Abstract 266P
Background
Palbociclib (PAL), a CDK4/6 inhibitor, is approved for the treatment of HR+/HER2– ABC. This report describes the COA analysis from a real-world setting of patients (pts) with ABC receiving PAL + endocrine therapy (ET).
Methods
POLARIS is a prospective, observational, multicentre real-world study of pts with HR+/HER2‒ ABC who received PAL as deemed appropriate by the treating physician. Global QoL, functional status, and geriatric health status are assessed descriptively with the patient-reported European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30), patient-reported Activities of Daily Living (ADL) screening tool, and the physician-reported Geriatric 8 (G8) Screening Tool, respectively, at baseline prior to PAL administration and throughout treatment (tx) with PAL + ET; results reported here as a mean change from baseline (BL) at months (mo) 6 and 12 using a paired t test. For Global QoL (range 0–100), higher scores indicate higher QoL; for ADL (range 6–18), higher scores indicate more independence; and for G8 (range 0–17), higher scores indicate less impairment. All available data were used.
Results
As of Mar 30, 2022, 1242 pts treated with PAL + ET had Global QoL, ADL, and G8 data collected and analysed at BL of PAL +ET tx. At enrolment the median age was 64.0 years, 98.8% were female, 94.8% had metastatic disease, 39.1% had visceral disease, and 34.3% had bone-only disease. Mean (SD) and change from baseline EORTC QLQ-C30, ADL, and G8 scores at 6 and 12 mo are shown in the table. Table: 266P
| Baseline (BL) | 6 mo | 12 mo | |
| Global QoL | |||
| n (missing) | 1160 (82) | 728 (514) | 478 (764) |
| Mean (SD) score | 63.93 (23.69) | 69.23 (21.27) | 70.10 (20.20) |
| Mean change* (n) | 3.49 (694) | 2.37 (461) | |
| 95% CI | 1.83, 5.16 | 0.27, 4.46 | |
| ADL† | |||
| n (missing) | 372 (42) | 232 (132) | 147 (170) |
| Mean (SD) score | 17.61 (1.14) | 17.60 (1.18) | 17.38 (1.52) |
| Mean change* (n) | –0.02 (218) | –0.27 (138) | |
| 95% CI | –0.16, 0.12 | –0.49, -0.05 | |
| G8† | |||
| n (missing) | 362 (52) | 219 (145) | 143 (174) |
| Mean (SD) score | 13.35 (2.23) | 13.55 (2.03) | 13.69 (1.97) |
| Mean change* (n) | –0.01 (200) | –0.02 (131) | |
| 95% CI | –0.32, 0.31 | –0.39, 0.34 |
CI=confidence interval; SD=standard deviation; n=sample size. *Mean change is post BL minus BL score. †Among ≥70 years: n=414 (BL); n=364 (6 mo); n=317 (12 mo)
Conclusions
In this COA analysis, PAL + ET treatment did not show any real or meaningful changes or any significant adverse impact on QoL, activities of daily living, or impairment in pts with HR+/HER2–ABC.
Clinical trial identification
NCT03280303.
Editorial acknowledgement
Editorial support was provided by Sonia Mohinta, PhD, of ICON plc (Blue Bell, PA, USA) and was funded by Pfizer Inc. Funded by Pfizer Inc.
Legal entity responsible for the study
Pfizer.
Funding
Pfizer.
Disclosure
G. Rocque: Financial Interests, Personal, Advisory Role: Flatiron, Giliad; Financial Interests, Institutional, Research Grant: Pfizer, Genentech, Carevive; Financial Interests, Personal and Institutional, Advisory Role, Advisory Role/Consulting: Pfizer. J.L. Blum: Financial Interests, Personal, Advisory Role: Pfizer, Amgen, Biotheranostics, Novartis, Genomic Health, Puma Biotechnology, Myriad Genetics, Immunomedics, Daiichi Sankyo, Research to Practice, Athenix Inc. T.J. Pluard: Financial Interests, Personal, Advisory Role: Gilead, Eisai, Novartis, SeaGen; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Gilead, SeaGen; Financial Interests, Institutional, Research Grant: Novartis, H3B, SeaGen, Gilead, Sermonix, Sanofi, Olema, Pfizer, Hibercell, Zymeworks. J. Migas: Financial Interests, Institutional, Other, Contracted Research: Pfizer. E. Jepsen: Financial Interests, Personal, Full or part-time Employment: Novant Health Cancer Institute. E. Gauthier: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. Y. Wang: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. J.C. Cappelleri: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. M.S. Karuturi: Financial Interests, Personal, Advisory Role: Pfizer. D. Tripathy: Financial Interests, Personal, Invited Speaker: GlaxoSmithKline, AstraZeneca, Gilead, OncoPep; Financial Interests, Institutional, Other, Contracted Research: Pfizer, Novartis. All other authors have declared no conflicts of interest.