Data from the observational AXSANA/EUBREAST 3® study (NCT04373655) show that less invasive surgical staging strategies provide outcomes comparable to axillary lymph node dissection (ALND) for breast cancer patients who convert from clinically node-positive (cN+) to node-negative (ycN0) status following neoadjuvant chemotherapy (NACT), according to results presented at the 2025 San Antonio Breast Cancer Symposium (SABCS).
The analysis, led by Thorsten Kühn, MD, PhD, head of the AXSANA study and senior physician at the University of Ulm’s Department of Gynecology and Obstetrics, included more than 2,500 patients who underwent ALND or less invasive procedures—targeted axillary dissection (TAD), sentinel lymph node biopsy (SLNB), or targeted lymph node biopsy (TLNB)—as their first axillary surgery.
Key Findings: Noninferiority of Less Invasive Procedures
At three years, axillary recurrence-free survival (ARFS) was 99.2% (95% CI, 98.2%-100.0%) after ALND and 98.8% (95% CI, 98.1%-99.5%) for TAD/SLNB/TLNB. The study met its primary endpoint, demonstrating noninferiority of less invasive procedures, with the lower bound of the 90% confidence interval (98.2%) exceeding the pre-specified noninferiority margin of 97%.
These findings suggest that less invasive staging strategies provide excellent oncologic outcomes while potentially reducing surgical morbidity, offering patients improved quality of life without compromising treatment efficacy.
Interim Outcomes: Recurrence and Survival
Univariate analyses showed higher hazard ratios (HRs) for distant recurrence (HR 1.41; 95% CI, 1.05-1.90), invasive breast cancer recurrence (HR 1.30; 95% CI, 0.99-1.71), and overall survival (HR 1.35; 95% CI, 0.89-2.04) in patients undergoing ALND. However, these differences did not translate into increased axillary, regional, or local recurrence.
Kühn noted that patients selected for ALND generally had higher baseline risk, including larger tumor size, greater nodal burden, more mastectomies, and more residual disease. After adjusting for these factors in multivariate analyses, differences between the surgical approaches disappeared, supporting comparable oncologic outcomes across procedures.
AXSANA Study Overview
AXSANA is a global, prospective cohort study launched by the European Breast Cancer Research Association of Surgical Trialists (EUBREAST) to evaluate axillary staging in patients who initially present with cN+ and convert to ycN0 after NACT. The study measures co-primary endpoints of ARFS, invasive breast cancer–specific survival (iBCSS), patient-reported quality of life, and arm morbidity.
Between June 2020 and April 2025, 6,474 patients were enrolled across 288 sites worldwide. The current analysis included 2,632 patients who completed first surgery by December 31, 2023. Among them, 69.6% underwent less invasive procedures (TAD, SLNB, TLNB), while 30.4% received ALND. Most patients (94.6%) also received post-NACT nodal radiotherapy.
Next Steps
Kühn emphasized the need for continued follow-up to assess long-term outcomes and the potential impact of staging accuracy on breast cancer–specific survival and overall survival.
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