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Incorporating the Results of the American College of Surgeons Oncology Group Z0011 Trial into Clinical Practice

  • Local-Regional Evaluation and Therapy (KK Hunt, Section Editor)
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Abstract

The American College of Surgeons Oncology Group Z0011 trial revealed that for women who have clinically node-negative breast cancer treated with breast-conserving therapy and found to have metastases in one or two sentinel lymph nodes, sentinel lymph node dissection alone results in local-regional control, disease-free survival, and overall survival similar to those achieved with axillary lymph node dissection. Use of these data to guide treatment has the potential to spare a substantial number of women with early-stage breast cancer the morbidity associated with axillary lymph node dissection. In this article, we review the trial data, discuss the applicability of the results, and identify strategies for implementing the findings of the study in clinical practice.

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References

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  1. Giuliano AE, Dale PS, Turner RR, et al. Improved axillary staging of breast cancer with sentinel lymphadenectomy. Ann Surg. 1995;222:394–9. discussion 399–401.

    Article  CAS  PubMed  Google Scholar 

  2. Lucci A, McCall LM, Beitsch PD, et al. Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection compared with SLND alone in the American College of Surgeons Oncology Group Trial Z0011. J Clin Oncol. 2007;25:3657–63.

    Article  PubMed  Google Scholar 

  3. Mansel RE, Fallowfield L, Kissin M, et al. Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial. J Natl Cancer Inst. 2006;98:599–609.

    Article  PubMed  Google Scholar 

  4. Giuliano AE, Haigh PI, Brennan MB, et al. Prospective observational study of sentinel lymphadenectomy without further axillary dissection in patients with sentinel node-negative breast cancer. J Clin Oncol. 2000;18:2553–9.

    CAS  PubMed  Google Scholar 

  5. Bergkvist L, de Boniface J, Jonsson PE, et al. Axillary recurrence rate after negative sentinel node biopsy in breast cancer: three-year follow-up of the Swedish Multicenter Cohort Study. Ann Surg. 2008;247:150–6.

    Article  PubMed  Google Scholar 

  6. Veronesi U, Paganelli G, Viale G, et al. A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. N Engl J Med. 2003;349:546–53.

    Article  PubMed  Google Scholar 

  7. Krag DN, Anderson SJ, Julian TB, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol. 2010;11:927–33.

    Article  PubMed Central  PubMed  Google Scholar 

  8. Veronesi U, Viale G, Paganelli G, et al. Sentinel lymph node biopsy in breast cancer: ten-year results of a randomized controlled study. Ann Surg. 2010;251:595–600.

    Article  PubMed  Google Scholar 

  9. Julian TB, Anderson SJ, Krag DN et al. 10-yr follow-up results of NSABP B-32, a randomized phase III clinical trial to compare sentinel node resection (SNR) to conventional axillary dissection (AD) in clinically node-negative breast cancer patients. J Clin Oncol 31, 2013 (suppl; abstr 1000).

    Google Scholar 

  10. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Breast, version 2.2008.

  11. Lyman GH, Giuliano AE, Somerfield MR, et al. American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. J Clin Oncol. 2005;23:7703–20.

    Article  PubMed  Google Scholar 

  12. Effect of mammographic service screening on stage at presentation of breast cancers in Sweden. Cancer 2007; 109: 2205–2212.

  13. Mittendorf EA, Hunt KK. Significance and management of micrometastases in patients with breast cancer. Expert Rev Anticancer Ther. 2007;7:1451–61.

    Article  PubMed  Google Scholar 

  14. Weaver DL, Ashikaga T, Krag DN, et al. Effect of occult metastases on survival in node-negative breast cancer. N Engl J Med. 2011;364:412–21.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  15. Giuliano AE, McCall L, Beitsch P, et al. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg. 2010;252:426–32. discussion 432–423. Initial report from the ACOSOG Z0011 trial detailing local and regional recurrences. After a median follow-up of 6.3 years, there were no statistically significant differences in local recurrence (P = 0.11) or regional recurrence (P = 0.45) between patients randomized to axillary lymph node dissection or no further surgery (sentinel lymph node dissection only).

    PubMed  Google Scholar 

  16. Giuliano AE, Hunt KK, Ballman KV, et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011;305:569–75. Report of the primary endpoint from the ACOSOG Z0011 trial. After a median follow-up of 6.3 years, there was no difference in overall survival for patients randomized to axillary lymph node dissection (91.8 % five-year overall survival) versus no further surgery (sentinel lymph node dissection only; 92.5 % five-year overall survival).

    Article  CAS  PubMed  Google Scholar 

  17. Morrow M, Giuliano AE. To cut is to cure: can we really apply Z11 in practice? Ann Surg Oncol. 2011;18:2413–5.

    Article  PubMed  Google Scholar 

  18. Yi M, Giordano SH, Meric-Bernstam F, et al. Trends in and outcomes from sentinel lymph node biopsy (SLNB) alone vs. SLNB with axillary lymph node dissection for node-positive breast cancer patients: experience from the SEER database. Ann Surg Oncol. 2010;17 Suppl 3:343–51.

    Article  PubMed  Google Scholar 

  19. Bilimoria KY, Bentrem DJ, Hansen NM, et al. Comparison of sentinel lymph node biopsy alone and completion axillary lymph node dissection for node-positive breast cancer. J Clin Oncol. 2009;27:2946–53.

    Article  PubMed  Google Scholar 

  20. Yi M, Kuerer HM, Mittendorf EA, et al. Impact of the american college of surgeons oncology group Z0011 criteria applied to a contemporary patient population. J Am Coll Surg. 2013;216:105–13.

    Article  PubMed  Google Scholar 

  21. Caudle AS, Hunt KK, Kuerer HM, et al. Multidisciplinary considerations in the implementation of the findings from the American College of Surgeons Oncology Group (ACOSOG) Z0011 study: a practice-changing trial. Ann Surg Oncol. 2011;18:2407–12. Manuscript from the MD Anderson Cancer Center detailing how they have implemented the Z0011 data into clinical practice after a multidisciplinary discussion of the trial results.

    Article  PubMed  Google Scholar 

  22. Reznik J, Cicchetti MG, Degaspe B, Fitzgerald TJ. Analysis of axillary coverage during tangential radiation therapy to the breast. Int J Radiat Oncol Biol Phys. 2005;61:163–8.

    Article  PubMed  Google Scholar 

  23. Schlembach PJ, Buchholz TA, Ross MI, et al. Relationship of sentinel and axillary level I-II lymph nodes to tangential fields used in breast irradiation. Int J Radiat Oncol Biol Phys. 2001;51:671–8.

    Article  CAS  PubMed  Google Scholar 

  24. Giuliano AE, Morrow M, Duggal S, Julian TB. Should ACOSOG Z0011 change practice with respect to axillary lymph node dissection for a positive sentinel lymph node biopsy in breast cancer? Clin Exp Metastasis. 2012;29:687–92.

    Article  PubMed  Google Scholar 

  25. Wiechmann L, Sampson M, Stempel M, et al. Presenting features of breast cancer differ by molecular subtype. Ann Surg Oncol. 2009;16:2705–10.

    Article  PubMed  Google Scholar 

  26. Foulkes WD, Grainge MJ, Rakha EA, et al. Tumor size is an unreliable predictor of prognosis in basal-like breast cancers and does not correlate closely with lymph node status. Breast Cancer Res Treat. 2009;117:199–204.

    Article  PubMed  Google Scholar 

  27. Grills IS, Kestin LL, Goldstein N, et al. Risk factors for regional nodal failure after breast-conserving therapy: regional nodal irradiation reduces rate of axillary failure in patients with four or more positive lymph nodes. Int J Radiat Oncol Biol Phys. 2003;56:658–70.

    Article  PubMed  Google Scholar 

  28. Yates L, Kirby A, Crichton S, et al. Risk factors for regional nodal relapse in breast cancer patients with one to three positive axillary nodes. Int J Radiat Oncol Biol Phys. 2012;82:2093–103.

    Article  PubMed  Google Scholar 

  29. Caudle AS, Hunt KK, Tucker SL, et al. American College of Surgeons Oncology Group (ACOSOG) Z0011: impact on surgeon practice patterns. Ann Surg Oncol. 2012;19:3144–51.

    Article  PubMed  Google Scholar 

  30. Mittendorf EA, Sahin AA, Tucker SL, et al. Lymphovascular invasion and lobular histology are associated with increased incidence of isolated tumor cells in sentinel lymph nodes from early-stage breast cancer patients. Ann Surg Oncol. 2008;15:3369–77.

    Article  PubMed  Google Scholar 

  31. Van Zee KJ, Manasseh DM, Bevilacqua JL, et al. A nomogram for predicting the likelihood of additional nodal metastases in breast cancer patients with a positive sentinel node biopsy. Ann Surg Oncol. 2003;10:1140–51.

    Article  PubMed  Google Scholar 

  32. Dengel L, Van Zee KJ, King TA et al. Axillary dissection can be avoided in the majority of clinically node-negative patients undergoing breast conserving therapy. Ann Surg Oncol iin press. Manuscript from the Memorial Sloan-Kettering Cancer Center detailing the procedure they have implemented following publication of the ACOSOG Z0011 trial results.

  33. Morrow M, Harris J. Practice guideline for breast conservation therapy in the management of invasive breast cancer. J Am Coll Surg. 2007;205:362–76.

    Article  Google Scholar 

  34. Gainer SM, Hunt KK, Beitsch P, et al. Changing behavior in clinical practice in response to the ACOSOG Z0011 trial: a survey of the American Society of Breast Surgeons. Ann Surg Oncol. 2012;19:3152–8. Results of a survey conducted among members of the American Society of Breast Surgeons detailing how they have interpreted the ACOSOG Z011 data and incorporated the trial results into practice.

    Article  PubMed  Google Scholar 

  35. Galimberti V, Cole BF, Zurrida S, et al. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23–01): a phase 3 randomised controlled trial. Lancet Oncol. 2013;14:297–305.

    Article  PubMed  Google Scholar 

  36. Rutgers EJ, Donker M, Straver ME et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer patients: Final analysis of the EORTC AMAROS trial [abstract]. J Clin Oncol. 2013.

  37. Ashikaga T, Krag DN, Land SR, et al. Morbidity results from the NSABP B-32 trial comparing sentinel lymph node dissection versus axillary dissection. J Surg Oncol. 2010;102:111–8.

    Article  PubMed Central  PubMed  Google Scholar 

  38. Whelan T, Olivotto I, Ackerman I et al. NCIC-CTG MA. 20: an intergroup trial of regional nodal irradiation in early breast cancer. [abstract] J Clin Oncol 2011; 29.

  39. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Breast, version 2.2013. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf Accessed August 28, 2013.

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Elizabeth A. Mittendorf and Tari A. King declare that they have no conflict of interest.

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This article does not contain any studies with human or animal subjects performed by any of the authors.

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Correspondence to Elizabeth A. Mittendorf.

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Mittendorf, E.A., King, T.A. Incorporating the Results of the American College of Surgeons Oncology Group Z0011 Trial into Clinical Practice. Curr Breast Cancer Rep 6, 17–23 (2014). https://doi.org/10.1007/s12609-013-0131-y

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  • DOI: https://doi.org/10.1007/s12609-013-0131-y

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