Evidence map›Paper›PMID 35552930›Full record

Trial reportAnnals of surgical oncology2022

Preservation of Axillary Lymph Nodes Compared with Complete Dissection in T1-2 Breast Cancer Patients Presenting One or Two Metastatic Sentinel Lymph Nodes: The SINODAR-ONE Multicenter Randomized Clinical Trial.

Corrado Tinterri, Damiano Gentile, Wolfgang Gatzemeier, Andrea Sagona, Erika Barbieri, Alberto Testori, Valentina Errico, Alberto Bottini, Emilia Marrazzo, Carla Dani and 11 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 89 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 6 pooled it
12.3field-weighted citation impact, top 1% 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

89 citing papers in PubMed, 6 syntheses or guidelines pooled it, 141 citations in OpenAlex.

  1. DEGRO practical guidelines: radiotherapy of breast cancer-regional nodal irradiation.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
    Guideline
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29 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

21 authors at 20 institutions in 1 country.

Corrado TinterriBreast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Damiano GentileBreast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy. damiano.gentile@humanitas.it.
Wolfgang GatzemeierBreast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Andrea SagonaBreast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Erika BarbieriBreast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Alberto TestoriBreast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Valentina ErricoBreast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Alberto BottiniBreast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Emilia MarrazzoBreast Unit, Ospedale Maggiore di Lodi, Lodi, Italy.
Carla DaniDepartment of Epidemiology, Biostatistics and Clinical Trials, IRCCS S. Martino, IST, Genoa, Italy.
Beatrice DozinDepartment of Epidemiology, Biostatistics and Clinical Trials, IRCCS S. Martino, IST, Genoa, Italy.
Luca BoniDepartment of Epidemiology, Biostatistics and Clinical Trials, IRCCS S. Martino, IST, Genoa, Italy.
Paolo BruzziDepartment of Epidemiology, Biostatistics and Clinical Trials, IRCCS S. Martino, IST, Genoa, Italy.
Bethania FernandesDepartment of Pathology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Davide FranceschiniRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Ruggero SpotoRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Rosalba TorrisiMedical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Marta ScorsettiDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Armando SantoroDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Giuseppe CanaveseBreast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
SINODAR-ONE Collaborative Group
IRCCS Humanitas Research Hospital · ITOspedale Policlinico San Martino · ITAzienda Unità Sanitaria Locale Della Romagna · ITAzienda Ospedaliera San Giovanni Addolorata · ITAzienda Ospedaliero-Universitaria di Modena · ITHumanitas University · ITIstituto Oncologico Veneto · ITOspedale Maggiore · ITOspedale San Paolo · ITUniversity of Insubria · ITAgenzia Sanitaria Regionale Abruzzo · ITAzienda Ospedaliera San Gerardo · ITAzienda Sanitaria Unità Locale di Reggio Emilia · ITAzienda Unita' Sanitaria Locale Di Modena · ITAzienda USL di Bologna · ITCasa Sollievo della Sofferenza · ITOspedale di Sanremo · ITAzienda di Rilievo Nazionale ed Alta Specializzazione · ITAzienda Ospedaliera Universitaria Integrata Verona · ITAzienda Ospedaliera Universitaria Pisana · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe SINODAR-ONE trial is a prospective noninferiority multicenter randomized study aimed at assessing the role of axillary lymph node dissection (ALND) in patients undergoing either breast-conserving surgery or mastectomy for T1-2 breast cancer (BC) and presenting one or two macrometastatic sentinel lymph nodes (SLNs). The endpoints were to evaluate whether SLN biopsy (SLNB) only was associated with worsening of the prognosis compared with ALND in terms of overall survival (OS) and relapse.

methodsPatients were randomly assigned (1:1 ratio) to either removal of ≥ 10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm).

resultsThe trial started in April 2015 and ceased in April 2020, involving 889 patients. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB-only arm, respectively (p = 0.936).

conclusionsThe 3-year survival and relapse rates of T1-2 BC patients with one or two macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND.

Indexed as

Breast NeoplasmsSentinel Lymph NodeAxillaFemaleHumansLymphatic MetastasisLymph Node ExcisionLymph NodesMastectomyNeoplasm Recurrence, LocalProspective StudiesSentinel Lymph Node Biopsy

Identifiers

PMID35552930
OpenAlexW4280558464

What OpenQuestion holds

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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.