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Sentinel-Lymph-Node-Based Management or Routine Axillary Clearance? Five-Year Outcomes of the RACS Sentinel Node Biopsy Versus Axillary Clearance (SNAC) 1 Trial: Assessment and Incidence of True Lymphedema

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

Abstract

Purpose

To determine whether the benefits of sentinel-node-based management (SNBM) over routine axillary clearance (RAC) persisted to 5 years.

Methods

A total of 1088 women with breast cancer less than 3 cm in diameter and clinically negative axillary nodes were randomized to SNBM with axillary clearance if the sentinel node was positive or RAC preceded by sentinel-node biopsy. The outcomes were: (1) objectively measured change in the volume of the operated and contralateral nonoperated arms; (2) the proportion with an increase in arm volume <15%; and (3) subjectively assessed arm morbidity for the domains swelling, symptoms, dysfunction, and disability. Assessments were performed at 1 and 6 months after surgery and then annually.

Results

Limb volume increased progressively in the operated and nonoperated arms for 2 years and persisted unchanged to year 5, accompanied by weight gain. Correction by change in the nonoperated arm showed a mean volume increase of 70 mL in the RAC group and 26 mL in the SNBM group (P < 0.001) at 5 years. Only 28 patients (3.3%) had a corrected increase >15% from baseline (RAC 5.0% vs. SNBM 1.7%). Significant predictors were surgery type (RAC vs. SNBM), obesity, diabetes, palpable tumor, and weight gain exceeding 10% of baseline value.

Conclusions

Subjective assessments revealed persisting patient concerns about swelling and symptoms but not overall disability at 5 years. Subjective scores were only moderately correlated with volume increase. SNAC1 has demonstrated that objective morbidity and subjective morbidity persist for 5 years after surgery and that SNBM significantly lowers the risk of both.

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Acknowledgement

Funded by Grants from the Australian National Health and Medical Research Council (NHMRC, 1046018, 512378, 1037786), the National Breast Cancer Foundation, the Australian Department of Health and Ageing, MBF Australia, and the Scottwood Trust, New Zealand. Rhana Pike, from the NHMRC Clinical Trials Centre, assisted with the manuscript. Funded by the Australian National Health and Medical Research Council, the National Breast Cancer Foundation, the Australian Department of Health and Ageing, MBF Australia, and the Scottwood Trust.

Disclosure

The authors report no conflicts of interest.

Author information

Authors and Affiliations

  1. Wesley Medical Centre, Brisbane, QLD, Australia

    Neil Wetzig MB BS, FRCS, FRACS

  2. Breast, Endocrine & Surgical Oncology Unit, Royal Adelaide Hospital, Adelaide, SA, Australia

    Peter Grantley Gill MB BS, MD, FRACS

  3. Department of Surgery, University of Adelaide, Adelaide, SA, Australia

    Peter Grantley Gill MB BS, MD, FRACS

  4. National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia

    David Espinoza BArch, BSc, Rebecca Mister Bsc, MSc, Martin R. Stockler MB BS, MSc, FRACP, Val J. Gebski BA, MStat & John Simes MD, BSc(Med), SM, FRACP

  5. Sydney Cancer Centre, Royal Prince Alfred and Concord Hospitals, Sydney, NSW, Australia

    Martin R. Stockler MB BS, MSc, FRACP

  6. Department of Medicine, University of Queensland, Brisbane, QLD, Australia

    Owen A. Ung MB BS, FRACP

  7. Centre for Breast Health, Royal Brisbane and Women’s Hospital, Brisbane, QLD, Australia

    Owen A. Ung MB BS, FRACP

  8. Waikato Hospital, Hamilton, New Zealand

    Ian Campbell MB ChB, FRACS

Authors
  1. Neil Wetzig MB BS, FRCS, FRACS
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  2. Peter Grantley Gill MB BS, MD, FRACS
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  3. David Espinoza BArch, BSc
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  4. Rebecca Mister Bsc, MSc
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  5. Martin R. Stockler MB BS, MSc, FRACP
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  6. Val J. Gebski BA, MStat
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  7. Owen A. Ung MB BS, FRACP
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  8. Ian Campbell MB ChB, FRACS
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  9. John Simes MD, BSc(Med), SM, FRACP
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Corresponding author

Correspondence to Peter Grantley Gill MB BS, MD, FRACS.

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Wetzig, N., Gill, P.G., Espinoza, D. et al. Sentinel-Lymph-Node-Based Management or Routine Axillary Clearance? Five-Year Outcomes of the RACS Sentinel Node Biopsy Versus Axillary Clearance (SNAC) 1 Trial: Assessment and Incidence of True Lymphedema. Ann Surg Oncol 24, 1064–1070 (2017). https://doi.org/10.1245/s10434-016-5669-2

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  • DOI: https://doi.org/10.1245/s10434-016-5669-2

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