Evidence map›Paper›PMID 41593108›Full record

ArticleNPJ breast cancer2026

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

Toralf Reimer, Angrit Stachs, Kristina Veselinovic, Thorsten Kuehn, Joerg Heil, Silke Polata, Frederik Marme, Elisabeth Trapp, Guido Hildebrandt, David Krug and 16 more

Registry-linked trialAbstract read
In one paragraph

Article in NPJ breast cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02466737 (Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Patients With Early-stage Invasive Breast Cancer and Breast-conserving Surgery), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02466737 naactive not recruitingnot on this map

Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Patients With Early-stage Invasive Breast Cancer and Breast-conserving Surgery: a Randomized Prospective Surgical Trial. Intergroup-Sentinel-Mamma (INSEMA)-Trial

TypeinterventionalSponsorUniversity of RostockRan2015 to 2029Enrolled5,505ConditionsBreast CancerArmsno axillary surgery versus SLNB, SLNB versus completion ALND
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. DEGRO practical guidelines: radiotherapy of breast cancer-regional nodal irradiation.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
    Guideline
  2. Trial
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Toralf ReimerDepartment of Obstetrics and Gynecology, University of Rostock, Rostock, Germany. toralf.reimer@kliniksued-rostock.de.
Angrit StachsDepartment of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.
Kristina VeselinovicUniversity Hospital Ulm, Ulm, Germany.
Thorsten KuehnHospital Esslingen, Esslingen, Germany.
Joerg HeilUniversity Hospital Heidelberg, Heidelberg, Germany.
Silke PolataEvangelical Forest Hospital Spandau, Berlin, Germany.
Frederik MarmeDepartment of Obstetrics and Gynecology, Faculty of Medicine Mannheim, University Heidelberg, Mannheim, Germany.
Elisabeth TrappDepartment of Obstetrics and Gynecology, University Hospital, Graz, Austria.
Guido HildebrandtDepartment of Radiation Oncology, University Hospital Rostock, Rostock, Germany.
David KrugDepartment of Radiotherapy and Radiation Oncology, University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany.
Beyhan AtasevenDepartment of Gynecology and Obstetrics, Medical School and University Medical Center OWL, Klinikum Lippe, Bielefeld University, Detmold, Germany.
Roland ReitsamerSalzburg Regional Hospital, Salzburg, Austria.
Sylvia RuthJohanniter-Hospital Genthin-Stendal, Stendal, Germany.
Carsten DenkertInstitute of Pathology, Philipps-University Marburg and University Hospital Marburg (UKGM), Marburg, Germany.
Inga BekesUniversity Hospital Ulm, Ulm, Germany.
Nicole StahlBreast Unit, Helios Clinic, Schwerin, Germany.
Marc ThillDepartment of Gynecology and Gynecologic Oncology, Agaplesion Markus Hospital, Frankfurt am Main, Germany.
Hans-Joachim StrittmatterRems-Murr-Hospital, Winnenden, Germany.
Thomas MuellerHanau City Hospital, Hanau, Germany.
Michael GolattaUniversity Hospital Heidelberg, Heidelberg, Germany.
Dirk-Michael ZahmSRH Wald-Klinikum, Gera, Germany.
Johannes HoltschmidtGerman Breast Group, Neu-Isenburg, Germany.
Michael KnauerTumor and Breast Center Eastern Switzerland, St. Gallen, Switzerland.
Valentina NekljudovaGerman Breast Group, Neu-Isenburg, Germany.
Sibylle LoiblGerman Breast Group, Neu-Isenburg, Germany.
Bernd GerberDepartment of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Identifiers

PMID41593108
PMCPMC12855813

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.