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 = 0 | 6 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 | ||
≤5 | 12/52 | 6/20 |
>5 | 83/194 | 45/99 |
(P < 0.0001) | (P = 0.0012) | |
6 month | ||
≤5 | 5/24 | 2/16 |
>5 | 40/95 | 36/80 |
(P < 0.0001) | (P < 0.0001) | |
G8 Score | ||
Baseline | ||
≤14 | 48/149 | 25/74 |
>14 | 46/95 | 23/40 |
(P = 0.0023) | (P = 0.0335) | |
6 month | ||
≤14 | 24/76 | 20/62 |
>14 | 19/38 | 18/32 |
(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.
Resources from the same session
2551 - Efficacy of dose-dense (DD) adjuvant chemotherapy (CT) in hormone receptor positive/HER2-negative early breast cancer (BC) patients (pts) according to immunohistochemically (IHC) defined luminal subtypes: an exploratory analysis of the GIM2 trial.
Presenter: Benedetta Conte
Session: Poster Display session 2
Resources:
Abstract
3426 - High dose Neo-adjuvant chemotherapy in Triple-Negative breast cancer with evidence of homologous recombination deficiency (HRD).
Presenter: Sonja Vliek
Session: Poster Display session 2
Resources:
Abstract
3792 - Risk factors for locoregional recurrence (LRR) after neoadjuvant chemotherapy: pooled analysis of prospective neoadjuvant breast cancer (BC) trials
Presenter: Gustavo Werutsky
Session: Poster Display session 2
Resources:
Abstract
4044 - Estimating radiotherapy-induced cardiovascular mortality in female breast cancer patients.
Presenter: Mark De Ridder
Session: Poster Display session 2
Resources:
Abstract
719 - 3-year follow-up of a phase III trial comparing the efficacy and safety of neoadjuvant and adjuvant trastuzumab and its biosimilar CT-P6 in HER2 positive early breast cancer (EBC)
Presenter: Justin Stebbing
Session: Poster Display session 2
Resources:
Abstract
3595 - Adjuvant chemotherapy in elderly breast cancer patients: pattern of use and impact on overall survival
Presenter: Axel Berthelot
Session: Poster Display session 2
Resources:
Abstract
3992 - Carboplatin-containing neoadjuvant chemotherapy for triple negative breast cancer (TNBC): a propensity score-matched study.
Presenter: Maria Vittoria Dieci
Session: Poster Display session 2
Resources:
Abstract
3477 - Impact of adjuvant trastuzumab emtansine (T-DM1) on incidence of metastatic breast cancer (mBC): an epidemiological model of patients with HER2-positive breast cancer (BC) who did not achieve pathological complete response (pCR) after neoadjuvant treatment (non-pCR)
Presenter: Mellissa Williamson
Session: Poster Display session 2
Resources:
Abstract
3928 - Chemotherapy (CT)-induced anaemia in patients (pts) treated with dose-dense regimen: Results of the prospectively randomised anaemia substudy from the neoadjuvant GeparOcto study
Presenter: Hans Tesch
Session: Poster Display session 2
Resources:
Abstract
2184 - The clinical impact of adjuvant dose-dense sequential chemotherapy (dds-CT) in patients with high-risk operable breast cancer (BC); pooled analysis of 6 clinical trials.
Presenter: Elena Fountzilas
Session: Poster Display session 2
Resources:
Abstract