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Sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) for the staging of clinically node-negative breast cancer patients, demonstrating equivalent survival to ALND for lymph node–negative patients while resulting in reduced morbidity.
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For the majority of patients with pathologically positive SLNs, completion ALND was recommended by the American Society of Clinical Oncology Guidelines and the National Comprehensive Cancer Network (NCCN):
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However, based on data from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial these guidelines have changed:
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ALND may be omitted in selected patients with 1 or 2 positive SLNs.
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The ACOSOG Z0011 trial:
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813 patients
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Clinical T1 to T2 node-negative tumors (N0) who were found to have hematoxylin and eosin (H&E)-positive SLNs were randomized to ALND vs no further axillary surgery:
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Patients with palpable lymph nodes or clinical T3 tumors were not eligible for this study.
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The protocol mandated the use of standard whole-breast radiation without an axillary field.
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Patients with > 3 positive SLNs were excluded from the study.
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The trial was closed early due to poor accrual with an enrollment of only 47% of the targeted 1900 patients.
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It still showed equivalent results between the two treatment arms for loco-regional failure and survival.:
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At 6.3 years’ follow-up, no differences were found between the two groups in the rates of:
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Axillary recurrence:
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0.5% vs 0.9%
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In-breast recurrence:
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3.6% vs 1.9%
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Overall locoregional recurrence:
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4.1% vs 2.8% (P = 0.53)
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Disease-free were similar:
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82.2% vs 83.8%
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Overall survival were similar:
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91.9% vs 92.5%
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The majority of women in this trial were:
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Older than 50 years (64%)
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Had clinical T1 tumors (68%)
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Had ER-positive tumors (77%)
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Had only one positive SLN (60%),
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Received whole-breast radiation (89%)
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Received systemic therapy (96%: 58% adjuvant chemotherapy and 46% adjuvant hormonal therapy).
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Forty percent of patients had micrometastases or isolated tumor cells and 60% had macrometastases in the sentinel nodes.
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Additional positive axillary nodes were found in 27.3% of the ALND patients.
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This study excluded patients:
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Undergoing mastectomy
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Patients receiving neoadjuvant chemotherapy.
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The results from ACOSOG Z0011 were practice changing and ALND is no longer the standard of care for patients who meet all of the following criteria:
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T1 to T2 tumors
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One to two positive SLNs without extracapsular extension
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Patient acceptance and completion of whole-breast radiation therapy without extended fields of therapy
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Patient acceptance and completion of adjuvant therapy (hormonal, cytotoxic, or both)
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The results from ACOSOG Z0011 are not directly applicable to patients who:
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Have T3 tumors
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Have more than 2 positive nodes
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Are undergoing mastectomy
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Are undergoing partial breast radiation
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Have been identified as having matted axillary nodes or preoperative palpable nodes
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Are receiving neoadjuvant chemotherapy
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Rodrigo Arrangoiz MS, MD, FACS a surgical oncologist and is a member of Sociedad Quirúrgica S.C at the America British CowdrayMedical Center in Mexico City:
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He is an expert in the management of breast cancer:
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If you have any questions about breast cancer AND the management of the axilla in patients with invasive cancer Dr. Arrangoiz
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Rodrigo Arrangoiz MS, MD, FACS, FSSO 