Thorsten Kühn MD PhD; SABCS 2025: No Need for Axillary Node Dissection When Clinically Node-Positive Breast Cancers Convert to Node-Negative After Neoadjuvant Chemotherapy

Thorsten Kühn MD PhD; SABCS 2025: No Need for Axillary Node Dissection When Clinically Node-Positive Breast Cancers Convert to Node-Negative After Neoadjuvant Chemotherapy

An interview with:

Thorsten Kühn MD PhD, Head, Breast Center, Filderklinik, Stuttgart, Germany; Senior Consultant, University of Ulm; Chairman, European Breast Cancer Research Association of Surgical Trialists

SAN ANTONIO, USA— Breast cancers that convert from clinically node-positive to node-negative as a result of neoadjuvant chemotherapy, do not need axillary lymph node dissection, regardless of tumor type.

Less invasive axillary surgical staging procedures (such as sentinel node dissection and targeted axillary dissection) were just as good in terms of three-year outcomes, regardless of initial tumor stage or subtype, in findings from the international, prospective, multicenter AXSANA/EUBREAST 3 (R) study reported at the 2025 San Antonio Breast Cancer symposium by Thorsten Kühn MD PhD, Head of the Breast Center at the Filderklinik near Stuttgart, Germany, Senior Consultant, at the University of Ulm and Chairman of the European Breast Cancer Research Association of Surgical Trialists. At the symposium he gave more details to Audio Journal of Oncology reporter, Peter Goodwin:

AUDIO JOURNAL OF ONCOLOGY, Thorsten Kühn

IN: [GOODWIN]”I’m at the San Antonio……

OUT:  ……of Oncology, I’m Peter Goodwin  9:29secs

SABCS Abstract GS2-01

TITLE:

“More versus less invasive axillary surgical staging procedures in breast cancer patients converting from a clinically node-positive to a clinically node-negative stage through neoadjuvant chemotherapy – primary endpoint analysis of the international prospective multicenter AXSANA/EUBREAST 3(R)study“

AUTHOR:

Thorsten Kühn MD PHD, Die Filderklinik gGmbH / University of Ulm, Ulm, Germany

Introduction:

In breast cancer patients converting from clinically positive (cN+) to negative (ycN0) lymph node status after neoadjuvant chemotherapy (NACT), surgical staging by axillary lymph node dissection (ALND) is increasingly replaced by less invasive procedures like targeted axillary dissection (TAD) or sentinel lymph node biopsy (SLNB), possibly followed by completion ALND or regional radiotherapy if positive. Prospective data comparing oncologic safety of different procedures as a primary approach after NACT are currently scarce. We report 3-year axillary recurrence-free survival (ARFS) as the first primary endpoint analysis of the AXSANA/EUBREAST 3(R) study (NCT04373655, www.eubreast.org/axsana), initiated by the European Breast Cancer Research Association of Surgical Trialists (EUBREAST e.V.).

Methods

In an international multicenter cohort study, patients with cN+ breast cancer who receive at least four cycles of NACT and convert to ycN0 are eligible. Axillary staging after NACT is performed according to institutional routine. Grouping of patients was based on the primary staging procedure, not on final axillary surgery, e.g., completion ALND following a positive SLNB was classified as SLNB. Co-primary endpoints are ARFS, invasive breast cancer-specific survival (iBCSS), and patient-reported quality of life. Data entry is systematically monitored. Less extensive axillary staging procedures as first surgery after NACT (TAD, SLNB, targeted lymph node biopsy (TLNB)) are considered non-inferior to staging by ALND if the lower bound of a two-sided 90% confidence interval (CI) around 3-year ARFS exceeds 97%. 750 patients were required per group (TAD/SLNB/TLNB vs ALND).

Results

From June 2020 to April 2025, 6,474 patients (26 countries, 288 study sites) were enrolled, 2,632 of whom had completed surgery by December 31, 2023 and were selected for analysis. Primary staging procedure was ALND in 799 patients (30.4%) and less invasive procedures (419 SLNB, 1399 TAD, 15 TLNB) in 1,833 (69.6%). Nodal complete pathological response was reported in 1,345 patients (51.1%): 423 (31.4%) after ALND and 922 (68.6%) after TAD/SLNB/TLNB. 2489 patients (94.6%) received post-NACT nodal radiotherapy: 759 (95.0%) after ALND and 1730 (94.4%) after TAD/SLNB/TLNB.

After a median follow-up of 2.0 years (range, 0.01-4.5), 15 axillary recurrences occurred after TAD/SLNB/TLNB and 4 after ALND (4.2 vs 2.5 events/1000 person-years, p=0.351). 3-year ARFS was 99.2% (95% CI 98.2-100.0) after ALND and 98.8% (95% CI 98.1-99.5) after TAD/SLNB/TLNB. For TAD/SLNB/TLNB, the lower bound of a 90% CI was 98.2%. After SLNB, 1 axillary recurrence occurred and 14 after TAD (1.2 vs 5.1 events/1000 person-years, p=0.132). Results

were similar upon controlling for clinicopathological risk factors and neoadjuvant treatment or exclusion of 143 patients without radiotherapy. iBCSS at 3 years was 85.7% (95% CI 82.6-89.0) for ALND and 88.2% (95% CI 86.0-90.3) for TAD/SLNB/TLNB.

Conclusion

In patients who convert from clinically node-positive to node-negative breast cancer, the AXSANA study showed that less invasive surgical staging procedures are associated with a low axillary recurrence rate, not inferior to ALND after 3 years, regardless of initial tumor stage or subtype. These findings reinforce efforts to minimize surgical morbidity without compromising oncologic outcomes.

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