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Poster Display session 2

4582 - Measures of functional status in adults aged ≥70 years with advanced breast cancer (ABC) receiving palbociclib (PAL) combination therapy in POLARIS

Date

29 Sep 2019

Session

Poster Display session 2

Topics

Tumour Site

Breast Cancer

Presenters

Meghan Karuturi

Citation

Annals of Oncology (2019) 30 (suppl_5): v104-v142. 10.1093/annonc/mdz242

Authors

M.S. Karuturi1, J.L. Blum2, J. Wallmark3, S. McCune4, S. Lakhanpal5, B. Telivala6, M. Tsai7, T. Rakowski8, A. Bardia9, J.C. Cappelleri10, E. Richardson11, Y. Wang12, D. Tripathy13

Author affiliations

  • 1 Department Of Breast Medical Oncology, Division Of Cancer Medicine, The University of Texas MD Anderson Cancer Center, 77057 - Houston/US
  • 2 Medical Oncology And Hematology, Texas Oncology, Baylor-Sammons Cancer Center, US Oncology, 75246 - Dallas/US
  • 3 Oncology And Hematology, Maryland Oncology Hematology, Rockville/US
  • 4 Hematology/oncology, Northwest Georgia Oncology Centers, 30060 - Marietta/US
  • 5 Hematology/oncology, Saint Vincent’s Birmingham, 35205 - Birmingham/US
  • 6 Medical Oncology And Hematology/oncology, Cancer Specialists of North Florida, 32256 - Jacksonville/US
  • 7 Hematology/oncology, Minnesota Oncology, 55433 - Minneapolis/US
  • 8 Hematology/medical Oncology, Valley Health System, 07652 - Paramus/US
  • 9 Hematology/oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, 02114 - Boston/US
  • 10 Biostatistics, Pfizer Inc, 06340 - Groton/US
  • 11 Clinical Research, CPi Global CRO, 08540 - Princeton/US
  • 12 Oncology Clinical Development And Medical Affairs, Pfizer Inc, 10017 - New York/US
  • 13 Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 77057 - Houston/US

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Abstract 4582

Background

Few 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).

Methods

Baseline (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 3 mo, and every 3 mo 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 6 mo were analyzed with descriptive statistics and the Fisher-Freeman-Halton test.

Results

Of 860 pts enrolled at 114 US sites, 282 (33%) were ≥70 y and had been observed for ≥6 mo. At BL, 61% of this group had G8 scores ≤14, and 21% had ADL scores ≤5. At 6 mo, 67% had G8 scores ≤14, 20% had ADL scores ≤5. BL G8 and ADL were associated with ECOG PS at BL and 6 mo, ADL at 6 mo was associated with ECOG PS at 6 mo, and G8 at 6 mo was marginally associated with ECOG PS at 6 mo (Table). No association was seen between ECOG PS, ADL, or G8 scores and dose modifications or AEs.Table:

365P Cross tabulations of ADL and G8 with ECOG PS

Baseline ECOG PS = 06 mo 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 score
ADL Score
Baseline
≤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 Score
Baseline
≤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.”

Conclusions

In 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 6 mo of therapy, indicating functional status was preserved in this elderly population receiving PAL.

Clinical trial identification

NCT03280303.

Editorial acknowledgement

Editorial 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 study

Pfizer Inc.

Funding

Pfizer Inc.

Disclosure

M.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.

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