Less Invasive Axillary Staging Procedures Show Noninferiority to Standard Lymph Node Dissection in Breast Cancer
核心洞察
The AXSANA study demonstrates that less invasive axillary staging procedures are noninferior to axillary lymph node dissection in breast cancer (搜索) patients who convert from node-positive to node-negative status after neoadjuvant chemotherapy (搜索).
At 3 years, axillary recurrence-free survival rates were comparable between procedures (99.2% for ALND vs 98.8% for less invasive methods), meeting the study's primary noninferiority endpoint.
These findings support reducing surgical morbidity while maintaining oncologic safety, potentially improving patient quality of life without compromising clinical outcomes.
The largest global study to date evaluating axillary staging procedures in breast cancer (搜索) has demonstrated that less invasive surgical techniques are noninferior to the standard axillary lymph node dissection (ALND) in patients who convert from clinically node-positive to node-negative status following neoadjuvant chemotherapy (搜索). The findings from the AXSANA/EUBREAST (搜索) 3(R) study were presented at the 2025 San Antonio Breast Cancer Symposium, providing crucial evidence for reducing surgical morbidity while maintaining oncologic safety.
Primary Endpoint Analysis Shows Noninferiority
The study's first primary endpoint analysis included over 2,500 patients who underwent either ALND or less invasive procedures including targeted axillary dissection (TAD), sentinel lymph node biopsy (SLNB), and targeted lymph node biopsy (TLNB) as first surgery. At 3 years, axillary recurrence-free survival (ARFS) rates were 99.2% (95% CI, 98.2%-100.0%) for ALND and 98.8% (95% CI, 98.1%-99.5%) for the less invasive procedures.
"The analysis demonstrated that less invasive procedures like TAD/SLNB/TLNB are noninferior to ALND in terms of axillary recurrence based on the lower bound of a 90% confidence interval around 3-year ARFS," said Thorsten Kühn, MD, PhD, head of the AXSANA study and senior physician at the University of Ulm (搜索). With a 98.2% lower bound exceeding the noninferiority criterion of 97%, the study's primary endpoint was met.
Addressing Baseline Risk Differences
Initial univariate analyses revealed concerning trends, with hazard ratios favoring the less invasive procedures for distant recurrence (HR 1.41; 95% CI, 1.05-1.90), invasive breast cancer (搜索) recurrence (HR 1.30; 95% CI, 0.99-1.71), and overall survival (HR 1.35; 95% CI, 0.89-2.04) when comparing ALND to TAD/SLNB/TLNB.
However, these differences disappeared upon multivariate adjustment for baseline risk factors. "Patients who underwent ALND had a higher initial risk in terms of T stage, a higher nodal burden, had more mastectomies, more axillary radiotherapy, and more patients had residual disease," Kühn explained. The adjusted analyses demonstrated comparable results between the two approaches after accounting for these patient factors.
Study Design and Patient Population
The ongoing AXSANA study is a large, global, prospective cohort study launched by the European Breast Cancer (搜索) Research Association of Surgical Trialists (EUBREAST (搜索)). Between June 2020 and April 2025, 6,474 patients with breast cancer were enrolled across 288 global sites. The current analysis included 2,632 patients who had completed first surgery by December 31, 2023.
For the primary staging procedure, 69.6% of patients underwent less invasive procedures, including TAD (n = 1,399), SLNB (n = 419), and TLNB (n = 15), while 30.4% underwent ALND. A majority (94.6%) of patients received post-neoadjuvant chemotherapy (搜索) nodal radiotherapy.
Clinical Implications and Future Directions
These findings support the use of less invasive procedures as staging tools for patients converting from node positivity to negativity under chemotherapy, regardless of initial tumor stage or subtype. The results potentially minimize surgical morbidities and enhance patient quality of life without compromising clinical benefit, moving away from ALND as the historic standard of care that has been associated with high morbidity.
"Further follow-up is necessary to assess long-term results and the effect of differences in staging accuracy on breast cancer (搜索)-specific survival and overall survival," Kühn noted regarding next steps. The study's recruitment continues, with estimated completion in 2030, as investigators work to solidify evidence for guideline recommendations regarding axillary staging techniques in this patient population.