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Palbociclib in combination with aromatase inhibitors in patients ≥ 75 years with oestrogen receptor-positive,human epidermal growth factor receptor 2 negative advanced breast cancer: A real-world multicentre UK study
Institution:1. Weston Park Hospital, Whitham Rd, Broomhall, Sheffield, S10 2SJ, UK;2. Department of Oncology and Metabolism, The University of Sheffield, Beech Hill Road, Sheffield, S10 2SF, UK;3. Charing Cross Hospital, Imperial College Healthcare NHS Trust, Fulham Palace Rd, London, W6 8RF, UK;4. Blackpool Victoria Hospital, Whinney Heys Rd, Blackpool, FY3 8NR, UK;5. The Christie NHS Foundation Trust, Ogelsby Cancer Research Centre, Manchester, M20 4GJ, UK;6. Singleton Hospital, Sketty Ln, Sketty, Swansea, SA2 8QA, UK;7. Nottingham City Hospital, Nottingham University Hospitals NHS Trust, Hucknall Rd, Nottingham, NG5 1PB, UK;8. School of Health and Related Research, The University of Sheffield, 30 Regent Street, Sheffield, S1 4DA, UK;9. Leeds Cancer Centre, St James''s University Hospital, Beckett St, Leeds, LS9 7TF, UK;10. York Teaching Hospitals NHS Trust, Wigginton Rd, York, YO31 8HE, UK;11. Mount Vernon Cancer Centre, Rickmansworth Rd, Northwood, HA6 2RN, UK;12. Sussex Cancer Centre, University Hospitals Sussex, Eastern Rd, Brighton, BN2 5BE, UK;13. Freeman Hospital, Freeman Rd, High Heaton, Newcastle upon Tyne, NE7 7DN, UK;14. Kent Oncology Centre, Maidstone and Tunbridge Wells NHS Trust, Hermitage Ln, Maidstone, ME16 9QQ, UK;15. Royal Preston Hospital, Sharoe Green Ln, Fulwood, Preston, PR2 9HT, UK;p. Velindre University NHS Trust, Velindre Rd, Whitchurch, Cardiff, CF10 2TL, UK
Abstract:BackgroundBreast cancer incidence increases with age and real-world data is essential to guide prescribing practices in the older population. The aim of this study was to collect large scale real-world data on tolerability and efficacy of palbociclib + AI in the first line treatment of ER+/HER2-advanced breast cancer in those aged ≥75 years.Methods14 cancer centres participated in this national UK retrospective study. Patients aged ≥75 years treated with palbociclib + AI in the first line setting were identified. Data included baseline demographics, disease characteristics, toxicities, dose reductions and delays, treatment response and survival data. Multivariable Cox regression was used to assess independent predictors of PFS, OS and toxicities.Results276 patients met the eligibility criteria. The incidence of febrile neutropenia was low (2.2%). The clinical benefit rate was 87%. 50.7% of patients had dose reductions and 59.3% had dose delays. The 12- and 24- month PFS rates were 75.9% and 64.9%, respectively. The 12- and 24- month OS rates were 85.1% and 74.0%, respectively. Multivariable analysis identified PS, Age-adjusted Charlson Comorbidity Index (ACCI) and number of metastatic sites to be independent predictors of PFS. Dose reductions and delays were not associated with adverse survival outcomes. Baseline ACCI was an independent predictor of development and severity of neutropenia.ConclusionPalbociclib is an effective therapy in the real-world older population and is well-tolerated with low levels of clinically significant toxicities. The use of geriatric and frailty assessments can help guide decision making in these patients.
Keywords:Palbociclib  Breast cancer  Real-world  Frail elderly  Toxicity  Treatment efficacy  Cost analysis
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