Abstract Objectives: This study focused on summarizing the quality of life (QoL), health state utility values, and patient-reported outcomes (PRO) associated with hormone receptor-positive (HR+) /human epidermal growth factor receptor 2-negative (HER2-) locally recurrent inoperable or metastatic breast cancer (BC). Methods: A PRISMA-compliant systematic literature review (SLR) was conducted to identify English language studies published from database inception till July 2024. Embase and MEDLINE databases were searched, along with recent conference proceedings (2021-2024) and bibliographies of relevant SLRs, to comprehensively identify the evidence. Results: Thirteen studies (sample sizes: 15-2,352; mean/median ages: 46.1-66 years; data collection period: 2010-2023) assessed QoL in HR+/HER2- metastatic BC patients across the Netherlands (1), Canada (2), Germany (1) and the USA (3) and multiple countries (6). These studies (9 cross-sectional, 4 longitudinal) primarily reported evidence for chemotherapy, hormonal, and targeted therapies. Patients with progressive disease (PD) health state had worse QoL compared to those in progression-free (PF) health state across most QoL/PRO scales. Lambert-Obry et al (2018) reported that in first-line (1L) and second and/or subsequent line (≥2L) settings, EQ-VAS (66.2 vs 76.8; 66.1 vs 71.7), EORTC QLQ-C30 Global Health Status (GHS) (52.9 vs 68.2; 54.0 vs 66.0), and EQ-5D utility scores (0.64 vs 0.73; 0.65 vs 0.74) were lower and BPI scores (3.1 vs 2.0; 2.6 vs 2.0) were higher for PD vs. PF patients. Lower scores on functional scales and EQ-VAS, and higher scores on symptom scales and BPI indicating worse QoL. QoL generally declined as patients progressed through treatment lines (Table 1). Functional scales (EORTC QLQ-C30 and QLQ-BR23) worsened, while symptom scales in both instruments increased, with fatigue significantly impacting PD vs. PF disease in 1L (43.1 vs 36.5) and 2L settings (45.2 vs 37.1) (Lambert-Obry 2018). FACT-G scores significantly declined in patients with visceral + bone metastases at 3- and 6-months vs baseline (-6.6 and -3.6, respectively, p0.05) (De Laurentiis 2018). Lower scores were seen in patients with visceral + bone metastases (FACT-G: 57.7; FACT-B: 79.7) compared to those with bone-only (63.7; 88.7) or visceral-only metastases (60.9; 84.8) (Wood 2016). This impacted Physical Well-Being (FACT-G: 17.1 vs 19.1 vs 18.7), Emotional Well-Being (FACT-G: 12.0 vs 13.7 vs 13.1), and Breast Cancer Subscale domains (FACT-G: 22.2 vs 25.0 vs 23.7), in visceral + bone vs. bone only and visceral only groups (Wood 2016). The EQUALS survey reported fatigue (74-78%), joint pain (64%), and vaginal atrophy (56%) as the most impacted symptoms. 12-20% of patients reported poor or very poor QoL (Sammons 2023 and Sammons 2024). Conclusion: The present SLR on HR+/HER2- locally recurrent inoperable or metastatic BC revealed significant humanistic burden with declining QoL and increasing symptom burden through progressive treatment lines. These findings highlight the need for new treatments balancing efficacy and QoL, particularly for patients with limited treatment options. Citation Format: A. Haiderali, J. R. Earla, J. Nathani, P. Singh, S. Sharma. Quality of Life and Patient-reported outcomes in HR+/HER2- metastatic breast cancer: a systematic literature review abstract. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS1-04-04.
Haiderali et al. (Tue,) studied this question.