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DOI: 10.1055/s-0045-1807692
Status of the international prospective multicenter AXSANA study (NCT04373655) evaluating different surgical methods of axillary staging in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy
Objective: The optimal surgical staging procedure of the axilla in patients who convert from a clinically positive (cN+) to a negative node status (ycN0) after neoadjuvant chemotherapy (NACT) is still controversial. Different techniques such as Axillary Lymph Node Dissection (ALND), Targeted Axillary Dissection (TAD), Target Lymph Node Biopsy (TLNB), and Sentinel Lymph Node Biopsy (SLNB) are given preference in international guidelines.
Methods: AXSANA is an international, non-interventional, prospective cohort study that includes initially cN+patients (cT1-4c-tumors) converting to ycN0-status after NACT and being treated with different axillary staging techniques according to the standard at their institution. All patients converting to ycN0 status undergo follow-up for 5 years regardless of the ypN status. Primary endpoints are invasive disease-free survival, axillary recurrence rate, and health-related quality of life.
Results: By November 2024, 5,969 patients had been enrolled at 288 study sites in 26 countries. A target lymph node was marked before NACT in 57.0% of patients (markers: clip/coil 75.7%, magnetic seed 10.5%, carbon 7.3%, radar marker 4.7%, other 1.8%). Among 3,656 ycN0-patients with a defined surgical concept, 982 (26.9%) women were scheduled for ALND, 1,966 (53.8%) for TAD, 594 (16.2%) for SLNB, 19 for TLNB (0.5%) and 95 (2.6%) for other procedures.
Summary: Since February 2024, AXSANA has continued as AXSANAplus study with unrestricted recruitment to evaluate additional secondary endpoints such as the comparison of the different axillary staging procedures in patients with high initial axillary tumor burden or minimal axillary lymph node involvement after NACT.
Interessenskonflikt
Ich erkläre als korrespondierende/r AutorIn, dass meine Ko-AutorenInnen mir mitgeteilt haben, dass sie während der letzten 3 Jahre keine wirtschaftlichen oder persönlichen Verbindungen im oben genannten Sinne hatten. Auch ich selbst hatte keine derartigen Verbindungen in den letzten 3 Jahren.
Publication History
Article published online:
04 June 2025
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