365P - Measures of functional status in adults aged ≥70 years with advanced breast cancer (ABC) receiving palbociclib (PAL) combination therapy in POLARIS

Abstract

BackgroundFew data are available on the treatment of ABC in older adults due to exclusion of this population from clinical trials. POLARIS is a real-world observational study in patients (pts) with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2-) ABC receiving PAL in the United States (US) and Canada. This sub-group analysis evaluates outcomes in geriatric pts aged ≥70 years (y). MethodsBaseline (BL) demographics, clinical characteristics, dose modifications, ECOG performance status (PS), and adverse events (AEs) in the first 6 months (mo) were analyzed. Frailty and functional status were assessed with the Geriatric 8 (G8) and Activities of Daily Living (ADL) screening tools, respectively. G8 and ADL were captured at BL, monthly for the first 3mo, and every 3mo thereafter. G8 and ADL scores were stratified by severity (G8: ≤14=impaired; >14=normal; ADL: ≤5=impaired, >5=normal). Associations between treatment outcomes (ECOG PS, dose modifications, AEs) and G8 and ADL scores at BL and 6mo were analyzed with descriptive statistics and the Fisher-Freeman-Halton test. ResultsOf 860 pts enrolled at 114US sites, 282 (33%) were ≥70 y and had been observed for ≥6mo. At BL, 61% of this group had G8 scores ≤14, and 21% had ADL scores ≤5. At 6mo, 67% had G8 scores ≤14, 20% had ADL scores ≤5. BL G8 and ADL were associated with ECOG PS at BL and 6mo, ADL at 6mo was associated with ECOG PS at 6mo, and G8 at 6mo was marginally associated with ECOG PS at 6mo (Table). No association was seen between ECOG PS, ADL, or G8 scores and dose modifications or AEs. ConclusionsIn this subanalysis of geriatric pts from the ongoing POLARIS study associations were found between ECOG PS and frailty and functional status as assessed by G8 and ADL. G8 and ADL scores were generally maintained during the first 6mo of therapy, indicating functional status was preserved in this elderly population receiving PAL.Table365P Cross tabulations of ADL and G8 with ECOG PSTableBaseline ECOG PS=06mo ECOG PS=0# of pts with ECOG PS=0 / # pts with ADL or G8 score# of pts with ECOG PS=0 / # pts with ADL or G8 scoreADL ScoreBaseline≤512/526/20>583/19445/99(P<0.0001)(P=0.0012)6 month≤55/242/16>540/9536/80(P<0.0001)(P<0.0001)G8 ScoreBaseline≤1448/14925/74>1446/9523/40(P=0.0023)(P=0.0335)6 month≤1424/7620/62>1419/3818/32(P=0.0699)(P=0.0506)ADL=activities of daily living; ECOG=Eastern Cooperative Oncology Group; G8=Geriatric 8; PS=performance status. P value from the Fisher’s exact test on the association of either ADL (≤5, >5) or G8 (≤14, >14) with ECOG PS at the specified timepoint. ECOG PS=0 represents “fully active, able to carry on all pre-disease performance without restriction.” Clinical trial identificationNCT03280303. Editorial acknowledgementEditorial support was provided by Catherine Grillo of Complete Healthcare Communications, LLC (North Wales, PA), a CHC Group company, and was funded by Pfizer Inc. Legal entity responsible for the studyPfizer Inc. FundingPfizer Inc. DisclosureM.S. Karuturi: Advisory / Consultancy: Pfizer Inc. J.L. Blum: Advisory / Consultancy: Pfizer Inc. B. Telivala: Research grant / Funding (self): Cancer Specialists of North Florida. A. Bardia: Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer Inc; Advisory / Consultancy: Spectrum Pharma. J.C. Cappelleri: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. E. Richardson: Full / Part-time employment: CPi Global CRO. Y. Wang: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. D. Tripathy: Advisory / Consultancy, Research grant / Funding (self): Novartis; Advisory / Consultancy, Research grant / Funding (self): Pfizer Inc. All other authors have declared no conflicts of interest.