abstract
PURPOSE: To evaluate patient-reported health-related quality-of-life (QoL) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced/metastatic breast cancer (ABC) treated with palbociclib in the longitudinal real-world study, POLARIS. METHODS: Data were prospectively collected from adult patients with HR+/HER2- ABC treated with palbociclib plus endocrine therapy (ET) in routine clinical practice. QoL was assessed with the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) and reported at baseline and months 6, 12, and 18. Data were expressed as absolute scores at a given time and change from baseline for global QoL and functional/symptom scales. Global Heath Status (GHS)/QoL scores were also determined across 6 patient subgroup categories (e.g., age, visceral disease status). Additionally, the proportions of patients with scores below (functional scales) or above (symptom scales) EORTC-validated thresholds reflecting clinical importance of a health problem were determined. RESULTS: Among patients treated with palbociclib plus ET (N = 1250) who completed questionnaires at any of the study timepoints, mean GHS/QoL scores at months 6 (69.3), 12 (70.1), and 18 (69.9) were higher than baseline (64.0). Similar trends were observed for functional and symptom scales. Mean GHS/QoL scores over time were consistent across the evaluated subgroups. Decreases in the proportions of patients with clinically important functional impairment/symptoms were observed for most functional/symptom scales from baseline through month 18. CONCLUSION: Findings from this real-world study indicate patients with HR+/HER2- ABC treated with palbociclib plus ET maintain their QoL for at least 18 months. CLINICAL TRIAL REGISTRATION: NCT03280303; registered 12 September 2017.
