ArticleEClinicalMedicine2023
Patient-reported outcomes for the Intergroup Sentinel Mamma study (INSEMA): A randomised trial with persistent impact of axillary surgery on arm and breast symptoms in patients with early breast cancer.
Article in EClinicalMedicine, 2023. 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 50 papers, 1 of them a synthesis that pooled 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.
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.
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
Who cites it
50 citing papers in PubMed, 1 synthesis or guideline pooled it, 90 citations in OpenAlex.
- Prediction of sentinel lymph node status in patients with early breast cancer using breast imaging as an alternative to surgical staging-a systematic review and meta-analysis.Systematic reviews · 2025Pooled it
- Three-year patient-reported outcomes of the BOOG 2013-08 RCT evaluating omission of sentinel lymph node biopsy in early-stage breast cancer patients treated with breast conserving surgery: Impact of personality traits on health-related quality of life.The British journal of surgery · 2025Trial
- Role of Sentinel Node Surgery in Identifying Candidates for Adjuvant CDK4/6 Inhibitors: Implications of Choosing Wisely and ASCO Omission Criteria.Annals of surgical oncology · 2026Article
- Article
- Role of sentinel lymph node biopsy in patients with early breast cancer undergoing mastectomy.BJS open · 2026Article
- The Past, Present, and Future of Sentinel Lymph Node Biopsy in Breast Cancer.Annals of surgical oncology · 2026Review
- Patient Selection for Partial Breast Irradiation in the Era of Sentinel Lymph Node Biopsy Omission: A Narrative Review.Cancers · 2026Review
- Predicting sentinel lymph node metastasis in breast cancer using an interpretable machine learning approach based on multi-domain clinical features.Breast cancer research : BCR · 2026Article
- Omission of Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer: Expanding Evidence in Clinically Node-Negative and Neoadjuvant Therapy Responders.World journal of oncology · 2026Review
- Research on Omitting Sentinel Lymph Node Biopsy after Neoadjuvant Therapy in cN1 Breast Cancer Patients.Cancer medicine · 2026Article
- Fragmentomic liquid biopsy enables early breast cancer detection, molecular subtyping and lymph node assessment.Nature communications · 2026Article
- Arm morbidity and financial difficulty in breast cancer survivors.Journal of cancer survivorship : research and practice · 2026Article
- Axillary Surgery in Breast Cancer: Evidence-Based De-escalation Across Upfront and Post-Neoadjuvant Settings.Journal of breast cancer · 2026Review
- Article
- Axillary surgery in patients with sentinel node macrometastases: secondary results of the randomized INSEMA trial.NPJ breast cancer · 2026Article
- Risk stratification system for sentinel lymph node metastasis in clinically node-negative early breast cancer with sonographically abnormal but cytologically negative axilla.Scientific reports · 2025Article
- Multi-omics prediction of axillary treatment response and tumour microenvironment alterations in lymph node-positive luminal breast cancer.Cell death & disease · 2025Article
- Partial breast irradiation after sentinel lymph node biopsy omission: Is it a valid alternative to whole breast Irradiation? Analysis of the dose to the sentinel lymph node region during whole breast irradiation vs. partial breast irradiation.Breast (Edinburgh, Scotland) · 2025Article
- Deep learning on routine full-breast mammograms enhances lymph node metastasis prediction in early breast cancer.NPJ digital medicine · 2025Article
- Development of a preoperative nomogram to identify low-risk early-stage breast cancer patients eligible for SLNB omission.World journal of surgical oncology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 13 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: In clinically node-negative breast cancer patients, the INSEMA trial (NCT02466737) assessed the non-inferiority of avoiding sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Here we present patient-reported outcomes (PROs) as a secondary endpoint. Methods: PROs were assessed for patients with no axillary surgery, SLNB alone, and ALND. Quality of life (QoL) questionnaire EORTC QLQ-C30 and its breast cancer module (BR23) were used at baseline (pre-surgery) and 1, 3, 6, 12, and 18 months after surgery. The QoL scores were compared using repeated measures mixed models based on the safety set. Findings: Between 2015 and 2019, 5502 patients were recruited for the first randomization, and 5154 were included in the intent-to-treat set (4124 SLNB versus 1030 no SLNB). In the case of one to three macrometastases after SLNB, 485 patients underwent second randomization (242 SLNB alone versus 243 ALND). Questionnaire completion response remained high throughout the trial: over 70% at all time points for the first randomization. There were significant differences for the BRBS (breast symptoms) and BRAS (arm symptoms) scores favoring the no SLNB group in all post-baseline assessments. Patients in the SLNB group showed significantly and clinically relevant higher scores for BRAS (differences in mean values ≥5.0 points at all times), including pain, arm swelling, and impaired mobility in all postoperative visits, with the highest difference at one month after surgery. Scoring of the QLQ-C30 questionnaire revealed no relevant differences between the treatment groups, although some comparisons were statistically significant. Interpretation: This is one of the first randomized trials investigating the omission of SLNB in clinically node-negative patients and the first to report comprehensive QoL data. Patients with no SLNB benefitted regarding arm symptoms/functioning, while no relevant differences in other scales were seen. Funding: Supported by German Cancer Aid (Deutsche Krebshilfe, Bonn, Germany), Grant No. 110580 and Grant No. 70110580 to University Medicine Rostock.
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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.