Evidence map›Paper›PMID 28331237›Full record

ArticleGeburtshilfe und Frauenheilkunde2017

Restricted Axillary Staging in Clinically and Sonographically Node-Negative Early Invasive Breast Cancer (c/iT1-2) in the Context of Breast Conserving Therapy: First Results Following Commencement of the Intergroup-Sentinel-Mamma (INSEMA) Trial.

T Reimer, A Stachs, V Nekljudova, S Loibl, S Hartmann, K Wolter, G Hildebrandt, B Gerber

Registry-linked trialAbstract read
In one paragraph

Article in Geburtshilfe und Frauenheilkunde, 2017. 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 74 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 4 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

74 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Deep learning-based breast MRI for predicting axillary lymph node metastasis: a systematic review and meta-analysis.Cancer imaging : the official publication of the International Cancer Imaging Society · 2025
    Pooled it
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  5. Trial
  6. Article
  7. Article
  8. Surgical management of breast cancer: a review.Annals of medicine and surgery (2012) · 2025
    Review
  9. Article
  10. Review
  11. Article
  12. Omitting sentinel lymph node biopsy in early breast cancer: too bold or the future?Translational breast cancer research : a journal focusing on translational research in breast cancer · 2025
    Article
  13. Article
  14. Article
  15. Article
  16. Review
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  19. Health-related quality of life (HRQoL) after different axillary treatments in women with breast cancer: a 1-year longitudinal cohort study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024
    Article
  20. Article

14 more citing papers are in PubMed but not listed here.

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

8 authors.

T ReimerDepartment of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.
A StachsDepartment of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.
V NekljudovaGerman Breast Group, Neu-Isenburg, Germany.
S LoiblGerman Breast Group, Neu-Isenburg, Germany.
S HartmannDepartment of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.
K WolterDepartment of Radiotherapy, University of Rostock, Rostock, Germany.
G HildebrandtDepartment of Radiotherapy, University of Rostock, Rostock, Germany.
B GerberDepartment of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Axillary lymph node status remains an important prognostic factor in early breast cancer. It is regarded as an indicator for (neo)adjuvant systemic treatment and postoperative radiotherapy of the regional lymphatics. Commenced in September 2015, the INSEMA trial is investigating whether operative determination of nodal status as part of breast conserving therapy (BCT) for early stage breast cancer (c/iT1-2 c/iN0) can be avoided without reducing oncological safety. After inclusion of 1001 patients there was general acceptance of the complex study design by patients and study doctors so that recruitment for the first randomisation (axillary sentinel lymph node biopsy [SLNB]: yes or no) achieved predicted case numbers. The second randomisation however (SLNB alone versus complete axillary dissection when one or two macrometastases are present at SLNB) recruited fewer cases than expected for the following three reasons: a) the 13 % rate of one or two macrometastases after SLNB in the INSEMA trial collective was lower than expected; b) around 20 % of patients refused the second randomisation; c) there was delayed inclusion of the Austrian study centres, which only recruited for the second randomisation. Lack of knowledge of nodal status when SLNB is avoided represents a new challenge for the postoperative tumour board. In particular decisions on chemotherapy for luminal-like tumours and irradiation of the lymphatics (excluding axilla) must be guided by tumour biological parameters. The INSEMA trial does not provide answers to some important questions, e.g. it remains unclear whether patients without SLNB can be offered partial breast irradiation alone in low-risk situations and whether SLNB can also be avoided in patients with stage T1-2 tumours who have a mastectomy indication.

Indexed as

breast cancerINSEMA trialnodal statusradiotherapysentinel lymph node biopsy

Identifiers

PMID28331237
PMCPMC5357224

What OpenQuestion holds

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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.