253P Patient-centric approach: Examining quality-of-life incorporation in 5-year phase III metastatic breast cancer trials

Metastatic breast cancer presents a significant challenge in oncology, requiring tailored treatment approaches for diverse molecular subtypes. While assessing treatment outcomes, it's imperative to consider factors beyond survival metrics. Emphasizing patient-centered care, the integration of Quality of Life (QoL) assessments is crucial. The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) includes criteria that highlight the importance of QoL improvement, particularly in non-curative settings. Our analysis suggests limited QoL incorporation in recent trials. This study conducted a systematic review of phase III metastatic breast cancer trials conducted between 2019 and 2023, retrieved from PubMed. Subgroup analyses categorized trials by receptor status (HR+, HER2+, TNBC), publication year, journal impact factor, trial type (superiority vs. non-inferiority), and study outcome (positive vs. negative). QoL incorporation was assessed as an endpoint. Systematic review of 122 phase III metastatic breast cancer trials revealed limited integration of QoL assessments, with 36.9% of trials incorporating such endpoints. Subanalyses by receptor status showed 42.2% for HR+, 32.2% for HER2+, and 36.4% for TNBC trials incorporated QoL. Stratification by publication year exhibited variations: 33.3% in 2019, 48% in 2020, 39.5% in 2021, 24% in 2022, and 40% in 2023. Journal impact factor (IF) analysis indicated 37.2% in journals ≥10 IF and 36.6% in journals <10 IF included QoL. Furthermore, superiority trials had 33.7% and non-inferiority trials had 50% incorporating QoL assessments. Among positive studies, 32.9% included QoL, compared to 45% in negative trials. Our study highlights a significant gap in incorporating QoL assessments in recent metastatic breast cancer trials. These findings underscore the need for a more comprehensive and standardized integration of QoL endpoints to enhance patient-centered care and treatment decision-making. Future research should prioritize holistic assessment of treatment outcomes to better address the multifaceted needs of patients with metastatic breast cancer.