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Comparing Observation, Axillary Radiotherapy, and Completion Axillary Lymph Node Dissection for Management of Axilla in Breast Cancer in Patients with Positive Sentinel Nodes: A Systematic Review

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

Abstract

Purpose

Several randomized controlled trials (RCTs) have investigated observation or axillary radiotherapy (ART) in place of completion axillary lymph node dissection (cALND) for management of positive sentinel nodes (SNs) in clinically node-negative women with breast cancer. The optimal treatment strategy for this population is not known.

Methods

MEDLINE, Embase, and EBM Reviews—NHS Economic Evaluation Database were searched from inception until July 2019. A systematic review and narrative summary was performed of RCTs comparing observation or ART versus cALND in clinically node-negative female breast cancer patients with positive SNs. The Cochrane risk of bias tool for RCTs was used to assess risk of bias. Outcomes of interest included overall survival (OS), disease-free survival (DFS), axillary recurrence, and axillary surgery-related morbidity.

Results

Three trials compared observation with cALND, and two trials compared ART with cALND. No studies blinded participants or personnel, and there was heterogeneity in inclusion criteria, study design, and follow-up. Neither observation nor ART resulted in statistically inferior 5- or 8-year OS or DFS compared with cALND. There was also no statistically significant increase in axillary recurrences associated with either approach. Four trials reported morbidity outcomes, and all showed cALND was associated with significantly more lymphedema, paresthesia, and shoulder dysfunction compared with observation or ART.

Conclusions

Women with clinically node-negative breast cancer and positive SNs can safely be managed without cALND.

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Acknowledgements

We thank Teruko Kishibe for her assistance with updating our search strategy.

Funding

None to declare.

Author information

Authors and Affiliations

  1. Division of General Surgery, Department of Surgery, St. Michael’s Hospital, University of Toronto, Toronto, ON, Canada

    Matthew Castelo MD, Fahima Dossa MD, Sergio A. Acuna MD, PhD & Adena S. Scheer MD, MSc

  2. Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada

    Matthew Castelo MD, Fahima Dossa MD, Sergio A. Acuna MD, PhD & Adena S. Scheer MD, MSc

  3. Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto, ON, Canada

    Matthew Castelo MD, Fahima Dossa MD, Sergio A. Acuna MD, PhD & Adena S. Scheer MD, MSc

  4. Department of Surgery, St. Michael’s Hospital, Toronto, ON, Canada

    Matthew Castelo MD, Fahima Dossa MD, Sergio A. Acuna MD, PhD & Adena S. Scheer MD, MSc

  5. School of Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland

    Shu Yang Hu BSc, MHS

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  1. Matthew Castelo MD
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Correspondence to Adena S. Scheer MD, MSc.

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Appendices

Appendix 1

Final search strategy for EBM Reviews—NHS Economic Evaluation Database. The electronic databases MEDLINE, Embase, and EBM Reviews—NHS Economic Evaluation Database were searched from inception until July 2017, and a second updated search was performed from the previous search date until July 2019.

figure a

Appendix 2

10-Year overall survival, disease-free survival, and regional recurrence outcomes for two trials22,23,25

Characteristic

ACSOG Z0011

IBCSG 23-01

cALND

Observation

cALND

Observation

Study design

Noninferiority

 

Noninferiority

 

Length of follow-up, median (IQR), years

9.3 (6.9–10.3)

 

9.7 (7.8–12.7)

 

OS,  % (95% CI)

83.6 (79.1–87.1)

86.3 (82.2–89.5)

88.2 (84.8–91.6)

90.8 (87.9–93.8)

HR (95% CI)

0.85 (0.00–1.16)1

 

0.78 (0.53–1.14)

 

DFS,  % (95% CI)

78.2 (73.5–82.2)

80.2 (75.6–84.1)

74.9 (70.5–79.3)

76.8 (72.5–81.0)

HR (95% CI)

0.85 (0.62–1.17)

 

0.85 (0.65–1.11)

 

Axillary recurrence,  % (95% CI)

0.5

1.5

0.6

1.9

Chi squared p value

0.276

 

0.083

 

HR (95% CI)

–

 

–

 

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Castelo, M., Hu, S.Y., Dossa, F. et al. Comparing Observation, Axillary Radiotherapy, and Completion Axillary Lymph Node Dissection for Management of Axilla in Breast Cancer in Patients with Positive Sentinel Nodes: A Systematic Review. Ann Surg Oncol 27, 2664–2676 (2020). https://doi.org/10.1245/s10434-020-08225-y

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