Abstract P4-01-04: Adaptation of the EORTC Quality of Life Breast Cancer Module for male Breast Cancer – Results of the Phase I-II module

Abstract 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.