The purposes of this multicenter retrospective cohort study are to determine the residual nodal burden in patients with isolated tumor cells detected in the SLN or the clipped node after NAC and to determine oncologic outcomes in this group of patients after ALND or nodal RT or observation.
In the context of upfront surgery, the extent of disease in the sentinel lymph nodes (SLNs) significantly predicts the chances of additional non-SLN metastases during axillary lymph node dissection (ALND). For patients with minimal SLN disease (isolated tumor cells \[ITCs\] and micrometastases), the probability of further non-SLN metastases is between 10-20%. In contrast, for patients with macrometastases, the risk increases to 27-33%. In patients undergoing neoadjuvant chemotherapy (NAC), those with positive SLNs exhibit a greater residual nodal burden compared to those treated with upfront surgery. For patients with remaining micro- or macrometastases post-NAC, additional positive lymph nodes are found in over 60% of ALND specimens, regardless of receptor subtype. Consequently, ALND remains the standard care for any residual nodal disease after NAC. Residual ITCs after NAC are present in about 1.5% of all patients undergoing NAC. There is limited data on the likelihood of discovering additional positive lymph nodes in this group, with fewer than 35 documented cases examining residual nodal burden. Therefore, the benefit of ALND for minimal residual disease is uncertain, and axillary management for patients with nodal ITCs is not standardized. Although omitting ALND reduces arm morbidity, identifying residual nodal disease can influence adjuvant therapy recommendations. Despite the lack of consensus on the oncologic safety of omitting ALND in this group, care patterns indicate a growing adoption of this approach. Given the rarity of this clinical scenario and the absence of forthcoming prospective studies, this study utilized real-world data from a large international cohort to determine the incidence of residual non-SLN involvement in patients with ITCs in the SLNs post-NAC, and to compare clinical outcomes in patients with and without ALND as definitive axillary treatment.
Study Type
OBSERVATIONAL
Enrollment
583
Observational study no intervention
Number of Axillary Lymph Node Dissection (ALND)
Evaluation of the number of ALNDs performed
Time frame: Day 0
Number of Tailored Axillary Dissection (TAD)
Evaluation of the number of TAD performed
Time frame: Day 0
Number of Sentinel Lymph Node Biopsy (SLNB)
Evaluation of the number of SLNB performed
Time frame: one time assessment before surgery
Number Axillary Radiotherapy
Evaluation of the number of axillary radiotherapy performed
Time frame: Up to 2 years
Number of additional micrometastases
Evaluation of the number of additional micrometastases removed by ALND
Time frame: Day 0
Number of additional macrometastases
Evaluation of the number of additional macrometastases removed by ALND
Time frame: Day 0
Axillary recurrence
Evaluation of the number of axillary recurrence
Time frame: Up to 14 years
Regional recurrence
Evaluation of the number of regional recurrence
Time frame: Up to 14 years
Locoregional recurrence
Evaluation of the number of locoregional recurrence
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Valleywise Health Medical Center
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Cancer Institute
Los Angeles, California, United States
Miami University
Miami, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
...and 52 more locations
Time frame: Up to 14 years
Invasive recurrence
Evaluation of the number of invasive recurrence
Time frame: Up to 14 years