by Salma El Badri, Bilal Tahir, Kirsty Balachandran, Pavel
Bezecny, Fiona Britton, Mark Davies, Karen Desouza, Simon Dixon, Daniel Hills,
Maung Moe, Thomas Pigott, Andrew Proctor, Yatri Shah, Richard Simcock, Anna
Stansfeld, Alicja Synowiec, Marianna Theodoulou, Mark Verrill, Anshu Wadhawan,
Catherine Harper-Wynne, Caroline Wilson
The Breast: FULL LENGTH ARTICLE| VOLUME
60, P199-205, DECEMBER 01, 2021
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
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
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
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.