Background: Approximately 1% of all new cases of breast cancer (BC) cases occur in men. Treatment and symptom management for male BC patients are largely based on strategies developed for women. While the impact of BC diagnosis and treatment on the quality of life (QoL) in women with BC is well documented, there is a paucity of comprehensive, prospective data on QoL in men treated for BC. Due to absence of a validated QoL questionnaire, QoL in male BC patients has recently been assessed using the EORTC QLQ-C30 and the breast module QLQ-BR23 with female-specific items replaced by male-specific items from the EORTC QoL prostate module (EORTC QLQ-PR25). The development of the first validated worldwide questionnaire for male BC is sponsored by the EORTC QoL Group and is conducted in collaboration with the EORTC BCG and the International Male BC Program (a collaboration of EORTC-BCG, TBCRC, within the BIG and NABCG networks). The trial design was presented at SABCS 2000 (abstract OT-14-01). This report presents the results from phase 1 and 2 of the EORTC module development study to assess QoL in male BC patients. Methods: Phase I and II of the EORTC module development study focused on identifying QoL issues relevant to male BC and translating these issues into a questionnaire for a comprehensive QoL assessment. The development process included a systematic literature review, interviews with patients and healthcare professionals (HCPs) and consultations with experts in oncology and QoL. According to the recommendations of the EORTC module development manual, an issue was included to the issue list if it had a patient and/or HCP relevance rating ≥ 2 (on a scale of 1 to 4) and there was a patient and/or HCP priority rating ≥ 30 %. The relevant issues were translated into items with the help of the EORTC item library and the experts, resulting in a preliminary questionnaire. This questionnaire has been reviewed by the EORTC Quality of Life Department translation unit and will be tested in the phase III. Results: The mixed methods approach (systematic literature search, questionnaires review, investigator brochures, focus group, research group meetings) identified 86 issues that appear to be related to QoL in male BC patients. An issue list was created and used for interviews with patients and HCPs, who rated each issue according to relevance for male BC patients (using a four-point EORTC response format: not at all, a little, quite a bit, very much) and priority (yes/no response format). Interviews were conducted with male patients (N=64) with histologically confirmed diagnosis of BC from a total of eleven centres. A total of 29 HCPs from seven centres representing different specialities participated in this study. Centres were located in northern, southern and eastern Europe, USA, Egypt, and Asia. Of the initial 86 issues, 27 (rated by patients) and 46 (rated by HCPs) fulfilled both inclusion criteria. Additionally, 24 issues are covered by the BR-45 (updated BR-23 module Phase III) and/or the PR-25, and 25 are new issues not covered by these modules. In phase II, these issues were translated into items and a preliminary Phase II module/questionnaire with 68 items to assess QoL in male BC patients was created and will be presented at SABCS 2024. Conclusion: The results of the phases I-II highlight that the current practice of using combining parts of the EORTC QLG breast module and prostate module does not sufficiently cover all the relevant QoL issues for male BC patients. Ten items commonly used in the assessment may not add value, and 25 potentially valuable new items are not included in existing modules. Therefore, a new, male BC dedicated QoL questionnaire should be developed. A preliminary phase II questionnaire will be tested in phase III of the EORTC module development. Note. This document represents preliminary findings of the module development and is subject to revision; subsequent modifications of the module in the next stages may reflect significant changes. Citation Format: Vesna Bjelic-Radisic, Fatima Cardoso, Joachim Weis, Evelien Bleiker, David Cameron, Galina Velikova, Katarzyna Pogoda, Samantha Serpentini, Kevin Punie, Rinat Yerushalmi, Erika Matos, Birgit Carly, Luisa Zoe Probst, Sina Schafer, Nora Nevries, Ivana Bozovic-Spasojevic, Nicola Russell, Adelheid Roelstraete, Sofie Tombeur, Joanna Vermeij, Ruddy Kathryn, Juan Ignatio Arraras, Carolina De la Pinta, Omar Shamieh, Yuichiro Kikawa, Edward Chow, Tom Bootsma, Ibrahim Sallam, Fatjona Kraja, Andrew Bottomley. Adaptation of the EORTC Quality of Life Breast Cancer Module for male Breast Cancer – Results of the Phase I-II module [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P4-01-04.

Introduction: The study aimed to assess the feasibility of calculating the European Society of Breast Cancer Specialists (EUSOMA) quality indicators (QIs) using Belgian cancer registry data coupled to administrative health data, and to provide national results. Methods: Women diagnosed with ductal carcinoma in situ (DCIS) or invasive breast cancer (IBC) in 2014-2018 were selected from the cancer registry. Fourteen EUSOMA QIs were chosen to assess the quality of care. Results: Overall, 46,035 patients with IBC and 3,973 patients with DCIS were included. Most QIs had to be rephrased so that they could be calculated with the available data. None of the selected QIs on systemic treatment could be calculated due to a lack of reliable receptor status information. For some QIs there is ample room for improvement in Belgian clinical practice: cTNM stage reporting, multidisciplinary team meetings, sentinel lymph-node biopsy only in IBC with clinically negative lymph nodes. The result was 1-5% lower than the target for mammography and breast ultrasound, pTNM reporting, start of treatment, single breast surgery in DCIS, and no axillary clearance in DCIS. For histological or cytological assessment, receptor status assessment, start of radiotherapy, and single breast surgery in IBC, the results were at or above the target. Conclusion: Several EUSOMA QIs can be calculated with routinely collected data, while for several important aspects of care additional data collection is indicated so that its quality can be assessed. The validity of the obtained results depends on the reporting accuracy.

Objectives The study was undertaken to assess the association between certification and volume of breast centres on the one hand and survival on the other in patients with invasive breast cancer (IBC). Methods The study comprises a cohort of 46,035 patients diagnosed with IBC between 2014 and 2018, selected from the nation-wide Belgian Cancer Registry (BCR) database, which was linked with health insurance, hospital discharge and vital status data. Overall and relative survival probabilities were obtained with Kaplan-Meier method and an actuarial approach based on Ederer II, respectively. The associations between centre certification/volume and relative survival were assessed using Poisson models, adjusted for potential confounders. Results Five years after the diagnosis of IBC, the observed and relative survival probabilities for the cohort were 83.4% (95%CI: [83.1, 83.8]) and 93.3% (95%CI: [92.9, 93.7]), respectively. After adjustment for age and combined tumour stage, the risk to die from BC was 44% higher (EHR: 1.44, 95%CI: [1.24, 1.66]) for patients treated in a low-volume centre and 30% higher (EHR: 1.30, 95%CI: [1.14, 1.48]) for patients treated in a medium-volume centre, compared to high-volume centres. Likewise, the risk to die from BC was 30% higher (EHR: 1.30, 95%CI: [1.15, 1.48], p<0.001) for patients treated in a non-certified centre (representing 23.8% of the cohort), compared to patients treated in a coordinating breast clinic. Conclusion This population-based study reveals that BC survival is higher when patients are treated in certified and high-volume breast clinics.

Introduction: Breast Cancer (BC) screening has been associated with reduced mortality and morbidity. This study compares tumor characteristics and treatment morbidity in screened versus diagnosed women. Materials and Methods: This retrospective study, conducted between 2010 and 2013, included 666 BC screened or diagnosed patients. We compared patients and tumors characteristics and received treatments. We also analyzed the results after excluding patients at risk of BC and conducted a multivariate analysis to assess odds ratios (OR). Results: Screened women had smaller tumors (16.5 vs. 22.6 mm, p<0.001), of lower grade (p<0.001) with a lower Proliferation Index (PI) (p<0.001) than diagnosed women. Screened women were more frequently treated using conservative surgery (82.8% vs. 59.7%, p<0.001), needed less often axillary dissection (15.1% vs. 35.4%, p<0.001) and less often chemotherapy (20.8% vs. 48.3% p<0.001) than diagnosed women. In the multivariate analysis after adjustment for age and BC history, diagnosed women had increased (OR: 4.79, 95% IC: 3.19-7.18) risk to be administered chemotherapy and to undergo axillary dissection (OR: 4.18, 95% IC: 1.56-11.17) than screened women. Conclusion: Patients should be informed about the benefits in terms of morbidity that screening confers to them.

e femme atteinte d’un cancer du sein sur cinq a été traitée dans un hôpital ne disposant pas d’un agrément spécifique pour la prise en charge de ce type de tumeur. Un constat anodin ? Absolument pas ! D’après une nouvelle étude réalisée par le Centre Fédéral d’Expertise des Soins de Santé (KCE) en collaboration avec la Fondation Registre du Cancer et avec des experts cliniques, qui porte sur 50 000 femmes atteintes d’un cancer du sein, ces patientes présentent en effet un risque sensiblement plus élevé de décéder de leur maladie par rapport à celles qui sont soignées dans une clinique du sein « coordinatrice »

In 2018 werd één vijfde van de vrouwen met borstkanker behandeld in een centrum zonder erkenning voor borstkanker. Maakt het uit? Absoluut! Volgens een nieuwe studie van het Federaal Kenniscentrum voor de Gezondheidszorg (KCE), in samenwerking met de Stichting Kankerregister en klinische experten, uitgevoerd bij 50 000 vrouwen met borstkanker, hebben deze patiënten een aanzienlijk hogere kans om aan borstkanker te overlijden in vergelijking met vrouwen die in een coördinerende borstkliniek worden behandeld.

Abstract Background: Approximately 1% of all new cases of breast cancer (BC) occur in men. Care of male BC is largely based on extrapolation from treatment strategies and management of symptoms in women. The impact of BC diagnosis and therapy on Quality of Life (QoL) in women with BC is well documented. Comprehensive, prospective data about QoL in men treated for BC are sparse. Due to the lack of a validated male BC QoL questionnaire, we previously evaluated the QoL of the male BC using the original EORTC QLQ-C30 and breast module QLQ BR23 with “female” items replaced by male-specific items from the EORTC QoL prostate module (EORTC QLQ-PR25). The development of a validated worldwide questionnaire for male BC is sponsored by EORTC QoL Group and will be completed in cooperation with EORTC Breast Group and the International Male BC Program (a cooperation between EORTC-BCG, TBCRC, within the BIG and NABCG networks) Trial design: The evaluation of the QoL issues relevant for male BC, as well as the translation of issues into items to build the tool for QoL assessment in male BC will be carried out through four phases: 1. A systematic Literature review 2. Interviews with patients 3. Interviews with Health Care Professionals (HCP) 4. Consultation of experts in Oncology and QoL Inclusion criteria: • Histologically proven early BC or metastatic BC in male patients • Age ≥ 18 years • Ability to understand and fill out questionnaires • Written informed consent Exclusion criteria: • Other cancer in the past 5 years except non-melanotic skin cancer • Patients participating in interventional clinical studies with QoL as primary endpoint • Any condition potentially hampering compliance with the study protocol Aims: The study proposes to carry out an evaluation of the QoL issues relevant for male patients with BC, and translating the issues into questions to build the tool for an adequate QoL assessment in these patients. The specific aims are: 1) To carry out an evaluation of the existing EORTC QLQ-BR 45 (adapting for male BC) and for suitability of use in male BC patients 2) To carry out an evaluation of the EORTC QLQ-PR25 (adapting for male BC) for suitability of use in male BC patients 3) To provide recommendations to the EORTC on a suitable assessment approach to assess QOL in male BC Statistical methods: A systematic literature review to assess what factors are unique to male BC patients in influencing their QoL and what QoL measures exist for them will be performed. This will be conducted by reviewing all studies with male BC participants and including investigator brochures describing side effects in male BC patients, as well as by evaluating issues captured by other existing EORTC modules. The final list of potential QoL issues relevant to the male BC will be tested for relevance and importance in semi-structured qualitative interviews with patients and HCP. A total of 2-5 patients per year will be recruited from collaborating hospitals/countries. At least 40 in total will be interviewed before, during, or after treatment for male BC. At least 2 experts/country from the all collaborating centres will be included in the interview to discuss and consider the potential issues. Finally, the issue list will be translated into questions to build the tool for a QoL assessment in male BC patients. Present accrual and target accrual This study started in October 2019. A systematic literature review has been completed. Seventeen centres from worldwide are participating in the study. New centers may still join. Contact information for people with a specific interest in the trial Vesna Bjelic-Radisic E-Mail: Vesna.Bjelic-Radisic@helios-gesundheit.de Fatima Cardoso e-mail: fatimacardoso@fundacaochampalimaud.pt Citation Format: Vesna Bjelic-Radisic, Fatima Cardoso, Joachim Weis, Eveline Bleiker, David Cameron, Galina Velikova, Karatzyna Pogoda, Samantha Serpentini, Kevin Punie, Rinat Yerushalmi, Erika Matos, Birgit Carly, Ivana Bozovic-Spasojevic, Markus Fleisch, Zoe Luisa Probst, Sina Maria Schafer, Nicola Russell, Sofie Tombeur, Joanna Vermeij, Heidi Roelstraete, Kathryn Ruddy, Juan I Arraras, Andrew Bottomley. Adaption of the EORTC quality of life breast cancer module for male breast cancer - phase I [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-14-01.

The term “cancer survivor” was introduced as a Mesh term, in Pubmed in 2018 and refers to “Persons who have experienced prolonged survival with or following neoplastic disease”. Survival begins at the time of diagnosis and may last through palliative care. But generally, this term refers to the post-treatment, survival period. Following the shock of learning of the diagnosis, the staging of the disease, its prognosis and treatment options, health providers and patients should discuss options that will increase the patients’ wellbeing. In women's health, these may include preserving fertility, desire of pregnancy, conservative therapy options (for breast cancer for instance), maintaining sexuality, rebuilding one's body image. Some discussions should occur before the start of treatment (fertility preservation) and the decisions resulting from these discussions must be taken by both health care providers (often in multidisciplinary teams) and patients in a “shared decision” process. Since cancer screening, diagnoses and treatment specificities have recently improved dramatically, a growing number of patients will have a prolonged life expectancy. Some patients, will be at increased risk of recurrences and of new malignancies, but also at increased risk of morbidity and mortality from other diseases, related to their treatment, such as cardiovascular issues, thrombosis, osteoporosis and other diseases. Some will develop symptoms such as lymphedema, peripheral neuropathy and cognitive problems, fatigue, depression and psychosocial distress affecting their work as well as their social and family relationships. The challenge of modern oncology lies not only in better treatments for cancer patients, but also in improving their quality of life after cancer. This challenge needs to be addressed by all health care providers, working in a multidisciplinary team.

Background: Data from recently published trials have provided practice-changing recommendations for the surgical approach to the axilla in breast cancer. Patients with T1-2 lesions, treated with breast conservation, who have not received neoadjuvant chemotherapy and have 1-2 positive sentinel nodes (Z0011-criteria) may avoid axillary lymph node dissection (ALND). We aim to describe the dissemination of this practice in Europe over an extended period of time. Methods: Our source of data was the eusomaDB, a central data warehouse of prospectively collected information of the European Society of Breast Cancer Specialists (EUSOMA). We identified cases fulfilling Z0011-criteria from 2005 to 2016 from 34 European breast centers and report trends in ALND. Data derived from Germany, Italy, Belgium, Switzerland, Austria, and Netherlands. Results: 6671 patients fulfilled Z0011-criteria. Rates of ALND showed a statistically significant decrease from 2010 (89%) to 2011 (73%), reaching 46% in 2016 (p < 0.001). After multivariable analysis, factors associated with higher probability of ALND were earlier year of surgery, younger age, increasing tumor size and grade, and being operated in Italy (p < 0.001). The minimum and maximal rates of ALND in the most recent two-year period (2015-2016) were 0% and 83% in two centers located in different countries (p < 0.001). Conclusion: Our study demonstrates, a decrease in rates of ALND that started after year 2010 through the end of the study period. Wide differences were observed among centers and countries indicating the need to spread unified clinical guidelines in Europe to allow for homogeneous evidence-based practice patterns. (C) 2019 Elsevier Ltd. All rights reserved.

Abstract This abstract was not presented at the symposium.

Abstract This abstract was not presented at the symposium.

Abstract This abstract was not presented at the symposium.