Rocque Gabrielle B, Blum Joanne L, Ji Yan, Pluard Timothy, Migas John, Lakhanpal Shailendra, Jepsen Erin, Gauthier Eric, Wang Yao, Montelongo Monica Z, Cappelleri Joseph C, Karuturi Meghan S, Tripathy Debu
University of Alabama at Birmingham, Birmingham, AL, USA.
Baylor-Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, TX, USA.
Breast Cancer Res Treat. 2025 Feb;209(3):613-627. doi: 10.1007/s10549-024-07524-2. Epub 2024 Nov 25.
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.
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.
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.
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.
NCT03280303; registered 12 September 2017.
在纵向真实世界研究POLARIS中，评估接受哌柏西利治疗的激素受体阳性/人表皮生长因子受体2阴性（HR+/HER2-）晚期/转移性乳腺癌（ABC）患者报告的健康相关生活质量（QoL）。
前瞻性收集常规临床实践中接受哌柏西利加内分泌治疗（ET）的成年HR+/HER2- ABC患者的数据。使用欧洲癌症研究与治疗组织生活质量问卷核心30（EORTC QLQ-C30）评估生活质量，并在基线以及第6、12和18个月报告。数据以给定时间的绝对分数以及全球生活质量和功能/症状量表相对于基线的变化表示。还在6个患者亚组类别（例如年龄、内脏疾病状态）中确定了全球健康状况（GHS）/生活质量得分。此外，确定了得分低于（功能量表）或高于（症状量表）反映健康问题临床重要性的EORTC验证阈值的患者比例。
在接受哌柏西利加ET治疗的患者（N = 1250）中，在任何研究时间点完成问卷的患者中，第6个月（69.3）、第12个月（70.1）和第18个月（69.9）的平均GHS/生活质量得分高于基线（64.0）。功能和症状量表也观察到类似趋势。随着时间的推移，评估的亚组中平均GHS/生活质量得分是一致的。从基线到第18个月，大多数功能/症状量表中具有临床重要功能损害/症状的患者比例有所下降。
这项真实世界研究的结果表明，接受哌柏西利加ET治疗的HR+/HER2- ABC患者至少18个月维持其生活质量。
NCT03280303；2017年9月12日注册。
