IBRANCE® (palbociclib)| RWE in Older Patients with mBC | PfizerPro Ireland

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RWE in older patients with mBC

A challenge when treating older patients is the lack of evidence to inform delivery of cancer care due to their under-representation in clinical trials. RWE may provide valuable information to supplement available data on efficacy and safety of treatment in this heterogeneous patient group.¹

In real-world studies, older patients with HR+/HER2- mBC derived clinical benefit from IBRANCE combined with ET treatment compared with ET alone.^2-4

FLATIRON Database real-world PFS and OS in older patients²

When analyzed by age group, median rwPFS and median OS remained longer in patients who received IBRANCE in combination with letrozole versus letrozole alone in both the 65–74 and the ≥75-years-old age groups.²

PalomAGE Cohort B: QoL in women aged ≥70⁵

In women with resistant and/or pre-treated mBC, global QoL was maintained at 6 months.⁵

Following 6 months of IBRANCE treatment, a clinically meaningful reduction in pain scores was observed (≥10 points). No clinically meaningful changes occurred in other domains and scales.⁵

PaloMAGE toxicities^6,7

The toxicity profile for older patients treated with IBRANCE was consistent with that seen in clinical trials.^6,7 No new safety signals were detected.⁶

Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.

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CI = confidence interval; ET = endocrine therapy; HR = hazard ratio; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; LET = letrozole; mBC = metastatic breast cancer; MedDRA = Medical Dictionary for Regulatory Activities; NE = not estimable; OS = overall survival; PFS = progression-free survival; QoL = quality of life; RWE = real-world evidence; rwPFS = real-world progression-free survival; sIPTW = stabilized inverse probability of treatment weighting.

References:

Habr D, et al. J Natl Cancer Inst. 2021;113:1460-1464.

Rugo HS, et al. ESMO 2021. Poster 236P.

Clifton K, et al. Breast Cancer Res Treat. 2019;175:667-674.

El Badri S, et al. Breast. 2021;60:199-205.

Brain E, et al. SABCS 2021. Poster P1-18-04.

Caillet P, et al. Oral presentation at ASCO 2021.

Rugo HS, et al. Eur J Cancer. 2018;101:123-133.

PalomAGE

IBRANCE Summary of Product Characteristics

Product Characteristics

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