Franziska Ruf (Lübeck, Germany)
UKSH - Universitätsklinikum Schleswig-Holstein - Campus LübeckAuthor Of 1 Presentation
120P - AXSANA (AXillary Surgery After NeoAdjuvant Treatment) EUBREAST-3: an international prospective multicenter cohort study to evaluate different surgical methods of axillary staging in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy (NCT04373655) (ID 133)
- Franziska Ruf (Lübeck, Germany)
- Thorsten Kühn (Esslingen am Neckar, Germany)
- Steffi Hartmann (Rostock, Germany)
- Jana De Boniface (Huddinge, Sweden)
- Oreste D. Gentilini (Milan, Italy)
- Elmar Stickeler (Aachen, Germany)
- Guldeniz K. Cakmak (Zonguldak, Turkey)
- Isabel Rubio (Madrid, Spain)
- Laura Niinikoski (Helsinki, Finland)
- Michalis Kontos (Athens, Greece)
- Dawid Murawa (Zielona Gora, Poland)
- Eduard-Alexandru Bonci (Cluj-Napoca, Romania)
- Michael Hauptmann (Brandenburg an der Havel, Germany)
- Marc Thill (Frankfurt am Main, Germany)
- Hahn Markus (Tuebingen, Germany)
- Michael Lux (Paderborn, Germany)
- Matilda Appelgren (Huddinge, Sweden)
- Jens-Uwe Blohmer (Berlin, Germany)
- Michael Untch (Berlin, Germany)
- Maggie Banys- Paluchowski (Lübeck, Germany)
Abstract
Background
The surgical staging procedure of the axilla in patients who convert from clinically positive (cN+) to clinically negative node status (ycN0) through neoadjuvant chemotherapy 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 recommended by the national and international guidelines. In case of TAD and TLNB, the target lymph node can be marked using such markers as clip/coil, carbon ink, magnetic or radioactive seed, or a radar or radiofrequency marker. The AXSANA study is aiming to compare outcomes and morbidity rates between different techniques and will hopefully contribute to defining the optimal axillary staging procedure resulting in high oncological safety and improved quality of life.
Methods
AXSANA is an international prospective, non-interventional cohort study including patients clinically node-positive and scheduled to receive neoadjuvant chemotherapy. The surgical staging procedure is performed according to the standard at their treating institution.
Results
So far, 1,524 patients from 19 countries were recruited and 68% converted to ycN0 status after NACT. In 53% of patients, the planned surgical staging procedure was TAD, followed by ALND (30%), SLNB (15%) and TLNB (2%). In 55% of enrolled patients, at least one node was marked before NACT, mostly using clips/coils (81%), carbon ink (10%), magnetic seeds (8%) and radar markers (1%).
Conclusions
The preliminary data show a strong heterogeneity regarding axillary staging among participating countries. After only 20 months of recruitment, over half of the target accrual (3,000 patients) has been reached. TAD is a widely used technique, but ALND and SLNB are also common. The results of the AXSANA study will clarify whether de-escalation of axillary surgery is a safe option for patients converting from cN+ to ycN0 through neoadjuvant chemotherapy.
Clinical trial identification
NCT04373655.
Editorial acknowledgement
Dr. Rosa Dr Micco; San Raffaele Hospital Milan, Milan, Italy Ellen Schlichting, MD, PhD; Department for Breast and Endocrine Surgery, Oslo University Hospital, Oslo, Norway Dr. Lia Pamela Rebaza, Unit of Basic and Transnational Reseach, Oncosalud-AUNA Clinic, Lima, Perus Dr. Petr V. Krivorotko, Department of Breast Surgical Oncology, N.N. Petrov National Medical Research Center of Oncology, St. Petersburg, Russia David Pinto, MD; Breast Unit, Champalimaud Clinical Center, Campalimaud Foundation, Lisbon, Portugal Prof. Florentia Peintinger, Medical University of Graz, Graz. Austria Dr. Maria Luisa Gasparri, Department of Gynecology and Obstetrics, Ente Ospedaliero Cantonale, Ospedale Regionale di Lugano, Lugano, Switzerland and University of the Italian Switzerland (USI), Faculty of Biomedicine, Lugano, Switzerland Dr. Hagigat Valiyeva; Oncology Clinc of Azerbaijan Medical University, Baku, Azerbaijan Lukas Dostalek, MD Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University, General University Hospital, Prague, Czech Republic Dr. Helidon Nina; University Medical Center \"Mother Teresa\", Tirana, Albania Dr. Semra Gunay; Ministry of Health Istanbul Provincal Health Directorate Prof. Dr. Cemil Tascioglu City Hospital, Turkey Dr. Meryem Gunay Gurleyik, Ministry of Health Istanbul Provincial Helath Directorate Istanbul Haydarpasa Numune Research and Training Hospita, Turkey Dr. Elisabeth Thiemann, Brustzentrum Osnabrück, Niels-Stensen-Kliniken, Osnabrück, Germany Dr. Gabriele Kaltenecker, Department of Obstetrics and Gynecology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.
Legal entity responsible for the study
EUBREAST.
Funding
AGO-B, AWOgyn e.V., Claudia von Schilling Foundation for Breast Cancer Research, Ehmann-Stiftung, Endomag, Merit Medical and Mammotome.
Disclosure
M. Thill: Financial Interests, Institutional, Advisory Board: Amgen; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Advisory Board: Aurikamed; Financial Interests, Institutional, Advisory Board: Becton/Dickinson; Financial Interests, Institutional, Advisory Board: Biom'Up; Financial Interests, Institutional, Advisory Board: Celgene; Financial Interests, Institutional, Advisory Board: ClearCut; Financial Interests, Institutional, Advisory Board: Clovis; Financial Interests, Institutional, Advisory Board: Daiichi Sankyo; Financial Interests, Institutional, Advisory Board: Eisai; Financial Interests, Institutional, Advisory Board: Exact Sciences; Financial Interests, Institutional, Advisory Board: Gilead Science; Financial Interests, Institutional, Advisory Board: Lilly; Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Advisory Board: Norgine; Financial Interests, Institutional, Advisory Board: Neodynamics; Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: Onkowissen; Financial Interests, Institutional, Advisory Board: Pfizer; Financial Interests, Institutional, Advisory Board: pff Medical; Financial Interests, Institutional, Advisory Board: Pierre Fabre; Financial Interests, Institutional, Advisory Board: Roche; Financial Interests, Institutional, Advisory Board: RTI Surgical; Financial Interests, Institutional, Advisory Board: Seagen; Financial Interests, Institutional, Advisory Board: Sysmex; Financial Interests, Institutional, Writing Engagements: Servier; Financial Interests, Personal and Institutional, Invited Speaker: Art Tempi; Financial Interests, Personal and Institutional, Invited Speaker: Connect Medica; Financial Interests, Personal and Institutional, Invited Speaker: Hexal; Financial Interests, Personal and Institutional, Invited Speaker: I-Med-Institute; Financial Interests, Personal and Institutional, Invited Speaker: Medtronic; Financial Interests, Personal and Institutional, Invited Speaker: Omniamed; Financial Interests, Institutional, Funding: Endomag; Financial Interests, Institutional, Funding: Exact Science. M.P. Lux: Financial Interests, Institutional, Advisory Board: SamanTree; Financial Interests, Institutional, Advisory Board: PFM; Financial Interests, Institutional, Advisory Board: Sysmex/Endomag. M. Banys- Paluchowski: Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: Roche; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Advisory Board: Pfizer; Financial Interests, Institutional, Advisory Board: pfm; Financial Interests, Institutional, Advisory Board: Gilead; Financial Interests, Institutional, Advisory Board: Lilly; Financial Interests, Institutional, Advisory Board: Daiichi Sankyo; Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Advisory Board: Amgen; Financial Interests, Institutional, Advisory Board: Seagen. All other authors have declared no conflicts of interest.
Presenter Of 1 Presentation
120P - AXSANA (AXillary Surgery After NeoAdjuvant Treatment) EUBREAST-3: an international prospective multicenter cohort study to evaluate different surgical methods of axillary staging in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy (NCT04373655) (ID 133)
- Franziska Ruf (Lübeck, Germany)
- Thorsten Kühn (Esslingen am Neckar, Germany)
- Steffi Hartmann (Rostock, Germany)
- Jana De Boniface (Huddinge, Sweden)
- Oreste D. Gentilini (Milan, Italy)
- Elmar Stickeler (Aachen, Germany)
- Guldeniz K. Cakmak (Zonguldak, Turkey)
- Isabel Rubio (Madrid, Spain)
- Laura Niinikoski (Helsinki, Finland)
- Michalis Kontos (Athens, Greece)
- Dawid Murawa (Zielona Gora, Poland)
- Eduard-Alexandru Bonci (Cluj-Napoca, Romania)
- Michael Hauptmann (Brandenburg an der Havel, Germany)
- Marc Thill (Frankfurt am Main, Germany)
- Hahn Markus (Tuebingen, Germany)
- Michael Lux (Paderborn, Germany)
- Matilda Appelgren (Huddinge, Sweden)
- Jens-Uwe Blohmer (Berlin, Germany)
- Michael Untch (Berlin, Germany)
- Maggie Banys- Paluchowski (Lübeck, Germany)
Abstract
Background
The surgical staging procedure of the axilla in patients who convert from clinically positive (cN+) to clinically negative node status (ycN0) through neoadjuvant chemotherapy 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 recommended by the national and international guidelines. In case of TAD and TLNB, the target lymph node can be marked using such markers as clip/coil, carbon ink, magnetic or radioactive seed, or a radar or radiofrequency marker. The AXSANA study is aiming to compare outcomes and morbidity rates between different techniques and will hopefully contribute to defining the optimal axillary staging procedure resulting in high oncological safety and improved quality of life.
Methods
AXSANA is an international prospective, non-interventional cohort study including patients clinically node-positive and scheduled to receive neoadjuvant chemotherapy. The surgical staging procedure is performed according to the standard at their treating institution.
Results
So far, 1,524 patients from 19 countries were recruited and 68% converted to ycN0 status after NACT. In 53% of patients, the planned surgical staging procedure was TAD, followed by ALND (30%), SLNB (15%) and TLNB (2%). In 55% of enrolled patients, at least one node was marked before NACT, mostly using clips/coils (81%), carbon ink (10%), magnetic seeds (8%) and radar markers (1%).
Conclusions
The preliminary data show a strong heterogeneity regarding axillary staging among participating countries. After only 20 months of recruitment, over half of the target accrual (3,000 patients) has been reached. TAD is a widely used technique, but ALND and SLNB are also common. The results of the AXSANA study will clarify whether de-escalation of axillary surgery is a safe option for patients converting from cN+ to ycN0 through neoadjuvant chemotherapy.
Clinical trial identification
NCT04373655.
Editorial acknowledgement
Dr. Rosa Dr Micco; San Raffaele Hospital Milan, Milan, Italy Ellen Schlichting, MD, PhD; Department for Breast and Endocrine Surgery, Oslo University Hospital, Oslo, Norway Dr. Lia Pamela Rebaza, Unit of Basic and Transnational Reseach, Oncosalud-AUNA Clinic, Lima, Perus Dr. Petr V. Krivorotko, Department of Breast Surgical Oncology, N.N. Petrov National Medical Research Center of Oncology, St. Petersburg, Russia David Pinto, MD; Breast Unit, Champalimaud Clinical Center, Campalimaud Foundation, Lisbon, Portugal Prof. Florentia Peintinger, Medical University of Graz, Graz. Austria Dr. Maria Luisa Gasparri, Department of Gynecology and Obstetrics, Ente Ospedaliero Cantonale, Ospedale Regionale di Lugano, Lugano, Switzerland and University of the Italian Switzerland (USI), Faculty of Biomedicine, Lugano, Switzerland Dr. Hagigat Valiyeva; Oncology Clinc of Azerbaijan Medical University, Baku, Azerbaijan Lukas Dostalek, MD Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University, General University Hospital, Prague, Czech Republic Dr. Helidon Nina; University Medical Center \"Mother Teresa\", Tirana, Albania Dr. Semra Gunay; Ministry of Health Istanbul Provincal Health Directorate Prof. Dr. Cemil Tascioglu City Hospital, Turkey Dr. Meryem Gunay Gurleyik, Ministry of Health Istanbul Provincial Helath Directorate Istanbul Haydarpasa Numune Research and Training Hospita, Turkey Dr. Elisabeth Thiemann, Brustzentrum Osnabrück, Niels-Stensen-Kliniken, Osnabrück, Germany Dr. Gabriele Kaltenecker, Department of Obstetrics and Gynecology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.
Legal entity responsible for the study
EUBREAST.
Funding
AGO-B, AWOgyn e.V., Claudia von Schilling Foundation for Breast Cancer Research, Ehmann-Stiftung, Endomag, Merit Medical and Mammotome.
Disclosure
M. Thill: Financial Interests, Institutional, Advisory Board: Amgen; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Advisory Board: Aurikamed; Financial Interests, Institutional, Advisory Board: Becton/Dickinson; Financial Interests, Institutional, Advisory Board: Biom'Up; Financial Interests, Institutional, Advisory Board: Celgene; Financial Interests, Institutional, Advisory Board: ClearCut; Financial Interests, Institutional, Advisory Board: Clovis; Financial Interests, Institutional, Advisory Board: Daiichi Sankyo; Financial Interests, Institutional, Advisory Board: Eisai; Financial Interests, Institutional, Advisory Board: Exact Sciences; Financial Interests, Institutional, Advisory Board: Gilead Science; Financial Interests, Institutional, Advisory Board: Lilly; Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Advisory Board: Norgine; Financial Interests, Institutional, Advisory Board: Neodynamics; Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: Onkowissen; Financial Interests, Institutional, Advisory Board: Pfizer; Financial Interests, Institutional, Advisory Board: pff Medical; Financial Interests, Institutional, Advisory Board: Pierre Fabre; Financial Interests, Institutional, Advisory Board: Roche; Financial Interests, Institutional, Advisory Board: RTI Surgical; Financial Interests, Institutional, Advisory Board: Seagen; Financial Interests, Institutional, Advisory Board: Sysmex; Financial Interests, Institutional, Writing Engagements: Servier; Financial Interests, Personal and Institutional, Invited Speaker: Art Tempi; Financial Interests, Personal and Institutional, Invited Speaker: Connect Medica; Financial Interests, Personal and Institutional, Invited Speaker: Hexal; Financial Interests, Personal and Institutional, Invited Speaker: I-Med-Institute; Financial Interests, Personal and Institutional, Invited Speaker: Medtronic; Financial Interests, Personal and Institutional, Invited Speaker: Omniamed; Financial Interests, Institutional, Funding: Endomag; Financial Interests, Institutional, Funding: Exact Science. M.P. Lux: Financial Interests, Institutional, Advisory Board: SamanTree; Financial Interests, Institutional, Advisory Board: PFM; Financial Interests, Institutional, Advisory Board: Sysmex/Endomag. M. Banys- Paluchowski: Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: Roche; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Advisory Board: Pfizer; Financial Interests, Institutional, Advisory Board: pfm; Financial Interests, Institutional, Advisory Board: Gilead; Financial Interests, Institutional, Advisory Board: Lilly; Financial Interests, Institutional, Advisory Board: Daiichi Sankyo; Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Advisory Board: Amgen; Financial Interests, Institutional, Advisory Board: Seagen. All other authors have declared no conflicts of interest.