461P - Impact of comorbidities on real-world patient-reported outcomes of patients (pts) with hormone receptor-positive human epidermal growth factor 2-negative (HR+/HER2-) advanced breast cancer (ABC) enrolled in the POLARIS trial

Background

POLARIS is a prospective, observational real-world study of pts with HR+/HER2− ABC receiving palbociclib in routine clinical practice. As part of this study, we evaluated the impact of comorbidities on pt quality of life (QoL) using the EORTC-QLQ-C30 questionnaire.

Methods

EORTC data were collected at baseline, monthly for the first 3 months, and every 3 months thereafter until palbociclib discontinuation; here we report absolute global QoL and functional/symptom subscales scores according to pt baseline Charlson comorbidity index (CCI) score (grouped 0, 1–2, and 3+) at study baseline, month 6, 12 and 18. EORTC differences of ≥10 between CCI groups at each timepoint and within a CCI group over time were considered clinically meaningful. Differences in global QoL/subscale scores between CCI groups at each timepoint were compared using a two-sample t-test.

Results

Between January 2017 and December 2018, 1285 pts were enrolled, and 1250 received ≥1 dose of palbociclib. At baseline, pts had a median of 2 (range 0–9) comorbidities. 30.2%, 54.6% and 15.3% of pts had a CCI score 0, 1–2, and 3+, respectively. The most frequent comorbidities were vascular (54.3%), psychiatric (26.6%), blood/lymphatic system (18.4%), and metabolic/nutritional (18.2%) disorders. Generally, absolute mean global QoL and functional/symptom subscale scores (range: 0 to 100) were preserved from baseline to Month 18 within each CCI group (Table). Overall, differences in mean global QoL scores (and functional/symptom subscale scores) between the CCI 0 and CCI 1‒2 were similar at each timepoint; while notably lower scores (less favorable) were observed for the smaller CCI 3+ group. Table: 461P

Global QoL in pts with HR+/HER2– ABC by CCI

*Higher scores more favorable. Subscales were consistent with global QoL. Data cut off January 2023. CCI, Charlson comorbidity index; Diff, difference; QoL, quality of life.

Conclusions

QoL of pts with HR+/HER2- ABC treated with palbociclib differed by comorbidity level, with a general preservation in their relationship over 18 months.

Clinical trial identification

NCT03280303.

Editorial acknowledgement

Medical writing support, conducted in accordance with Good Publication Practice (GPP3) and the International Committee of Medical Journal Editors (ICMJE) guidelines, was provided by Sophie Wicken and Martin Dalziel, PhD of Oxford PharmaGenesis, Inc., Newtown, PA, with funding provided by Pfizer Inc., USA.

Legal entity responsible for the study

Pfizer Inc., USA.

Funding

This work was supported by Pfizer Inc., USA.

Disclosure

J.L. Blum: Financial Interests, Personal, Other, Paid consultant: Puma Biotechnology, Athenix, Inc., OncLive, Biotheranostics, AstraZeneca, Immunomedics, Inc.; Other, Personal, Other, Research to Practice: Sanofi, Pfizer Inc., Tempus, TD2; Other, Personal, Other, Speaker's Bureau: Pfizer, Tempus. G. Rocque: Financial Interests, Institutional, Funding, Research funding: Genentech, Pfizer, and Carevive ; Financial Interests, Personal, Other, Consulting fees: Pfizer, Gilead, and Flatiron. Y. Ji: Financial Interests, Personal, Advisory Board: Janssen, AstraZeneca and BeiGene. J. Migas: Financial Interests, Institutional, Other, Contracted research (clinical trials): Pfizer, Inc., AstraZeneca, Jazz Pharmaceuticals. E. Jepsen: Financial Interests, Personal, Other, Employee: Novant Health Cancer Institute. E. Gauthier: Financial Interests, Full or part-time Employment: Pfizer Inc.; Financial Interests, Stocks/Shares: Pfizer Inc. Y. Wang: Financial Interests, Full or part-time Employment: Pfizer Inc.; Financial Interests, Stocks/Shares: Pfizer Inc. M.Z. Montelongo, C. Chen: Financial Interests, Personal, Full or part-time Employment: ICON; Financial Interests, Institutional, Funding: Pfizer Inc. J. Cappelleri: Financial Interests, Full or part-time Employment: Pfizer Inc.; Financial Interests, Stocks/Shares: Pfizer Inc. . D. Tripathy: Financial Interests, Institutional, Research Funding: Novartis, Pfizer, Polyphor; Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, OncoPep, GSK, Gilead, Personalis, Sermonix, Pfizer, Novartis, Puma Biotechnology, Roche. All other authors have declared no conflicts of interest.