Maggie Banys- Paluchowski (Lübeck, Germany)
UKSH - Universitätsklinikum Schleswig-Holstein - Campus LübeckAuthor Of 2 Presentations
74P - Management of early-stage hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer in a real-word setting in Germany: a patient perspective (ID 89)
- Christian Jackisch (Offenbach am Main, Germany)
- Maggie Banys- Paluchowski (Lübeck, Germany)
- Agnieszka Korfel (Bad Homburg, Germany)
- Clemens Stoffregen (Bad Homburg vor der Höhe, Germany)
- Thorsten Otto (Bad Homburg vor der Höhe, Germany)
- Jacqueline Brown (Windlesham, United Kingdom)
- Isaac Sanderson (Bollington, United Kingdom)
- Alex Rider (Bollington, United Kingdom)
- Diana Luftner (Berlin, Germany)
Abstract
Background
Better understanding of patient (pt) perspectives could help in the management of HR+, HER2- early breast cancer (EBC).
Methods
Real-world data were analyzed descriptively from the Adelphi EBC Disease Specific Programme (Jun–Aug 2019). Fifty physicians practicing in Germany completed 400 pt record forms (PRFs) for pts with HR+, HER2- EBC who received/completed adjuvant therapy in the prior 12 months; 281 of these pts completed a pt self-completion form (PSC) including questions on pts’ knowledge/perceptions of, and satisfaction with coping with their illness (Functional Assessment of Cancer Therapy – Breast item GE2).
Results
Among 281 pts (mean [SD] age 56.4 [12.19] years, 59% Eastern Cooperative Onology Group status 0, 100% female) most had tumor size 1–3cm (76%), Grade 1 tumor (54%) and were node negative (73%). Of 48 pts considered by physicians to have high Ki-67, 80% had Ki-67 ≥20%. Most pts were aware of their EBC stage (83%), HER2 status (67%), nodal status (67%) and HR status (64%); 68% felt involved in treatment decisions; 79% thought the goal of current treatment was cure; and 59% were satisfied and 41% less satisfied with how they were coping with their EBC. Among pts satisfied/less satisfied with how they were coping (mean age 56.5/56.3 years), 55%/75% were aware of 3–4 (of a total of 4) aspects of their EBC, 71%/62% felt involved in treatment decisions and 49%/61% had used the internet to find information on EBC. Rates of adverse events (AEs) reported in both PRFs (for 72 of 400 pts with AEs) and 281 PSCs were: nausea 58%/17%, joint/muscle pain 25%/28% (pain), fatigue 24%/43%, vomiting 14%/16%, headache 11%/25%, diarrhea 8%/15% and hair loss/thinning 6%/38%. Differences (≥10%) in AE rates in pts satisfied/less satisfied with how they were coping were found for fatigue 39%/51%, nausea 13%/24%, vomiting 12%/22% and diarrhea 11%/21%.
Conclusions
In pts with HR+, HER2- EBC, behaviors differed in those satisfied with how they were coping with their EBC vs those less satisfied. There was discrepancy in the perception of AEs between physicians and pts. By addressing these points, physicians/caregivers could potentially help optimize pt satisfaction.
Editorial acknowledgement
Medical writing support from Rx Communications (Gill Gummer).
Legal entity responsible for the study
Eli Lilly and Company.
Funding
Eli Lilly and Company.
Disclosure
C. Jackisch: Financial Interests, Other, Travel Grant and Housing Support form Lilly: Eli Lilly and Company. M. Banys- Paluchowski: Financial Interests, Other, Honoraria for lectures and advisory role: Eli Lilly and Company; Financial Interests, Other, Honoraria for lectures and advisory role: Pfizer; Financial Interests, Other, Honoraria for lectures and advisory role: Roche; Financial Interests, Other, Honoraria for lectures and advisory role: Amgen; Financial Interests, Other, Honoraria for lectures and advisory role: Daiichi Sankyo; Financial Interests, Other, Honoraria for lectures and advisory role: Novartis; Financial Interests, Other, Honoraria for lectures and advisory role: GSK. A. Korfel, C. Stoffregen, T. Otto: Financial Interests, Institutional, Affiliate: Eli Lilly and Company. J. Brown: Financial Interests, Institutional, Stocks/Shares: Eli Lilly and Company; Financial Interests, Institutional, Affiliate: Eli Lilly and Company. D.I. Lüftner: Financial Interests, Other, Honoraria and advisory boards: Eli Lilly and Company. All other authors have declared no conflicts of interest.
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.