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Sentinel Lymph Node Biopsy Versus Axillary Dissection in Node-Negative Early-Stage Breast Cancer: 15-Year Follow-Up Update of a Randomized Clinical Trial

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

Sentinel lymph node biopsy (SLNB) allows for staging of the axillary node status in early-stage breast cancer (BC) patients and avoiding complete axillary lymph node dissection (ALND) when the sentinel lymph node (SLN) is proven to be free of disease. In a previous randomized trial we compared SLNB followed by ALND (ALND arm) with SLNB followed by ALND only if the SLN presented metastasis (SLNB arm). At a mid-term of ≈ 6 years median follow-up, the two strategies appeared to ensure similar survival and locoregional control. We have revised these previous findings and update the results following a 15-year observation period.

Methods

Patients were randomly assigned to either the ALND or SLNB arm. The main endpoints were event-free survival (EFS), overall survival (OS), and axillary disease recurrence. EFS and OS were assessed using Kaplan–Meier analysis and the log-rank test.

Results

The ALND and SLNB arms included 115 and 110 patients, respectively. At 14.3 years median follow-up, 39 primary BC-related recurrences occurred, 22 (19 %) of which occurred in the ALND arm and 17 (16 %) occurred in the SLNB arm (p = 0.519). No axillary relapse developed in the SLNB arm, while two were observed in the ALND arm. OS (82.0 vs. 78.8 %) and EFS (72.8 vs. 72.9 %) were not statistically different between the ALND and SLNB arms (p = 0.502 and 0.953, respectively).

Conclusions

SLNB is a safe and efficacious component of the surgical treatment of early-stage BC patients. In the long-term, SLNB is equivalent to ALND in terms of locoregional nodal disease control and survival in this subset of patients.

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Acknowledgments

The authors acknowledge the extremely valuable contribution of the ‘Registro Tumori Ligure’ for the assessment of primary tumor recurrences.

Disclosure

None.

Author information

Author notes

  1. Giuseppe Canavese MD

    Present address: Breast Unit, Istituto Clinico Humanitas IRCCS, Rozzano, MI, Italy

Authors and Affiliations

  1. Advanced Surgical Senology Unit, IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

    Giuseppe Canavese MD, Alessandra Catturich MD, Daniela Tomei MD, Stefano Spinaci MD & Federico Lacopo MD

  2. Breast Unit, Istituto Clinico Humanitas IRCCS, Rozzano, MI, Italy

    Corrado Tinterri MD

  3. Clinical Epidemiology Unit, IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

    Paolo Bruzzi MD, Elsa Garrone PhD & Beatrice Dozin PhD

  4. Pathological Anatomy and Cytohistology Unit, IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

    Franca Carli MD

Authors
  1. Giuseppe Canavese MD
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  2. Paolo Bruzzi MD
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  3. Alessandra Catturich MD
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  4. Daniela Tomei MD
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  5. Franca Carli MD
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  6. Elsa Garrone PhD
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  7. Stefano Spinaci MD
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  8. Federico Lacopo MD
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  9. Corrado Tinterri MD
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  10. Beatrice Dozin PhD
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Corresponding author

Correspondence to Beatrice Dozin PhD.

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Canavese, G., Bruzzi, P., Catturich, A. et al. Sentinel Lymph Node Biopsy Versus Axillary Dissection in Node-Negative Early-Stage Breast Cancer: 15-Year Follow-Up Update of a Randomized Clinical Trial. Ann Surg Oncol 23, 2494–2500 (2016). https://doi.org/10.1245/s10434-016-5177-4

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  • DOI: https://doi.org/10.1245/s10434-016-5177-4

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