.6% (81.0%-90.7%) in the SLNB-alone arm and 93.8% (88.7%-96.6%) in the cALND arm (P = 0.058). The 5-year overall survival rates are 94.9% (90.6%-97.2%) in the SLNB-alone arm and 96.2% (91.7%-98.3%) in the cALND arm (P = 0.663). Locoregional recurrences (LRR) were infrequent, with 5-year incidence rates of 1.1% versus 0.0% (P = 0.405) in the SLNB-alone arm compared to cALND. In summary, no significant differences were observed between SLNB alone versus cALND for iDFS, overall survival, and LRR. Trial registration number: NCT02466737
Item Description:Gesehen am 20.04.2026
Physical Description:Online Resource
ISSN:2374-4677
DOI:10.1038/s41523-026-00902-7

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