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AXSANA (AXillary Surgery After NeoAdjuvant Treatment): A European prospective multicenter cohort study to evaluate different surgical methods of axillary staging (sentinel lymph node biopsy, targeted axillary dissection, axillary dissection) in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy
Banys-Paluchowski M.1, Stickeler E.2, de Boniface J.3,4, Gentilini O.5, Thill M.6, Hartmann S.7, Fasching P.A.8, Huebner H.8, Krawczyk N.9, Blohmer J.-U.10, Solbach C.11, Untch M.12, Kühn T.13, European Breast Cancer Research Association of Surgical Trialists (EUBREAST)
1Asklepios Klinik Hamburg-Barmbek, Hamburg, Deutschland, 2Klinik für Gynäkologie und Geburtsmedizin, Uniklinik RWTH Aachen, Aachen, Deutschland, 3Dept. of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Schweden, 4Dept. of Surgery, Capio St. Göran's Hospital, Stockholm, Schweden, 5San Raffaele Hospital Milan, Milano, Italien, 6Klinik für Gynäkologie und Gynäkologische Onkologie, Agaplesion Markus Krankenhaus, Frankfurt am Main, Deutschland, 7Universitäts-Frauenklinik, Klinikum Südstadt Rostock, Rostock, Deutschland, 8Frauenklinik, Universitätsklinikum Erlangen, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Deutschland, 9Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Düsseldorf, Düsseldorf, Deutschland, 10Klinik für Gynäkologie mit Brustzentrum der Charité, CCM, Berlin, Deutschland, 11Brustzentrum, Universitätsklinikum Frankfurt, Frankfurt am Main, Deutschland, 12Klinik für Gynäkologie und Geburtshilfe, Helios Klinikum Berlin-Buch, Berlin, Deutschland, 13Klinik für Frauenheilkunde und Geburtshilfe, Klinikum Esslingen, Esslingen, Deutschland

Introduction: The surgical treatment of the axilla in patients who convert from a clinically positive to a clinically negative node status through neoadjuvant chemotherapy is still unclear. Multiple techniques such as full Axillary Lymph Node Dissection (ALND), Targeted Axillary Dissection (TAD), Targeted Lymph Node Biopsy (TLNB) and Sentinel Lymph Node Biopsy (SLNB) are recommended in international guidelines. So far, no data with respect to outcome (recurrences/survival) or morbidity of the competing procedures are available. In view of the uncertainties related to innovative procedures, further research is urgently needed to safely de-escalate surgical treatment in this patient group.
Materials and methods: The EUBREAST study group, with the support of AWOgyn,AGO-B and NOGGO, will initiate an international prospective cohort study (“AXSANA”) including cN+→ycN0 patients treated with different axillary staging techniques according to the standard at their treating institution. The endpoints of the study are 5-year invasive disease-free survival, 3-year axillary recurrence rate and health-related quality of life. AXSANA will be initiated in February 2020, enrolling 3000 patients who will be followed for 5 years.
Results: The study concept and enrollment status will be presented at the conference. The frequency of various surgical (ALND, TAD, SLNB) and marking techniques (e.g. clip, radioactive/magnetic seed, ink) in different countries will be reported.
Conclusions: Due to high complexity and discordant recommendations, a randomized trial comparing surgical staging techniques is hardly feasible and therefore would not clarify currently open issues within a reasonable timeframe. The prospective international cohort study AXSANA will hopefully help to clarify these issues.