Observational studyThe oncologist2025
Enhancing the interpretation of real-world quality of life in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer enrolled in the POLARIS study.
Observational study in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03280303 (POLARIS), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Polaris: palbociclib in hormone receptor positive advanced breast cancer: a prospective multicenter non-interventional study
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Authors and funding
14 authors.
Funding
Abstract
importancePatient-reported outcomes are recommended clinical outcome assessments of quality of life (QoL) by patient advocacy groups and regulatory agencies to gain a better understanding of treatment effectiveness, tolerability and safety.
objectivesIn this study, we aimed to enhance and contextualize the interpretation of patient-reported scores on global health status (GHS) and QoL from the EORTC QLQ-C30 questionnaire into more meaningful terms using data from POLARIS. DESIGN, SETTING, AND
participantsPatients ≥ 18 years of age who had a diagnosis of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced/metastatic breast cancer (ABC/mBC) were enrolled in the prospective, observational, multicenter, real-world POLARIS study.
interventionPatients received palbociclib plus endocrine therapy as first-line, second-line or later line of therapy. MAIN OUTCOMES AND MEASURES: Proportions of patients with "favorable" (numeric scores 5-7) and "unfavorable" (numeric scores ≤ 4) responses were determined at baseline and months 6, 12, and 18.
resultsBetween 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 AND RELEVANCE: 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 registrationNCT03280303; registered September 12, 2017.
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