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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

Annals of Surgical Oncology volume 29, pages 5732–5744 (2022)Cite this article

Abstract

Background

The 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.

Methods

Patients 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).

Results

The 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).

Conclusions

The 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.

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Acknowledgment

We thank Mrs Elena Bissolotti for clinical data acquisition and collection.

The SINODAR-ONE Collaborative Group: Olindo Custodero, MD8, Vito Leopoldo Troilo, MD8, Mario Taffurelli, MD9, Maria Cristina Cucchi, MD10, Valentina Galluzzo, MD10, Carlo Cabula, MD11, Roberta Cabula, MD11, Maria Grazia Lazzaretti, MD12, Francesco Caruso, MD, PhD13, Gaetano Castiglione, MD13, Simona Grossi, MD14, Maria Saveria Tavoletta, MD14, Camilla Rossi, MD15, Annalisa Curcio, MD, PhD16, Daniele Friedman, MD17, Piero Fregatti, MD, PhD17, Carla Magni, MD18, Giovanni Tazzioli, MD19, Simona Papi, MD19, Riccardo Giovanazzi, MD20, Camelia Chifu, MD20, Rossella Bettini, MD21, Modestino Pezzella, MD21, Silvia Michieletto, MD22, Tania Saibene, MD22, Manuela Roncella, MD23, Matteo Ghilli, MD23, Andrea Sibilio, MD24, Anna Cariello, MD24, Saverio Coiro, MD25, Giuseppe Falco, MD25, Emanuele Zarba Meli, MD26, Lucio Fortunato, MD26, Luigi Ciuffreda, MD27, Roberto Murgo, MD, PhD27, Claudio Battaglia, MD28, Luca Rubino, MD28, Nicoletta Biglia, MD, PhD29, Valentina Bounous, MD, PhD29, Francesca Angela Rovera, MD30, Corrado Chiappa, MD30, Giovanni Pollini, MD31, Sara Mirandola, MD31, Graziano Meneghini, MD32, Francesco Di Bartolo, MD32

8UOSVD Chirurgia Senologica – Breast Unit ASL BA P.O. San Paolo, Bari, Italy; 9IRCCS – Azienda Ospedaliero Universitaria di Bologna – Policlinico di Sant’Orsola, Bologna, Italy; 10U.O. Chirurgia Senologica Dipartimento Chirurgie Specialistiche USL di Bologna, Italy; 11 Oncologia e Senologia Azienda di Rilievo Nazionale Alta Specializzazione ARNAS – Cagliari, Italy; 12Unità semplice di Chirurgia Senologica, Ospedale Ramazzini di Carpi, AUSL Modena, Italy; 13Humanitas Istituto Clinico Catanese – Contrada Cubba SP 54 n. 11, 95045, Misterbianco (CT), Italy; 14U.O.C. di Chirurgia Generale a indirizzo Senologico – EUSOMA Breast Centre ASL 2 Abruzzo, Italy; 15U.O. Chirurgia Senologica, Ospedale degli Infermi, Viale Stradone 9, Faenza, Italy; 16Chirurgia Senologica Ospedale di Forlì – Ravenna, Azienda USL della Romagna, Italy; 17UO Clinica di Chirurgia Policlinico San Martino – IRCCS, Genova, Italy; 18SSD Breast Unit ASST Lecco, Italy; 19Chirurgia Oncologica Senologica, Azienda Ospedaliera-Universitaria di Modena, Italy; 20Breast Unit – Surgery – San Gerardo Hospital, Monza, Italy; 21UOC Chirurgia Senologica IRCCS Sacro Cuore Don Calabria, Presidio Ospedaliero Accreditato – Regione Veneto, Italy; 22Breast Surgery, Istituto Oncologico Veneto, Padova, Italy; 23Breast Surgery Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy; 24Oncology Department AUSL Romagna, Ravenna Hospital, Ravenna, Italy; 25Breast Surgery Unit, Azienda USL – IRCCS di Reggio Emilia, Italy; 26UOC Senologia, Azienda ospedaliera San Giovanni-Addolorata, Rome, Italy; 27Chirurgia Senologica, Dipartimento Scienze Chirurgiche, IRCCS ‘Casa Sollievo della Sofferenza’ Opera di San Pio da Pietralcina, 71013, San Giovanni Rotondo (FG), Italy; 28Breast Unit, Civic Hospital of Sanremo, ASL 1 Imperiese, Sanremo, Italy; 29SCDU Gin e Ost, Ospedale Mauriziano Umberto primo, Torino, Italy; 30Centro Ricerche in Senologia, Università degli Studi dell’Insubria, S.S.D. Breast Unit, ASST SetteLaghi, Varese, Italy; 31UOC Chirurgia Senologica – Breast Unit, AOUI Verona, Italy; 32Breast Unit, Ospedale Montecchio Maggiore, Vicenza, Italy

Funding

The clinical trial was supported by Fondazione Humanitas per la Ricerca – Rozzano (MI). No other disclosures or conflicts of interest are declared.

Author information

Authors and Affiliations

  1. Breast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

    Corrado Tinterri MD, Damiano Gentile MD, Wolfgang Gatzemeier MD, Andrea Sagona MD, Erika Barbieri MD, Alberto Testori MD, Valentina Errico MD, Alberto Bottini MD & Giuseppe Canavese MD

  2. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy

    Corrado Tinterri MD, Marta Scorsetti MD, PhD & Armando Santoro MD

  3. Breast Unit, Ospedale Maggiore di Lodi, Lodi, Italy

    Emilia Marrazzo MD

  4. Department of Epidemiology, Biostatistics and Clinical Trials, IRCCS S. Martino, IST, Genoa, Italy

    Carla Dani MD, Beatrice Dozin MD, Luca Boni MD & Paolo Bruzzi MD, MPH, PhD

  5. Department of Pathology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

    Bethania Fernandes MD

  6. Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

    Davide Franceschini MD, Ruggero Spoto MD & Marta Scorsetti MD, PhD

  7. Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

    Rosalba Torrisi MD & Armando Santoro MD

  8. UOSVD Chirurgia Senologica – Breast Unit ASL BA P.O. San Paolo, Bari, Italy

    Olindo Custodero MD & Vito Leopoldo Troilo MD

  9. IRCCS – Azienda Ospedaliero Universitaria di Bologna – Policlinico di Sant’Orsola, Bologna, Italy

    Mario Taffurelli MD

  10. U.O. Chirurgia Senologica Dipartimento Chirurgie Specialistiche, USL di Bologna, Bologna, Italy

    Maria Cristina Cucchi MD & Valentina Galluzzo MD

  11. Oncologia e Senologia, Azienda di Rilievo Nazionale Alta Specializzazione ARNAS, Cagliari, Italy

    Carlo Cabula MD & Roberta Cabula MD

  12. Unità semplice di Chirurgia Senologica, Ospedale Ramazzini di Carpi, AUSL Modena, Modena, Italy

    Maria Grazia Lazzaretti MD

  13. Humanitas Istituto Clinico Catanese, Misterbianco, CT, Italy

    Francesco Caruso MD, PhD & Gaetano Castiglione MD

  14. U.O.C. di Chirurgia Generale a indirizzo Senologico – EUSOMA Breast Centre ASL 2 Abruzzo, Abruzzo, Italy

    Simona Grossi MD & Maria Saveria Tavoletta MD

  15. U.O. Chirurgia Senologica, Ospedale Degli Infermi, Faenza, Italy

    Camilla Rossi MD

  16. Chirurgia Senologica Ospedale di Forlì – Ravenna, Azienda USL della Romagna, Emilia-Romagna, Italy

    Annalisa Curcio MD, PhD

  17. UO Clinica di Chirurgia Policlinico San Martino – IRCCS, Genoa, Italy

    Daniele Friedman MD & Piero Fregatti MD, PhD

  18. SSD Breast Unit ASST Lecco, Lecco, Italy

    Carla Magni MD

  19. Chirurgia Oncologica Senologica, Azienda Ospedaliera-Universitaria di Modena, Modena, Italy

    Giovanni Tazzioli MD & Simona Papi MD

  20. Breast Unit – Surgery – San Gerardo Hospital, Monza, Italy

    Riccardo Giovanazzi MD & Camelia Chifu MD

  21. UOC Chirurgia Senologica IRCCS Sacro Cuore Don Calabria, Presidio Ospedaliero Accreditato, Regione Veneto, Italy

    Rossella Bettini MD & Modestino Pezzella MD

  22. Breast Surgery, Istituto Oncologico Veneto, Padua, Italy

    Silvia Michieletto MD & Tania Saibene MD

  23. Breast Surgery Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy

    Manuela Roncella MD & Matteo Ghilli MD

  24. Oncology Department AUSL Romagna, Ravenna Hospital, Ravenna, Italy

    Andrea Sibilio MD & Anna Cariello MD

  25. Breast Surgery Unit, Azienda USL – IRCCS di Reggio Emilia, Emilia-Romagna, Italy

    Saverio Coiro MD & Giuseppe Falco MD

  26. UOC Senologia, Azienda Ospedaliera San Giovanni-Addolorata, Rome, Italy

    Emanuele Zarba Meli MD & Lucio Fortunato MD

  27. Chirurgia Senologica, Dipartimento Scienze Chirurgiche, IRCCS ‘Casa Sollievo della Sofferenza’ Opera di San Pio da Pietralcina, San Giovanni Rotondo, FG, Italy

    Luigi Ciuffreda MD & Roberto Murgo MD, PhD

  28. Breast Unit, Civic Hospital of Sanremo, ASL 1 Imperiese, Sanremo, Italy

    Claudio Battaglia MD & Luca Rubino MD

  29. SCDU Gin e Ost, Ospedale Mauriziano Umberto primo, Torin, Italy

    Nicoletta Biglia MD, PhD & Valentina Bounous MD, PhD

  30. S.S.D. Breast Unit, Centro Ricerche in Senologia, Università degli Studi dell’Insubria, ASST SetteLaghi, Varese, Italy

    Francesca Angela Rovera MD & Corrado Chiappa MD

  31. UOC Chirurgia Senologica – Breast Unit, AOUI Verona, Verona, Italy

    Giovanni Pollini MD & Sara Mirandola MD

  32. Breast Unit, Ospedale Montecchio Maggiore, Vicenza, Italy

    Graziano Meneghini MD & Francesco Di Bartolo MD

Authors
  1. Corrado Tinterri MD
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  2. Damiano Gentile MD
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  3. Wolfgang Gatzemeier MD
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  4. Andrea Sagona MD
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  5. Erika Barbieri MD
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  6. Alberto Testori MD
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  7. Valentina Errico MD
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  8. Alberto Bottini MD
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  9. Emilia Marrazzo MD
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  10. Carla Dani MD
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  11. Beatrice Dozin MD
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  12. Luca Boni MD
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  13. Paolo Bruzzi MD, MPH, PhD
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  14. Bethania Fernandes MD
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  15. Davide Franceschini MD
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  16. Ruggero Spoto MD
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  17. Rosalba Torrisi MD
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  18. Marta Scorsetti MD, PhD
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  19. Armando Santoro MD
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  20. Giuseppe Canavese MD
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Consortia

the SINODAR-ONE Collaborative Group

  • Olindo Custodero MD
  • , Vito Leopoldo Troilo MD
  • , Mario Taffurelli MD
  • , Maria Cristina Cucchi MD
  • , Valentina Galluzzo MD
  • , Carlo Cabula MD
  • , Roberta Cabula MD
  • , Maria Grazia Lazzaretti MD
  • , Francesco Caruso MD, PhD
  • , Gaetano Castiglione MD
  • , Simona Grossi MD
  • , Maria Saveria Tavoletta MD
  • , Camilla Rossi MD
  • , Annalisa Curcio MD, PhD
  • , Daniele Friedman MD
  • , Piero Fregatti MD, PhD
  • , Carla Magni MD
  • , Giovanni Tazzioli MD
  • , Simona Papi MD
  • , Riccardo Giovanazzi MD
  • , Camelia Chifu MD
  • , Rossella Bettini MD
  • , Modestino Pezzella MD
  • , Silvia Michieletto MD
  • , Tania Saibene MD
  • , Manuela Roncella MD
  • , Matteo Ghilli MD
  • , Andrea Sibilio MD
  • , Anna Cariello MD
  • , Saverio Coiro MD
  • , Giuseppe Falco MD
  • , Emanuele Zarba Meli MD
  • , Lucio Fortunato MD
  • , Luigi Ciuffreda MD
  • , Roberto Murgo MD, PhD
  • , Claudio Battaglia MD
  • , Luca Rubino MD
  • , Nicoletta Biglia MD, PhD
  • , Valentina Bounous MD, PhD
  • , Francesca Angela Rovera MD
  • , Corrado Chiappa MD
  • , Giovanni Pollini MD
  • , Sara Mirandola MD
  • , Graziano Meneghini MD
  •  & Francesco Di Bartolo MD

Contributions

CT, DG, and GC had full access to all data in the study and take responsibility for the integrity of the data and the accuracy of the analyses. Concept and design: CT, DG, WG, AS, EB, AT, VE, AB, EM, BF, DF, RS, RT, MS, AS, GC, and the SINODAR-ONE Collaborative Group. Acquisition, analysis, and interpretation of data: CT, DG, WG, AS, EB, AT, VE, AB, EM, CD, BD, LB, PB, GC, and the SINODAR-ONE Collaborative Group. Statistical analyses: DG, CD, BD, LB, PB. Drafting of the manuscript: DG, PB, CT, GC. Critical revision of the manuscript for important intellectual content: All authors and the SINODAR-ONE Collaborative Group. Supervision: CT, GC. Final approval of the version to be published: All authors and the SINODAR-ONE Collaborative Group.

Corresponding author

Correspondence to Damiano Gentile MD.

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Tinterri, C., Gentile, D., Gatzemeier, W. et al. 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. Ann Surg Oncol 29, 5732–5744 (2022). https://doi.org/10.1245/s10434-022-11866-w

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  • DOI: https://doi.org/10.1245/s10434-022-11866-w

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