Senologie - Zeitschrift für Mammadiagnostik und -therapie 2025; 22(02): e27-e28
DOI: 10.1055/s-0045-1807692
Abstracts

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

Authors

  • E Schmidt

    1   Universitätsfrauenklinik Rostock, Rostock, Germany

  • M Banys-Paluchowski

    2   Universitätsklinikum Schleswig Holstein, Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe, Lübeck, Germany

  • S Hartmann

    1   Universitätsfrauenklinik Rostock, Rostock, Germany

  • N Ditsch

    3   Universitätsklinikum Augsburg, Klinik für Frauenheilkunde und Geburtshilfe, Augsburg, Germany

  • E Stickeler

    4   Universitätsklinikum Aachen, Klinik für Frauenheilkunde und Geburtshilfe, Aachen, Germany

  • J de Boniface

    5   Capio St. Göran's Hospital, Department of Surgery, Breast Center,, Stockholm, Sweden

  • O Gentilini

    6   San Raffaele University and Research Hospital, Breast Surgery Unit, Milan, Italy

  • M Hauptmann

    7   Brandenburg Medical School Theodor Fontane, Neuruppin, Germany

  • G Karadeniz Cakmak

    8   Zonguldak BEUN The School of Medicine, Breast and Endocrine Unit, Zonguldak, Turkey

  • I T Rubio

    9   Clínica Universidad de Navarra, Breast Surgical Unit, Madrid, Spain

  • M L Gasparri

    10   Ospedale Regionale di Lugano, Department of Gynecology and Obstetrics, Lugano, Switzerland

  • M Kontos

    11   National and Kapodistrian University of Athens, Department of Surgery, Laiko Hospital, Athen, Greece

  • E-A Bonci

    12   ”Prof. Dr. Ion Chiricuță” Institute of Oncology, Department of Surgical Oncology, Cluj-Napoca, Romania

  • L Niinikoski

    13   Helsinki University Hospital, Breast Surgery Unit, Helsinki, Finland

  • D Murawa

    14   University of Zielona Góra, Department of General Surgery and Surgical Oncology, Zielona Góra, Poland

  • G Kadayaprath

    15   MAX Hospital Patparganj, New Delhi, India

  • D Pinto

    16   Champalimaud Clinical Center, Breast Unit, Lissabon, Portugal

  • F Peintinger

    17   Medical University of Graz, Department of Gynecology and Obstetrics, Graz, Austria

  • E Schlichting

    18   Oslo University Hospital, Department of Oncology, Oslo, Norway

  • L Dostálek

    19   Charles University, General University Hospital, Gynecologic Oncology Center, Prag, Czech Republic

  • H Nina

    20   Oncology Hospital, Department of Surgery, Tirana, Albania

  • H Valiyeva Qanimat

    21   Azerbaijan Medical University, Oncologic Clinic, Baku, Azerbaijan

  • A Kothari

    22   Guy's & St Thomas NHS Foundation Trust, London, United Kingdom

  • M Vanhoeij

    23   Universitair Ziekenhuis Brussel, Brüssel, Belgium

  • A Perhavec

    24   Institute of Oncology, Ljubljana, Slovenia

  • T Ivanov

    25   Heart and Brain Hospital, Pleven, Bulgaria

  • D Zippel

    26   Chaim Sheba Medical Centre, Surgical Oncology Unit, Ramat Gan, Israel

  • L P Rebaza

    27   Oncosalud, Breast Surgery, Lima, Peru

  • S Thongvitokomarn

    28   Queen Sirikit Centre for Breast Cancer, Bangkok, Thailand

  • S Fröhlich

    1   Universitätsfrauenklinik Rostock, Rostock, Germany

  • T Berger

    29   Müritz-Klinikum Waren, Department of Gynecology and Obstetrics, Waren, Germany

  • F Ruf

    2   Universitätsklinikum Schleswig Holstein, Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe, Lübeck, Germany

  • A Rief

    17   Medical University of Graz, Department of Gynecology and Obstetrics, Graz, Austria

  • K Wihlfahrt

    30   Practice for Gynecology and Obstetrics Wihlfahrt, Kiel, Germany

  • T Basali

    31   Klinikum Stuttgart – Olgahospital, Department of Gynecology and Obstetrics, Stuttgart, Germany

  • M Thill

    32   AGAPLESION Markus Krankenhaus, Department of Gynecology and Gynecological Oncology, Frankfurt am Main, Germany

  • M P Lux

    33   Frauenklinik St. Louise, Paderborn, Department of Gynecology and Obstetrics, Paderborn, Germany

  • S Loibl

    34   German Breast Group, Neu-Isenburg, Germany

  • H-C Kolberg

    35   Marienhospital Bottrop, Department of Gynecology and Obstetrics, Bottrop, Germany

  • T Reimer

    1   Universitätsfrauenklinik Rostock, Rostock, Germany

  • J-U Blohmer

    36   Charité-Universitätsmedizin, Department of Gynecology and Breast Center, Berlin, Germany

  • M Hahn

    37   University Hospital Tübingen, Department of Gynecology and Obstetrics, Tübingen, Germany

  • S-T Graßhoff

    38   Harzklinikum Dorothea Christiane Erxleben, Department of Gynecology and Obstetrics, Quedlinburg, Germany

  • D Watermann

    39   Evangelisches Diakoniekrankenhaus Freiburg, Department of Gynecology and Obstetrics, Freiburg, Germany

  • M Schrauder

    40   Klinikum Aschaffenburg-Alzenau, Department of Gynecology and Obstetrics, Aschaffenburg, Germany

  • E Thiemann

    41   Niels-Stensen-Kliniken Marienhospital Osnabrück, Department of Gynecology and Obstetrics, Osnabrück, Germany

  • S Paepke

    42   Klinikum rechts der Isar, Department of Gynecology and Obstetrics, München, Germany

  • S Seitz

    43   Caritas Krankenhaus St. Josef Regensburg, Department of Gynecology and Obstetrics, Regensburg, Germany

  • G Kaltenecker

    44   Städtisches Klinikum Karlsruhe, Department of Gynecology and Obstetrics, Karlsruhe, Germany

  • T Kühn

    45   Die Filderklinik, Breast Cancer Center, Filderstadt, Germany
Further Information
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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.



Publication History

Article published online:
04 June 2025

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