OBJECTIVES: There is a need to better understand PROMs in the context of observational studies in the real world to capture what is important to the early breast cancer (eBC) population and their patient experience. This review aimed to evaluate PROMs used in the eBC patient population and understand relevant eBC patient concepts that assess important aspects of health and impacts on daily life.

METHODS: A targeted literature review was conducted via MEDLINE/PubMed and Embase databases to identify articles published between 2016-2022 based on pre-defined inclusion/exclusion criteria. Patient organization websites, clinical trials.gov and clinical/research guidelines were also reviewed for concepts and PROMs. PROMs were extracted from selected articles, followed by concept mapping to align PROMs with patient concepts.

RESULTS: In total, 872 abstracts were screened, and 88 studies met inclusion/exclusion criteria. Twenty-five disease-specific and 40 generic PROMs were identified. Eight of these were shortlisted based on frequency of use: EORTC-QLQ-30 & EORTC-QLQ-BR23, FACT-G & FACT-B, EQ-5D-5L, SF-36, HADS, and PROMIS-29. Important health concepts included breast symptoms, fatigue, pain/discomfort, as well as impacts relating to physical functioning, activities of daily living, sexual functioning, social & family impacts, financial concerns, and work. Emotional impacts of anxiety, depressive symptoms, irritability, mood changes, post-traumatic stress were critical themes across the treatment journey. However, several concepts related to unmet needs in psychological support, financial assistance, symptom management communication, and treatment options were not adequately addressed.

CONCLUSIONS: The PROMs identified capture a range of concepts, however, given the complexity of eBC patient experience due to varying tumor subtypes, stages and treatment paths, the next phase of this work will assess these results with patient experts, followed by qualitative interviews to understand patient perceptions of current PROMs in the real-world setting. This will help ensure future prospective research captures the eBC patient experience adequately, further supporting real world decisions for patients.