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.
Breast cancer
Cost analysis
Frail elderly
Palbociclib
Real-world
Toxicity
Treatment efficacy
Journal
Breast (Edinburgh, Scotland)
ISSN: 1532-3080
Titre abrégé: Breast
Pays: Netherlands
ID NLM: 9213011
Informations de publication
Date de publication:
Dec 2021
Dec 2021
Historique:
received:
07
09
2021
revised:
27
10
2021
accepted:
28
10
2021
pubmed:
5
11
2021
medline:
28
12
2021
entrez:
4
11
2021
Statut:
ppublish
Résumé
Breast 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. 14 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. 276 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. Palbociclib 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.
Sections du résumé
BACKGROUND
BACKGROUND
Breast 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.
METHODS
METHODS
14 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.
RESULTS
RESULTS
276 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.
CONCLUSION
CONCLUSIONS
Palbociclib 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.
Identifiants
pubmed: 34736090
pii: S0960-9776(21)00980-2
doi: 10.1016/j.breast.2021.10.010
pmc: PMC8569699
pii:
doi:
Substances chimiques
Aromatase Inhibitors
0
Piperazines
0
Pyridines
0
Receptors, Estrogen
0
ERBB2 protein, human
EC 2.7.10.1
Receptor, ErbB-2
EC 2.7.10.1
palbociclib
G9ZF61LE7G
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
199-205Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest S El Badri, BA Tahir, K Balachandran, P Bezecny, F Britton, M Davies, S Dixon, D Hills, M Moe, T Pigott, Y Shah, A Stansfeld, A Synowiec, M Theodoulou and A Wadhawan have no conflicts of interest. K Desouza has research grants from Roche and has been an invited speaker for Pfizer. C Harper-Wynne is on the advisory board for Pfizer, Roche, Lilly and Exact sciences and has been an invited speaker for Novartis, Myriad and Veracyte. A Proctor is on the advisory board for GSK and has been an invited speaker for Pfizer and GSK. R Simcock is on the advisory board for Novartis and Exact Sciences and has been an invited speaker for Novartis. M Verrill has received honoraria from Pfizer, Lilly, Novartis, Roche, MSD, Seagen, Daiichi-Sankyo, Exact Sciences and Gilead, and research funding from Seagen, Roche, Novartis, Pfizer, Lilly and Exact Sciences. C Wilson has institutional grants from Pfizer and has been an invited speaker for Pfizer, Novartis, Lilly and Roche.