Evidence map›Paper›PMID 35499695›Full record

Observational studyStrahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]2022

Whole breast radiotherapy in cN0 early breast cancer patients with pathological sentinel lymph nodes (pN1mic, pN1a) without axillary dissection: preliminary results of the observational LISEN trial.

Lucia Anna Ursini, Marianna Nuzzo, Consuelo Rosa, Marzia Borgia, Luciana Caravatta, Monica Di Tommaso, Marianna Trignani, Fiorella Cristina Di Guglielmo, Giampiero Ausili Cefaro, Domenico Angelucci and 14 more

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 44% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Radiation therapy of breast cancer in the Nahe Breast Center: first results of an analysis in the context of health services research.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2024
    Article
  2. Article
  3. The role of radiotherapy in the updated German S2k guideline for management of Merkel cell carcinoma.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2023
    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

24 authors at 4 institutions in 1 country.

Lucia Anna UrsiniDepartment of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
Marianna NuzzoDepartment of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
Consuelo RosaDepartment of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy. c.rosa155@gmail.com.
Marzia BorgiaDepartment of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
Luciana CaravattaDepartment of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
Monica Di TommasoDepartment of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
Marianna TrignaniDepartment of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
Fiorella Cristina Di GuglielmoDepartment of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
Giampiero Ausili CefaroDepartment of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
Domenico AngelucciDepartment of Pathological Anatomy, ASL 02 Lanciano-Vasto-Chieti, Via dei Vestini, 66100, Chieti, Italy.
Marzia MuziDivision of Breast Radiology, Department of Radiology, G. Bernabeo Hospital, Contrada Santa Liberata, 66026, Ortona, Chieti, Italy.
Gianluigi MartinoDepartment of Radiological Sciences, Institute of Nuclear Medicine, SS. Annunziata Hospital, Via dei Vestini, 66100, Chieti, Italy.
Ettore CianchettiDivision of Surgical Senology, G. Bernabeo Hospital, Contrada Santa Liberata, 66026, Ortona, Chieti, Italy.
Simona GrossiDivision of Surgical Senology, G. Bernabeo Hospital, Contrada Santa Liberata, 66026, Ortona, Chieti, Italy.
Saveria TavolettaDivision of Surgical Senology, G. Bernabeo Hospital, Contrada Santa Liberata, 66026, Ortona, Chieti, Italy.
Davide BroccoClinical Oncology Unit, SS. Annunziata Hospital, Via dei Vestini, 66100, Chieti, Italy.
Antonino GrassadoniaDepartment of Medical, Oral and Biotechnological Sciences and CeSI-MeT, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
Nicola TinariDepartment of Medical, Oral and Biotechnological Sciences and CeSI-MeT, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
Simona GildettiDepartment of Oncology, Floraspe Renzetti Hospital, Via per Fossacesia 1, Lanciano, 66034, Chieti, Italy.
Nicola D'OstilioDepartment of Oncology, Floraspe Renzetti Hospital, Via per Fossacesia 1, Lanciano, 66034, Chieti, Italy.
Liborio StuppiaCenter for Advanced Studies and Technology (CAST), "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
Annamaria PorrecaDepartment of Economics, "G. D'Annunzio" University of Chieti-Pescara, Pescara, Italy.
Marta Di NicolaLaboratory of Biostatistics, Department of Medical, Oral and Biotechnological Sciences, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
Domenico GenovesiDepartment of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
University of Chieti-Pescara · ITOspedale "Floraspe Renzetti" · ITOspedale SS. Annunziata · ITBassano Bresciano Astronomical Observatory · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAxillary management remains unclear when sentinel lymph node (SLN) results are positive in cN0 patients with breast cancer (BC). The trial ACOSOG Z0011 represented a revolution with axillary lymph node dissection (ALND) omission in SLN+ patients, despite critiques regarding non-uniformity of radiation fields. We conducted an observational study (LISEN) where whole breast radiotherapy (WBRT) was planned with tangential fields without nodal irradiation in patients eligible for the Z0011 trial.

methodsInclusion criteria were female patients with histologically proven BC, cT1-2cN0, planned conservative surgery, no neoadjuvant therapy. Patients were stratified into two groups: micrometastatic (pN1mic, group 1) and macrometastatic (pN1a, group 2) lymph nodes. Tangential field WBRT was mandatory. Clinical outcomes were analysed, measured from surgery until the first event.

resultsIn all, 199 patients underwent conservative surgery and SLN biopsy; 133 patients meeting criteria were analysed: 41 patients (30.8%) pN1mic and 92 (69.2%) pN1a. The 5‑year disease-free survival (DFS) was 95.0% (85.9-100%) in group 1 and 93.0% (86.3-100.0%) in group 2 (p = 0.78). Overall survival (OS) was 100% (100-100%) in group 1 and 97.4% (92.4-100%) in group 2 (p = 0.74). For the whole cohort DFS and OS were 93.6% (88.2-99.4%) and 96.9% (91.5-100.0%), respectively. For groups 1 and 2, the 5‑year outcomes were 5.0% (0.0-14.4%) and 2.3% (0.0-6.1%) for local recurrence (p = 0.51), and 6.2% (0.0-17.4%) and 7.0% (0.0-13.7%) for distant metastasis (p = 0.61), respectively. In group 1, regional recurrence (RR) and local regional recurrence (LRR) were 5.0% (0.0-14.1%; p = 0.13). In group 2, RR and LRR were 0.0% (0.0-0.0%).

conclusionOur results showed good regional control in patients who met the Z0011 trial criteria. WBRT, without nodal surgery or RT, avoiding axillary morbidity, seems to be a good choice.

Indexed as

Breast NeoplasmsSentinel Lymph NodeAxillaFemaleHumansLymphatic MetastasisLymph Node ExcisionLymph NodesSentinel Lymph Node BiopsyAxillary surgery omissionBreast cancerConservative surgeryRadiotherapySentinel lymph node

Identifiers

PMID35499695
PMCPMC9217844
OpenAlexW4225276689

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Registered trials

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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.