- The standard of care with respect to surgical management of early stage breast cancer with a clinically negative axilla:
- Is to undergo axillary staging with sentinel lymph node biopsy (SLNB)
- In patients who are clinically node negative undergoing lumpectomy with SLNM and SLNB:
- A completion axillary lymph node dissection (ALND) is not required if one or two lymph nodes are positive:
- These patients should go on to receive adjuvant therapy:
- Omission of ALND does not lead to a difference in 10-year locoregional recurrence or overall survival
- These patients should go on to receive adjuvant therapy:
- There is, however, a role for omission of axillary staging in elderly women:
- Who are clinically node negative with ER+ tumors:
- Particularly if co-morbidities are present
- Who are clinically node negative with ER+ tumors:
- The Cancer and Leukemia Group B (CALBG) 9343 study:
- Evaluated women ≥ 70 years of age who underwent lumpectomy:
- For clinical T1, N0, ER+ breast cancer +/- adjuvant radiation (RT):
- With tamoxifen (Tam) recommended for all patients
- For clinical T1, N0, ER+ breast cancer +/- adjuvant radiation (RT):
- Of the 636 participants:
- 404 (64%) did not undergo any initial axillary surgery
- At 12-year follow-up:
- There were no axillary recurrences among women who underwent initial axillary dissection
- Among those who did not undergo axillary dissection:
- There were no axillary recurrences:
- In the Tam + RT group
- Six of 200 in the Tam group (3%) had axillary recurrences
- There were no axillary recurrences:
- Evaluated women ≥ 70 years of age who underwent lumpectomy:
- The International Breast Cancer Study Group Trial 10-93:
- Evaluated 473 patients with early stage breast cancer who were clinically node negative
- Patients had a mean age of 74
- The majority of patients were ER+, and patients were randomized to breast surgery +/- axillary dissection followed by endocrine therapy
- Overall, 2% of patients had an axillary recurrence (1% of those with axillary surgery vs. 3% in patients without axillary surgery):
- With no difference in disease-free and overall survival.
- A completion axillary lymph node dissection (ALND) is not required if one or two lymph nodes are positive:
- Results from these and other studies recently led the Society of Surgical Oncology to release the Choosing Wisely guidelines:
- Recommending against routine use of SLNB in clinically node-negative women ≥70 years of age with hormone positive cancer:
- Hormonal therapy is typically recommended for patients with hormone receptor positive disease
- Omission of SLNB in clinically node-negative women ≥70 years of age treated with hormonal therapy does not result in a significantly increased rate of locoregional recurrence and does not impact breast cancer mortality:
- Thus, although axillary staging with SLNB continues to be the standard of care:
- Omission of axillary staging can be considered in some patients ≥70 years of age with:
- Early stage, clinically node-negative, hormone receptor positive breast cancer
- Omission of axillary staging can be considered in some patients ≥70 years of age with:
- Thus, although axillary staging with SLNB continues to be the standard of care:
- References
- Giuliano AE, Ballman K, McCall L, et al. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: long-term follow-up from the American College of Surgeons Oncology Group (Alliance) ACOSOG Z0011 randomized trial. Ann Surg. 2016;264(3):413-420.
- Giuliano AE, Ballman KV, McCall L, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: the ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017;318(10):918-926.
- Hughes KS, Schnaper LA, Bellon JR, et al. Lumpectomy plus tamoxifen with or without irradiation in women age 70 years or older with early breast cancer: long-term follow-up of CALGB 9343. J Clin Oncol. 2013;31(19):2382-2387.
- International Breast Cancer Study Group: Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: first results of International Breast Cancer Study Group Trial 10-93. J Clin Oncol.2006;24(3):337-344.
- Society of Surgical Oncology. Five things physicians and patients should question. Choosing Wisely website. Released July 12, 2016; updated June 20, 2019. http://www.choosingwisely.org/societies/society-of-surgical-oncology. Accessed August 25, 2019.

