Božović‐Spasojević, Ivana

ImportanceYoung women with breast cancer who have germline pathogenic variants in BRCA1 or BRCA2 face unique challenges regarding fertility. Previous studies demonstrating the feasibility and safety of pregnancy in breast cancer survivors included limited data regarding BRCA carriers.ObjectiveTo investigate cumulative incidence of pregnancy and disease-free survival in young women who are BRCA carriers.Design, Setting, and ParticipantsInternational, multicenter, hospital-based, retrospective cohort study conducted at 78 participating centers worldwide. The study included female participants diagnosed with invasive breast cancer at age 40 years or younger between January 2000 and December 2020 carrying germline pathogenic variants in BRCA1 and/or BRCA2. Last delivery was October 7, 2022; last follow-up was February 20, 2023.ExposurePregnancy after breast cancer.Main Outcomes and MeasuresPrimary end points were cumulative incidence of pregnancy after breast cancer and disease-free survival. Secondary end points were breast cancer–specific survival, overall survival, pregnancy, and fetal and obstetric outcomes.ResultsOf 4732 BRCA carriers included, 659 had at least 1 pregnancy after breast cancer and 4073 did not. Median age at diagnosis in the overall cohort was 35 years (IQR, 31-38 years). Cumulative incidence of pregnancy at 10 years was 22% (95% CI, 21%-24%), with a median time from breast cancer diagnosis to conception of 3.5 years (IQR, 2.2-5.3 years). Among the 659 patients who had a pregnancy, 45 (6.9%) and 63 (9.7%) had an induced abortion or a miscarriage, respectively. Of the 517 patients (79.7%) with a completed pregnancy, 406 (91.0%) delivered at term (≥37 weeks) and 54 (10.4%) had twins. Among the 470 infants born with known information on pregnancy complications, 4 (0.9%) had documented congenital anomalies. Median follow-up was 7.8 years (IQR, 4.5-12.6 years). No significant difference in disease-free survival was observed between patients with or without a pregnancy after breast cancer (adjusted hazard ratio, 0.99; 95% CI, 0.81-1.20). Patients who had a pregnancy had significantly better breast cancer–specific survival and overall survival.Conclusions and RelevanceIn this global study, 1 in 5 young BRCA carriers conceived within 10 years after breast cancer diagnosis. Pregnancy following breast cancer in BRCA carriers was not associated with decreased disease-free survival.Trial RegistrationClinicalTrials.gov Identifier: NCT03673306

Abstract Introduction Prospective data about quality of life (QoL) in men with breast cancer (BC) are lacking. A prospective registry (EORTC10085) of men with all BC stages, including a QoL correlative study, was performed as part of the International Male Breast Cancer Program. Methods Questionnaires at BC diagnosis included the EORTC QLQ-C30 and BR23 (BC specific module), adapted for men. High functioning and global health/QoL scores indicate high functioning levels/high QoL; high symptom-focused measures scores indicate high symptoms/problems levels. EORTC reference data for healthy men and women with BC were used for comparisons. Results Of 422 men consenting to participate, 363 were evaluable. Median age was 67 years, and median time between diagnosis and survey was 1.1 months. A total of 114 men (45%) had node-positive early disease, and 28 (8%) had advanced disease. Baseline mean global health status score was 73 (SD: 21), better than in female BC reference data (62, SD: 25). Common symptoms in male BC were fatigue (22, SD: 24), insomnia (21, SD: 28), and pain (16, SD: 23), for which women’s mean scores indicated more burdensome symptoms at 33 (SD: 26), 30 (SD: 32), and 29 (SD: 29). Men’s mean sexual activity score was 31 (SD: 26), with less sexual activity in older patients or advanced disease. Conclusions QoL and symptom burden in male BC patients appears no worse (and possibly better) than that in female patients. Future analyses on impact of treatment on symptoms and QoL over time, may support tailoring of male BC management.

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.