Enhancing the interpretation of real-world quality of life in patients with HR+/HER2- advanced breast cancer enrolled in the POLARIS study

Abstract

Background: In this study, we aimed to enhance and contextualize the interpretation of patient-reported scores on global health status (GHS) and quality of life (QoL) from the EORTC QLQ-C30 questionnaire into more meaningful terms using data from POLARIS.

Methods: Proportions of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced/metastatic breast cancer (ABC/mBC) treated with palbociclib plus endocrine therapy with "favorable" (numeric scores 5 - 7) and "unfavorable" (numeric scores ≤ 4) responses were determined at baseline and months 6, 12, and 18.

Results: Between January 2017 and January 2023, 1250 patients were enrolled and received ≥ 1 palbociclib dose. EORTC QLQ-C30 GHS/QoL domain completion rates were 93.4%, 66.5%, 49.5%, and 42.3% at baseline and months 6, 12, and 18, respectively. For Question 29 (GHS), the proportion of patients with a favorable response significantly increased by ∼13% to 69.3% by month 6, which was maintained at month 12 (68.6%) and month 18 (70.0%). For Question 30 (QoL), the proportion of patients with a favorable response significantly increased by ∼9% to 74.5% by month 6, which was maintained at month 12 (75.0%) and month 18 (73.4%).

Conclusions: The proportions of patients with HR+/HER2- ABC/mBC indicating a favorable response on GHS and QoL questions of the EORTC QLQ-C30 increased early on after the start of palbociclib treatment and were preserved through month 18 across the overall study population and most evaluated subgroups. This simple interpretation of GHS and QoL scores is intended to enhance their meaning to benefit patients and other stakeholders.

Clinical trial registration: NCT03280303; registered September 12, 2017.

Keywords: HR+/HER2−; POLARIS; advanced/metastatic breast cancer; palbociclib; patient-reported outcomes; real-world evidence.